araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Randomized Trial of Adjuvant Chemotherapy With Cisplatin Followed by UFT in Serosa-positive Gastric Cancer (JCOG9206-2)

Summary: To evaluate the survival benefit of adjuvant chemotherapy after curative resection with D2 or greater lymph node dissection in T3-4 gastric cancer patients.

Detailed description: Purpose: To evaluate the survival benefit of adjuvant chemotherapy after curative resection in serosa-positive gastric cancer patients, a multicenter phase III clinical trial was conducted by 13 participating centers in Japan. Methods: From January 1993 to March 1998, 268 patients were randomized to either adjuvant chemotherapy (135 pts) or surgery alone (133 pts). The chemotherapy comprised intraperitoneal cisplatin 70 mg/m2 before closing the abdomen, and after surgery intravenous cisplatin 70 mg/m2 (day 14) and 5-fluorouracil (5-FU) 700 mg/m2 daily (day 14-16), and oral FU (UFT) 267 mg/m2 daily from 4 weeks after surgery for the next 12 months. The primary endpoint was overall survival. Relapse-free survival and the site of recurrence were secondary endpoints.
  Comparison: gastrectomy with D2 or greater lymph node dissection versus gastrectomy with adjuvant chemotherapy after curative resection in serosa-positive gastric cancer patients.

Eligibility: Inclusion Criteria:
  1. Curative operation with D2 or greater lymph node dissection
  2. Histologically proven gastric adenocarcinoma
  3. Macroscopically serosa-positive (T3-4)
  4. No metastases to level 3 - 4 lymph nodes station (N0-2)
  5. 75 years or younger
  6. Negative peritoneal lavage cytology
  7. Adequate organ function WBC >=4000/mm3,Hb >=11.0g/dl,Plt >=100.000/mm3,AST/ALT, T.Bil, BUN, Creatinine <=2.5 x Normal Upper Limit,Creatinine clearance <=70 ml/min
  8. Written informed consent
  Exclusion Criteria:
  1. Prior chemotherapy or radiotherapy
  2. Synchronous or metachronous malignancy in other organs

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

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: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Paclitaxel-HDFL for Locally Advanced and Recurrent/Metastatic Gastric Cancers

Summary: The purpose of this study is to evaluate the efficacy,response rate,time to treatment failure,overall survival,toxicities of Paclitaxel-HDFL regimen in locally advanced/inoperable and recurrent/metastatic gastric cancers. To evaluate the resectability and relapse pattern after potentially curative resection of neoadjuvant Paclitaxel-HDFL regimen

Detailed description: In the treatment of metastatic breast cancer, paclitaxel followed by weekly HDFL has been shown to have a 55% response rate in anthracycline-resistant patient. Recently, regimen combining paclitaxel and moderately-high-dose 5-FU (1500mg/m2) has had response rate up to 61.5% (including 23%CR) in a small group of gastric cancer patients (8 responders in 13 patients). Thus, the sequential use of weekly paclitaxel followed by weekly HDFL regimen may become a new generation of chemotherapeutic regimen for the treatment of gastric cancer. Further study with a larger group of patients and further testing of possible schedules of administration are warranted.

Eligibility: Inclusion Criteria: 1.Histologically or cytologically confirmed gastric adenocarcinoma 2.Measurable or evaluable disease 3.No previous C/T 4.Age 18 ~ 70 years 5.KPS >=60% 6.WBC>=4,000, pltate>=100K, Creatinine<=1.5mg/dl, serum bil<=1x UNL, transaminase<=3.5x ULN
  Exclusion Criteria: 1.CNS metastasis 2.Patients receive concomitant anti-cancer C/T or R/T 3.Patients who are pregnant and with an expected life expectancy less than 3months 4.Symptomatic heart disease,active infection, extensive liver disease or liver cirrhosis 5.TG<=70mg/dl 6.Mental status is not fit for clinical trial

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Taxol(Paclitaxel),UFT and Leucovorin in Patients With Advanced Gastric Cancer

Summary: The purpose of this study is to evaluate the response rate of Paclitaxel combination chemotherapy with UFT and Leucovorin in patients with advanced gastric cancer.

Detailed description: Since 1982,cancer has been the leading cause of death in Taiwan. In particular,gastric cancer is the fourth leading cause of death in male cancer patients and the sixth for female patients in 2000,accounting for an estimated 2,374 deaths. In recent years, the treatment of gastric cancer patients has gradually been improving due to advances in early diagnosis and surgical techniques. Although chemotherapy and radiation therapy have been used in either the adjuvant or palliative setting, their values are still limited due to their unacceptable toxicity or inadequate efficiency.

Eligibility: Inclusion Criteria:
  1. At least 18 years old
  2. Patients with histologically confirmed gastric adenocarcinoma, defined as locally advanced unresectable or metastatic or recurrent disease
  3. Patients with at least one measurable lesion
  4. ECOG performance status of 0,1 or 2
  5. Patients with no prior chemotherapy and radiotherapy for metastatic disease (patients who have received and completed prior adjuvant chemotherapy at least 6 months prior to study enrollment may be enrolled into the study, prior taxane chemotherapy should be excluded)
  6. Patients with physiological functions (bone marrow, heart, liver, kidney, etc.) meeting the following criteria: WBC >4000/mm3, ANC >1500/mm3, PLT >100,000/mm3, Hb >9.0g/dL, ALT<3 times the ULN (<5 times the ULN for liver metastasis cases), Total bilirubin <1.5mg/dL, Creatinine <the upper limit of normal
  7. Accessible for treatment and follow-up
  8. Give written informed consent
  9. Women of child bearing potential must have a negative plasma or urine pregnancy test within 72 hours prior to start of the study medication
  Exclusion Criteria:
  1. Patients who received surgery within 14 days prior to enrollment
  2. Patients with CNS metastasis
  3. History of hypersensitivity related to the administration of polyoxyethylated-castor-oil (cremophor EL)-containing preparation (e.g. cyclosporin,etc.) or hardened-castor-oil-containing preparation (e.g. vitamin preparation for injection,etc.)
  4. Patients with a history of severe hypersensitivity
  5. Active infectious symptoms
  6. Patients with active gastrointestinal bleeding, intestinal obstruction or other situation that dose not allow oral intake of medication
  7. Patients with ascites that adversely affects performance status
  8. Pre-existing CTC Grade 2 or greater neuropathy (motor or sensory)
  9. Pregnant or nursing females
  10. Patients who have participated in other clinical trials within 30 days prior to the first dose of the study drug

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Role of Routine Nasogastric Decompression After Subtotal Gastrectomy

Summary: The aim of the study is to evaluate whether subtotal gastrectomy without post-operative nasogastric decompression is better in terms of early post-operative bowel function and chest complication.

Detailed description: Nasogastric decompression is an intra-operative routine in most of the time to facilitate exposure of operative field during elective subtotal gastrectomy, but whether it should be retained post-operatively is controversial. Nasogastric decompression helps to drain the gastric remnant in case there is edema around the gastrojejunostomy, ileus and delayed gastric emptying, which can theoretically relieve nausea and abdominal distension. Besides, it may help decrease diaphragmatic splintage and hence decrease chance of chest infection if ileus occurs. However, nasogastric intubation could cause patient discomfort; also it has been shown that it would cause gastroesophageal reflux which may be associated with chest complication. There have been studies showing that routine post-operative nasogastric decompression is not necessary for gastrectomy in general, but the role in subtotal gastrectomy for stomach cancer is not well defined.

Eligibility: Inclusion Criteria:All patients suffering from carcinoma of stomach, decided for operation
  -  subtotal, D1/D2 dissection
  -  palliative resection
  Exclusion Criteria:
  -  actively bleeding tumor
  -  perforation of tumor
  -  patient present with gastric outlet obstruction
  -  combine organ excision
  -  known diabetes with nephropathy

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Study of Adjuvant Radiochemotherapy for Gastric Cancer

Summary: In 1991, the South West Oncology Group (SWOG) conducted a randomized study of adjuvant chemotherapy (5-fluorouracil and folinic acid) with concurrent radiation (4500 cGy/25 fractions) versus surgery alone for patients with completely resected gastric carcinoma.
  This landmark study showed the benefit of adjuvant treatment for gastric cancer and radically changed the treatment of this disease. However, the resulting standard treatment has severe acute toxicity, and despite this advance, 50% of patients still die of gastric cancer. The investigators hope to develop a modified protocol using active chemotherapy agents, but with reduced acute toxicity. Such an approach could ultimately be studied against the current SWOG approach to determine whether or not the addition of cisplatinum improves efficacy.
  Patients who decide to participate in the study will receive a chemotherapy drug called 5-Fluorouracil (5FU)through an intravenous catheter continuously over 12 weeks. Patients will not be admitted to hospital to receive the chemotherapy but will need to wear a waist pack to carry a small pump that will deliver the medication. They will however need to make regular visits to have their medication bags changed. Patients will also receive Cisplatin intravenously every 2 weeks for 4 doses. In addition, patients will also receive radiation to their stomach, lymph nodes, and the area where they had their surgery. This study also comprise of a questionnaire for us to see how patient's cancer and treatment is affecting their quality of life. Patients will have regular follow-up by their physicians.


Eligibility: Inclusion Criteria:
  -  R0 resection (no microscopic residual) of adenocarcinoma of stomach or gastroesophageal (GE) junction, prior to starting chemotherapy and radiation
  -  Tumor must not extend more than 2 cm along the esophagus; bulk of the tumor must be in the stomach.
  -  Adequate pre-operative cross-sectional imaging (computed tomography [CT] or magnetic resonance imaging [MRI])
  -  International Union Against Cancer (UICC)/American Joint Committee on Cancer (AJCC) Stage IB - IV, excluding patients with metastatic disease (T1N1, T2N0 to T4N1, N2, and any T, N3). T2N0 eligible only if disease extends beyond muscularis propria.
  -  No previous abdominal radiotherapy or contraindication to radiotherapy
  -  Eastern Cooperative Oncology Group (ECOG) performance status < 2
  -  Adequate major organ function
  -  Nutritional intake of at least 1500 calories per day at nutrition assessment
  -  Treatment started within 20-90 days post-op of surgery date.
  -  Informed consent
  Exclusion Criteria:
  -  Less than 70 years of age

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Cytokine Gene Polymorphisms in Gastric Diseases

Summary: Recently, cytokine polymorphisms are considered to play an important role in the pathogenesis of peptic ulcer and gastric cancer. We intended to clarify the association between polymorphisms of pro-inflammatory and anti-inflammatory cytokines, and the susceptibility to gastric cancer, gastric ulcer and duodenal ulcer in Japan, and to detect the individuals who have higher risks for gastrointestinal disease development.

Detailed description: H. pylori infection has close associations with the development of peptic ulcer diseases as well as gastric cancer, gastric adenoma, and gastric MALT lymphoma. The association of the host genetics with the susceptibility to various gastroduodenal disorders has been intensively investigated in the pathogenesis of peptic ulcer and gastric cancer by H. pylori infection .
  In chronic active gastritis induced by H. pylori infection, activated neutrophils and mononuclear cells produce several pro-inflammatory and anti-inflammatory cytokines. In fact, levels of pro-inflammatory and anti-inflammatory cytokines are elevated in gastric mucosa infected with H. pylori.
  Cytokine polymorphisms are associated with various inflammatory and autoimmune diseases. Recently, cytokine polymorphisms are considered to play an important role in the pathogenesis of peptic ulcer and gastric cancer. However, the roles of the IL-10 polymorphisms on the pathogenesis of H. pylori-related gastric cancer and peptic ulcer have not been fully elucidated.It is unclear whether pro-inflammatory and anti-inflammatory cytokines polymorphisms were associated with pathogenesis of peptic ulcer and gastric cancer in Japan. Then, we intended to clarify the association between polymorphisms of IL-10 and the susceptibility to gastric cancer, gastric ulcer and duodenal ulcer in Japan, and to detect the individuals who have higher risks for gastrointestinal disease development.

Eligibility: Inclusion Criteria:
  Exclusion Criteria:
  -  patinets without H. pylori

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Study of S-1, S-1/CDDP, and 5-FU/CDDP for Advanced Gastric Cancer

Summary: This is an open-label, multicenter, three arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of S-1 alone compared with S-1 plus CDDP, and S-1 plus CDDP compared with 5-FU plus CDDP in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease. Patients will be randomly assigned (1:1:1) to S-1 (Arm A), S-1/CDDP (Arm B) or 5-FU/CDDP (Arm C). Patients will be stratified to achieve balanced distribution of patients to each arm according to following stratifications, performance status (0, 1, or 2), the number of metastatic sites (1 vs >1), prior gastrectomy, and center.


Eligibility: Inclusion Criteria:
  -  Non-prior chemotherapy treated advanced gastric adenocarcinoma
  -  Age 18 and over
  -  Performance status 0, 1, or 2 (ECOG)
  -  Life expectancy 3 months
  -  Hematopoietic WBC lower limit of normal-12,000/mm^3 Absolute granulocyte count ≥ 2,000/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 8.0 g/dL
  -  Hepatic AST and ALT ≤ 100 U/L ALP ≤ 2 times upper limit of normal (ULN) Bilirubin ≤ 1.5 mg/dL
  -  Renal Plasma creatinine ≤ ULN Creatinine clearance ≥ 60 mL/min
  Exclusion Criteria:
  -  Interstitial pneumonia, pulmonary fibrosis
  -  Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure
  -  Intestinal paralysis, intestinal obstruction, uncontrollable diabetes

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years of Age and Older With Gastric Cancer

Summary: The number of patients over 70 years old with cancer is increasing in France. This population is heterogenous: physiological functions, presence of co-morbidities, and autonomy can vary a lot between subjects of the same age. Physicians hesitate to treat them with optimal doses because they are afraid of the risk of toxicity in spite of the benefits of treatment. Fifty eight percent of gastric cancers are diagnosed in patients over the age of 70 in France. FOLFIRI (irinotecan, leucovorin and fluorouracil) chemotherapy appears to be a promising treatment for digestive cancer. It increases the level of response and survival without major toxicity. It becomes necessary to evaluate patients, to propose adapted treatments for their conditions.
  The principal objectives are to demonstrate the efficacy of treatment, safety, survival and to find out if geriatric assessment data can help to better predict chemotherapy toxicity. The researchers plan to accrue 43 patients diagnosed with locally advanced or metastatic gastric cancer. They will receive FOLFIRI and 4 geriatric evaluations: before treatment, day 1 cycle 2, day 1 cycle 4 and at the end of chemotherapy. These evaluations include tests of cognitive functions (MMS), nutritional status (MNA), co-morbidity (CIRS-G), mobility (Get up and Go), activities (ADL; IADL), quality of life (QLQ-C30), depression (GDS-15) and Lachs-Balducci screening.


Eligibility: Inclusion Criteria:
  -  70 years of age or older
  -  Gastric cancer, locally advanced or metastatic
  -  No previous adjuvant treatment (surgery, radiotherapy, chemotherapy) in the last 6 months
  -  One measurable lesion
  -  ECOG < 3
  -  Biology and biochemistry within normal limits
  -  Life expectancy > 12 weeks
  Exclusion Criteria:
  -  Other palliative chemotherapy for this cancer
  -  Other cancer in the last 5 years
  -  Previous treatment with irinotecan
  -  Atropine treatment not possible
  -  Concomitant cancer therapy except bone radiotherapy
  -  Metastases to brain or meninges with symptoms
  -  Other severe pathology uncontrolled
  -  Problem of compliance

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Oxaliplatin in Gastric Cancer

Summary: To determine the objective response to oxaliplatin/5FU/leucovorin combination chemotherapy in patients with advanced unresectable or metastatic gastric cancer.


Eligibility: Inclusion Criteria:
  -  ECOG performance status of 0-2.
  -  Histologically proven gastric or gastro-esophageal junction adenocarcinoma.
  -  At least unidimensional measurable disease. If a unique metastasis constitutes the only disease sign, it requires histological confirmation.
  -  First line locally unresectable or metastatic gastric cancer.
  -  Relapsing gastric cancer after local and/or systemic treatment with a post-surgical period of at least 4 weeks, a post-adjuvant or neoadjuvant chemoradiotherapy period of at least 6 months.
  -  Serum bilirubin < 2 mg/dl
  -  Serum creatinine < or = 2 mg/dl
  -  Hemoglobin > or = 10 g/dl
  -  Absolute neutrophil count > or = 2000/dl
  -  Platelet count >or = 100, 000/dl
  -  AST/ALT < or = 2.5 time-fold the institutional normal upper limit
  -  Alkaline phosphatase < or = 5 time-fold the institutional normal upper limit
  -  Imagenological evaluation of the patient at least 2 weeks prior to the drug infusion
  -  Laboratory tests at least 1 week prior to the first infusion
  -  Patient available for follow up and able to answer to the quality of life questionnaire
  Exclusion Criteria:
  -  Symptomatic sensorial peripheral neuropathy
  -  Uncontrolled concomitant disease
  -  Another malignant neoplastic disease diagnosed within the previous 5 years to the diagnosis of advanced or metastatic gastric cancer, with the exception of 'in situ' cervix carcinoma or non-melanoma skin cancer
  -  Concomitant antitumoral treatment
  -  Cerebral metastases
  -  Unstable heart disease, even though in treatment
  -  Myocardial infarction within the last 6 months
  -  Radiotherapy within the last 6 weeks, surgery within the last 4 weeks, or chemotherapy within the last 6 months.
  -  Pregnancy or nursing ( or women in reproductive life without adequate contraception)
  -  Significant neurological or psychiatric disorders.

Relevance to patient case: not relevant