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

Primary Purpose

Esophageal Cancer, Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cisplatin
paclitaxel
adjuvant therapy
radiation therapy
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring stage I gastric cancer, stage II gastric cancer, stage III gastric cancer, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • Mobile Infirmary Medical Center
  • Providence Alaska Medical Center
  • Foundation for Cancer Research and Education
  • Providence Saint Joseph Medical Center - Burbank
  • City of Hope Comprehensive Cancer Center
  • Sutter Health Western Division Cancer Research Group
  • Loma Linda University Cancer Institute at Loma Linda University Medical Center
  • CCOP - Bay Area Tumor Institute
  • University of California Davis Cancer Center
  • CCOP - Santa Rosa Memorial Hospital
  • Memorial Hospital Cancer Center
  • University of Colorado Cancer Center at University of Colorado Health Sciences Center
  • Yale Comprehensive Cancer Center
  • Baptist Hospital of Miami
  • Alexian Brothers Cancer Care Center
  • Wendt Regional Cancer Center of Finley Hospital
  • Cancer Center at Lexington Clinic
  • Cancer Research Center at Boston Medical Center
  • CCOP - Metro-Minnesota
  • CCOP - Kansas City
  • Siteman Cancer Center
  • Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
  • John F. Kennedy Medical Center
  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
  • Community Medical Center
  • New York Methodist Hospital
  • Highland Hospital of Rochester
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
  • Wayne Memorial Hospital, Inc.
  • Rutherford Hospital
  • Akron General Medical Center
  • Akron City Hospital - Summa Health System
  • Ireland Cancer Center
  • CCOP - Dayton
  • Blanchard Valley Medical Associates
  • Lima Memorial Hospital
  • St. Charles Hospital
  • Cancer Care Center, Incorporated
  • Firelands Regional Medical Center
  • Flower Hospital - ProMedica Health System
  • Medical College of Ohio Cancer Institute
  • CCOP - Toledo Community Hospital
  • Fulton County Health Center
  • Natalie Warren Bryant Cancer Center
  • John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
  • Bryn Mawr Hospital
  • Mercy Fitzgerald Hospital
  • Delaware County Memorial Hospital
  • Pocono Cancer Center
  • Paoli Memorial Hospital
  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  • Western Pennsylvania Hospital
  • Lankenau Cancer Center at Lankenau Hospital
  • CCOP - Upstate Carolina
  • University of Texas - MD Anderson Cancer Center
  • Cottonwood Hospital Medical Center
  • McKay-Dee Hospital Center
  • Dixie Regional Medical Center
  • University of Utah Health Sciences Center
  • LDS Hospital
  • University of Washington Medical Center
  • CCOP - St. Vincent Hospital Cancer Center, Green Bay
  • St. Vincent Hospital
  • CCOP - Marshfield Clinic Research Foundation
  • Columbia Hospital
  • St. Luke's Medical Center
  • Medical College of Wisconsin Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 3, 2001
Last Updated
November 14, 2015
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00011960
Brief Title
Chemotherapy and Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Stomach Who Have Undergone Surgery
Official Title
A Randomized Phase II Comparison Of Two Cisplatin-Paclitaxel Containing Chemoradiation Regimens In Resected Gastric Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Gastric Cancer
Keywords
stage I gastric cancer, stage II gastric cancer, stage III gastric cancer, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Paul Kelsen, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Mobile Infirmary Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36652-2144
Country
United States
Facility Name
Providence Alaska Medical Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99519-6604
Country
United States
Facility Name
Foundation for Cancer Research and Education
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Providence Saint Joseph Medical Center - Burbank
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Sutter Health Western Division Cancer Research Group
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Loma Linda University Cancer Institute at Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
CCOP - Bay Area Tumor Institute
City
Oakland
State/Province
California
ZIP/Postal Code
94609-3305
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
CCOP - Santa Rosa Memorial Hospital
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Memorial Hospital Cancer Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
University of Colorado Cancer Center at University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Yale Comprehensive Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8040
Country
United States
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33256-2110
Country
United States
Facility Name
Alexian Brothers Cancer Care Center
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Wendt Regional Cancer Center of Finley Hospital
City
Dubuque
State/Province
Iowa
ZIP/Postal Code
52001
Country
United States
Facility Name
Cancer Center at Lexington Clinic
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Cancer Research Center at Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114-4199
Country
United States
Facility Name
John F. Kennedy Medical Center
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08818
Country
United States
Facility Name
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
Community Medical Center
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
New York Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Highland Hospital of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
City
Syracuse
State/Province
New York
ZIP/Postal Code
13217
Country
United States
Facility Name
Wayne Memorial Hospital, Inc.
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27533
Country
United States
Facility Name
Rutherford Hospital
City
Rutherfordton
State/Province
North Carolina
ZIP/Postal Code
28139-0000
Country
United States
Facility Name
Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44302
Country
United States
Facility Name
Akron City Hospital - Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
CCOP - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Blanchard Valley Medical Associates
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Lima Memorial Hospital
City
Lima
State/Province
Ohio
ZIP/Postal Code
45804
Country
United States
Facility Name
St. Charles Hospital
City
Oregon
State/Province
Ohio
ZIP/Postal Code
43616
Country
United States
Facility Name
Cancer Care Center, Incorporated
City
Salem
State/Province
Ohio
ZIP/Postal Code
44460
Country
United States
Facility Name
Firelands Regional Medical Center
City
Sandusky
State/Province
Ohio
ZIP/Postal Code
44870
Country
United States
Facility Name
Flower Hospital - ProMedica Health System
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Medical College of Ohio Cancer Institute
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
CCOP - Toledo Community Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623-3456
Country
United States
Facility Name
Fulton County Health Center
City
Wauseon
State/Province
Ohio
ZIP/Postal Code
43567
Country
United States
Facility Name
Natalie Warren Bryant Cancer Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
Facility Name
Bryn Mawr Hospital
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Mercy Fitzgerald Hospital
City
Darby
State/Province
Pennsylvania
ZIP/Postal Code
19023
Country
United States
Facility Name
Delaware County Memorial Hospital
City
Drexel Hill
State/Province
Pennsylvania
ZIP/Postal Code
19026
Country
United States
Facility Name
Pocono Cancer Center
City
East Stroudsburg
State/Province
Pennsylvania
ZIP/Postal Code
18301
Country
United States
Facility Name
Paoli Memorial Hospital
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301-1792
Country
United States
Facility Name
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5541
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Lankenau Cancer Center at Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Cottonwood Hospital Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
McKay-Dee Hospital Center
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Dixie Regional Medical Center
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6043
Country
United States
Facility Name
CCOP - St. Vincent Hospital Cancer Center, Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
St. Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54307-3508
Country
United States
Facility Name
CCOP - Marshfield Clinic Research Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Columbia Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19273696
Citation
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.
Results Reference
result
Citation
Schwartz GK, Winter K, Minsky B, et al.: A randomized phase II trial comparing two paclitaxel (P)-cisplatin (C) containing chemoradiation (CRT) regimens as adjuvant therapy in resected gastric cancer (RTOG 0114). [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-1069, S169, 2006.
Results Reference
result

Learn more about this trial

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

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