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

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ClinicalTrials.gov Identifier: NCT00335959
Recruitment Status : Terminated (Closed due to slow accrual)
First Posted : June 12, 2006
Results First Posted : August 17, 2012
Last Update Posted : August 17, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with radiation therapy works in treating patients with stomach cancer that can be removed by surgery.


Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: capecitabine Drug: oxaliplatin Procedure: conventional surgery Radiation: radiation therapy Phase 2

Detailed Description:

OBJECTIVES:

  • Determine the pathologic complete response rate in patients with primary gastric adenocarcinoma treated with neoadjuvant chemoradiotherapy comprising oxaliplatin, capecitabine, and radiotherapy. (This will not be completed as this study was closed early due to poor accrual.)
  • Assess the frequency and severity of toxicities associated with this regimen.
  • Explore, preliminarily, the association between DNA repair genes (ERCC-1, XRCC1, GST-P1, XPD, XPA, ribonucleotide reductase), target enzymes (thymidylate synthase [TS], dihydropyrimidine dehydrogenase, thymidine phosphorylase [TP]), and angiogenic factors (vascular endothelial growth factor [VEGF], epidermal growth factor [EGF], PD-ECGF, basic fibroblast growth factor, TSP-1 and -2, transforming growth factor [TGF]-β, and IL-8) and response to neoadjuvant therapy in patients with adenocarcinoma of the stomach. (This will not be completed as this study was closed early due to poor accrual.)
  • Explore, preliminarily, the association of haplotypes of candidate genes of TS, TP, ERCC-1, XPD, GST-P1, cyclooxygenase-2, EGF receptor, TGF-β, VEGF, and IL-8 with response and toxicity to neoadjuvant chemoradiation therapy in these patients. (This will not be completed as this study was closed early due to poor accrual.)
  • Explore, preliminarily, the feasibility of performing comparative genomic hybridization for analysis of DNA copy number changes in predicting response to neoadjuvant chemoradiation therapy. (This will not be completed as this study was closed early due to poor accrual.)

OUTLINE: This is a multicenter, pilot study.

  • Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours on days 1 and 22 and oral capecitabine twice daily on days 1-14 and 22-35 in the absence of disease progression or unacceptable toxicity.
  • Neoadjuvant chemoradiotherapy: Patients receive oral capecitabine twice daily on days 43-77 and undergo radiotherapy once daily on days 43-47, 50-54, 57-61, 64-68, and 71-75 in the absence of disease progression or unacceptable toxicity.
  • Surgery: Patients with stable or responding disease undergo surgery 4-6 weeks after completion of chemoradiotherapy.

Tumor tissue is obtained at surgery or endoscopic biopsy. Gene expression analysis and comparative genomic hybridization testing are conducted on the tissue. Blood is drawn prior to beginning study treatment and is analyzed for germline polymorphisms.

After completion of study treatment, patients are followed periodically for up to 3 years.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Chemoradiation Therapy With Oxaliplatin and Capecitabine for Patients With Surgically Resectable Gastric Cancer: A Pilot Phase II Trial With Molecular Correlates
Study Start Date : May 2006
Actual Primary Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Chemotherapy, Chemoradiation, Surgery

Chemotherapy: Oxaliplatin, 130 mg/m2, 2 hour IV infusion on Days 1 and 22; Capecitabine 850 mg/m2/dose, PO q 12 hours on Days 1-14 and 22-35 Chemoradiation: Capecitabine 650 mg/m2/dose, PO q 12 hours on days 43-77; Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43.

Surgery: Distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy

Drug: capecitabine
850 mg/m2/dose PO q 12 hours Days 1-14 and 22-35. 650 mg/m2/dose PO q 12 hours Days 43-77.
Other Name: Xeloda (NSC-712807)

Drug: oxaliplatin
130 mg/m2 by 2-hour infusion Days 1 and 22
Other Name: Eloxatin (NSC-266046)

Procedure: conventional surgery
Distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy
Other Name: gastrectomy

Radiation: radiation therapy
Beginning Day 43, patients will be treated 5 days/week at 180 cGy/day times 25 fractions to a total dose of 4,500 cGy.
Other Name: RT




Primary Outcome Measures :
  1. Pathologic Complete Response [ Time Frame: 17-19 weeks ]
    Pathologic complete response rates (pCR) of primary gastric adenocarcinoma when treated with oxaliplatin and capecitabine followed by capecitabine and radiation pre-operatively. On review of the resected gastric specimen and accompanying lymph nodes, pCR is no cancer recognized by the pathologist. Margins are free of tumor.


Secondary Outcome Measures :
  1. Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug [ Time Frame: Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery. ]
    Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5= Fatal.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335959


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Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Lawrence P. Leichman, MD Desert Regional Medical Center Comprehensive Cancer Center
Study Chair: Syed A. Ahmad, MD Barrett Cancer Center

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Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00335959     History of Changes
Other Study ID Numbers: CDR0000476577
U10CA032102 ( U.S. NIH Grant/Contract )
S0425 ( Other Identifier: SWOG )
First Posted: June 12, 2006    Key Record Dates
Results First Posted: August 17, 2012
Last Update Posted: August 17, 2012
Last Verified: July 2012

Keywords provided by Southwest Oncology Group:
adenocarcinoma of the stomach
stage I gastric cancer
stage II gastric cancer
stage III gastric cancer

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents