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

Clinical trial: Simultaneous Integrated Boost Radiotherapy and Concurrent Nimotuzumab or Chemotherapy for Esophageal Carcinoma

Summary: This prospective, non-randomized phase II study aims to compare radiotherapy and concurrent nimotuzumab with concurrent chemoradiotherapy to obtain a non-inferior pCR rate and pathological lymph node metastases rate in premise of lower toxicities in locally advanced esophageal cancer.

Detailed description: In the era of IMRT and concurrent chemoradiotherapy, the 5-year overall survival of esophageal cancer increase from 10% to about 20%-40%, recurrence rate decrease from 80% to 50%-60%, and local recurrence remains to be the most important type of failure. What called for is to enhance local control without increasing toxicity to improve survival. The investigators have found effective and safe regimen of simultaneously integrated boost radiotherapy in previous study, which can achieve high dose in tumor area with avoid of normal tissues. However, a recent prospective study reported that neoadjuvant chemoradiotherapy resulted in much higher toxicities compares to neoadjuvant chemotherapy (46% vs. 15%, p= 0.04). Although chemoradiotherapy reached a higher pCR rate (28% vs. 9%, p=0.002), patients did not differ in survival in two groups.
  Nimotuzumab is an humanized monoclonal antibody against EGFR. Radiotherapy combines Nimotuzumab reveals synergistic effect in head and neck cancers with lower toxicities as compared to concurrent chemoradiotherapy. Our previous study showed that EGFR expression rate were similar in esophageal cancer and head and neck cancers. Based on above results, the investigators design this study which aims to obtain a non-inferior pCR rate and pathological lymph node metastases rate in premise of lower toxicities.

Eligibility: Inclusion Criteria:
  -  Diagnosis of clinical stage T1-4aN0-1M1a untreated squamous esophageal carcinoma
  -  KPS≥70
  -  Adequate organ function
  -  No known history of drug allergy
  Exclusion Criteria:
  -  Known drug allergy
  -  Insufficient hepatorenal function
  -  Severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.

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

Clinical trial: Predictive Value of Diffusion-weighted MRI Performed in Early Post-treatment in the Occurrence of Tumor Recurrence or Progression in Head and Neck Squamous Cell Carcinoma Treated With Chemoradiotherapy: a Pilot Study

Summary: Head and neck squamous cell carcinoma are frequent. The chemoradiotherapy protocols are part of the reference treatment of locally advanced stage tumors. Diffusion-weighted MRI (DW-MRI) is a non radiating imaging, not requiring injection of gadolinium, giving informations on tumor activity, based on the brownian motion of water molecules. The differences in motion are expressed by the apparent diffusion coefficient (ADC). The ADC variations reflect changes in water molecules motion and redistribution between the intra- and extracellular compartments. Several studies have shown that malignant lesions have an ADC coefficient lowered as compared to benign lesions.

Detailed description: study the diagnostic performance of diffusion MRI performed in early post treatment, notably changes in the ADC factor, in the onset of tumor recurrence or progression in patients showing no residual tumor at the end a treatment by chemoradiotherapy for squamous cell carcinoma of head and neck seat.
  compare the characteristics of diffusion MRI, such as ADC coefficient, between patients with residual tumor and patients with no residual tumor after chemoradiotherapy for squamous cell carcinoma of head and neck location.

Eligibility: Inclusion Criteria:
  -  patients with head and neck squamous cell carcinoma
  -  patients with indication of a treatment by chemoradiotherapy (without surgical indication)
  -  patient consenting to participate to the study
  -  patient enrolled in the national healthcare insurance program
  -  patient older than 18 years
  Exclusion Criteria:
  -  patients with contraindications for MRI

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

Clinical trial: Serum Squamous Cell Carcinoma Antigen Level and Tumor Volume in Head and Neck Cancer

Summary: Correlation between serum squamous cell carcinoma antigen level and tumor volume in Head and Neck Cancer is to determine a correlation between level of serum squamous cell carcinoma antigen and tumor volume in Head and Neck Caner measured by cross-sectional imaging.

Detailed description: The study is a cross-sectional study. A single measurement of serum squamous cell carcinoma antigen level is performed in the eligible Head and Neck squamous cell carcinoma patients.
  The study tool measuring serum squamous cell carcinoma antigen level is ARCHITECT SCC (Abbott).
  The gross tumor volume in the cross sectional imaging obtained within 2 weeks of each patient is calculated with the typical ellipsoid formula.
  Correlation between both parameters will be determined.

Eligibility: Inclusion Criteria:
  -  Histologically proven squamous cell carcinoma in Head and Neck
  -  Getting a cross-sectional imaging of Head and Neck within 2 weeks of collecting serum squamous cell carcinoma antigen
  Exclusion Criteria:
  -  Metastatic disease
  -  Accompanied Non-Head and Neck squamous cell carcinoma
  -  Nasopharyngeal, thyroid, salivary, nose and paranasal sinus carcinoma
  -  Skin disease: eczema, erythrodermic epidermitis, pemphigus, and psoriasis
  -  Pulmonary disease: tuberculosis, adult respiratory distress syndrome, pulmonary infiltration with eosinophilia, sarcoidosis, and bronchogenic cyst
  -  Renal failure
  -  Using antihistamine eye drops

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 Clinical Study of the Poorly Differentiated Head and Neck Squamous Cell Carcinoma

Summary: Head and neck Squamous Cell Carcinoma (HNSCC) is one of the most common head and neck malignant tumors .Investigators found that several patients with early TNM stage and poor differentiated HNSCC had poor prognosis, yet someone with advanced TNM stage and well differentiated HNSCC had good prognosis. Hence, Investigators suggested that prognosis factors and survival rates probably related to the differentiation of HNSCC, and prognosis factor of poorly differentiated HNSCC were rare discussed and controversy. Investigating the prognostic factors of poorly differentiated HNSCC is undoubtedly crucial.

Detailed description: Head and neck Squamous Cell Carcinoma (HNSCC) is one of the most common head and neck malignant tumors. Investigators found that several patients with early TNM stage and poor differentiated HNSCC had poor prognosis, yet someone with advanced TNM stage and well differentiated HNSCC had good prognosis. Hence, Investigators suggested that prognosis factors and survival rates probably related to the differentiation of HNSCC, and prognosis factor of poorly differentiated HNSCC were rare discussed and controversy. Investigating the prognostic factors of poorly differentiated HNSCC is undoubtedly crucial.
  About this study ,inclusion criteria were the following parts:
  the patients of poor differentiated HNSCC ; T1-4aN0-2M0; pathological examination: poor differentiated squamous cell carcinoma; initial treatment(primary, without surgery, radiotherapy and chemotherapy); range:18-70 years old; KPS>80; hemogram and the function of main organ such as heart, lung, liver and kidney were normal; having the endoscopy, CT and MRI before formed into different groups; sign the informed consent file, good compliance.
  AND the exclusion criteria were:
  uncontrollable epileptic seizure, disorder of central nervous system or unconsciousness cause by psychosis; serious and uncontrollable infection; main organ system failure (including heart ,lung ,liver and kidney); reject training; high and moderate differentiated squamous cell carcinoma

Eligibility: Inclusion Criteria:
  -  Patients of poor differentiated HNSCC ;
  -  Patients within the stage of T1-4aN0-2M0;
  -  The pathological examination of the patients show poor differentiated squamous cell carcinoma;
  -  Patients with initial treatment(primary, without surgery, radiotherapy and chemotherapy);
  -  18-70 years old;
  -  KPS>80;
  -  Hemogram and the function of main organ such as heart, lung, liver and kidney were normal
  -  Having the endoscopy, CT and MRI Signed the informed consent file, good compliance.
  Exclusion Criteria:
  -  Uncontrollable epileptic seizure, disorder of central nervous system or unconsciousness cause by psychosis;
  -  Serious and uncontrollable infection;
  -  Main organ system failure (including heart ,lung ,liver and kidney); reject training;
  -  High and moderate differentiated 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: Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients in China

Summary: To evaluate the concordance of sensitizing mutations detected between paired plasma and tissue samples; the correlation between the clonal status of sensitizing mutations and targeted therapy response; and the prognostic impact of the relative abundance of sensitizing / resistance mutations.

Detailed description: In the study, 500 advanced NSCLC patients will be recruited. All the patients will receive biopsy genotype assay and circultating tumor DNA (ctDNA) liquid biopsy. Patients who carry actionable EGFR mutation, ROS1 fusion, ALK fusion or MET exon 14 skipping mutation will receive TKI treatment according to guidelines. During the TKI treatment, every patients will take liquid biopsy assay to monitor the mutation status. The study will be ended when all the patients had a progressive disease (PD) in their targeted lesion.

Eligibility: Inclusion Criteria:
  -  Provision of informed consent
  -  Newly diagnosed and histological or cytological confirmed stage IIIB-IV lung adenocarcinoma or non-smoking squamous cell carcinoma patients according to the AJCC staging system. The stage IV lung cancer and brain metastasis can be diagnosed by imaging and enhanced CT respectively
  -  ECOG performance status 0-2 with expected more than 6 months of survival time
  -  Willingness to comply with required protocols and give permission to use the data for clinical research and products development
  Exclusion Criteria:
  -  Patients have other primary cancers
  -  Patients have symptomatic brain metastasis, complications that are associated with brain metastasis or cognitive disorders
  -  Patients failed in either plasma or tissue sample QC

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia, Osteosarcoma, or Non-Hodgkin's Lymphoma

Summary: RATIONALE: Drugs used in chemotherapy, such as trimetrexate glucuronate and leucovorin, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
  PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating children with recurrent acute lymphoblastic leukemia, recurrent osteosarcoma, or refractory non-Hodgkin's lymphoma.

Detailed description: OBJECTIVES:
  -  Determine the efficacy of trimetrexate glucuronate with leucovorin calcium rescue in children with recurrent acute lymphoblastic leukemia, recurrent osteogenic sarcoma, or refractory non-Hodgkin's lymphoma resistant to methotrexate.
  -  Evaluate the toxicity of this treatment regimen in this patient population.
  OUTLINE: Patients are stratified according to disease (acute lymphocytic leukemia, non-Hodgkin's lymphoma vs osteogenic sarcoma).
  Patients receive trimetrexate glucuronate orally or IV every 12 hours on days 1-21 and oral leucovorin calcium every 12 hours on days 1-24. Treatment repeats every 4 weeks. Patients with stable or responsive disease may receive up to 4 courses of therapy.
  PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologic evidence of one of the following malignancies that has failed conventional therapy:
  -  Acute lymphoblastic leukemia
  -  Non-Hodgkin's lymphoma with bone marrow involvement
  -  Osteogenic sarcoma
  -  In vitro transport resistance to methotrexate demonstrated by bone marrow aspirate assay
  PATIENT CHARACTERISTICS:
  Age:
  -  21 and under at diagnosis
  Performance status:
  -  ECOG 0-2
  Life expectancy:
  -  At least 8 weeks
  Hematopoietic:
  -  Granulocytopenia allowed with bone marrow involvement
  -  Thrombocytopenia allowed with bone marrow involvement
  -  Anemia allowed with bone marrow involvement
  Hepatic:
  -  (unless due to disease)
  -  Bilirubin no greater than 2.0 mg/dL
  -  AST no greater than 100
  Renal:
  -  Creatinine less than 1.5 mg/dL OR
  -  Creatinine clearance at least 60 mL/min
  Other:
  -  No other serious medical illness
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Prior bone marrow transplantation allowed
  Chemotherapy:
  -  At least 1 week since prior intrathecal treatment
  -  At least 2 weeks since prior systemic chemotherapy and recovered
  -  At least 10 days for rapidly proliferating leukemia (i.e., WBC greater than 50,000)
  -  No concurrent chemotherapy
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  Prior radiotherapy allowed and recovered
  -  No concurrent radiotherapy
  Surgery:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Interferon Alfa in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia

Summary: RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Low doses of interferon alfa may be as effective as high doses.
  PURPOSE: Randomized phase III trial to compare the effectiveness of low-dose or high-dose interferon alfa in treating patients who have newly diagnosed chronic myelogenous leukemia.

Detailed description: OBJECTIVES: I. Compare the duration of chronic phase and survival following low- vs. high-dose interferon alfa maintenance therapy in patients with chronic myelogenous leukemia in chronic phase. II. Compare the toxicity profiles, assessed by WHO criteria, and the percentage of patients requiring dose reduction or discontinuation with these two regimens. III. Compare hematologic and cytogenetic responses every 6 months in patients treated on these two regimens.
  OUTLINE: This is a randomized study. Patients receive daily hydroxyurea until their white blood cell count (WBC) is maintained at a normal level for 2-3 weeks. Patients are randomized to two groups: one group receives daily high-dose interferon alfa, and the other receives low-dose interferon alfa, 5 days per week. Both groups continue to receive hydroxyurea at reduced doses as needed to maintain a normal WBC. Treatment continues until disease progression occurs. Patients may receive cytarabine in addition to interferon in either treatment arm at the investigator's discretion. Cytarabine is given subcutaneously for 10 days every calendar month and continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for survival.
  PROJECTED ACCRUAL: Approximately 800 patients will be enrolled over 8 years on this multicenter study.

Eligibility: DISEASE CHARACTERISTICS: Chronic myelogenous leukemia in chronic phase Molecular evidence of BCR/ABL rearrangement OR Presence of Philadelphia chromosome Eligibility for allogeneic bone marrow transplantation does not exclude
  PATIENT CHARACTERISTICS: Age: Adult Performance status: WHO 0-2 Hematopoietic: Not specified Hepatic: Bilirubin less than twice normal No severe hepatic problem Renal: Creatinine less than twice normal No severe renal problem Cardiovascular: No severe cardiovascular problem Other: No contraindication to interferon therapy No history of severe depression No pregnant women Effective contraception required of fertile women
  PRIOR CONCURRENT THERAPY: No prior therapy Prior therapeutic or back-up leukapheresis allowed Hydroxyurea may be started up to 4 weeks prior to entry

Relevance to patient case: definitely relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

Summary: RATIONALE: Bone marrow that has been treated to remove certain white blood cells may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy, and may reduce the chance of developing graft-versus-host disease following bone marrow transplantation.
  PURPOSE: Phase IV trial to study the incidence of graft-versus-host disease in patients who have hematologic cancer and who are undergoing bone marrow transplantation from a donor.

Detailed description: OBJECTIVES: I. Evaluate the incidence of acute graft versus host disease in patients undergoing transplantation with an unrelated or related matched or mismatched antigen donor. II. Evaluate the rapidity of engraftment and CD4 count recovery post-transplantation in this patient population.
  OUTLINE: Patients receive total body irradiation (TBI) three or two times a day on days -8 to -5. Following TBI, patients receive thiotepa IV over 4 hours daily on days -4 and -3 plus cyclophosphamide IV over 1 hour daily on days -2 and -1. Antithymocyte globulin is administered by IV over at least 4 hours on days -4 to -1. Patients undergo an allogenic bone marrow transplantation on day 0. Bone marrow is harvested from patient's donor, depleted of T-cells, and infused. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 4.
  PROJECTED ACCRUAL: Approximately 26-45 patients will be accrued for this study within 3-4 years.

Eligibility: DISEASE CHARACTERISTICS: Histologically proven malignancy or condition of the following types: Acute myelogenous leukemia (not M5 or M6) or lymphocytic leukemia in first or greater remission or early relapse OR Chronic myelogenous leukemia OR Myelodysplastic syndrome OR Aggressive or refractory non-Hodgkin's lymphoma OR Aggressive or refractory Hodgkin's disease OR Multiple myeloma at early relapse or after conventional chemotherapy to reduce tumor mass OR High risk chronic lymphocytic leukemia OR Aplastic anemia HLA-matched or 1 antigen mismatched (related or unrelated) available as donor
  PATIENT CHARACTERISTICS: Age: 50 and under Performance status: Karnofsky 70-100% Life expectancy: Greater than 8 weeks Hematopoietic: Not specified Hepatic: Bilirubin less than 2 mg/dL SGOT less than 4 times upper limit of normal (ULN) Renal: Creatinine less than 2 times ULN OR Creatinine clearance greater than 60 mL/min Cardiovascular: LVEF at least 50% by MUGA Pulmonary: DLCO at least 50% Other: HIV negative No active extramedullary disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY: See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Genetic Study of Children With Soft Tissue Sarcoma or Rhabdomyosarcoma

Summary: RATIONALE: Determination of genetic markers for soft tissue sarcoma or rhabdomyosarcoma may help doctors identify patients who are at risk for therapy-related leukemia.
  PURPOSE: Clinical trial to study genetic testing of children with soft tissue sarcoma or rhabdomyosarcoma to identify children who are at risk of developing leukemia from the chemotherapy used to treat sarcoma.

Detailed description: OBJECTIVES:
  -  Identify genetically susceptible patients to therapy-induced myelodysplastic syndrome or acute myelogenous leukemia (t-MDS/AML) prior to initiation of high-dose chemotherapy for sarcoma.
  -  Identify patients who are at increased risk of t-MDS/AML during or after therapy.
  OUTLINE: Blood is collected from patients at diagnosis (preferably before chemotherapy or transfusion), at end of therapy, and at 6 months, 1 year, 2 years, and 3 years after therapy.
  Blood specimens are examined by clonality analysis (HUMARA), variant cell frequency (glycophorin A assay), GST NAT2/CYP1A1 genotyping, microsatellite instability, and ras mutation detection (single strand conformation polymorphism and sequencing of mutant alleles).
  Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.
  PROJECTED ACCRUAL: A total of 321 patients will be accrued for this study within 4 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of sarcoma including:
  -  Rhabdomyosarcoma
  -  Ewing's sarcoma
  -  Primitive neuroectodermal tumor
  -  Fibrosarcoma
  -  Malignant peripheral nerve sheath tumor
  -  Synovial cell sarcoma
  -  Osteosarcoma
  -  Other soft tissue sarcoma
  -  Must be currently receiving intensive or high-dose chemotherapy for sarcoma
  PATIENT CHARACTERISTICS:
  Age:
  -  Children
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  See Disease Characteristics
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  Not specified
  Surgery
  -  Not specified

Relevance to patient case: not relevant