araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: A Retrospective, Non-interventional, Multicenter, Observational Chart Review Study to Explore the Clinical Benefits of Retreatment With TKI in the Real World.

Summary: This is a retrospective, non-interventional, multicenter, observational chart review study to explore the clinical benefits of retreatment with TKI in the real world.

Detailed description: This study is designed to retrospectively review the medical and chemotherapy records of 300 patients with EGFR mutation positive adenocarcinoma NSCLC. Eligible patients are as follows: histologically or cytologically confirmed NSCLC, undergone EGFR-TKI retreatment sometime after the failure of the initial EGFR-TKI. After initial treatment, patients had been treated with chemotherapy and subsequently re-treated with EGFR-TKI will be identified. The target population will be derived from multicentre in Taiwan. The study aim is to evaluate clinical effect in re-administration of EGFR-TKI using retrospectively collected data from these eligible patients to provide valuable information.

Eligibility: Inclusion Criteria:
  1. Patients diagnosed with advanced adenocarcinoma or positive result of thyroid transcription factor 1 NSCLC
  2. Positive Epidermal Growth Factor Receptor mutation result with sensitive mutation
  3. Female or male aged ≧20 years
  4. Patients treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor and subsequently treated with chemotherapy before re-administration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor. Exclusion Criteria:
  1. Patients with EGFR mutation status of positive exon 20 T790M mutation only. 2. Patients who are confirmed of squamous type NSCLC

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: A Phase 1 Study of IMGN289 in Adult Patients With EGFR-positive Solid Tumors

Summary: This is a Phase 1, first-in-human study to determine the recommended dose of IMGN289 in adult patients with advanced EGFR-positive tumors.


Eligibility: Inclusion Criteria:
  -  18 years old at time of consent
  -  Diagnosed with a solid tumor that has progressed despite standard therapy or for which no standard effective or curative options exist or are suitable
  -  EGFR-positive tumor expression
  -  Adequate blood and organ function
  -  Must agree to use contraception while on study and for 12 weeks after the last dose of IMGN289 as applicable
  -  Must be willing and able to sign informed consent and follow the study schedule and other protocol requirements
  Exclusion Criteria:
  -  Other anti-cancer treatment during the study
  -  Symptomatic brain metastases
  -  Other clinically significant disease as defined by the protocol
  -  Chronic skin condition that requires prescribed oral or intravenous treatment
  -  History of severe rash that required discontinuation of prior EGFR targeted therapy
  -  Receiving therapeutic doses of warfarin or heparin for anti-coagulation
  -  Known diagnosis of HIV or active viral hepatitis
  -  Women who are pregnant or breast feeding

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Esophageal Stump Washout

Summary: Intraluminally shed viable tumor cells might contribute to local recurrence in cancer of the esophagus and the cardia. The aim of the the study was to establish a method of mechanical lavage of the remaining part of the esophagus and, hence, to reduce the intraluminal cancer cells before doing the esophageal anastomosis.

Detailed description: See study protocol!

Eligibility: Inclusion Criteria:
  -  histologically confirmed cancer of gastro-esophageal junction with indication for surgery
  Exclusion Criteria:
  -  missing informed consent

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Pilot Study: Utilizing Manometry to Assess Radiation-Induced Changes in Esophageal Function

Summary: The purpose of this study is to prospectively assess the feasibility of high-resolution manometry to identify radiation-induced changes in esophageal motility and contractility or "function" in patients undergoing radiation therapy for the treatment of locally advanced lung cancer.

Detailed description: As there is no standard of care to evaluate/visualize the effects of radiation therapy (RT) -induced esophageal injury, this is routinely assessed by patient reported accounts, and the symptoms are then managed supportively (e.g. with pain medicines, parenteral nutrition, feeding tubes etc). Manometry has been frequently used to study the effects of RT on gastrointestinal function in the setting of numerous malignancies, including colorectal, cervical and prostate cancers. What is often seen after RT is decreased sphincter function in the anorectal region leading to problems with continence and fecal urgency, however there has not been as rigorous of an evaluation of esophageal function after RT.
  One study performed more than 15 years ago included only 4 patients with lung cancer and concluded that mucosal irritation was likely the primary cause of RT-associated esophageal injury and no abnormalities in motility were seen. Radiation is known to cause long-term esophageal injury including stricture, and there is manometric evidence of impaired motility long-term after RT. The recent introduction of high-resolution manometry permits more extensive evaluation of the effects of RT on esophageal function.

Eligibility: Inclusion Criteria:
  -  Age ≥ 18 years or older
  -  Absence of any severe disorders of esophageal motility (patients with reflux and/or a hiatal hernia are eligible)
  -  Histologically confirmed lung cancer scheduled to undergo conventionally fractionated radiation treatment
  -  Patients that will be treated with a minimum of 45 Gy of radiation therapy
  -  Patients with mediastinal nodal disease, or primary lesions that are near the esophagus are eligible provided that they are not having esophageal symptoms believed to be due to the tumor.
  Exclusion Criteria:
  -  History of esophageal motility disorder that pre-dates and is unrelated to the present diagnosis of lung cancer
  -  History of any prior radiotherapy to the esophagus
  -  Pregnant or lactating women
  -  Inability to understand and follow swallowing instructions for the esophageal manometry procedure; this is to ensure patient compliance of performing the breath hold technique throughout the radiation therapy treatment
  -  Patients with mediastinal nodal disease, or primary lesions, that are having esophageal symptoms believed to be due to the tumor

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Narrow Band Imaging (NBI) Against Lugol for Squamous Esophageal Cancer

Summary: This study aimed to compare Narrow Band Imaging (NBI) against Lugol chromoendoscopy for diagnosis of early esophageal cancers among high risk patients.

Detailed description: The investigators recruited consecutive patients with head and neck cancers, history of squamous esophageal cancers treated by chemoradiotherapy or endoscopic resection. Endoscopic surveillance first started with NBI for detection and characterization of early esophageal cancers through observation of abnormal intrapapillary capillary loops (IPCL). Superficial esophageal neoplasia were diagnosed by IPCL Type IV, V1,V2 and Vn. Lugol chromoendoscopy would be performed subsequently and suspicious neoplasia were classified as understain or unstain lesions. The diagnostic accuracy, sensitivity and specificity of NBI were compared to Lugol chromoendoscopy with histology serving as a gold standard.

Eligibility: Inclusion Criteria:
  1. Patients with Head and Neck Cancer
  2. Patients with esophageal cancer treated by chemoradiotherapy and in remission for 2 years
  3. Patients with esophageal cancer treated by endoscopic resection
  4. Age 18 to 80
  Exclusion Criteria:
  1. Allergy to Lugol iodine
  2. Pregnancy
  3. Previous esophagectomy

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer

Summary: Lugol's solution staining was regarded as a gold standard to detect early superficial lesion during esophageal cancer screening using endoscopy. However, the sensitivity and specificity were influenced by mucus and food debris of esophagus. Pronase, a kind of protease, was previously shown to improve the visibility of gastrointestinal tract. It's unknown if the pre-treatment with pronase would also improve the quality of iodine staining in esophagus.A randomized double-blind clinical trial was designed to investigate whether or not pronase might improve detection rate of early esophageal lesion, especially high grade dysplasia and early cancer by improving the esophageal visibility.


Eligibility: Inclusion Criteria:
  -  Patients 60 years to 75 years old
  -  Patients less than 60 years old, but with one or multiple high risk factors for esophageal cancer including smoking and drinking addiction,family history of esophageal cancer, personal history of esophageal or head and neck malignancies, previous endoscopy documenting iodine void superficial lesion.
  Exclusion Criteria:
  -  Allergy to iodine or any other medicine which used in this trial.
  -  Previous endoscopy revealing advanced esophageal cancer or other non-superficial lesions.
  -  Conditions interfering visibility of endoscope including gastrointestinal obstruction and upper gastrointestinal bleeding.
  -  Anatomic variation by surgery.
  -  Pregnancy
  -  Other conditions which investigator consider the patient at high risk for complications.

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Neoadjuvant Chemotherapy of Nimotuzumab Plus Nab-Paclitaxel in Squamous Cell Carcinoma of Esophagus

Summary: Nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor (EGFR),has been shown to be effective and safe in some studies with head-neck cancers.Nab-paclitaxel regimen in advanced NSCLC has a better tumor response rate and safety than solvent-based paclitaxel.However,the safety and efficacy of Nimotuzumab plus nab-paclitaxel regimen is uncertain in neoadjuvant therapy in esophageal cancer.The investigators then initiated a phase II clinical trial with Nimotuzumab plus Nab-paclitaxel/cisplatin as the neoadjuvant chemotherapy in patients with locally advanced esophageal squamous cell carcinoma to observe the efficacy and safety of the combination.

Detailed description: In the past decade, clinical trials have evaluated the role of neoadjuvant chemotherapy, radiation, or both, for patients with surgically resectable esophageal carcinoma, but have all failed to demonstrate a consistent survival benefit. In Eastern countries, preoperative chemotherapy followed by radical surgery became one of the treatment strategies for resectable, clinical stage II or III esophageal cancer. In an effort to improve the efficacy of systemic chemotherapy, we conducted a prospective study to evaluate the regimen of Nimotuzumab plus Nab-paclitaxel/cisplatin as perioperative therapy for patients with resectable esophageal squamous cell carcinoma.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed squamous cell carcinoma of the thoracic esophagus, including the gastroesophageal junction (Siewert type I)
  -  Locally advanced disease that is technically operable with curative intent (R0)
  -  T3, N0 OR T1-3, N+ OR T4, Nx
  -  No T1-2, N0
  -  No inoperable T4 (unequivocal organ involvement)
  -  No distant metastasis, including M1a lymph node status
  -  Lymph nodes suspicious of M1a status by CT scan, PET scan, or ultrasound must be verified by fine-needle aspiration cytology
  -  No carcinoma of the cervical esophagus
  -  Obstructive tumors allowed
  Exclusion Criteria:
  -  Not suitable to surgery
  -  cervical Esophageal Carcinoma(distance of incisor tooth<19cm)
  -  early Esophageal Carcinoma(Stage I)
  -  complete esophageal obstruction，Esophageal perforation or hematemesis
  -  other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
  -  pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
  -  Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
  -  History of serious allergic or castor oil allergy
  -  Patients who are not suitable to participate in the trial according to researchers

Relevance to patient case: definitely relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Changes in Tumor Tissue and Serum Biomarkers Before and After Cetuximab Combined With Preoperative Radiotherapy in Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Summary: This study aim to investigate Changes in tumor tissue and serum biomarkers before and after cetuximab combined with preoperative radiotherapy in locally advanced thoracic middle-lower segment esophageal squamous cell carcinoma.We want to find one or more effective biomarkers to predict and evaluate the patients who will be benefit from cetuximab combined with preoperative radiotherapy.


Eligibility: Inclusion Criteria:
  (1)18 to 65 years old,male or female (2)Pathologically or cytologically proven thoracic middle-lower esophageal squamous cell carcinoma; (3)clinical stage II or stage III; (4)Primary tumors can be measured; (5)Karnofsky score >70; (6)Estimated life expectancy of at least 12 weeks; (7)reproductive age women should ensure that before entering the study period contraception; (8)Hemoglobin≥90.0g/dL,white blood cell count（WBC）≥ 4000 cells/mm³,Platelet count≥100,000 cells/mm³; (9)Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal,bilirubin normal; (10)Creatinine normal OR creatinine clearance ≥ 60 mL/min; (11)Patients have good compliance to treatment and follow-up of acceptance; (12)Forced expiratory volume in one second（FEV1） ≥ 1.5 litre or ≥ 75% of the reference value; (13)Considered operable (i.e. appropriate organ functions and ability to undergo general anesthesia); (14)No severe or uncontrolled cardiovascular disease; (15)No active uncontrolled infection;
  Exclusion Criteria:
  1. Patient who have distant metastasis
  2. The primary tumor or lymph node already received surgical treatment (except for biopsy);
  3. Patient who received radiotherapy for primary tumor or lymph node;
  4. Patient who received the the epidermal growth factor targeted therapy;
  5. Patient who received chemotherapy or immunotherapy;
  6. Patient who suffered from other malignant tumor;
  7. Epidermal growth factor receptor（EGFR）mutation（-）;
  8. Patient who have taken other drug test within 1 month;
  9. Pregnant woman or Lactating Women and Women in productive age who refuse to take contraception in observation period;
  10. Subject with a severe allergic history or idiosyncratic;
  11. Subject with severe pulmonary and cardiopathic disease history; Refuse or incapable to sign the informed consent form of participating this trial;
  12. Drug abuse or alcohol addicted;
  13. Subject with a Personality or psychiatric diseases, people with no legal; capacity or people with limited capacity for civil conduct;

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Dose-Guided Radiotherapy in Oesophageal Cancer: Managing the Real Dose

Summary: This study will prospectively collect patients undergoing the standard CROSS regimen in the neoadjuvant setting of the treatment for gastro-oesophageal cancer. The investigators will focus on the potential geometric differences between the OAR and target volume on the initial planning CT and on the kilovolt (kV) cone-beam computed tomography (CBCT). They expect a potential difference in the abdominal part of the planned target volume (PTV) and/or gastro-oesophageal junction part. Furthermore, the impact of gastric filling , potential tumor regression and the accuracy of 5 mm PTV margin in the thoracic PTV will be monitored.

Detailed description: Optimal radiotherapy planning and delivery is essential for irradiation of gastro-oesophageal junction tumors. There is a need for individualized radiotherapy delivery to the upper abdomen, because of mobility. Likewise, controlling gastric filling by instructing patients about fluid and food intake before treatment, may contribute to positional reproducibility. There is evidence that missing microscopic disease in treating the clinical target volume (CTV) results in a worse prognostic outcome. The investigators want to evaluate wether positional difference of stomach, with and without fasting prescription, has an impact of the delivered dose. They will focus on the part of the CTV extending in the stomach. The investigators hypothesize that measurement of the dose using verification kilovoltage cone beam CTs will provide information on potential cold/hot spots of dose delivery and monitor potential geometric differences during treatment. This may result in a suboptimal treatment and a reconsideration of matching target volume on soft tissue instead of bony landmarks. The investigators will evaluate the first clinical results with DGRT in patients with esophageal cancer.

Eligibility: Inclusion Criteria:
  -  Histologically proven adenocarcinoma of the gastro-oesophageal junction
  -  Age 18 years or older
  -  International Union Against Cancer (UICC) T2-4 N0-2 M0, potentially resectable disease treated by the CROSS regimen
  -  WHO 0-2
  Exclusion Criteria:
  -  Thoracic adenocarcinoma/squamous cell carcinoma
  -  Palliative treatment for the oesophageal cancer

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Erlotinib and Momelotinib for the Treatment of Epidermal Growth Factor Receptor (EGFR) Mutated EGFR Tyrosine Kinase Inhibitor (TKI) Naive Metastatic Non-Small Cell Lung Cancer (NSCLC)

Summary: This study will evaluate the safety, preliminary efficacy, and pharmacokinetics (PK) of momelotinib (MMB) and erlotinib, as well as define the maximum tolerated dose (MTD) of momelotinib (MMB) combined with erlotinib in adults with epidermal growth factor receptor (EGFR)-mutated, EGFR tyrosine kinase inhibitor (TKI) naive metastatic non-small cell lung cancer (NSCLC). Participants will be sequentially enrolled to receive progressively increasing doses of MMB in combination with erlotinib. Escalation of MMB doses will proceed to the MTD, defined as the highest tested dose associated with dose-limiting toxicities (DLT) during the first 28 days of combined erlotinib and MMB treatment. There will be four dose levels and each treatment cycle will consist of 28 days.


Eligibility: Key Inclusion Criteria:
  -  Metastatic NSCLC with documented EGFR exon 19 deletion or exon 21 (L858R) substitution mutation
  -  Treatment naive OR one prior standard chemotherapy that is platinum-based
  -  Adequate organ function defined as follows:
  -  Hepatic: Total bilirubin < upper limit of the normal range (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN
  -  Hematological: absolute neutrophil count (ANC) ≥1500 cells/mm^3, platelet ≥ 100,000 cells/mm^3, hemoglobin ≥ 9.0 g/dL
  -  Renal: Serum creatinine < ULN OR calculated creatinine clearance (CLcr) of ≥ 60 ml/min
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  Key Exclusion Criteria:
  -  Known positive status for human immunodeficiency virus (HIV)
  -  Chronic active or acute viral hepatitis A, B, or C infection (testing required for hepatitis B and C)
  -  Presence of > Grade 1 peripheral neuropathy
  -  Symptomatic leptomeningeal, brain metastases, or spinal cord compression.
  -  History of interstitial pneumonitis
  Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: A Study of Patient-reported Outcomes in Patients With Lung or Esophageal Cancer

Summary: This survey study is looking to determine if patient reported outcomes(using the PROMIS survey) will vary according to the presence of recurrent or metastatic lung or esophageal cancer.

Detailed description: A patient-centered approach to lung cancer surveillance following resection needs to incorporate patient reported outcomes. The Patient Reported Outcomes Measurement Information System (PROMIS®) was designed to revolutionize the assessment of patient reported outcomes by establishing a national resource for the measurement of patient-reported symptoms and other health outcomes.
  The PROMIS Assessment Center, the management tool within the larger PROMIS system, will be used to securely store de identified data, provide automated accrual reports and data export for this specific study. This study will have it's own study specific website.
  Patients seen at the University of Virginia Cancer Center will be identified and invited to participate in an assessment of their reported outcomes over multiple domains available in PROMIS. Collecting this information on lung cancer survivors may provide a robust platform to design a patient-centered surveillance strategy following resection.
  The study team hypothesizes that patient reported outcomes will vary according to the presence of recurrence or metastasis of lung or esophageal cancer. The study team also believes including patient reported outcomes into routine post-treatment surveillance will improve patient satisfaction and improve outcomes.

Eligibility: Inclusion Criteria:
  -  ≥18 years of age
  -  Suspected or Known diagnosis of lung or esophageal cancer
  -  Willing and able to complete questionnaires
  Exclusion Criteria:
  -  Subjects unwilling to provide informed consent
  -  Subjects unwilling or unable to answer the questionnaires

Relevance to patient case: not relevant