araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: A Study of 5-FU Versus MTX+5-FU in Gastric Cancer With Peritoneal Metastasis

Summary: To develop effective chemotherapy regimen against gastric cancer with peritoneal metastasis

Detailed description: Peritoneal metastasis is common in advanced gastric cancer and is considered an incurable disease state. Peritoneal metastasis may cause serious complications, such as intestinal obstruction, massive ascites, and hydronephrosis associated with the clinical presentation of abdominal pain and fullness, vomiting, constipation, malnutrition and renal dysfunction.5-FU continuous infusion remains the mainstay for chemotherapy against gastric cancer. On the other, sequential MTX+5-FU was reported to be effective in advanced gastric cancer with peritoneal metastasis in some phase II studies. Therefore, the randomized phase III study of 5-FU versus sequential MTX+5-FU in gastric cancer with peritoneal metastasis was conducted.

Eligibility: Inclusion Criteria:
  1. histologic confirmation of gastric adenocarcinoma
  2. inoperable metastatic disease or recurrent metastatic disease after surgery
  3. disease with peritoneal metastasis
  4. 20 years or more but less than 75 years
  5. performance status 2 or less on the Eastern Cooperative Oncology Group scale
  6. no prior treatment for gastric carcinoma except for surgery and adjuvant chemotherapy
  7. no prior chemotherapy or radiotherapy for other disease except for gastric cancer
  8. adequate bone marrow function, adequate liver function, and adequate renal function
  9. no prior transfusion for anemia
  10. provision of written informed consent
  Exclusion Criteria:
  1. Massive pleural effusion
  2. brain metastasis with symptoms
  3. severe diarrhea
  4. other severe medical conditions (infection, diabetes, hypertension, acute myocardial infarction, unstable angina, liver cirrhosis, intestinal pneumonia, pulmonary fibrosis)
  5. other active malignancies

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Randomized Controlled Trial to Evaluate Surgical Approaches to Gastric Cancer Invading the Esophagus (JCOG9502)

Summary: To compare left thoraco-abdominal approach with abdominal and transhiatal approach to cardia or subcardia cancer

Detailed description: For gastric cancers with esophageal invasion (Siewert type II and III), thoraco-abdominal approach has shown better survival results than abdominal approach in retrospective analyses. However, patients having mediastinal nodal metastasis have poor prognosis and the benefit of thoraco-abdominal approach is still controversial. We evaluated the two approaches in a prospective randomized trial.

Eligibility: Inclusion Criteria:
  1. histologically proven adenocarcinoma
  2. 75 years old or younger
  3. forced expiratory volume in one second ≥ 50 %
  4. arterial oxygen pressure in room air ≥ 70 mmHg
  5. clinically T2/T3/T4 with ≤3 cm esophageal invasion
  6. written consent
  Exclusion Criteria:
  1. Carcinoma in the remnant stomach
  2. Borrmann type 4 (linitis plastica)
  3. synchronous or metachronous malignancy in other organs except for cervical carcinoma in situ and colorectal focal cancer in adenoma
  4. history of left thoracotomy, or left pleural adhesion
  5. past history of myocardial infarction or positive results of exercise ECG
  6. liver cirrhosis, or chronic liver disease with indocyanine green test ≥15%

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

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: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Phase II Trial of Gleevec and Taxotere as a Combined Regimen for Advanced Gastric Adenocarcinoma

Summary: The purpose of this trial is to test the combination of Gleevec® (also known as imatinib mesylate) and Taxotere (also known as docetaxel) in patients with incurable stomach cancer. This study is being performed to see if the combination of Gleevec and Taxotere is an effective treatment for incurable stomach cancer with minimal side effects.

Detailed description: The purpose of this trial is to test the combination of Gleevec® (also known as imatinib mesylate) and Taxotere (also known as docetaxel) in patients with incurable stomach cancer. Gleevec is a pill form of chemotherapy and is indicated for the treatment of adult patients with chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). It is considered experimental for the treatment of stomach cancer. Taxotere (docetaxel) is a chemotherapy which is injected into the vein. It is approved for breast and lung cancer but has been shown to shrink many different types of tumors. Taxotere has been shown to shrink stomach cancer in about 20% - 30% of patients treated with Taxotere only. This study is being performed to see if the combination of Gleevec and Taxotere is an effective treatment for incurable stomach cancer with minimal side effects.
  Treatment on this study consists of two drugs, Gleevec® and Taxotere. Patients will be take four tablets of Gleevec® daily throughout the study. After one week of Gleevec®, patients will then begin receiving doses of Taxotere intravenously once a week for two weeks in a row followed by one week without Taxotere.

Eligibility: Inclusion Criteria:
  -  This study is for patients with histologically confirmed unresectable gastric adenocarcinoma and who have not received any chemotherapy other than 5-FU for adjuvant therapy either alone or in conjunction with radiation.
  Exclusion Criteria:
  -  Patients may not have received any chemotherapy agents other than 5-FU.
  -  Patients may not have received 5-FU for for therapy for metastatic gastric cancer.
  -  Patients must be more than 5 years free of another primary malignancy except: if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.
  -  Patients must not have Grade III/IV cardiac problems, or any severe and/or uncontrolled medical disease (i.e. uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
  -  Patient must not have had previously received radiotherapy to >/= 25% of the bone marrow, or have had major surgery within 2 weeks prior to study entry
  -  Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: MATRIX EG (Matuzumab Treatment With ECX in Esophago-Gastric Cancer)

Summary: The purpose of this study is to compare the effectiveness and safety of experimental treatment matuzumab and ECX chemotherapy, with ECX chemotherapy. Subjects invited to take part have metastatic cancer of the esophagus (gullet) or stomach.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus
  -  metastatic disease
  -  immunohistological evidence of EGFR expression from archived tissues
  -  ECOG PS 0-1
  -  at least 1 measurable lesion (modified WHO criteria)
  Exclusion Criteria:
  -  previous chemotherapy, unless neo-adjuvant or adjuvant therapy completed > 12 months prior to study treatment
  -  radiotherapy or major surgery within 4 weeks prior to treatment
  -  brain metastases
  -  peripheral neuropathy or ototoxicity >/= Grade 2 (NCICTC V3)
  -  abnormal ECG

Relevance to patient case: definitely relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Gefitinib in Combination With Chemoradiation in Resectable Gastric Cancer

Summary: To assess safety, efficacy and explorative objectives of gefitinib in combination with chemoradiation in resectable gastric cancer


Eligibility: Inclusion Criteria:
  -  Histologically-confirmed intestinal GC (T2-T4)
  -  Local or locally advanced stage II or stage III gastric cancer of an upper part of the stomach or GE junction
  -  Lymph node positive or negative
  -  Metastasis negative
  -  Resection with curative intent (R0, D2)
  -  Chemo- and radiotherapy naïve
  -  Measurable lesion according RECIST
  -  Written informed consent
  Exclusion Criteria:
  -  Aged below 45 or over 70
  -  Prior gastric surgery
  -  Active ILD

Relevance to patient case: definitely relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Neural Changes in the Aging Auditory System

Summary: The purpose of this study was to determine the effects of hormone replacement therapy (HRT) on hearing in post-menopausal women.

Detailed description: Background: Female hormone influences on the development and aging of the auditory system are not completely understood. The present study retrospectively analyzed and compared hearing abilities among post-menopausal women taking hormone replacement therapy (HRT), treated with estrogen and progesterone (E+P); estrogen alone (E), and a third (control - NHRT) group, matched for age, who did not receive any HRT.
  Methods: 126 subjects, (60-86 yr), N=32, E+P; N=31, E; N= 63, NHRT; matched for age and health status participated. All had relatively healthy medical histories, absence of significant noise exposure, middle ear problems, major surgeries or current/heavy smoking. Hearing tests included pure tone audiometry (PTA), tympanometry, distortion-product otoacoustic emissions (DPOAEs), transient otoacoustic emissions (TEOAEs) and hearing-in-noise-test (HINT). The latter is a test for speech perception in background noise: the major complaint of hearing-impaired persons.

Eligibility: Inclusion Criteria:
  -  Healthy middle ears
  Exclusion Criteria:
  -  ototoxic medications
  -  serious medical health problems
  -  neurological conditions
  -  Meniere’s disease or labyrinthitis
  -  those who failed cognitive screening tests (Mini-Mental Test)
  -  current/heavy smokers
  -  conductive hearing loss
  -  history of noise damage and/or audiograms signifying noise damage
  -  poor speech discrimination scores (80% or less)

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone

Summary: This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen


Eligibility: Inclusion Criteria:
  -  Patients with locally advanced/metastatic non-small cell lung cancer
  -  Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen
  Exclusion Criteria:
  -  Prior treatment with any receptor tyrosine kinase inhibitors, Vascular endothelial growth factor (VEGF) inhibitors or other angiogenic inhibitors
  -  History of or known brain metastases

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Cetuximab Plus P-HDFL for the First-line Treatment of Advanced Gastric Cancer

Summary: The investigators have initial evidence that the combination of cetuximab and cisplatin-HDFL may further improve the efficacy of the cisplatin-HDFL combination chemotherapy.

Detailed description: The clinical efficacy (confirmed objective response rates, progression-free survival, overall survival), and treatment-related toxicities of this novel regimen will be examined as the first-line treatment in patients with nonresectable or recurrent/metastatic gastric cancer.

Eligibility: Inclusion Criteria:
  1. Age 18 to 75 years
  2. Histologically proven adenocarcinoma
  3. At least one "measurable" lesion (by RECIST)
  4. No prior chemotherapy for gastric cancer
  5. WHO performance status ≦ 2
  6. Adequate baseline organ functions
  7. Fasting serum triglyceride level > 70 mg/dL
  8. Written informed consent
  9. At least one month from gastrectomy
  10. Availability of tumor sample for immunohistochemical or pharmacogenomic testing of EGFR
  Exclusion Criteria:
  1. Concomitant anti-cancer biological agents, chemotherapy, or radiotherapy
  2. CNS metastasis
  3. Pregnancy, breast-feeding women and women of child-bearing potential
  4. Life expectancy less 3 months
  5. Serious concomitant illness
  6. Concurrent or prior second malignancy
  7. Known hypersensitivity reaction to any of the components of study treatments

Relevance to patient case: definitely relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Short-term Presurgical Study to Assess Molecular Predictors of Lapatinib's Effects in Primary Breast Cancer

Summary: To provide an in vivo measure of the activity of lapatinib. To assess the antiproliferative effects of lapatinib in breast cancer, ie how much lapatinib slows down the growth of cancer cells by measuring K167 (a marker of proliferation) in breast tumours before and after a short treatment with lapatinib.

Detailed description: Randomised multi centre double blind pre-surgical study in women with a histological diagnosis of breast cancer by core biopsy.

Eligibility: Inclusion Criteria:
  Patients must have a histological or cytologic diagnosis of primary breast cancer with a tumour size adequate for multiple core biopsies Informed signed consent Scheduled for primary surgery Expected to be compliant for duration of study Age<80 ECOG performance status 0-2 (Karnofsky >60%) Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan Eligibility of patients receiving medications known to affect, or with the potential to affect the activity or pharmacokinetics of lapatinib will be determined following review by the Trial Coordinator The effects if lapatinib on the developing fetus are unknown. For this reason, women of childbearing potential must agree to use adequate non-hormonal contraception for the duration of study participation.
  Able to swallow and retain oral medication.
  Exclusion Criteria:
  Patients with prior diagnosis of malignancy except in situ disease or basal cell carcinoma of the skin.
  Patients may be receiving any other investigational agents or receiving concurrent anticancer therapy. In addition, all herbal (alternative) medicines are excluded.
  Evidence of metastatic disease. Use of hormonal therapy such as oral contraceptives or hormonal replacement therapy within 4 weeks of study entry.
  Regular use of steroid hormones or other agents that could influence study endpoints History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016.
  Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/ social situations that would limit compliance with study requirements.

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Topical Sunscreen in Preventing Skin Rash in Patients Receiving Drugs Such as Erlotinib or Cetuximab for Cancer

Summary: RATIONALE: Topical sunscreen may be effective in preventing skin rash caused by treatment with drugs such as erlotinib or cetuximab. It is not yet known whether topical sunscreen is more effective than a placebo in preventing skin rash in patients receiving drugs such as erlotinib or cetuximab for cancer.
  PURPOSE: This randomized phase III trial is studying topical sunscreen to see how well it works compared with a placebo in preventing skin rash in patients receiving drugs such as erlotinib or cetuximab for cancer.

Detailed description: OBJECTIVES:
  -  Compare the incidence and severity of erlotinib-, cetuximab-, or other epidermal growth factor receptor inhibitor-induced skin rash development in patients with cancer treated with prophylactic topical sunscreen vs placebo.
  -  Determine the toxicity of topical sunscreen vs placebo in these patients.
  -  Determine whether discontinuation of treatment intervention is followed by rash development.
  OUTLINE: This is a multicenter, randomized, double-blind, placebo-controlled study. Patients are stratified according to chemotherapy regimen (first-line chemotherapy vs other), epidermal growth factor receptor (EGFR) inhibitor therapy (small molecule vs monoclonal antibodies), concurrent medication that increases sun hypersensitivity (yes vs no), and gender. Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients apply sunscreen generously to the entire body twice daily for 4 weeks.
  -  Arm I: Patients apply placebo generously to the entire body twice daily for 4 weeks.
  Patients complete self-reported questionnaires regarding their rash status at baseline and then weekly for 8 weeks.
  After completion of study treatment, patients are followed for 8 weeks.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of cancer
  -  Receiving ≥ 1 of the following epidermal growth factor receptor (EGFR) inhibitor treatments:
  -  Gefitinib
  -  Cetuximab
  -  Erlotinib
  -  Panitumumab
  -  ICR-62
  -  Matuzumab
  -  CI-1033
  -  EGFR treatment must have begun within the past 3 days
  -  No rash (of any etiology) at study entry
  PATIENT CHARACTERISTICS:
  -  Able to apply sunscreen on face, trunk, and extremities
  -  Able to complete questionnaire(s)
  -  No history of allergic reactions or severe intolerance to sunscreen or its derivatives
  -  No history of skin problems likely to reoccur during treatment
  -  Must avoid heavy sun exposure, especially during the hours of noon to 4 pm daily
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No concurrent tanning bed usage
  -  No other concurrent topical sunscreens

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Zalutumumab in Patients With Non-curable Head and Neck Cancer

Summary: The purpose of this study is to investigate if zalutumumab in combination with Best Supportive Care (BSC) is superior to BSC in non-curable patients with head and neck cancer

Detailed description: This is an open parallel group trial. Patients will be randomized in a 2:1 manner to receive either treatment with zalutumumab in combination with Best Supportive Care (BSC) or BSC.
  Patients randomized to treatment with zalutumumab in combination with BSC will receive weekly infusions with zalutumumab starting with a loading dose (8mg/kg) followed by weekly maintenance doses until disease progression, intercurrent illness preventing further administration, unacceptable toxicity or patient decision. After Visit 2 the patient should be evaluated for presence of skin rash prior to each infusion to allow dose titration.
  Individual dose titration until the patient develops grade 2 skin rash will be applied. The maximum dose used in study will be 16 mg/kg.

Eligibility: Inclusion Criteria:
  1. Males and Females age ≥ 18 years
  2. Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy
  3. Failure to at least one course of standard platinum-based chemotherapy
  Exclusion Criteria:
  1. Three or more chemotherapy regimens other than platinum-based chemotherapy
  2. Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors
  3. Past or current malignancy other than SCCHN, except for certain other cancer diseases

Relevance to patient case: not relevant