Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer

October 15, 2020 updated by: Radiation Therapy Oncology Group

A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1999

Primary Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 15, 2020

Last Verified

September 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTOG-9904
  • CDR0000067026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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