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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00011960
• Other study ID #: RTOG-G-0114
• Secondary ID: CDR0000068464
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2001
• Last updated: November 14, 2015
• Start date: May 2001

Study information

• Verified date: November 2015
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• cisplatin

• paclitaxel

Procedure:
• adjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Akron City Hospital - Summa Health System	Akron	Ohio
United States	Akron General Medical Center	Akron	Ohio
United States	John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Providence Alaska Medical Center	Anchorage	Alaska
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Cancer Research Center at Boston Medical Center	Boston	Massachusetts
United States	New York Methodist Hospital	Brooklyn	New York
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Providence Saint Joseph Medical Center - Burbank	Burbank	California
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Memorial Hospital Cancer Center	Colorado Springs	Colorado
United States	Mercy Fitzgerald Hospital	Darby	Pennsylvania
United States	CCOP - Dayton	Dayton	Ohio
United States	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Denver	Colorado
United States	Delaware County Memorial Hospital	Drexel Hill	Pennsylvania
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Wendt Regional Cancer Center of Finley Hospital	Dubuque	Iowa
United States	Pocono Cancer Center	East Stroudsburg	Pennsylvania
United States	John F. Kennedy Medical Center	Edison	New Jersey
United States	Alexian Brothers Cancer Care Center	Elk Grove Village	Illinois
United States	Blanchard Valley Medical Associates	Findlay	Ohio
United States	Wayne Memorial Hospital, Inc.	Goldsboro	North Carolina
United States	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin
United States	St. Vincent Hospital	Green Bay	Wisconsin
United States	Sutter Health Western Division Cancer Research Group	Greenbrae	California
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Cancer Center at Lexington Clinic	Lexington	Kentucky
United States	Lima Memorial Hospital	Lima	Ohio
United States	Loma Linda University Cancer Institute at Loma Linda University Medical Center	Loma Linda	California
United States	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	Baptist Hospital of Miami	Miami	Florida
United States	Columbia Hospital	Milwaukee	Wisconsin
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital	Mount Holly	New Jersey
United States	Cottonwood Hospital Medical Center	Murray	Utah
United States	Yale Comprehensive Cancer Center	New Haven	Connecticut
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	McKay-Dee Hospital Center	Ogden	Utah
United States	Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha	Omaha	Nebraska
United States	St. Charles Hospital	Oregon	Ohio
United States	Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Foundation for Cancer Research and Education	Phoenix	Arizona
United States	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Highland Hospital of Rochester	Rochester	New York
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	University of California Davis Cancer Center	Sacramento	California
United States	Dixie Regional Medical Center	Saint George	Utah
United States	Siteman Cancer Center	Saint Louis	Missouri
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Cancer Care Center, Incorporated	Salem	Ohio
United States	LDS Hospital	Salt Lake City	Utah
United States	University of Utah Health Sciences Center	Salt Lake City	Utah
United States	Firelands Regional Medical Center	Sandusky	Ohio
United States	CCOP - Santa Rosa Memorial Hospital	Santa Rosa	California
United States	University of Washington Medical Center	Seattle	Washington
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Flower Hospital - ProMedica Health System	Sylvania	Ohio
United States	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	Medical College of Ohio Cancer Institute	Toledo	Ohio
United States	Community Medical Center	Toms River	New Jersey
United States	Natalie Warren Bryant Cancer Center	Tulsa	Oklahoma
United States	Fulton County Health Center	Wauseon	Ohio
United States	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

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 Intergroup #0114). [Abstract] J Clin Oncol 23 (Su

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 — View Citation