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

Clinical trial: Parenteral Nutrition for Patients Treated for Locally Advanced Inoperable Tumors of the Head and Neck

Summary: Prevention of critical weight loss. In patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN) weight loss is a relevant clinical problem during radiotherapy and might result in higher treatment related toxicity and discontinuation of a potential curative treatment. Thus the investigators want to evaluate the efficacy of overnight parenteral nutritional (PN) support in patients with SCCHN treated with curative radiotherapy (RTX) in combination with Cetuximab (E) or Cisplatin (P).

Detailed description: The investigators hypothesize that about 60% of patients receiving RTX without supplemental PN will suffer from critical weight loss of more than 5% during treatment - supplemental overnight PN might result in significant improvement of the nutritional status .

Eligibility: Inclusion Criteria:
  -  Any patient who is eligible for definitive curative radio-chemotherapy with Cisplatin or radio-immunotherapy with Cetuximab.
  -  Written informed consent obtained prior to any study specific screening activities and patients have to be able to comply with this protocol.
  -  Histologically confirmed local advanced squamous cell carcinoma of the Larynx, Hypopharynx, Oropharynx or Cavum oris treated with definitive radiotherapy in combination with Cisplatin or Cetuximab.
  -  p16 status available
  -  Age ≥ 18
  -  Women of childbearing potential must have a negative pregnancy test at screening and must use effective contraception.
  Exclusion Criteria:
  -  Distant metastases
  -  Prior radiation (Head and neck area)
  -  Pregnant or lactating women
  -  History of other malignancy; yet patients who have been disease-free for 5 years or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
  -  Concurrent other cancer therapy (chemotherapy, immunotherapy, antihormonal or biologic therapy) or concurrent treatment with an investigational drug.
  -  Serious medical or psychiatric disorders that would interfere with the patient's safety or informed consent.
  -  Participation in another interventional clinical study at time of study inclusion (except follow-up period without treatment for more than 30 days) or denial of the simultaneous participation in a non-interventional study by the PI of the study center.

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

Clinical trial: Single Dose Escalation Study of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck

Summary: maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine


Eligibility: Inclusion Criteria:
  1. male and female patients aged 18 years or older
  2. patients with histologically confirmed squamous cell carcinoma of the head and neck
  3. patients with local and / or regional recurrent disease or distant metastases who are refractory to or not amenable to established treatments
  4. measurable tumour deposits by one or more radiological techniques (MRI, CT)
  5. life expectancy of at least 6 months
  6. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
  7. patients must have given written informed consent (which must be consistent with International Conference of Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation)
  Exclusion Criteria:
  1. hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs
  2. known secondary malignancy requiring therapy
  3. active infectious disease
  4. brain metastases
  5. neuropathy grade 2 or above (excluding pre-existing neuropathy of cranial nerves due to surgery, radiotherapy or tumour growth)
  6. absolute neutrophil count less than 1,500/mm3
  7. platelet count less than 100,000/mm3
  8. bilirubin greater than 1.5 mg/dl (> 26 μmol/L, système internationale (SI) unit equivalent)
  9. aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 3 times the upper limit of normal
  10. serum creatinine greater than 1.5 mg/dl (> 132 μmol/L, SI unit equivalent)
  11. concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
  12. chemo- or immunotherapy within the past three weeks prior to treatment with the trial drug or during the trial
  13. radiotherapy to head and neck region within the past four weeks before inclusion or during the trial
  14. men and women who are sexually active and unwilling to use a medically acceptable method of contraception
  15. pregnancy or lactation
  16. treatment with other investigational drugs or participation in another clinical trial within the past three weeks before start of therapy or concomitantly with this trial
  17. patients unable to comply with the protocol

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

Clinical trial: Dual-Energy CT in Patients With Head and Neck Squamous Cell Carcinomas

Summary: The purpose of this study is to utilize dual-energy computed tomography (DECT) to investigate changes in tumor iodine concentration in patients with head and neck squamous cell carcinomas (HNSCC). Dual-energy computerized tomography could easily replace a standard CT neck with the added benefit of providing functional information that would only be possible with advanced computerized tomography perfusion, magnetic resonance diffusion (MRI) or positron emission tomography (PET) imaging techniques.

Detailed description: Patients with head and/or neck tumors routinely have head and neck imaging completed with a computerized tomography scan, commonly called a CT scan. A CT scan combines a series of x-ray views that are taken from many different angles and uses computer processing to create cross-sectional images inside your body. These cross-sectional images are very thin slices, often less than 1 mm thick and allow the radiologist to examine parts of your tissue very closely.
  Dual energy computed tomography (DECT) is a fairly new technology that uses both the normal x-ray and also a second less powerful x-ray to make the images. The Ottawa Hospital has scanners in use that are able to take the images that oncologists typically order for patients and can also be set to obtain DECT images at the same time.
  The purpose of this study is to investigate whether DECT images can provide helpful information to better predict how the tumor will respond to treatment and the likely course of head and neck tumors.

Eligibility: Inclusion Criteria:
  -  18 years and older
  -  untreated, histologically confirmed head and neck squamous cell carcinoma
  Exclusion Criteria:
  -  paranasal sinus involvement of head and neck squamous 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: Phase I Panitumumab IRDye800 Optical Imaging Study

Summary: Phase I trial to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent.

Detailed description: This is a Phase I trial that is designed to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 used in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent. Safety data from this trial will be studied to assist in the selection of dose levels of panitumumab-IRDye800 for future research. It is hoped that this study will also help in finding better methods for identifying cancer intraoperatively for a more complete surgical resection.

Eligibility: Inclusion Criteria
  -  Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck
  -  Patients diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed.
  -  Planned standard of care surgery with curative intent for squamous cell carcinoma
  -  Age ≥ 19 years
  -  Have life expectancy of more than 12 weeks
  -  Karnofsky performance status of at least 70% or ECOG/Zubrod level 1
  -  Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results: Hemoglobin ≥ 9 gm/dL; White blood cell count > 3000/mm3; Platelet count ≥ 100,000/mm3; Serum creatinine ≤ 1.5 times upper reference range
  Exclusion Criteria
  -  Received an investigational drug within 30 days prior to first dose of panitumumab IRDye800
  -  Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
  -  History of infusion reactions monoclonal antibody therapies
  -  Pregnant or breastfeeding
  -  Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
  -  Magnesium or potassium lower than the normal institutional values
  -  Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
  -  Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
  -  TSH > 13 micro International Units/mL

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

Clinical trial: The Role of Chromoendoscopy in the Early Detection of Esophageal Cancer in Patients With Prior Head and Neck Cancers

Summary: This study evaluates the role of narrow band imaging (NBI) endoscopy compared with Lugol chromoendoscopy in the early detection of esophageal cancer in patients with prior head and neck cancers.

Detailed description: Patients with head and neck cancers have an increased risk for developing an esophageal squamous cell carcinoma (ESCC). Small, superficial, curable lesions are difficult to diagnose using only white light endoscopy. To improve detection chromoendoscopy is recommended. In this project patients are divided into two groups based on received chromoendoscopy (NBI versus Lugol). The results of two methods will be compare regarding positive predictive value to establish usage of chromoendoscopy in early detection of ESCC.

Eligibility: Inclusion Criteria:
  -  Patients with past history ( >= 1 year ) of head and neck cancer treated curatively and receiving regular follow - up at the outpatient clinic of the Head and Neck Department of Maria Skłodowska - Curie Memorial Cancer Center, Institiut of Oncology
  -  18 years and older
  -  Diagnosis of squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx
  -  Zubrod scale 0-2
  -  Provided written informed consent
  Exclusion Criteria:
  -  Lack of written informed consent
  -  Known allergy to iodine
  -  Clinical conditions precluding upper GI endoscopy

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

Clinical trial: Super-Selective Intraarterial Infusion of Cetuximab (Erbitux) With or Without Radiation Therapy for the Treatment of Unresectable Recurrent Squamous Cell Carcinoma of the Head and Neck

Summary: This is an open-label, non-randomized, two arm, Phase I research study of superselective intraarterial Cetuximab (Erbitux) with or without radiation therapy for treatment of recurrent unresectable squamous cell carcinoma of the head and neck (HNSCC).


Eligibility: Inclusion Criteria:
  1. Male or female patients of ≥18 years of age.
  2. Patients with a documented diagnosis of recurrent head and neck squamous cell cancer (squamous cell carcinoma, including nasopharyngeal cancer, or adenoid cystic carcinoma).
  Patients must have at least one confirmed and evaluable tumor site.* The recurrence must have bidimensional measurements by clinical examination or CT/MRI/PET scan. A confirmed recurrence site may also be biopsy-proven
  3. Tumor Recurrence which is surgically unresectable
  4. Patients must have a Karnofsky performance status ≥70% (or the equivalent ECOG level of 0-2) (see Appendix Performance Status Evaluation) and an expected survival of ≥ three months.
  5. Patients must have adequate hematologic reserve with WBC≥3000/mm3, absolute neutrophils ≥1500/mm3 and platelets ≥100,000/ mm3. Patients who are on Coumadin must have a platelet count of ≥150,000/ mm3
  6. Pre-enrollment chemistry parameters must show: bilirubin<1.5X the institutional upper limit of normal (IUNL); AST or ALT<2.5X IUNL and creatinine<1.5X IUNL.
  7. Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5X the IUNL.
  8. Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study.
  9. Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening.
  10. Patients who refuse surgery.
  Exclusion Criteria:
  1. Women who are pregnant or lactating.
  2. Women of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period.
  3. Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring.
  4. Pre-existing cardiac or respiratory disorders
  5. Unrelated malignancy within 3 years
  6. History of hypersensitivity reactions to other EGFR inhibitors
  7. Metastatic disease
  8. Less than 6 months from prior Radiation Therapy (Arm 1)
  9. Previous exposure to Cetuximab

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 for Treatment of Patients With Recurrent or Metastatic SCCHN or SCCS

Summary: This phase 2 study is designed to evaluate the safety and activity of TH-4000 (Tarloxotinib), a hypoxia-activated prodrug in participants with recurrent or metastatic squamous cell carcinoma of the head and neck or skin.

Detailed description: An open label, parallel-group, multi-center Phase 2 study in which the pharmacokinetics, safety, tolerability and efficacy of TH-4000 (Tarloxotinib) will be assessed in participants with recurrent or metastatic squamous cell carcinoma of the head and neck or skin.
  Hypoxia PET scans will be obtained in select centers to analyze potential predictors of tumor response.

Eligibility: Inclusion Criteria:
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  -  Confirmed squamous cell carcinoma of the head and neck (oropharynx, oral cavity, hypopharynx, or larynx) or skin
  -  For patients with oropharyngeal cancer, p16 status is known or can be determined
  -  Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
  -  Acceptable laboratory results as indicated by protocol
  -  Acceptable cardiac function as indicated by protocol
  Exclusion Criteria:
  -  Received prior EGFR TKI therapy for recurrent or metastatic SCC (e.g., oral EGFR TKIs such as erlotinib, gefitinib, or afatinib)
  -  Family history of long QTc syndrome
  -  Receiving medication that prolongs QT interval ,with a risk of causing Torsades de Pointes (TdP), unless ECG meets inclusion criteria while on a stable dose of the medication
  -  Family history of long QTc syndrome
  -  Symptomatic central nervous system (CNS) lesions, or CNS lesions that require therapy
  -  Radiation therapy within 2 weeks prior to the first dose of study medication
  -  Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication
  -  Concurrent active malignancy requiring systemic treatment
  -  Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection
  -  Pregnant or breast-feeding

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

Clinical trial: Palliative Radiotherapy Protocol in Head and Neck Cancer

Summary: Phase II prospective study or Palliative Radiotherapy of 25 Gy in 5 fractions, Intensity Modulated, for frail patients with incurable head and neck cancer. Comprehensive Quality of life (QLQ-C30, head and neck module, QLQ C15 PAL) and toxicity data (CTCAE v 4.0) collected.

Detailed description: Patients deemed too frail for radical treatment or incurable because of tumour extension, as determined by an experienced tumour board, were eligible for this study of palliative radiotherapy delivered by intensity modulation, 25 Gy in 5 daily fractions over one week. This study was conducted in two academic centers.

Eligibility: Inclusion Criteria:
  -  Able to give an informed consent
  -  Able to complete QOL questionnaires
  -  Deemed incurable by an experienced tumour board or unwilling to receive a radical course of radiation therapy
  -  Presence of measurable disease
  -  Biopsy proven squamous or salivary cancer of the head and neck region
  -  Expected survival of at least 2 months.
  Exclusion Criteria:
  -  Pregnancy
  -  No previous RT to the neck and no plan to receive concomitant chemotherapy
  -  Special histology (Lymphoma, small cell cancer, metastasis from a site other than the head and neck region)
  -  Unavailable for follow-up

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 SCB01A in Patient With Head and Neck Cancer

Summary: To evaluate the safety and efficacy of SCB01A in head and neck cancer.

Detailed description: The study is designed to evaluate the safety and efficacy of SCB01A in patients with recurrent or metastatic squamous cell carcinoma in head and neck.

Eligibility: Inclusion Criteria:
  1. Confirmed squamous cell carcinoma of head and neck
  2. Patients with nonresectable, unfeasible radiotherapy, recurrent or metastatic carcinoma, after previous treatment with platinum agent.
  3. At least one measurable tumor lesion according to RECIST
  4. Suitable Eastern Cooperative Oncology Group (ECOG) performance status
  5. All eligible patients of childbearing potential have to use effective contraception
  6. Signed informed consent before enrolment
  Exclusion Criteria:
  1. Receiving Chemotherapy, radiation therapy, major surgery or investigational agents
  2. Severe pulmonary obstructive or restrictive disease
  3. Uncontrolled inflammatory disease
  4. Clinically significant cardiac disease
  5. Results of laboratory tests
  6. Pregnancy or nursing status
  7. Known hypersensitivity to any component of SCB01A
  8. History of exposure to SCB01A or its analogues
  9. History of malignancy other than head and neck cancer
  10. History of active or significant neurological disorder or psychiatric disorder
  11. Any other reason the investigator deems the patient to be unsuitable for 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: Mometasone Furoate Cream Reduces Acute Radiation Dermatitis in Head and Neck Squamous Cell Carcinomas' Patients

Summary: Radiation dermatitis is an acute effect of radiation therapy,Especially in the neck skin of head and neck squamous cell carcinomas' patients.The investigators wanted to confirm the benefit of mometasone furoate (MF) in preventing acute radiation reactions, as shown in a previous study.

Detailed description: A randomized,self-comparative controlled trial was undertaken comparing MF cream with no cream administered from the first day of treatment for 5-6 weeks to prevent radiation dermatitis of neck during radiation therapy to the head and neck squamous cell carcinomas' Patients.
  One side of patients' neck will begin to use MF cream from the first day of radiation therapy, while the other side accept no preventive measures.

Eligibility: Inclusion Criteria:
  -  pathological diagnosis for head and neck squamous cell carcinomas and
  -  going to have radiotherapy.
  Exclusion Criteria:
  -  pregnant,
  -  lactating women,
  -  infants,
  -  elderly people with atrophy skin,
  -  allergic constitution patients,
  -  the corresponding parts of 5 radiotherapy skin ulceration or infection and
  -  allergic patients to Mometasone Furoate Cream.

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

Clinical trial: Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer

Summary: The purpose of this study is to determine whether the combination of palbociclib with cetuximab is superior to cetuximab in prolonging overall survival in HPV-negative, cetuximab-naive patients with recurrent/metastatic squamous cell carcinoma of the head and neck.


Eligibility: Key Inclusion Criteria:
  -  Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy.
  -  Measurable disease as defined per RECIST v. 1.1. Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measureable if disease progression at the treated site after completion of therapy is clearly documented.
  -  HPV- negative SCCHN tumor as determined per institutional standard (eg, p16 IHC; multiplex nucleic acid sequence based amplification [NASBA] or other polymerase chain reaction [PCR]-based assays).
  -  Documented progressive disease according to RECIST v1.1 (Appendix 2) following receipt of at least 2 cycles of one platinum-containing chemotherapy regimen administered for R/M disease (min. 50 mg/m2 for cisplatin, minimum area under the curve [AUC] > 4 for carboplatin).
  -  Availability of a tumor tissue specimen (ie, archived formalin fixed paraffin embedded tissue [block preferred, or 15 unstained slides]), which will be used for centralized, retrospective biomarker analysis. If archived tumor tissue is not available, then a de novo biopsy will be required for patient participation.
  Key Exclusion Criteria:
  -  Prior nasopharyngeal cancer, salivary gland or sinus tumors.
  -  More than one chemotherapeutic regimen given for R/M disease. Prior treatment with immunotherapy is allowed.
  -  Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization.
  -  Progressive disease within 3 months after completion of curatively intended treatment for locoregionally advanced SCCHN.
  -  Difficulty swallowing capsules.
  -  Prior use of cetuximab in the R/M disease treatment setting (except cetuximab during curative radiotherapy)

Relevance to patient case: not relevant