Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer

Gastric Cancer Clinical Trial

Official title:

A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003862
• Other study ID #: RTOG-9904
• Secondary ID: CDR0000067026
• Status: Completed
• Phase: Phase 2
• Start date: November 1999

Study information

• Verified date: September 2003
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy 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. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy and radiation therapy in treating patients who have stomach cancer.

Description:

OBJECTIVES:

• Determine the feasibility of preoperative chemoradiotherapy in patients with potentially resectable adenocarcinoma of the stomach.

• Determine the pathologic response rate, curative resection rate, and survival in patients treated with this regimen.

• Determine the tolerability of this regimen in these patients.

OUTLINE: Patients receive fluorouracil IV over 24 hours on days 1-21, cisplatin IV over 1 hour on days 1-5, and leucovorin calcium IV over 15 minutes on days 1, 8, 15, and 22. A second course is administered beginning on day 29.

Chemoradiotherapy begins at the end of the second course of chemotherapy and 1 week of rest (day 57). Patients receive fluorouracil IV over 24 hours 5 days a week concurrently with radiotherapy for 5 weeks and paclitaxel IV over 3 hours once weekly during these 5 weeks on days 1, 8, 15, 22, and 29.

Approximately 4-5 weeks after chemoradiotherapy, patients with no evidence of metastatic disease undergo surgical resection.

Patients are followed every 3 months for 1 year, every 6 months for 5 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 21-49 patients will be accrued for this study within 2.5 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically proven adenocarcinoma of the stomach

• Stage IB, II, IIIA, IIIB, and IV (T2-3, any N, M0)

• No lymph node metastases outside the field of resection (e.g., supraclavicular, mediastinal, or paraaortic nodes)

• Potentially resectable

• May involve the gastroesophageal junction, but bulk of tumor must be in the stomach

• No distant metastases

• No pleural or pericardial effusion

• No peritoneal disease diagnosed by laparoscopy

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• Zubrod 0-2

Life expectancy:

• At least 16 weeks

Hematopoietic:

• Absolute granulocyte count greater than 2,000/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

Renal:

• Creatinine less than 1.5 mg/dL

Cardiovascular:

• No New York Heart Association class III or IV heart disease

• No hypertension

Neurologic:

• No cerebrovascular disease

• No diabetic neuropathy

• No mental status abnormalities

Other:

• No uncontrolled diabetes

• No infection

• No other malignancies within past 5 years except resected squamous cell or basal cell skin cancer

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior immunotherapy

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to stomach

Surgery:

• No prior surgery to stomach

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• cisplatin

• fluorouracil

• leucovorin calcium

• paclitaxel

Procedure:
• conventional surgery

• neoadjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Harrington Cancer Center	Amarillo	Texas
United States	Providence Alaska Medical Center	Anchorage	Alaska
United States	CCOP - Atlanta Regional	Atlanta	Georgia
United States	St. Luke's Hospital Cancer Center	Bethlehem	Pennsylvania
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Presbyterian Hospital	Charlotte	North Carolina
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Penrose - St. Francis Health Services	Colorado Springs	Colorado
United States	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri
United States	Mount Diablo Medical Center	Concord	California
United States	Mercy Fitzgerald Hospital	Darby	Pennsylvania
United States	CCOP - Dayton	Dayton	Ohio
United States	CCOP - Colorado Cancer Research Program, Incorporated	Denver	Colorado
United States	Presbyterian-St Luke's Medical Center	Denver	Colorado
United States	Rose Medical Center	Denver	Colorado
United States	St. Joseph Hospital	Denver	Colorado
United States	Delaware County Memorial Hospital	Drexel Hill	Pennsylvania
United States	Wendt Regional Cancer Center of Finley Hospital	Dubuque	Iowa
United States	Swedish Medical Center	Englewood	Colorado
United States	McLaren Regional Cancer Center	Flint	Michigan
United States	Wayne Memorial Hospital, Inc.	Goldsboro	North Carolina
United States	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center	Grand Junction	Colorado
United States	CCOP - Greenville	Greenville	South Carolina
United States	Greenville Hospital System	Greenville	South Carolina
United States	Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina	Greenville	North Carolina
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Veterans Affairs Medical Center - Indianapolis (Roudebush)	Indianapolis	Indiana
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Norris Cotton Cancer Center at Dartmouth Medical School	Lebanon	New Hampshire
United States	Monmouth Medical Center	Long Branch	New Jersey
United States	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	Columbia Hospital	Milwaukee	Wisconsin
United States	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital	Mount Holly	New Jersey
United States	Ball Memorial Hospital Cancer Center	Muncie	Indiana
United States	Northridge Hospital Medical Center	Northridge	California
United States	McKay-Dee Hospital Center	Ogden	Utah
United States	Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha	Omaha	Nebraska
United States	Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Lutheran General Hospital Cancer Care Center	Park Ridge	Illinois
United States	Albert Einstein Cancer Center	Philadelphia	Pennsylvania
United States	Foundation for Cancer Research and Education	Phoenix	Arizona
United States	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	University of California Davis Cancer Center	Sacramento	California
United States	LDS Hospital	Salt Lake City	Utah
United States	University of Washington Medical Center	Seattle	Washington
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
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	Fox Chase Cancer Center at St. Francis Medical Center	Trenton	New Jersey
United States	Porter Memorial Hospital	Valparaiso	Indiana
United States	CCOP - MainLine Health	Wynnewood	Pennsylvania
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 (2)

Ajani JA, Winter K, Okawara GS, Donohue JH, Pisters PW, Crane CH, Greskovich JF, Anne PR, Bradley JD, Willett C, Rich TA. Phase II trial of preoperative chemoradiation in patients with localized gastric adenocarcinoma (RTOG 9904): quality of combined moda — View Citation

Okawara GS, Winter K, Donohue JH, et al.: A phase II trial of preoperative chemotherapy and chemoradiotherapy for potentially resectable adenocarcinoma of the stomach (RTOG 99-04). [Abstract] J Clin Oncol 23 (Suppl 16): A-4019, 312s, 2005.