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Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer
This study has been completed.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsor: Radiation Therapy Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003862
  Purpose

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 II

Study Type: Interventional
Study Design: Treatment, Open Label
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 National Cancer Institute (NCI):

Study Start Date: November 1999
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Zubrod 0-2

Life expectancy:

  • At least 16 weeks

Hematopoietic:

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

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL

Renal:

  • Creatinine less than 1.5 mg/dL

Cardiovascular:

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

Neurologic:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy to stomach

Surgery:

  • No prior surgery to stomach
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003862

  Hide Study Locations
Locations
United States, Alaska
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99519-6604
United States, Arizona
Foundation for Cancer Research and Education
Phoenix, Arizona, United States, 85013
United States, California
Mount Diablo Medical Center
Concord, California, United States, 94524-4110
Northridge Hospital Medical Center
Northridge, California, United States, 91328
University of California Davis Cancer Center
Sacramento, California, United States, 95817
United States, Colorado
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80224
Penrose - St. Francis Health Services
Colorado Springs, Colorado, United States, 80933
Presbyterian-St Luke's Medical Center
Denver, Colorado, United States, 80218
Rose Medical Center
Denver, Colorado, United States, 80220
St. Joseph Hospital
Denver, Colorado, United States, 80218-1191
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502-1628
Swedish Medical Center
Englewood, Colorado, United States, 80110
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
United States, Illinois
Lutheran General Hospital Cancer Care Center
Park Ridge, Illinois, United States, 60068
United States, Indiana
Ball Memorial Hospital Cancer Center
Muncie, Indiana, United States, 47303-3499
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Porter Memorial Hospital
Valparaiso, Indiana, United States, 46383
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States, 46202
United States, Iowa
Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, United States, 52001
United States, Michigan
McLaren Regional Cancer Center
Flint, Michigan, United States, 48532-3685
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
United States, Nebraska
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, United States, 68114-4199
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth Medical School
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
Mount Holly, New Jersey, United States, 08060
Fox Chase Cancer Center at St. Francis Medical Center
Trenton, New Jersey, United States, 08629
United States, New York
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13217
United States, North Carolina
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
Greenville, North Carolina, United States, 27835-6028
Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
Wayne Memorial Hospital, Inc.
Goldsboro, North Carolina, United States, 27533
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623-3456
CCOP - Dayton
Dayton, Ohio, United States, 45429
United States, Pennsylvania
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
Mercy Fitzgerald Hospital
Darby, Pennsylvania, United States, 19023
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141-3098
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States, 18015
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Greenville Hospital System
Greenville, South Carolina, United States, 29605
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
United States, Texas
Harrington Cancer Center
Amarillo, Texas, United States, 79106
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Utah
LDS Hospital
Salt Lake City, Utah, United States, 84143
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
United States, Wisconsin
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
Columbia Hospital
Milwaukee, Wisconsin, United States, 53211
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Jaffer A. Ajani, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Ajani JA, Winter K, Okawara GS, Donohue JH, Pisters PW, Crane CH, Greskovich JF, Anne PR, Bradley JD, Willett C, Rich TA. Phase II trial of preoperative chemoradiation in patients with localized gastric adenocarcinoma (RTOG 9904): quality of combined modality therapy and pathologic response. J Clin Oncol. 2006 Aug 20;24(24):3953-8.
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.

Study ID Numbers: CDR0000067026, RTOG-9904, RTOG-DEV-1046
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003862     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I gastric cancer
stage II gastric cancer
stage III gastric cancer
stage IV gastric cancer
adenocarcinoma of the stomach

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Gastrointestinal Diseases
Physiological Effects of Drugs
Leucovorin
Stomach Diseases
Neoplasms by Site
Cisplatin
Stomach Neoplasms
Therapeutic Uses
Vitamins
Micronutrients
Digestive System Neoplasms
Vitamin B Complex
Growth Substances
Mitosis Modulators
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Paclitaxel
Fluorouracil
Tubulin Modulators
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 27, 2009