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Status:

TERMINATED

S0425 Oxaliplatin, Capecitabine, and RT in Treating Patients W/Stomach Cancer That Can Be Removed By Surgery

Lead Sponsor:

SWOG Cancer Research Network

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Gastric Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Gi...

Detailed Description

OBJECTIVES: * Determine the pathologic complete response rate in patients with primary gastric adenocarcinoma treated with neoadjuvant chemoradiotherapy comprising oxaliplatin, capecitabine, and radi...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed primary adenocarcinoma of the stomach, meeting the following criteria:
  • Newly diagnosed disease amenable to curative resection
  • Stage IB-III (T2-4)
  • Measurable or nonmeasurable disease
  • Enlarged lymph nodes outside of radiation fields must have preoperative biopsies
  • No positive lymph nodes outside of radiation fields
  • No distant metastasis
  • No gastroesophageal junction tumors
  • PATIENT CHARACTERISTICS:
  • Zubrod performance status 0-1
  • Absolute neutrophil count ≥ 1,500/mm³
  • WBC ≥ 3,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 1.5 times upper limit of normal
  • Albumin ≥ 3 g/dL
  • Bilirubin normal
  • No evidence of ischemic heart disease by EKG
  • No coronary artery disease requiring active medical treatment
  • No symptoms of angina
  • No history of myocardial infarction
  • No deep vein thrombosis within the past 12 months
  • No pre-existing peripheral neuropathy
  • No active pneumonia or inflammatory lung infiltrate
  • No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for ≥ 5 years
  • No clinically significant comorbid medical conditions that would prevent delivery of chemotherapy, radiotherapy, or the performance of surgery
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • PRIOR CONCURRENT THERAPY:
  • At least 4 weeks since prior and no concurrent sorivudine or brivudine
  • No prior therapy for this malignancy, including chemotherapy, surgery, immunotherapy, or radiotherapy
  • No prior coronary angioplasty or stenting
  • No concurrent 2-dimensional or intensity-modulated radiotherapy

Exclusion

    Key Trial Info

    Start Date :

    May 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    7 Patients enrolled

    Trial Details

    Trial ID

    NCT00335959

    Start Date

    May 1 2006

    Last Update

    August 17 2012

    Active Locations (75)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 19 (75 locations)

    1

    Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, United States, 72205

    2

    Providence Saint Joseph Medical Center - Burbank

    Burbank, California, United States, 91505

    3

    USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, United States, 90089-9181

    4

    Desert Regional Medical Center Comprehensive Cancer Center

    Palm Springs, California, United States, 92262