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

Clinical trial: Randomised Study of Mucositis Prevention After Radiochemotherapy Treatment for Head and Neck Cancer

Summary: This randomised, double-blind study will compare an oral immunomodulatory solution to a placebo for the prevention of acute severe mucositis in head and neck cancer patients treated surgically and concomitantly with radiochemotherapy. The investigators expect a decrease of 25% of severe acute mucositis in experimental arm.


Eligibility: Inclusion Criteria:
  -  Epidermal carcinoma proven histologically of the sphere ORL (all locations except nasopharynx).
  -  Patients with tumours of the oral cavity, the oropharynx, the hypopharynx and the larynx treated initially by surgery and eligible for post-operative radio- chemotherapy concomitantly.
  NB. The patients with tumours of the larynx or hypopharynx are eligible if the radiotherapy to the oropharyngeal mucosa will be at least 54 Gy and the mucositis can be visualised without the use of instruments.
  -  Radio-chemotherapy to be given postoperatively.
  -  Maximum delay of 8 weeks between the operative date and the planned starting date of radio-chemotherapy.
  -  Performance status (grade OMS): 0, 1, 2
  -  Nutritional Risk Index ≥ 83.5
  -  No mucositis.
  -  Age: 18-75 years
  -  Life expectancy ≥ 3 months.
  -  Informed consent obtained from the patient.
  -  Affiliation with a social security system.
  Exclusion Criteria:
  -  Tumour of nasopharynx
  -  Mucositis
  -  Severe sepsis
  -  Treatment by immunomodulators in the month preceding inclusion
  -  ATCD allergy to the components of Oral Impact.
  -  Parenteral nutrition at inclusion
  -  Usual contraindications to concomitant radio-chemotherapy
  -  Patient already included in another therapeutic trial involving an experimental molecule
  -  Female pregnant or susceptible to being pregnant, or breast-feeding. Patient not using appropriate contraceptive measures during the treatment
  -  Persons deprived of liberty or under guardianship
  -  Patients unable to commit to the trial schedule for geographical, social or psychological 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: Efficacy Study of Temsirolimus to Treat Head and Neck Cancer

Summary: The purpose of this study is to determine whether temsirolimus is effective in the treatment of relapsed/recurrent squamous cell cancer of the head and neck (HNSCC)

Detailed description: Temsirolimus is an inhibitor of the mammalian target of rapamycin (mTOR), a crucial regulator of cell cycle progression. It was approved in the treatment of advanced renal cell carcinoma. Temsirolimus demonstrated also antitumor activity in a variety of other human cancer models, such as gliomas, rhabdomyosarcomas, neuroblastomas, prostata and breast cancer through induction of apoptosis or inhibition of proliferation. A similar effect was noted in HNSCC cell lines.
  This is the first study evaluating the efficacy and safety of temsirolimus in platinum/cetuximab-refractory HNSCC.

Eligibility: Inclusion Criteria:
  -  Signed written informed consent must be given prior to study inclusion
  -  Histological or cytological confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC)
  -  Measurable progressive disease after platinum-based radiochemotherapy or recurrence or metastatic progressive disease after 1st line platinum-based chemotherapy
  -  Patients with loco-regional recurrence need to be progression free for at least 6 months after platinum-based radiochemotherapy, if locoregional recurrence is the only lesion
  -  Cetuximab must have been included in at least one prior line of therapy
  -  Disease is not amenable to surgery, radiotherapy or platinum-based chemotherapy
  -  At least one measurable lesion according to RECIST (Version 1.0) criteria
  -  Age > 18 years
  -  ECOG performance status 0-2
  -  Brain metastases require completion of local therapy with discontinuation of steroids prior to start of treatment
  -  If of childbearing potential, willingness to use effective contraceptive method (double barrier method) for the study duration and 2 months after last dose
  -  Willingness and ability to comply with the protocol
  -  Adequate bone marrow function, liver and renal function
  Exclusion Criteria:
  -  Live expectancy less than 3 months
  -  Anticancer treatment during the last 30 days prior to start of treatment, including systemic therapy, radiotherapy or major surgery
  -  Participation in a clinical trial within the last 30 days prior to study treatment
  -  Serious illness or medical condition other than the disease under study
  -  Other malignancies within 3 years, with exception of HNSCC, history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
  -  Inability to potentially complete follow up and treatment per protocol for psychological, familial, sociological or geographical reasons
  -  Pregnancy or breast feeding
  -  Known allergic/hypersensitivity reaction to any component of the treatment
  -  Concurrent treatment with oral anticoagulants
  -  Uncontrolled diabetes: fasting serum glucose > 2.0 ULN
  -  Active or uncontrolled infection

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

Clinical trial: Combined FDG PET/CT Imaging in Response Evaluation After Radiochemotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

Summary: To determine if combined [18F]fluoro-2-deoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT) is performant enough with respect to detecting residual lymph node involvement after chemoradiation in order to omit planned neck dissections in patients with locally advanced potentially operable, N2 and N3 head and neck squamous cell carcinoma (HNSCC).
  Primary study hypothesis: FDG PET/CT will have a negative predictive value (NPV) higher than 90% to detect residual malignant lymph node involvement at 12 weeks after completing chemoradiation.

Detailed description: Patients with locally advanced, N2 and N3 head and neck squamous cell carcinoma (HNSCC) will be recruited. All subjects receiving induction chemotherapy will undergo a baseline integrated [18F]fluoro-2-deoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT) scan before the start of concurrent chemoradiation. This baseline assessment is optional in patients not receiving neo-adjuvant treatment.
  All patients will undergo a dedicated FDG PET/CT protocol 12 weeks after the end of chemoradiation (primary endpoint). In PET/CT negative patients, 2 monthly control visits will be performed complemented with additional imaging as required. All patients will undergo PET/CT 1 year after completing chemoradiation unless recurrent/residual disease was already proven pathologically. Patients with a PET/CT suspected for residual nodal disease must have pathological proof of nodal involvement (fine needle aspiration in non-operable patients or neck dissection in the others) before salvage chemotherapy is started.
  In a subset of patients receiving induction chemotherapy prior to concurrent chemoradiation, an additional FDG PET/CT scan will be performed at baseline and after 1 cycle of chemotherapy to evaluate the metabolic response to the treatment (secondary endpoint).

Eligibility: Inclusion Criteria:
  -  Patients with locoregionally advanced HNSCC (clinically and/or radiological N2 or N3 disease, any T stage) with no evidence of distant metastases, scheduled for concurrent chemoradiation and being potential candidates for a subsequent neck dissection.
  -  Induction chemotherapy is allowed if this approach is followed by concurrent chemo-radiation.
  Exclusion Criteria:
  -  Other head and neck cancer histologies
  -  Upfront inoperable patients in the neck (eg. carotid invasion)
  -  Presence of distant metastases
  -  A history of another primary malignancy, except when disease-free for at least 5 years after radical treatment, or except for treated basaloid skin cancer or in situ carcinoma of the cervix

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

Clinical trial: Transcutaneous Electrical Nerve Stimulation (TENS) and Head and Neck Cancer Pain (HNC) (TENS & HNC)

Summary: The overall goal of this study is to examine the effect of a single dose of TENS on mucositis pain and function secondary to head and neck radiation therapies. Oral mucositis is an extremely debilitating, unpreventable condition (inflammation, ulcers, bleeding in the mouth, nose, and throat) that causes significant pain, functional impairment, and diminished quality of life. Head and neck cancers pose specific challenges to effective pain management and past studies suggest the use of effective non-pharmacologic strategies such as TENS may be particularly beneficial for avoiding sources of acute and chronic pain, thereby improving quality of life. The investigators hypothesize that a single dose of TENS will decrease pain and improve function and quality of life in head and neck cancer patients. This project is particularly innovative because it is the first known study to examine the efficacy of TENS, an established safe, inexpensive and easy-to-use non-pharmacologic pain management intervention, for treating acute oral mucositis pain. The investigators research translates bench (animal model) science to human subjects using an interdisciplinary approach to pain management. Establishing whether TENS is effective for reducing mucositis pain is a critical first step toward establishing an effective, non-pharmacologic pain relief intervention for mucositis.


Eligibility: Inclusion Criteria:
  -  Head and Neck Cancer Diagnosis
  -  Oral mucositis diagnosis
  Exclusion Criteria:
  -  TENS use ≤ 5 years
  -  Pacemaker
  -  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: Biomarkers of Response in Blood and Tumor Tissue Samples From Patients With Unresectable Stage IV Squamous Cell Cancer of the Head and Neck Previously Treated With Cetuximab, Cisplatin, and Radiation Therapy

Summary: RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how patients respond to treatment.
  PURPOSE: This research study is studying biomarkers of response in blood and tumor tissue samples from patients with unresectable stage IV squamous cell carcinoma of the head and neck previously treated with cetuximab, cisplatin, and radiation therapy.

Detailed description: OBJECTIVES:
  Primary
  -  To expand upon the list of molecular correlates indicated in clinical trial ECOG-E3303, including EGFR expression, EGFR phosphorylation, map kinase, AKT, and STAT3.
  -  To correlate the status or expression level of each biomarker with clinical outcome (response, progression-free survival, overall survival).
  OUTLINE: Archived tumor and blood specimens are analyzed for human papilloma virus and p16 status; EGFR gene amplification; levels of ERCC1, XPF, and c-Met proteins; expression and activation of several signaling pathways including PI3 kinase gene and mTOR; levels of ErbB2, ErbB3, P70S6 kinase, S6 , and Akt; expression of amphiregulin (AR), TGF-alpha (TGF-α), heparin-binding EGF-like growth factor (HB-EGF), EGF, epiregulin and c-Met ligand, and hepatocyte growth factor by fluorescence in situ hybridization (FISH), automated in situ quantitative measurements of protein analysis (AQUA), IHC, PCR, and ELISA.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of squamous cell carcinoma of the head and neck
  -  Stage IV disease
  -  Unresectable disease
  -  Treated with cetuximab, cisplatin, and radiotherapy on clinical trial ECOG-E3303
  -  Archived blood and tumor tissue samples available
  PATIENT CHARACTERISTICS:
  -  Not specified
  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: Docetaxel/Cisplatin/5-Fluorouracil (TPF) Human Papillomavirus (HPV) Squamous Cell Carcinoma Study

Summary: In this research study, the investigators are studying whether a reduced dose of radiation when given with standard doses of chemotherapy can reduce side effects without compromising control of the cancer. An approved treatment for squamous cell carcinoma of the head and neck is initial chemotherapy followed by radiation and chemotherapy together. This treatment is effective but has many immediate and long-term side effects. People who have squamous cell carcinoma of the head and neck (SSCHN) that is related to an infection by the human papillomavirus (HPV) have been shown to have a high response to this treatment along with a high cure rate. The investigators think that by reducing the intensity of this treatment, they may be able to reduce immediate and long-term side effects which may lead to long term improvements in quality of life and function.

Detailed description: OBJECTIVES:
  Primary
  To determine rate of local-regional control at 2 years
  Secondary
  To determine Progression Free Survival at 2 and 5 years
  To determine Overall Survival at 2 and 5 years
  To assess acute toxicity and long term toxicity of reduced radiation dose at 2 and 5 years

Eligibility: Inclusion Criteria
  -  Histologically or cytologically confirmed squamous cell carcinoma of the oropharynx or unknown primary that is HPV 16 positive as determined by ISH and p16 positive as determined by IHC.
  -  Stage 3 or 4 disease without evidence of distant metastases
  -  At least one evaluable or uni- or bi-dimensionally measurable lesion by RECIST 1.1 criteria
  -  18 years of age or older
  -  No previous surgery, radiation therapy or chemotherapy for SSCHN is allowed at time of study entry
  -  ECOG Performance Status of 0 or 1
  -  No active alcohol addiction
  -  Adequate bone marrow, hepatic and renal function as defined in the protocol
  -  Women of child-bearing potential must have a negative pregnancy test within 7 days of starting treatment
  Exclusion Criteria
  -  Pregnant or breast feeding women or women and men of childbearing potential not willing to use adequate contraception while on treatment and for at least 3 months after
  -  Previous or current malignancies at other sites
  -  Symptomatic peripheral neuropathy of grade 2 or greater
  -  Symptomatic altered hearing greater than grade 2
  -  Other serious illnesses or medical conditions
  -  Patients that have experienced an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry
  -  Concurrent treatment with any other anticancer therapy
  -  Participation in an investigational trial within 30 days of study entry

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

Clinical trial: Hematologic Toxicity Observation of the Docetaxel+ Cisplatin+ Fluorouracil (TPF)Medical Protocol

Summary: The ending of this study is to describe the effect of febrile neutropenia on patients who receive a chemotherapy by docetaxel+cisplatin+fluorouracil(TPF).

Detailed description: In this study we will describe
  -  habits of medical staff in prescription of growth factors or antibiotic prophylaxis
  -  ratio of patients treated by growth factors in primary or secondary prophylaxis
  -  ratio of patients treated in primary prophylaxis who present a febrile neutropenia
  -  ratio of patients who need to be hospitalized and the duration of those hospitalizations.
  -  causes of lateness, of decreasing, and of stop of chemotherapy
  -  antibiotic and growth factors prophylaxis tolerance .

Eligibility: Inclusion Criteria:
  -  patients with histologically proved head and neck squamous cell carcinoma
  -  age: more than 18
  -  patients who are beginning a chemotherapy (docetaxel+cisplatin+ 5FU)
  -  patients must have been informed of automatic data processing concerning them.
  Exclusion Criteria:
  -  previous chemotherapy for the head and neck squamous cell carcinoma
  -  previous chemotherapy for an other cancer in the two years before
  -  intercurrent illness that could significantly interfere with chemotherapy such as HIV infection, infection or active febrile illness, a chronic intestinal 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: Study of the P16 Gene as a Predictor of Myelosuppression in Breast Cancer Patients

Summary: The primary purpose of this study is to measure the association between baseline expression of the senescence effector protein p16INK4a and myelosuppression due to chemotherapy in patients with breast cancer. Patients with Stage I-IV breast cancer will be included and myelosuppression will be assessed after the first cycle of chemotherapy via measurement of an absolute neutrophil count (ANC) measured one time between days 7-11 post cycle one. Study subjects will also be asked to complete a brief health behaviors questionnaire to gather information on other relevant variables.


Eligibility: Inclusion Criteria:
  -  ≥ 18 years of age;
  -  Histologically confirmed Stage I-IV breast cancer;
  -  ECOG Performance Status 0-3;
  -  Scheduled to start a new course of chemotherapy in the neo-adjuvant, adjuvant or metastatic setting for newly diagnosed or recurrent disease;
  -  Growth factors, e.g., filgrastim, pegfilgrastim, are allowed, but their dose and duration will be tracked.
  -  Absolute Lymphocyte Count (ALC) > 500 cells/μL as determined by routine CBC with differential;
  -  Signed, IRB approved written informed consent.
  Exclusion Criteria:
  -  Presence of acute, active infection;
  -  History of clonal bone marrow disorder (i.e., myelodysplastic or myeloproliferative disorder, acute or chronic leukemia);
  -  Other co-morbid illness which would impair ability to participate in the study;
  -  Concurrent experimental therapy (Note: concurrent biologic therapy IS permitted, provided it is not experimental).
  -  Prior or current receipt of histone deacetylase (HDAC) inhibitors

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 as Salvage Treatment in Squamous Cell Carcinoma of Head and Neck

Summary: The aim of the study is to evaluate the efficacy and safety of pemetrexed monotherapy as salvage treatment in patients with relapsed or metastatic squamous cell carcinoma of head and neck.

Detailed description: The treatment option in patients with platinum-resistant relapsed or metastatic squamous cell carcinoma of head and neck is limited. Previous randomized phase III study showed a borderline benefit of pemetrexed added to cisplatin. Therefore, we aim to evaluate the efficacy of pemetrexed in salvage setting.

Eligibility: Inclusion Criteria:
  -  Age range: 18-65 years old
  -  Histological confirmed incurable relapsed or metastatic squamous cell carcinoma of head and neck
  -  Prior exposure of at least one line of platinum-containing regimen
  -  At least one site of measurable disease according to RECIST criteria
  -  ECOG performance status 0-1
  -  Life expectancy of more than 3 months
  -  Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L
  -  Liver function: total bilirubin, ALT and AST <1.5×UNL
  -  Renal function: Cr<1.5×UNL, CCR≧45ml/min
  Exclusion Criteria:
  -  With curable treatment option
  -  Prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy
  -  History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  -  Significant active infection
  -  Pregnant or lactating women

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

Clinical trial: Role of Immune Activation in Response of Head and Neck Squamous Cell Carcinoma to Therapy

Summary: The purpose of this study is to investigate the role of the immune system in the response of squamous cell cancers of the head and neck to treatment that includes radiation therapy. Current research demonstrates that several natural immune cells and molecules affect the way the body's immune system interacts with a cancerous growth. Some cancers may be related to infection with a virus, such as the Human Papilloma Virus (HPV). Studying the activity of the immune system in head and neck cancers, especially cancers related to HPV infections, can provide valuable information to better understand the body's interaction with cancer cells.

Detailed description: This is a study of the immune response in patients with oropharyngeal cancer who undergo treatment with radiation, chemoradiation, or robotic surgery. Many oropharyngeal cancers are caused by infection with the human Papillomavirus (HPV), and patients with HPV-mediated tumors have much better prognosis and treatment response compared to patients with HPV-negative tumors. The investigators will test the hypothesis that radiation-based therapy of oropharyngeal cancer is associated with activation of the endogenous HPV-specific immune response. In this study the investigators will collect blood at several time points before, during, and after treatment to monitor the immune response in patients with tumors positive and negative for HPV versus normal healthy volunteers.

Eligibility: Inclusion Criteria:
  -  The patient has biopsy-proven squamous cell carcinoma, Stage II-IV, of the oropharynx or larynx.
  -  The patient is to undergo treatment with radiation, chemo-radiation, or robotic surgery.
  -  The patient is able to give informed consent.
  -  The patient is at least 18 years old.
  -  The patient's ECOG performance status is </=2.
  Exclusion Criteria:
  -  The patient has had prior head and neck squamous cell carcinoma, with the exception of superficial cutaneous basal cell or squamous cell carcinomas.
  -  The patient has active cancer in another part of the body, with the exception of superficial cutaneous basal cell or squamous cell carcinomas.
  -  If a cancer survivor, the disease free interval is less than 5 years, with the exception of superficial cutaneous basal cell or squamous cell carcinomas.
  -  The patient is a minor.
  -  The patient is pregnant.
  -  The patient is a prisoner.
  -  The patient is incapable of understanding the consent process.
  -  The patient has previously received definitive surgical, radiation, or chemoradiation treatment for HNSCC.
  -  The patient has a history of HIV or other known cause of immunosuppression, or is actively taking immunosuppressive medications due to organ transplantation, rheumatoid disease, or other medical conditions.

Relevance to patient case: not relevant