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

Clinical trial: Neurocognitive Functioning in Patients With Newly Diagnosed Upper Aerodigestive Tract Cancer Receiving Treatment at Henry-Joyce Cancer Clinic

Summary: RATIONALE: Gathering information about how often problems with neurocognitive functioning occur in patients with newly diagnosed upper aerodigestive tract cancers may help doctors learn more about the disease.
  PURPOSE: This clinical trial is studying neurocognitive functioning in patients with newly diagnosed upper aerodigestive tract cancers receiving treatment at Henry-Joyce Cancer Clinic.

Detailed description: OBJECTIVES:
  Primary
  -  To establish an estimate of the prevalence of baseline neurocognitive impairment prior to initiation of outpatient cancer treatment.
  -  To establish an estimate of the incidence of neurocognitive impairment during outpatient cancer treatment.
  -  To describe how neurocognitive functioning changes over time during cancer treatment.
  Secondary
  -  To identify sociodemographic and clinical factors associated with neurocognitive impairment.
  -  To examine health-related outcomes associated with neurocognitive impairment.
  OUTLINE: Patients undergo interview to complete measures of domain-specific neurocognitive functioning, global neurocognitive functioning, subjective neurocognitive functioning, delirium, physical functioning, symptom prevalence and distress, mood states, and medications at baseline before initiation of cancer treatment, at scheduled treatment visits, and at the follow-up visit 3 months after completion of cancer treatment.
  Measures of comorbidity, alcohol use, sensory functioning (vision and hearing), and sociodemographic are completed at baseline only. Cancer-related information (diagnosis, staging, and sites of metastasis, if applicable), treatment-related information (planned treatment regimen - chemotherapy and/or radiation therapy), and current medications are obtained at baseline by medical record review.
  Health service use and complications are assessed at each scheduled treatment visit and at the 3-month post-treatment follow-up visit. Measures of domain-specific neurocognitive functioning, coping, and quality of life are completed at baseline and at the 3-month follow-up visit.

Eligibility: DISEASE CHARACTERISTICS:
  -  Newly diagnosed solid tumors of the upper aerodigestive system, including cancers of the head and neck, esophagus, or lung
  -  Receiving treatment at the Henry-Joyce Cancer Clinic at the Vanderbilt-Ingram Cancer Center
  -  No known brain metastasis
  PATIENT CHARACTERISTICS:
  -  Able to hear, speak, and understand English
  -  No prior diagnosis of other cancer except basal cell carcinoma
  PRIOR CONCURRENT THERAPY:
  -  No treatment plans including prophylactic cranial irradiation

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

Clinical trial: Oxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer

Summary: A study of Oxaliplatin and Docetaxel followed by Cetuximab for head and neck cancer patients to determine their effect on the control and reduction of tumor size

Detailed description: This is a non-randomized, open-label, phase II study to assess the effects of oxaliplatin and docetaxel followed by epidermal factor-antibody (EGFR-AB) cetuximab on patients with previously treated recurrent /metastatic squamous cell carcinoma of the head and neck. Head and neck tissue will also be tested to determine if the protein Epidermal Growth Factor Receptor is present in the cancer cells.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed recurrent SCCHN
  -  18 years or older
  -  Tumor site accessible by biopsy
  -  Measurable disease
  -  Receiving no other therapy
  -  ECOG performance status 0-1
  -  Adequate bone marrow, renal function and hepatic function
  Exclusion Criteria:
  -  Active infection or fever within 3 days of treatment
  -  Active CNS metastases
  -  Prior malignancy within 5 years
  -  Hypersensitivity to study drugs
  -  Chemotherapy within 30 days of treatment
  -  Concurrent investigational therapy within 30 days
  -  Radiotherapy of more than 25% of bone marrow
  -  Peripheral neuropathy of grade 2 or greater
  -  Pregnant or lactating patients
  -  History of allogeneic transplant
  -  Active or previously treated HIV or Hepatitis B or C
  -  Patients with a tracheostomy

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

Clinical trial: Insomnia in Patients Undergoing Chemotherapy and Radiation Therapy for Head and Neck Cancer

Summary: RATIONALE: Learning about insomnia and quality of life in patients undergoing chemotherapy and radiation therapy for cancer may help doctors learn about the effects of treatment and plan the best treatment.
  PURPOSE: This clinical trial is studying insomnia in patients undergoing chemotherapy and radiation therapy for head and neck cancer.

Detailed description: OBJECTIVES:
  -  To assess the prevalence of insomnia, extent of sleep disturbance, and possible contributing factors to sleep disturbance in head and neck cancer patients undergoing chemoradiotherapy.
  -  To evaluate the relationships between insomnia and symptom burden, quality of life, mood, fatigue, and tumor/treatment variables in these patients.
  OUTLINE: Patients complete a demographic survey and a questionnaire packet comprising The Pittsburgh Sleep Quality Index, The Head and Neck Symptom Survey, Profile of Mood States, Suspected Causes of Insomnia Survey, and a Quality of Life Survey on day 1 of chemoradiotherapy to obtain baseline data on sleep quality, possible causes of sleep disruption, head and neck symptoms, mood state, fatigue, quality of life, and patient demographics. Questionnaires are administered weekly thereafter during therapy visits for up to 6-7 weeks and take 15-30 minutes to complete.
  Medical records are reviewed to obtain information regarding medications and tumor- and treatment-related variables.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of head or neck carcinoma
  -  Currently undergoing chemoradiotherapy
  PATIENT CHARACTERISTICS:
  -  Able to communicate in English
  -  Able to give informed consent
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: Proximal Molecular Effects of Concurrent Chemoradiotherapy on Head and Neck Squamous Cell Carcinoma

Summary: This pilot study seeks to evaluate the feasibility of measuring the proximal effects of concurrent chemoradiotherapy (CRT) on the expression of potential therapeutic target molecules in Head and Neck Squamous Cell Carcinoma (HNSCC). Specifically, this study proposes to evaluate the extent to which CRT induces the differential expression of components along two critical, and potentially interdependent, molecular pathways: the arachidonic acid and epidermal growth factor receptor (EGFR) signaling pathways.


Eligibility: Inclusion Criteria:
  -  Untreated HNSCC (> Stage I) amenable to transoral biopsy.
  -  Scheduled for concurrent CRT (Cisplatin or Carboplatin/5-FU based) as definitive primary treatment
  -  Older than 18 years of age.
  -  Understand and sign informed consent.
  Exclusion Criteria:
  -  Any prior treatment of the index cancer (chemotherapy, immunotherapy, hormonal therapy or radiation therapy) or similar treatment of an unrelated malignancy within 6 weeks of enrollment into this study.
  -  Breast-feeding, pregnancy or of childbearing potential (including those women who are less than two years post menopausal) and unable to confirm adequate contraception (abstinence, IUD, birth control pills, or spermicidal gel with diaphragm or condom) since last menses.
  -  History of chronic inflammatory disease (e.g. ulcerative colitis, Crohn's disease, rheumatoid arthritis or pancreatitis).
  -  Corticosteroid use within 6 weeks of enrollment, excluding topical nasal sprays.
  -  NSAID (including celecoxib) or aspirin (> 81 mg/day) use within 1 week of enrollment.
  -  Investigational medication use within 6 weeks of enrollment or is scheduled to receive an investigational drug during the course of the study.

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

Clinical trial: Cetuximab as Induction Treatment in Head and Neck Squamous Cell Carcinoma (HNSCC)

Summary: The aim of the study is to investigate the efficacy and safety of cetuximab, docetaxel, cisplatin combination as induction therapy in locally advanced head and neck squamous cell carcinoma.


Eligibility: Inclusion Criteria:
  -  Unresectable, locally advanced (cT4b &/or cN2-3) HNSCC
  -  ECOG performance status 0-1
  -  Age 18 or older than 18 years
  -  Measurable disease by RECIST criteria
  -  Having signed informed consent
  -  ALT and AST<2.5 times ULN
  -  Serum albumin level ≥3.0g/dL
  -  Serum AKP < 2.5 times ULN
  -  Bilirubin level < 1.5mg/dL
  -  Serum creatinine <1.5 times ULN
  -  WBC>3000/mm3, absolute neutrophil count ≥1500/mm3, platelet>75,000/mm3, Hb>9g/dl
  Exclusion Criteria:
  -  Previous cytotoxic chemotherapy for HNSCC
  -  Radiotherapy for targeted lesions within six months
  -  Previous EGFR pathway-targeting therapy
  -  Prior surgery for cancer (excluding diagnostic biopsy within 4 weeks prior to study entry)
  -  Distant metastatic disease
  -  Heart failure, coronary artery disease, myocardial infarction within the last 6 months
  -  Known allergy to any study treatment
  -  Pregnancy or lactation period
  -  Any investigational agent within the past 28 days
  -  Other previous malignancy within 5 year, except adequately treated in situ cervical cancer, or non-melanoma skin cancer
  -  Legal incapacity

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

Clinical trial: STAT3 DECOY in Head and Neck Cancer

Summary: The primary goal of this study is to evaluate the safety of a transcription factor decoy targeting Signal Transducer and Activator of Transcription 3(STAT3) in patients with head and neck cancer. The rationale for targeting STAT3 using this approach is to decrease STAT3-mediated gene regulation. The study has the following scientific objectives:
  1. To assess the safety of a single dose of intratumoral STAT3 decoy.
  2. To estimate the effect of STAT3 decoy therapy on STAT3 activation levels, STAT3-mediated gene expression, and apoptosis in treated tumors.

Detailed description: The decision to proceed with an exploratory IND study to be conducted in a phase 0 setting was based upon the expectation that the trial will involve very limited human exposure to the STAT3 decoy, and as administered, will have no therapeutic or diagnostic intent. Rather, the trial is designed to determine if intratumoral administration of the STAT3 decoy in human head and neck tumors inhibits STAT3 target gene expression. Given the cumulative evidence supporting STAT3 as a therapeutic target in cancer, and the absence of any clinical trial to date using a STAT3 inhibitor, it was felt that there would be utility in a proof of principal study to determine if the STAT3 decoy inhibits the expression of STAT3 target genes in human head and neck cancers. To support the proposed study design, the Grandis lab carried out a kinetic study in a xenograft model of SCCHN. Preliminary results demonstrated that administration of the STAT3 decoy, but not the mutant control decoy, decreased expression of STAT3 target genes (Bcl-xL and/or Cyclin D1) at time points ranging from 1 to 6 hours.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed diagnosis of head and neck squamous cell carcinoma(primary or recurrent) amenable to surgical resection.
  -  ECOG performance status of 0, 1, or 2.
  -  Adequate organ function
  -  Age greater than or equal to 18 years
  -  Written informed consent.
  -  Patients with second primary lesions will be eligible for this trial.
  -  Negative pregnancy test, nonlactating, and using effective means of contraception if childbearing potential.
  Exclusion Criteria:
  -  Subjects who fail to meet the above criteria.
  -  Subjects who are pregnant.
  -  Subjects with an ECOG performance status >2.
  -  Subjects with tumors that are too small to biopsy prior to resection and reserve a portion of the resected specimen for research purposes.
  -  Subjects who receive neoadjuvant radiotherapy and/or chemotherapy within four week prior to enrollment

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

Clinical trial: Head & Neck Cancer Survivorship: Physical and Functional Status

Summary: RATIONALE: Early physical therapy may be effective in improving range of motion of the neck and shoulders in head and neck cancer survivors who are undergoing chemotherapy and radiation therapy.
  PURPOSE: This phase I trial is studying how well early physical therapy works in improving physical and functional well-being in head and neck cancer survivors receiving chemoradiotherapy.

Detailed description: OBJECTIVES:
  -  Describe the physical and functional well-being of head and neck cancer (HNC) survivors undergoing physical therapy during adjuvant chemoradiotherapy.
  -  Describe clinical measure of range of motion for the cervical spine and shoulder of HNC survivors undergoing physical therapy during adjuvant chemoradiotherapy.
  -  Determine the feasibility of an early physical therapy intervention (prior to and during adjuvant treatment) targeting the physical needs of HNC survivors.
  OUTLINE: Patients undergo physical therapy weekly for 10 weeks beginning 1 week prior to initiating adjuvant chemoradiotherapy and continuing until 2 weeks after the completion of adjuvant chemoradiotherapy.
  Patients undergo range of motion assessment and complete a Cancer Survivorship Survey (CSS) at baseline and in weeks 4, 8, 9, and 10 of physical therapy.

Eligibility: Inclusion Criteria:
  DISEASE CHARACTERISTICS:
  -  Head and neck cancer survivor
  -  Planning to receive adjuvant chemoradiotherapy for head and neck cancer
  -  Has not yet initiated adjuvant therapy
  -  Referred to rehabilitation oncology physical therapy program
  Exclusion Criteria:
  -  No metastatic disease
  -  No CNS cancer
  PATIENT CHARACTERISTICS:
  -  Speaks English
  -  No significant history of cardiovascular or neurovascular disease involving disability
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  Not currently in hospice care

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

Clinical trial: A Phase II Study to Assess Acute Toxicity and Quality of Life of Patients With Carcinoma of the Anal Canal Receiving Chemotherapy and Radiation Using Helical Tomotherapy

Summary: The hypothesis is that helical tomotherapy could minimize radiation related toxicity by avoiding or limiting doses to structures such as small bowel, external genitalia, skin, bladder, rectum, and femoral neck and head.

Detailed description: This is a phase II study using tomotherapy for radiation treatment delivery along with concurrent 5-FU/mitomycin C for the treatment of T2-T4 cancer of the anal canal. They hypothesis is that helical tomotherapy could minimize radiation related toxicity by avoiding or limiting doses to structures such as small bowel, external genitalia, skin, bladder, rectum, and femoral neck and head. This is expected to limit or reduce treatment related toxicity and hence prevent or reduce treatment breaks. This may result in delivery of radical treatment with better local control and treatment outcome than using the current radiation treatment technique at our center.

Eligibility: Inclusion Criteria:
  -  Patient should have histologically proven primary squamous carcinoma or its variant
  -  No history of prior malignancy.
  -  Patients must be free of metastatic disease out of pelvis at the time of diagnosis
  -  Patients must be at least 18 years of age
  -  Performance status 0, 1 or 2 ECOG
  -  T stage 2-4, Any N, stage MO
  -  Patient should be eligible for concomitant chemotherapy
  -  Informed written consent required to participate
  Exclusion Criteria:
  -  Prior radiation to pelvis
  -  Pregnant or lactating
  -  prior surgical treatment for anal cancer other than biopsy
  -  prior surgical or chemotherapy treatment for anal cancer
  -  T1 tumours (2cm) or evidence of distant mets
  -  comorbid medical conditions precluding radical treatment at the discretion of oncologist

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

Clinical trial: Open-Label Trial Of Oral PF-00299804 By Continuous Dosing In Patients With Recurrent Or Metastatic Head And Neck Squamous Cell Cancer

Summary: This study will investigate the safety and efficacy of oral PF-00299804 in patients who have not yet undergone any other drug treatment for recurrent and/ or metastatic head and neck squamous cell cancer.


Eligibility: Inclusion Criteria:
  -  Recurrent or metastatic Squamous Cell Cancer of the Head and Neck;
  -  Measurable disease;
  -  Eastern Cooperative Oncology Group (ECOG) 0-1 in Stage 1 = first 23 patients;
  -  Eastern Cooperative Oncology Group (ECOG) 0-2 in Stage 2 = 33 patients;
  Exclusion Criteria:
  -  prior therapy for recurrence;
  -  platelets < 75,000;
  -  prior Epidermal Growth Factor Receptor (EGFR) therapy;
  -  interstitial lung disease;
  -  primary of nasopharynx

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

Clinical trial: Docetaxel and S-1 in Head and Neck Squamous Cell Carcinoma (HNSCC)

Summary: To assess response rate of docetaxel and S-1 combination in metastatic or recurrent head and neck squamous cell carcinoma


Eligibility: Inclusion Criteria:
  -  histologically confirmed HNSCC
  -  adequate primary site: oral cavity, oropharynx, hypopharynx, nasal cavity, paranasal sinus, other head and neck site (except nasopharynx)
  -  at least one measurable lesion
  -  no previous palliative chemotherapy (adjuvant/neoadjuvant chemotherapy and/or radiotherapy longer than 6 months ago is permitted)
  -  18 years or older
  -  ECOG 0 or 1
  -  adequate laboratory result
  -  written, informed consent
  Exclusion Criteria:
  -  pregnant or lactating women (negative pregnancy test within 7 days is required for women with potential of child-bearing)
  -  experimental drug clinical trial within 30 days
  -  other malignancy (exemption: treated basal cell carcinoma of skin, CIS, cured cancer with disease-free interval with more than 5 years)
  -  patient with organ transplantation
  -  grade 2 or more peripheral neuropathy
  -  grade 2 or more hearing loss
  -  severe, medical condition

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

Clinical trial: Methylation of p16 CpG Island And Malignant Transformation of Oral Epithelial Dysplasia

Summary: Oral epithelial dysplasia (OED) is one of the common precancerous lesions among Chinese adults. Biomarker is not available for detection of malignant potential of OED till now. p16 is an important tumor suppressor gene, which is inactivated frequently by methylation of CpG island in early stage of carcinogenesis. The present cohort study is to investigate whether p16 methylation is correlated with malignant transformation of OED.

Detailed description: -  Background: Identification of malignant potential of oral epithelial dysplasia (OED) is virtually impossible on histopathological grounds alone. Inactivation of p16 gene by CpG methylation is an early frequent event during oral carcinogenesis. To investigate the predictive value of p16 methylation on malignant potential in OED, we carried out the prospective cohort study.
  -  Methods: 101 patients with histologically confirmed mild or moderate OED were included in the present study. Baseline information of p16 methylation status of the OED lesions from 93 cases was obtained by methylation-specific PCR. Progression of the OEDs lesions was examined in 78 cases histologically during the 45.8 months double-blind followup survey (78/93). The association between p16 methylation and progression of OED was analyzed with SPSS13.0 software. All P-values were two-sided.

Eligibility: Inclusion Criteria:
  -  histological diagnosis of mild or moderate grade OED; and
  -  enough amount of tissue sample from OED lesion for genomic DNA extraction; and
  -  available of methylation status of p16 CpG island in the extracted DNA sample.
  Exclusion Criteria:
  -  histological diagnosis of severe grade OED or malignant disease; or
  -  amount of tissue sample is not enough for preparation of genomic DNA (20ng); or
  -  quality of the prepared DNA is not good enough for detection of p16 methylation; or
  -  OED treatment history by LASER, radiotherapy, or chemotherapy

Relevance to patient case: not relevant