Clinical trial NCT00011960: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Radiation Therapy Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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

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