Chemotherapy and Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Stomach Who Have Undergone Surgery

November 14, 2015 updated by: Radiation Therapy Oncology Group

A Randomized Phase II Comparison Of Two Cisplatin-Paclitaxel Containing Chemoradiation Regimens In Resected Gastric Cancers

RATIONALE: Drugs used in chemotherapy such as cisplatin and paclitaxel 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. Cisplatin and paclitaxel may make the tumor cells more sensitive to radiation therapy and may kill any tumor cells remaining after surgery.

PURPOSE: Randomized phase II trial to study the effectiveness of cisplatin, paclitaxel, and radiation therapy with or without fluorouracil in treating patients who have stage IB, stage IIB, or stage IIIB stomach cancer that has been removed during surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the 2-year disease-free survival in patients with resected stage IB-IIIB gastric cancer treated with cisplatin, paclitaxel, and radiotherapy with or without fluorouracil vs therapy in the adjuvant arm of the intergroup adjuvant protocol 0116 (RTOG 90-18). (Arm I closed to accrual as of 6/18/03.)
  • Compare the safety and success of these regimens vs therapy in the intergroup adjuvant study.
  • Compare the toxic effects of these regimens vs therapy in the adjuvant arm of the intergroup study.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor stage (T1-2 vs T3 vs T4) and by number of involved lymph nodes (none vs 1-3 vs 4 or more). Patients are randomized to one of two treatment arms. (Arm I closed to accrual as of 6/18/03.)

  • Arm I (closed to accrual as of 6/18/03): Patients receive fluorouracil IV continuously and cisplatin IV over 1 hour on days 1-5 and 29-33 and paclitaxel IV continuously on days 1 and 29.

At 3-4 weeks after completion of chemotherapy, patients receive radiotherapy once daily and fluorouracil IV continuously on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive paclitaxel IV over 3 hours on days 1, 8, 15, 22, and 29.

  • Arm II: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on days 1 and 29.

At 3-4 weeks after completion of chemotherapy, patients receive radiotherapy once daily and paclitaxel IV continuously on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive cisplatin IV over 1 hour on days 1, 8, 15, 22, and 29.

Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 94 patients will be accrued for this study within 3 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
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • University of Alabama at Birmingham Comprehensive Cancer Center
      • Mobile, Alabama, United States, 36652-2144
        • Mobile Infirmary Medical Center
    • Alaska
      • Anchorage, Alaska, United States, 99519-6604
        • Providence Alaska Medical Center
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Foundation for Cancer Research and Education
    • California
      • Burbank, California, United States, 91505
        • Providence Saint Joseph Medical Center - Burbank
      • Duarte, California, United States, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • Greenbrae, California, United States, 94904
        • Sutter Health Western Division Cancer Research Group
      • Loma Linda, California, United States, 92354
        • Loma Linda University Cancer Institute at Loma Linda University Medical Center
      • Oakland, California, United States, 94609-3305
        • CCOP - Bay Area Tumor Institute
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center
      • Santa Rosa, California, United States, 95403
        • CCOP - Santa Rosa Memorial Hospital
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Memorial Hospital Cancer Center
      • Denver, Colorado, United States, 80010
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8040
        • Yale Comprehensive Cancer Center
    • Florida
      • Miami, Florida, United States, 33256-2110
        • Baptist Hospital of Miami
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Alexian Brothers Cancer Care Center
    • Iowa
      • Dubuque, Iowa, United States, 52001
        • Wendt Regional Cancer Center of Finley Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Cancer Center at Lexington Clinic
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Cancer Research Center at Boston Medical Center
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, United States, 63110
        • Siteman Cancer Center
    • Nebraska
      • Omaha, Nebraska, United States, 68114-4199
        • Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
    • New Jersey
      • Edison, New Jersey, United States, 08818
        • John F. Kennedy Medical Center
      • Mount Holly, New Jersey, United States, 08060
        • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
      • Toms River, New Jersey, United States, 08755
        • Community Medical Center
    • New York
      • Brooklyn, New York, United States, 11215
        • New York Methodist Hospital
      • Rochester, New York, United States, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Rochester, New York, United States, 14620
        • Highland Hospital of Rochester
      • Syracuse, New York, United States, 13217
        • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
    • North Carolina
      • Goldsboro, North Carolina, United States, 27533
        • Wayne Memorial Hospital, Inc.
      • Rutherfordton, North Carolina, United States, 28139-0000
        • Rutherford Hospital
    • Ohio
      • Akron, Ohio, United States, 44302
        • Akron General Medical Center
      • Akron, Ohio, United States, 44304
        • Akron City Hospital - Summa Health System
      • Cleveland, Ohio, United States, 44106-5065
        • Ireland Cancer Center
      • Dayton, Ohio, United States, 45429
        • CCOP - Dayton
      • Findlay, Ohio, United States, 45840
        • Blanchard Valley Medical Associates
      • Lima, Ohio, United States, 45804
        • Lima Memorial Hospital
      • Oregon, Ohio, United States, 43616
        • St. Charles Hospital
      • Salem, Ohio, United States, 44460
        • Cancer Care Center, Incorporated
      • Sandusky, Ohio, United States, 44870
        • Firelands Regional Medical Center
      • Sylvania, Ohio, United States, 43560
        • Flower Hospital - ProMedica Health System
      • Toledo, Ohio, United States, 43614
        • Medical College of Ohio Cancer Institute
      • Toledo, Ohio, United States, 43623-3456
        • CCOP - Toledo Community Hospital
      • Wauseon, Ohio, United States, 43567
        • Fulton County Health Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Natalie Warren Bryant Cancer Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18105
        • John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
      • 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
      • East Stroudsburg, Pennsylvania, United States, 18301
        • Pocono Cancer Center
      • Paoli, Pennsylvania, United States, 19301-1792
        • Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, United States, 19107-5541
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15224
        • Western Pennsylvania Hospital
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Cancer Center at Lankenau Hospital
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina
    • Texas
      • Houston, Texas, United States, 77030-4009
        • University of Texas - MD Anderson Cancer Center
    • Utah
      • Murray, Utah, United States, 84107
        • Cottonwood Hospital Medical Center
      • Ogden, Utah, United States, 84403
        • McKay-Dee Hospital Center
      • Saint George, Utah, United States, 84770
        • Dixie Regional Medical Center
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Health Sciences Center
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital
    • Washington
      • Seattle, Washington, United States, 98195-6043
        • University of Washington Medical Center
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • CCOP - St. Vincent Hospital Cancer Center, Green Bay
      • Green Bay, Wisconsin, United States, 54307-3508
        • St. Vincent Hospital
      • Marshfield, Wisconsin, United States, 54449
        • CCOP - Marshfield Clinic Research Foundation
      • Milwaukee, Wisconsin, United States, 53211
        • Columbia Hospital
      • Milwaukee, Wisconsin, United States, 53215
        • St. Luke's Medical Center
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin Cancer Center

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IB-IIIB adenocarcinoma of the stomach or gastroesophageal junction having undergone potentially curative resection of primary tumor

    • No more than 8 weeks since primary tumor resection
  • No metastatic disease

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC (white blood cell count) at least 4,000/mm^3
  • Platelet count at least 150,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • AST (aspartate aminotransferase) and ALT (alanine amino transferase) no greater than 2.5 times upper limit of normal

Renal:

  • BUN(blood urea nitrogen)less than 30 mg/dL
  • Creatinine no greater than 1.4 mg/dL
  • Creatinine clearance greater than 50 mL/min

Cardiovascular:

  • No New York Heart Association class III or IV heart disease
  • No active angina or myocardial infarction within the past 6 months
  • No history of significant ventricular arrhythmia requiring medication with antiarrhythmics
  • No history of clinically significant conduction system abnormality

Other:

  • No concurrent serious infection that is uncontrolled or would preclude study participation
  • No nonmalignant medical illness that is uncontrolled or would preclude study participation
  • No psychiatric disorders that would preclude study participation
  • No other active malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No clinically significant hearing loss
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy to the treatment field

Surgery:

  • See Disease Characteristics

Other:

  • No other concurrent anticancer therapy

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
  • Allocation: Randomized

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)

Investigators

  • Study Chair: David Paul Kelsen, MD, Memorial Sloan Kettering Cancer Center

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

May 1, 2001

Primary Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

March 3, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 14, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTOG-G-0114
  • CDR0000068464

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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