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

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: Gastric Cancer; Esophageal Cancer
• Intervention / Treatment: Radiation: radiation therapy; Procedure: adjuvant therapy; Drug: cisplatin; Drug: paclitaxel

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

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

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized

Collaborators and Investigators

• 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

General Publications

• Schwartz GK, Winter K, Minsky BD, Crane C, Thomson PJ, Anne P, Gross H, Willett C, Kelsen D. Randomized phase II trial evaluating two paclitaxel and cisplatin-containing chemoradiation regimens as adjuvant therapy in resected gastric cancer (RTOG-0114). J Clin Oncol. 2009 Apr 20;27(12):1956-62. doi: 10.1200/JCO.2008.20.3745. Epub 2009 Mar 9.

Study record dates

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: stage III gastric cancer; stage II esophageal cancer; stage III esophageal cancer; adenocarcinoma of the stomach; adenocarcinoma of the esophagus; stage I gastric cancer; stage II gastric cancer; stage I esophageal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Stomach Neoplasms; Esophageal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Cisplatin
• Other Study ID Numbers: RTOG-G-0114; CDR0000068464