araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Very Intense Radiotherapy-Chemotherapy Regimen in Advanced HNSCC

Summary: Altered fractionated radiotherapy and concomitant radio-chemotherapy have been shown to be two possibilities for improving efficacy of radiotherapy in locally advanced head and neck carcinomas. In this multicentric study, we tested the hypothesis that accelerated radiotherapy could be delivered concomitantly with conventional high doses of CDDP-5FU, aiming to improve both local control and on distant metastases as compared to very accelerated radiotherapy.

Detailed description: Patients with a palpable N2b-c or N3 HNSCC strictly unresectable were randomized to receive either accelerated RT-CT delivering to the primary tumor 62-64 Gy / 5 weeks in 31-32 fractions of 2 Gy BID or very accelerated RT delivering 62-64 Gy in 31-32 fractions of 2 Gy BID and 22-23 days. In the accelerated RT-CT arm, 3 cycles of CDDP 100 mg/m2 were delivered at day 1, 16, 32 and 2 cycles of 5 Fu 1000 mg/m2 day 1 to 5 and 31 to 35. One month after completion of the concomitant RT-CT, 2 additional cycles of CDDP-5FU were given in patients responding (> 50%) to the initial course of RT-CT. The end points were event free survival and survival.

Eligibility: Inclusion Criteria:
  -  palpable N2b-c or N3 (UICC 1997) squamous cell carcinoma of the head and neck (oropharynx, oral cavity, hypopharynx or larynx)
  -  primary tumor and / or nodal extension strictly inoperable due to the extension of the disease
  -  performance status of 0 to 2 (WHO scoring system)
  -  renal/liver/cardiac functions and blood counts compatible with the use of CDDP and 5-FU
  -  signed inform consent
  Exclusion Criteria:
  -  distant metastasis
  -  previous history of cancer
  -  previous radiotherapy or chemotherapy

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Post-operative Radiotherapy With Cisplatin Alone or in Combination With Iressa in Upper Aerodigestive Tract Carcinomas

Summary: This trial will be an open multicentric randomized phase II study comparing post-operative radiotherapy + cisplatin associated or not with Iressa in upper aerodigestive tract carcinomas.


Eligibility: Inclusion Criteria:
  -  Patients with upper aerodigestive tract carcinomas (all sites included) having surgical resection and eligible for post-operative radiation + cisplatin.
  -  Patient having a tumoral biopsy (0.5 - 1 cm3) stored in liquid nitrogen at time of surgical resection (patients with small tumors located in larynx for instance will not be included)
  -  Patients receiving post-operative radiation (>=60 Gy on tumor bed and/or cervical area), associated with cisplatin, 6 weeks after surgery at the latest.
  Exclusion Criteria:
  -  previous history of cancer (except skin basal cell carcinoma)

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Reirradiation With Concomitant Chemotherapy After Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area

Summary: Interest of a reirradiation with concomitant chemotherapy after salvage surgery for recurrence of head and cancer in irradiated area : a multicentric Phase III randomized trial


Eligibility: Inclusion Criteria:
  -  head and neck squamous cancer
  -  both sexes
  -  >=18 years
  -  recurrence treated by surgery and initially treated by radiotherapy
  -  with written informed consent at entry time
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Cisplatin and ZD1839 + Re-Irradiation in Recurrent Squamous Cell Cancer of the Head and Neck

Summary: To determine safety profile of the epidermal growth factor receptor (EGFR) antagonist, ZD1839 in combination with cisplatin and radiation therapy in patients with local-regional recurrent squamous cell cancer of the head and neck.
  To study the effects of ZD1839 combined with either cisplatin or radiotherapy on signal transduction pathway gene expression in tumor cells in patients with local-regional recurrent squamous cell cancer of the head and neck using micro array analysis from tumor samples taken at the time of relapse and during treatment.


Eligibility: Inclusion Criteria:- Patients must have pathologically confirmed recurrence (reappearance of previously cleared) squamous cell cancer primary in the upper aerodigestive tract or a second squamous cell primary (excluding nasopharynx or salivary gland tumors). Patients may have experienced more than one recurrence as long as the first recurrence occurred greater than or equal to 6 months following the end of the prior RT.
  -  The recurrence or second primary must have defined bi- or uni-dimensional measurements.
  -  Recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence).
  -  The patient must not be a candidate for complete surgical resection. The previous irradiation must not exceed a maximum of 75 Gy.
  -  The entire tumor volume must be included in a treatment field that limits the total spinal cord dose to 50 Gy (prior RT and anticipated RT).
  -  Patients must be at least 6 months from prior radiation therapy.
  -  Patients may have received prior chemotherapy as a component of their primary treatment, but not for recurrent disease.
  -  Zubrod performance status 0-1.
  -  Granulocytes greater than or equal to 1500/mm3, platelets greater than or equal to 100,000/mm3, serum bilirubin less than or equal to 1.5 mg/dl, creatinine less than or equal to 1.5 mg/dl within 2 weeks prior to registration.
  -  LFT's less than or equal to 2 x normal (SGOT/SGPT/Alkaline Phosphatase). If greater than 2 x normal, liver ultrasound or CT is required to exclude metastases. If negative for metastases, patients are eligible.
  -  Must be able to submit previous radiation records, including simulation and portal films, in order to assure that cord tolerance is not exceeded.
  -  Patients must sign a study-specific informed consent form prior to study entry.
  Exclusion Criteria:- Primary in the nasopharynx or the salivary gland.
  -  Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival.
  -  A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ZD1839 or other agents used in study.
  -  Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns.

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Computed Tomography (CT) in Head and Neck Patients

Summary: This study is conducting a comparison of chest x-ray (CXR) and minimum dose thoracic CT (MnDCT) in the detection of lung nodules (metastases) in patients with head and neck carcinoma.

Detailed description: A comparison of chest x-ray (CXR) and minimum dose thoracic CT (MnDCT)in the detection of lung nodules (metastases) in patients with head and neck carcinoma

Eligibility: Inclusion Criteria:
  -  Patients with squamous cell carcinoma of the head and neck
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Chemotherapy Plus Gefitinib Followed by Chemotherapy, Radiation Therapy, and Gefitinib For Head and Neck Cancer

Summary: Although gefitinib has been combined successfully with various chemotherapeutic regimens with minimal increase in overall toxicity, experience with concurrent radiation therapy is limited. In this trial, we will evaluate the feasibility, toxicity, and effectiveness a novel combination of chemotherapy, radiation therapy, and gefitinib.

Detailed description: Upon determination of eligibility, patients will receive:
  Induction Therapy
  -  Docetaxel
  -  Carboplatin
  -  5-FU
  -  Gefitinib
  Combined Modality Therapy
  Cohort 1:
  -  Radiation therapy
  -  Gefitinib
  Cohort 2:
  -  Radiation therapy
  -  Gefitinib
  -  Docetaxel

Eligibility: Inclusion Criteria:
  To be included in this study, you must meet the following criteria:
  -  Squamous carcinoma of the head and neck.
  -  Primary tumor nasopharynx, oral cavity, oropharynx, hypopharynx, and larynx
  -  Squamous carcinoma in cervical nodes no identified primary site
  -  Must be considered to have low cure rates with local therapy
  -  Previously untreated with chemotherapy or radiation therapy.
  -  Able to perform activities of daily living without assistance
  -  Adequate bone marrow, liver, and kidney function
  -  Mild peripheral neuropathy is allowed
  -  Measurable or evaluable disease
  -  Voluntarily give written informed consent.
  Exclusion Criteria:
  You cannot participate in this study if any of the following apply to you:
  -  Age < 18 years
  -  History of prior malignancy within the last five years
  -  Severe or uncontrolled systemic disease
  -  Significant clinical disorder or laboratory finding
  -  Women who are pregnant or breast-feeding
  -  Active interstitial lung disease
  Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Iressa and Radiotherapy in the Treatment of the Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck

Summary: The aim of the study is to determine if Iressa added to radiotherapy is effective and safe in shrinking tumour dimensions.


Eligibility: Inclusion Criteria:
  -  Histologically Confirmed locally advanced Squamous Cell Carcinoma of Head and neck
  -  At least one measurable tumour lesion
  Exclusion Criteria:
  -  No previous treatment such as chemotherapy, radiotherapy and/or surgery for Carcinoma Head and Neck
  -  No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  -  Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Gefitinib (Iressa) in Combo With Chemoradiation in Patients With Locally Advanced Head & Neck Cancer

Summary: To determine the safety and tolerability of gefitinib in combination with cisplatin and radiation (3D-CRT or IMRT) in patients with locally advanced head and neck cancer.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed head and neck cancer
  -  Lymph node negative or positive
  -  Metastasis negative
  -  Chemo- and radiotherapy naïve
  -  WHO 0-2
  -  Measurable disease by RECIST
  -  Written informed consent
  Exclusion Criteria:
  -  Severe alcohol abuse
  -  Active ILD
  -  Co-existing chronic gastrointestinal disease(s)
  -  Brain metastasis

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: IRESSA in Combination With Cisplatin & Radiotherapy in Patients With Advanced Head & Neck Carcinoma

Summary: · To evaluate the disease free survival rate at 2 years of patients with advanced head and neck carcinoma treated with ZD1839 250 mg administered once daily in combination with cisplatin and a standard course of radiotherapy.


Eligibility: Inclusion Criteria:
  1. Histologically confirmed squamous head and neck carcinoma
  2. Extra-laryngeal tumour or laryngeal tumour that is inoperable (not resectable) considered by Head and Neck Cancer Committee
  3. Stage III-IV (IVa and IVb) disease
  4. Measurable disease according to RECIST criteria
  5. Aged 18 years or older
  6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
  7. Normal renal, haematological (neutrophils >1´5 x 109/ L and platelets > 100 x 109/L) and liver function
  Exclusion Criteria:
  -  1. Previous treatment for initial disease (neck dissection in N3 is allowed) 2. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ 3. Incomplete healing from previous oncologic or other surgery 4. Absolute neutrophil count (ANC) less than 1.5 x 109/ L, or platelets less than 100x 109/L 5. Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR) 6. In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease) 7. Serum creatinine greater than 1.25 times the ULRR 8. ALT or AST greater than 2.5 times the ULRR 9. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial 10. Active dermatoses (e.g. psoriasis, eczema) 11. Corneal abnormalities (other than scars, congenital abnormality or corneal tear film), history of dry eye syndrome or ocular surface diseases and neurological disorders 12. Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin or drugs with known corneal toxicity 13. Pregnancy or breastfeeding (women of child-bearing potential) 14. Patient incapacity to reliably follow the treatment or follow up for family, economic or geographical reasons.

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: ZD1839 (IRESSA™) in Combination With Docetaxel & Cisplatin in Subjects With Metastatic Head & Neck Cancer

Summary: The primary objective of the study is to evaluate the activity of the combination ZD1839, docetaxel and cisplatin in subjects with recurrent and/or metastatic head and neck cancer by estimating the objective response rate (complete response [CR] and partial response [PR]) at study closure.


Eligibility: Inclusion Criteria:
  1. Male or female, aged 18 and 70 years, inclusive
  2. Histologically- or cytologically-confirmed recurrent and/or metastatic SCCHN
  3. Primary tumour site of oral cavity, oropharynx, hypopharynx or larynx
  4. At least one uni-dimensionally measurable lesion according to the RECIST
  5. World Health Organisation (WHO) performance status (PS) of 0 or 1
  6. No previous chemotherapy for recurrent or metastatic disease
  7. Before subject registration a quality of life questionnaire should be completed
  Exclusion Criteria:
  1. Previous chemotherapy for recurrent or metastatic disease
  2. Less than 6 months since prior induction or adjuvant platinum and/or taxanes chemotherapy
  3. Known severe hypersensitivity to ZD1839 or any of the excipients of this product
  4. Known, severe hypersensitivity to docetaxel or cisplatin or any of the excipients of these products, or to other drugs formulated with polysorbate 80
  5. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  6. Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy (except alopecia)
  7. Absolute neutrophil count (ANC) less than 1.5 x109/litre (L), platelets less than 100 x 109/L or haemoglobin less than 10 g/dl
  8. Serum bilirubin greater than the upper limit of the reference range (ULRR)
  9. Serum creatinine greater than 1.5 mg/dl despite adequate rehydration
  10. Creatinine clearance less than 60 ml/min assessed in over a 24 hour urine collection
  11. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
  12. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 1.5 times the ULRR or alkaline phosphatase (ALP) greater than 2.5 times the ULRR
  13. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
  14. Pregnancy or breast feeding (women of child-bearing potential)
  15. Concomitant use of phenytoin, carbamazepine, rifampicin, or barbiturates, or St John's Wort
  16. Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment
  17. Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Testosterone Replacement in Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial

Summary: Growing evidence supports the notion that Late-onset Dysthymic disorder in middle aged men may be associated with age-related HPG hypofunctioning. In this study we seek to examine the efficacy of Testosterone replacement for this condition.
  Hypothesis:
  Testosterone replacement will be more effective than placebo, in treating men with late onset Dysthymic Disorder and hypo-gonadism.


Eligibility: Inclusion Criteria:
  1. Male, age 40-80 years.
  2. Diagnosed with hypogonadism (total T level below 350 ng/dl), but not previously treated.
  3. Diagnosis of Dysthymic disorder with onset after age 40.
  4. PSA < 4.0.
  5. Normal digital exam of the prostate in the preceding 1 year.
  6. For subjects currently taking an antidepressant: Current antidepressant treatment last 6 weeks or longer, with decent dose and with no remission (or with partial remission only HAM-D > 12).
  7. Able to give informed consent.
  Exclusion Criteria:
  1. Acute, severe, or unstable prostatitis, symptomatic prostatic hypertrophy, polycythemia, severe acne, breast cancer, prostate cancer, or hypopituitarism.
  2. Currently being treated with testosterone.
  3. Meets lifetime criteria for schizophrenia, schizoaffective disorder, any bipolar disorder (i.e., BP-I, BP-II, or BP NOS); or a major depressive episode in the preceding 5 years.
  4. Current suicidal risk.
  5. Current (past year) substance abuse or dependence.

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer

Summary: This study will estimate overall response rate of pemetrexed in poor risk patients with advanced, metastatic, or recurrent squamous cell carcinoma of the head and neck.

Detailed description: Rationale: Patients with advanced stage head and neck cancer, especially those with disease in the hypopharynx, oropharynx, or oral cavity, and poor performance status defined through clinical testing, are often not eligible for clinical trials and treated with best supportive care. The possibility of developing a well-tolerated chemotherapy regimen in these patients may lead to an equivalent benefit and better palliation. The current study offers the chemotherapy drug pemetrexed to patients with advanced head and neck cancer. Researchers consider this agent to have some anti-tumor efficacy against a variety of site-specific cancers, including head and neck cancer with a response rate that is similar to other single chemotherapy drugs. In addition, previous research indicates that toxicities associated with pemetrexed have been reduced when patients are given folic acid and B12 vitamin supplementation. Along with pemetrexed, the current study provides study participants with both folic acid and B12.
  Purpose: The primary objective of this study is to evaluate tumor response, including complete and partial remission, and toxicities from pemetrexed in patients with advanced head and neck cancer. Secondary objectives of this study include measurements of time to tumor progression, survival, and patient quality of life.
  Treatment: Study participants will be given pemetrexed through intravenous infusions. Pemetrexed will be administered once every three weeks. This schedule of pemetrexed once every three weeks will be repeated up to six times. Study participants will also be provided with both folic acid and B12 vitamin supplementation before, during, and after study treatments with pemetrexed. Vitamin supplementation is considered critical and compliance must be followed closely. Several tests and exams will be given throughout the study to monitor patients. Treatments will be discontinued due to disease growth and unacceptable side effects.

Eligibility: Inclusion Criteria:
  -  Advanced, metastatic, or recurrent head and neck cancers
  -  Poor risk patients with ECOG performance status of 2
  Exclusion Criteria:
  -  Prior treatment for recurrent or metastatic disease
  -  No clinical or radiological evidence of brain metatases
  -  Patients with bone only disease are not eligible
  -  Patients with pleural or peritoneal effusion as only manifestation of diesase

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Cervical Nodal Mets in Squamous Cell Carcinoma of H&N - MRI, FDG-PET, & Histopathologic Correlation

Summary: The purpose of this study is to determine the value of novel non-invasive medical imaging methods for detecting the spread of head and neck squamous cell carcinoma to the lymph nodes in the neck by comparing their results to findings at the time of surgery.


Eligibility: Inclusion Criteria:- Adult patients with newly diagnosed (biopsy-proven), untreated squamous cell carcinoma (SCC) of the head and neck who will undergo neck dissection as part of primary surgical therapy.
  Exclusion Criteria:- A prior adverse reaction to the contrast/tracer agents being used in the imaging methods being studied.
  - Pregnancy.

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Imaging Study in Patients With Cancer of the Head & Neck, Lung, Renal Cell, Brain, Lymphoma and Neuroendocrine Tumours

Summary: Positron Emission Tomography (PET) is a Nuclear Medicine procedure that uses positron emitting radiolabeled tracer molecules to visualize biological activity. The presence of hypoxia (low oxygen) is associated with poor prognosis in a variety of tumour types and treatment strategies targeting hypoxic cells have been developed. The PET tracer [18]F-FAZA can identify hypoxic areas, and changes in uptake during treatment may predict tumour response.

Detailed description: The proposed clinical trial will be a Phase I/II imaging, open label, single site study. In Phase I, one 18F-FAZA PET scan will be conducted in patients with known squamous cell carcinoma of the Head & Neck, SCLC, NSCLC, lymphoma, GGM, neuroendocrine tumours or renal cell carcinoma. In Phase II, three 18F-FAZA PET scans will be done on patients with the above tumours as follows: one pre-treatment, one mid course and one post-treatment.

Eligibility: Inclusion Criteria:
  -  Male or female greater than or equal to 16 years of age.
  -  If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required.
  -  Patients with known primary or suspected metastatic squamous cell carcinoma of the head and neck, non-small cell or small cell carcinoma of the lung, lymphoma, GBM (greater than or equal to 3 glioma), neuroendocrine tumours, or renal cell carcinoma with at least one lesion >1 cm in diameter.

Relevance to patient case: not relevant