araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: A Retrospective Clinical Records Review of Patients Diagnosed With Gastrointestinal Stromal Tumour at Two Tertiary Institutes in Singapore

Summary: To review the characteristics and treatment of gastrointestinal tumours at the two tertiary centres in Singapore

Detailed description: A retrospective clinical records review of patients diagnosed with gastrointestinal stromal tumour (GIST) in the two tertiary centres in Singapore i.e. Singapore General Hospital and National University Hospital.
  Gastrointestinal tumours are the most common soft-tissue tumours of the gastrointestinal tracts. Remarkable progress has been made during the last several years in the diagnosis and treatment of GIST. Understanding of the molecular pathogenesis of GIST which is linked to deregulated KIT tyrosine-kinase activity has improved diagnosis, such that GIST is now more frequently and specifically identified. More importantly, systemic tyrosine kinase inhibitor, imatinib, has been used successfully in the treatment of GIST patients with advanced or unresectable disease.
  GIST has been reviewed in the Western literature but there is a lack of Asian data. The review will help us to better understand the disease in our population.Furthermore we will also examine several unresolved issues in the Western literature by looking into our local data. These include required duration of imatinib therapy, role of imatinib in the adjuvant setting (application of chemotherapy after macroscopically complete removal of tumour) and role of combination therapies.
  The medical records of all patients diagnosed with the disease at the two centres will be reviewed.
  Analysis of the results aims to:
  1. to compare the characteristics of the GIST (epidemiology, site, morphology, immunohistochemistry profile) in our centres compared to the well-published literature.
  2. to compare the treatment regimen and results of our centres compared to others
  3. to review the role of chemotherapy in the adjuvant settings in the centres.

Eligibility: Inclusion Criteria:
  -  Patients diagnosed with Gastrointestinal stromal tumor.

Relevance to patient case: definitely relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib

Summary: This study will evaluate the efficacy and safety of nilotinib in gastrointestinal stromal tumors patients who failed imatinib and sunitinib therapy.


Eligibility: Inclusion Criteria:
  -  Documented disease progression during imatinib and sunitinib therapy OR intolerance to imatinib and/or sunitinib
  -  At least one measurable site of disease on CT/MRI scan
  -  PS≤2
  -  Normal organ, electrolyte, and bone marrow function
  Exclusion Criteria:
  -  Previous treatment with nilotinib or any other drug in this class or other targeted therapy
  -  Treatment with any cytotoxic and/or investigational drug ≤ 4 weeks prior to study entry
  -  Impaired cardiac function
  -  Use of coumarin derivatives (i.e. warfarin)
  -  Women who are pregnant or lactating
  Other protocol-defined inclusion/exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: A Study In Patients With Advanced Solid Tumor

Summary: This study designed to evaluate the pharmacokinetics and safety of AG-013736 at single doses and multiple doses


Eligibility: Inclusion Criteria:
  -  Patients histologically or cytologically diagnosed with advanced solid tumors
  -  Patients for whom standard therapies have not been effective, or for whom there are no suitable therapies
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
  -  Patients with no uncontrolled hypertension
  Exclusion Criteria:
  -  Patients who have central lung lesions involving major blood vessels
  -  Patients who require anticoagulant therapy.
  -  Patients with active epilepsy seizure or symptoms, with brain metastases requiring treatment, with spinal cord compression and with carcinomatous meningitis.

Relevance to patient case: not relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: Imatinib Mesylate in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor

Summary: RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
  PURPOSE: This phase II trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with liver metastasis from a gastrointestinal stromal tumor.

Detailed description: OBJECTIVES:
  -  To evaluate the safety and efficacy of imatinib mesylate in patients with resectable hepatic metastasis secondary to gastrointestinal stromal tumor.
  OUTLINE: This is a multicenter study.
  Patients receive oral imatinib mesylate daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of gastrointestinal stromal tumor (GIST)
  -  Hepatic metastasis meeting the following criteria:
  -  No more than 3 hepatic metastases
  -  Clinically diagnosed as surgically resectable with no macroscopic residual tumor
  -  Synchronous hepatic metastasis allowed provided primary tumor is also resectable
  -  No metastatic tumor that requires radiofrequency ablation and/or microwave coagulation therapy to control the disease
  -  No extrahepatic metastasis
  -  No history of GIST recurrence
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-1
  -  Leukocyte count ≥ 3,000/μL
  -  Neutrophil count ≥ 1,500/μL
  -  Hemoglobin ≥ 8.0 g/dL
  -  Platelet count ≥ 75,000/μL
  -  Total bilirubin ≤ 2.0 mg/dL
  -  ALT and AST < 120 IU/L
  -  GTP < 210 IU/L
  -  Not pregnant
  -  No poorly controlled diabetes mellitus
  -  No NYHA class III-IV cardiac function
  -  No hepatitis B or hepatitis B carriers
  -  No other malignancy requiring treatment
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No prior imatinib mesylate
  -  No prior interventional radiology for metastatic disease
  -  No other concurrent treatment, including surgery or radiotherapy, for metastatic lesions

Relevance to patient case: not relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: Treatment of Patients With RAD001 With Progressive Sarcoma

Summary: The purpose of this multicenter, three-arm, exact binomial single-stage, phase II trial is to determine the preliminary efficacy and safety of RAD001 in patients with histological evidence of progressive or metastatic bone or soft tissue sarcoma.


Eligibility: Inclusion Criteria:
  Histological evidence of progressive or metastatic bone or soft tissue sarcoma.
  The following tumor types are included:
  -  malignant fibrous histiocytoma
  -  liposarcoma
  -  synovial sarcoma
  -  malignant paraganglioma
  -  fibrosarcoma
  -  leiomyosarcoma
  -  angiosarcoma including haemangiopericytoma
  -  malignant peripheral nerve sheath tumor
  -  STS, not otherwise specified
  -  miscellaneous sarcoma including mixed mesodermal tumors of the uterus
  -  osteosarcoma
  -  Ewing's sarcoma
  -  rhabdomyosarcoma
  -  gastrointestinal stromal tumor (only after failure or intolerance of imatinib or sunitinib in 1st and 2nd line)
  -  alveolar soft part sarcoma (ASPS)
  -  Objective progression of disease may be documented by RECIST criteria. Any of the following would be sufficient according to RECIST:
  -  a 20% increase in the sum of unidimensionally measured target lesions
  -  a new lesion
  -  unequivocal increase in non-measurable disease.
  -  Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent.
  -  ECOG performance status 0 - 2.
  Exclusion Criteria:
  Anticancer therapy within 3 weeks of enrollment including chemotherapy, hormonal therapy, immunotherapy, or radiotherapy.
  -  The following tumor types will not be included:
  -  gastrointestinal stromal tumor (except for patients after treatment with imatinib or sunitinib in 1st and 2nd line)
  -  chondrosarcoma
  -  malignant mesothelioma
  -  neuroblastoma.
  -  Prior therapy with RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus).
  -  Neurotoxicity > grade 2 CTC.
  -  Radiation of the lung.
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: Surgery in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor

Summary: RATIONALE: Surgery may be an effective treatment for liver metastasis from a gastrointestinal stromal tumor.
  PURPOSE: This phase II trial is studying how well surgery works in treating patients with liver metastasis from a gastrointestinal stromal tumor.

Detailed description: OBJECTIVES:
  -  To evaluate the safety and efficacy of surgery in patients with resectable hepatic metastasis secondary to gastrointestinal stromal tumor.
  OUTLINE: This is a multicenter study.
  Patients undergo surgical resection of hepatic metastasis.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of gastrointestinal stromal tumor (GIST)
  -  Hepatic metastasis meeting the following criteria:
  -  Clinically diagnosed as surgically resectable with no macroscopic residual tumor
  -  No more than 3 hepatic metastases
  -  Synchronous hepatic metastasis allowed provided primary tumor is also resectable
  -  Does not require radiofrequency ablation and/or microwave coagulation therapy to control the disease
  -  No extrahepatic metastasis
  -  No history of GIST recurrence
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-1
  -  Leukocyte count ≥ 3,000/μL
  -  Neutrophil count ≥ 1,500/μL
  -  Hemoglobin ≥ 8.0 g/dL
  -  Platelet count ≥ 75,000/μL
  -  Total bilirubin ≤ 2.0 mg/dL
  -  ALT and AST < 120 IU/L
  -  GTP < 210 IU/L
  -  Not pregnant
  -  No poorly controlled diabetes mellitus
  -  No NYHA class III-IV cardiac function
  -  No hepatitis B or hepatitis B carriers
  -  No other malignancy requiring treatment
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No prior interventional radiology for metastatic disease
  -  No prior or concurrent imatinib mesylate
  -  No other concurrent treatment

Relevance to patient case: not relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

Summary: Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

Detailed description: Masitinib is a selective tyrosine kinase inhibitor with potent activity against wild-type c-Kit, the juxta membrane domain of c-Kit, and PDGFR. In addition to its direct inhibitory action against these kinase targets, masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective of this prospective, multicenter, randomized, open-label, active-controlled study is to compare the efficacy and safety of masitinib with respect to imatinib in the first line treatment of gastro-intestinal stromal tumor (GIST). Treatment will be given until disease progression, limiting toxicity or patient consent withdrawal.

Eligibility: Main inclusion criteria include:
  -  Histologically proven, metastatic or locally advanced non resectable, or recurrent post-surgery GIST
  -  Naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after imatinib discontinuation
  -  c-Kit (CD117) positive tumours detected by immuno-histochemically or PDGFR positive if c-Kit negative
  Main exclusion criteria include:
  -  Patient previously treated by tyrosine kinase inhibitors except imatinib in case of inclusion criteria
  -  Patient treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
  -  Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis

Relevance to patient case: definitely relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: Epidermal Growth Factor Receptor and K-ras Mutations in Patients With Stage III Non-Small Cell Lung Cancer

Summary: RATIONALE: Collecting and storing samples of tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at epidermal growth factor receptor mutations and k-ras oncogene mutations in patients with stage III non-small cell lung cancer.

Detailed description: OBJECTIVES:
  -  Determine the frequency of epidermal growth factor receptor (EGFR) and K-ras mutations in patients with stage III non-small cell lung cancer (NSCLC) treated on CALGB 30106.
  -  Correlate presence or absence of EGFR and/or K-ras mutations with radiographic response to treatment in these patients.
  OUTLINE: Tissue samples are analyzed for epidermal growth factor receptor and K-ras mutations.

Eligibility: Inclusion criteria:
  1. Eligible patients had histologic documentation of un- treated stage III NSCLC.
  2. Radiation oncologist confirmation was required that radiation could be given per protocol.
  3. Eastern Cooperative Group Criteria Performance Status of 0 to 2
  4. Tumor specimen paraffin block or unstained slides and standard initial laboratory tests
  5. Signed institutional review board-approved, protocol-specific in- formed consent in accordance with federal and institutional guidelines
  Exclusion criteria:
  1. Patients with scalene, supraclavicular, or contralateral hilar lymph node involvement, or direct invasion of the vertebral body or with a pleural effusion were ineligible.

Relevance to patient case: not relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

Summary: This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.


Eligibility: Inclusion Criteria:
  -  histologically or cytologically proven diagnosis of non-small cell lung cancer
  -  positive for the ALK fusion gene (test provided by a central laboratory)
  -  must have had disease progression after only one prior chemotherapy and that regimen but must have included one platinum drug
  -  tumors must be measurable
  Exclusion Criteria:
  -  prior treatment with PF-02341066
  -  current treatment in another clinical trial

Relevance to patient case: not relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: A Prospective, Multicenter Study on Best Clinical Use of Imatinib in the Advanced Gastrointestinal Stromal Tumors

Summary: Open-label, multicenter study of imatinib (400mg/die p.o.)in patients with advanced gastrointestinal stromal tumors. Patients will be treated for up to 12 months. Data regarding its best clinical use in terms of tumor response, survival, tolerability and safety profile will be prospectively collected.


Eligibility: Inclusion Criteria:
  1. Patients ≥ 18 years of age.
  2. Histologically documented diagnosis of GIST, unresectable and/or metastatic and therefore incurable with any conventional multimodality approach.
  3. Immunohistochemical documentation of c-kit (CD117) expression by tumor, as detected on a tumor sample taken within 6 weeks of study entry.
  4. At least one measurable site of disease (RECIST Criteria), or other response assessment criteria, as appropriate.
  5. Performance status 0,1, 2 or 3 (ECOG).
  6. Adequate end organ function.
  7. Adequate bone marrow function.
  8. Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing.
  Exclusion Criteria:
  1. Previous treatment with any other investigational agents within 28 days of first day of study drug dosing, unless the disease is rapidly progressing.
  2. Other primary malignancy with < 5 years clinically assessed disease free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged after consultation with the Steering committee to entail a low risk of relapse.
  3. Grade III/IV cardiac problems as defined by the New York Heart Association Criteria.
  4. Pregnancy, breast-feeding.
  5. Severe and/or uncontrolled medical disease.
  6. Known brain metastasis.
  7. Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
  8. Known diagnosis of human immunodeficiency virus (HIV) infection.
  9. Previous treatment with chemotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin-C).
  10. Previous radiotherapy to ≥ 25 % of the bone marrow.
  11. Major surgery within 2 weeks prior to study entry.

Relevance to patient case: definitely relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: Study of Tumor Samples in Patients Undergoing Treatment for Gastrointestinal Stromal Tumors on Clinical Trial ACOSOG-Z9001

Summary: RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.
  PURPOSE: This research study is looking at tumor samples in patients undergoing treatment for gastrointestinal stromal tumors on clinical trial ACOSOG-Z9001.

Detailed description: OBJECTIVES:
  Primary
  -  To examine polymorphisms in selected genes involved in the detoxifying/metabolizing and DNA repair pathways in relation to specific mutations and types of mutation in the c-kit gene in tumor tissue from patients with gastrointestinal tumors (GIST) undergoing treatment on clinical trial ACOSOG-Z9001.
  Secondary
  -  To examine approximately 758 polymorphisms among candidate genes involved in detoxification/metabolism, cell cycle control, and DNA damage/repair in relation to specific mutations and types of mutation in the c-kit gene in tumor tissue from GIST patients for hypothesis generation. (exploratory)
  -  To conduct an exploratory analysis of the polymorphism distribution in these patients. (exploratory)
  -  To examine the association between the above polymorphisms and major toxicity (Grade 3/4) of adjuvant imatinib mesylate. (exploratory)
  OUTLINE: Tumor samples are used for polymorphism and mutation analysis.

Eligibility: DISEASE CHARACTERISTICS:
  -  Tumor samples from patients with gastrointestinal stromal tumors enrolled on clinical trial ACOSOG-Z9001

Relevance to patient case: definitely relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation

Summary: The purpose of this study is to determine whether nilotinib is efficacious in the treatment of metastatic and/or inoperable melanoma harboring a c-Kit mutation.

Detailed description: This trial began as a multi-center, randomized, Phase III, controlled trial for nilotinib vs (DTIC) dacarbazine to assess the efficacy and safety of nilotinib (400 mg bid) in patients with c-Kit mutated metastatic and/or inoperable melanoma. The study was open to patients with mucosal or acral melanoma.
  Due to substantial difficulties identifying and recruiting eligible patients, the trial design was altered from a randomized, two-arm, Phase III study to a single-arm, Simon two-stage Phase II study with protocol Amendment 2 (27-Jul-2011). While the original protocol required the recruitment of 120 patients, this amendment required the study to recruit only 41 patients (patients randomized to nilotinib prior to Amendment 2 were to be counted in this total, but those randomized to dacarbazine ( DTIC ) DTIC were not). Patients randomized to DTIC were allowed to cross-over to nilotinib, either immediately or at the time of progression.

Eligibility: Inclusion Criteria:
  1. Histologically confirmed mucosal or acral 2. Presence of a c-Kit mutation of exon 9, 11 or 13, or mutations Y822D and mutations D820Y, Y823D of exon 17, as confirmed by the central laboratory 3. Stage III unresectable or stage IV disease 4. The presence of one or more measurable lesions as detected by radiological or photographic methods and assessed according to RECIST 1.0. Lesions must have a size of at least 10mm at longest diameter (using a slice thickness of 5 mm)or double the slice thickness to be considered a target lesion. Target lesions should not be selected in previously irradiated fields unless there is clear evidence of progression 5. WHO performance status 0 - 2
  Exclusion Criteria:
  1. C-Kit mutation of exons 17(except mutations D820Y, Y822D or Y823D) or any other exon not allowed by the inclusion criteria
  2. Patients with c-Kit amplifications only and no mutation
  3. Patients with any history of brain metastases
  4. Patients who have had any prior treatment with TKIs
  5. Patients receiving medications or herbal extracts which interfere with nilotinib metabolism which are not discontinued by the time of the baseline visit
  6. Acute or chronic liver or renal disease considered unrelated to melanoma
  Other protocol-defined inclusion/exclusion criteria may have applied.

Relevance to patient case: not relevant