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Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group Identifier:
First received: November 1, 1999
Last updated: July 17, 2013
Last verified: September 2003

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy and radiation therapy in treating patients who have stomach cancer.

Condition Intervention Phase
Gastric Cancer
Drug: cisplatin
Drug: fluorouracil
Drug: leucovorin calcium
Drug: paclitaxel
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach

Resource links provided by NLM:

Further study details as provided by Radiation Therapy Oncology Group:

Study Start Date: November 1999
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Detailed Description:


  • Determine the feasibility of preoperative chemoradiotherapy in patients with potentially resectable adenocarcinoma of the stomach.
  • Determine the pathologic response rate, curative resection rate, and survival in patients treated with this regimen.
  • Determine the tolerability of this regimen in these patients.

OUTLINE: Patients receive fluorouracil IV over 24 hours on days 1-21, cisplatin IV over 1 hour on days 1-5, and leucovorin calcium IV over 15 minutes on days 1, 8, 15, and 22. A second course is administered beginning on day 29.

Chemoradiotherapy begins at the end of the second course of chemotherapy and 1 week of rest (day 57). Patients receive fluorouracil IV over 24 hours 5 days a week concurrently with radiotherapy for 5 weeks and paclitaxel IV over 3 hours once weekly during these 5 weeks on days 1, 8, 15, 22, and 29.

Approximately 4-5 weeks after chemoradiotherapy, patients with no evidence of metastatic disease undergo surgical resection.

Patients are followed every 3 months for 1 year, every 6 months for 5 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 21-49 patients will be accrued for this study within 2.5 years.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven adenocarcinoma of the stomach

    • Stage IB, II, IIIA, IIIB, and IV (T2-3, any N, M0)

      • No lymph node metastases outside the field of resection (e.g., supraclavicular, mediastinal, or paraaortic nodes)
    • Potentially resectable
    • May involve the gastroesophageal junction, but bulk of tumor must be in the stomach
    • No distant metastases
    • No pleural or pericardial effusion
  • No peritoneal disease diagnosed by laparoscopy



  • Not specified

Performance status:

  • Zubrod 0-2

Life expectancy:

  • At least 16 weeks


  • Absolute granulocyte count greater than 2,000/mm^3
  • Platelet count greater than 100,000/mm^3


  • Bilirubin no greater than 1.5 mg/dL


  • Creatinine less than 1.5 mg/dL


  • No New York Heart Association class III or IV heart disease
  • No hypertension


  • No cerebrovascular disease
  • No diabetic neuropathy
  • No mental status abnormalities


  • No uncontrolled diabetes
  • No infection
  • No other malignancies within past 5 years except resected squamous cell or basal cell skin cancer
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy:

  • No prior immunotherapy


  • No prior chemotherapy

Endocrine therapy:

  • Not specified


  • No prior radiotherapy to stomach


  • No prior surgery to stomach
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00003862

  Show 55 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Study Chair: Jaffer A. Ajani, MD M.D. Anderson Cancer Center
  More Information

Okawara GS, Winter K, Donohue JH, et al.: A phase II trial of preoperative chemotherapy and chemoradiotherapy for potentially resectable adenocarcinoma of the stomach (RTOG 99-04). [Abstract] J Clin Oncol 23 (Suppl 16): A-4019, 312s, 2005.

Responsible Party: Radiation Therapy Oncology Group Identifier: NCT00003862     History of Changes
Other Study ID Numbers: RTOG-9904
Study First Received: November 1, 1999
Last Updated: July 17, 2013

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

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents processed this record on April 28, 2017