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Neoadjuvant Chemoradiation Therapy With Oxaliplatin and Capecitabine for Patients With Surgically Resectable Gastric Cancer: A Pilot Phase II Trial With Molecular Correlates

Phase 2
18 Years
Not Enrolling
Gastric Cancer

Thank you

Trial Information

Neoadjuvant Chemoradiation Therapy With Oxaliplatin and Capecitabine for Patients With Surgically Resectable Gastric Cancer: A Pilot Phase II Trial With Molecular Correlates


- 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

- 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.

Inclusion Criteria


- Histologically confirmed primary adenocarcinoma of the stomach, meeting the following

- 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


- 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


- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic Complete Response

Outcome Description:

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.

Outcome Time Frame:

17-19 weeks

Safety Issue:


Principal Investigator

Lawrence P. Leichman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Desert Regional Medical Center Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 2006

Completion Date:

Related Keywords:

  • Gastric Cancer
  • adenocarcinoma of the stomach
  • stage I gastric cancer
  • stage II gastric cancer
  • stage III gastric cancer
  • Stomach Neoplasms



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