Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer

NCT00003862 | Completed Phase 2 DMC

• 2 other identifiers: RTOG-9904CDR0000067026
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 55

Brief 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.

Conditions

Gastric Cancer

Keywords

stage I gastric cancer; stage II gastric cancer; stage III gastric cancer; stage IV gastric cancer; adenocarcinoma of the stomach

Interventions

cisplatin DRUG

fluorouracil DRUG

leucovorin calcium DRUG

paclitaxel DRUG

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 0 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (55)

Providence Alaska Medical Center

Anchorage, Alaska, 99519-6604, United States

Location

Foundation for Cancer Research and Education

Phoenix, Arizona, 85013, United States

Location

Mount Diablo Medical Center

Concord, California, 94524-4110, United States

Location

Northridge Hospital Medical Center

Northridge, California, 91328, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Penrose - St. Francis Health Services

Colorado Springs, Colorado, 80933, United States

Location

St. Joseph Hospital

Denver, Colorado, 80218-1191, United States

Location

Presbyterian-St Luke's Medical Center

Denver, Colorado, 80218, United States

Location

Rose Medical Center

Denver, Colorado, 80220, United States

Location

CCOP - Colorado Cancer Research Program, Incorporated

Denver, Colorado, 80224, United States

Location

Swedish Medical Center

Englewood, Colorado, 80110, United States

Location

St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

Grand Junction, Colorado, 81502-1628, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342-1701, United States

Location

Lutheran General Hospital Cancer Care Center

Park Ridge, Illinois, 60068, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Veterans Affairs Medical Center - Indianapolis (Roudebush)

Indianapolis, Indiana, 46202, United States

Location

Ball Memorial Hospital Cancer Center

Muncie, Indiana, 47303-3499, United States

Location

Porter Memorial Hospital

Valparaiso, Indiana, 46383, United States

Location

Wendt Regional Cancer Center of Finley Hospital

Dubuque, Iowa, 52001, United States

Location

McLaren Regional Cancer Center

Flint, Michigan, 48532-3685, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha

Omaha, Nebraska, 68114-4199, United States

Location

Norris Cotton Cancer Center at Dartmouth Medical School

Lebanon, New Hampshire, 03756-0002, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740-6395, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital

Mount Holly, New Jersey, 08060, United States

Location

Fox Chase Cancer Center at St. Francis Medical Center

Trenton, New Jersey, 08629, United States

Location

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

Syracuse, New York, 13217, United States

Location

Presbyterian Hospital

Charlotte, North Carolina, 28233-3549, United States

Location

Wayne Memorial Hospital, Inc.

Goldsboro, North Carolina, 27533, United States

Location

Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina

Greenville, North Carolina, 27835-6028, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43623-3456, United States

Location

St. Luke's Hospital Cancer Center

Bethlehem, Pennsylvania, 18015, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Mercy Fitzgerald Hospital

Darby, Pennsylvania, 19023, United States

Location

Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, 19026, United States

Location

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301-1792, United States

Location

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, 19141-3098, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

Lankenau Cancer Center at Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

Utah Valley Regional Medical Center - Provo

Provo, Utah, 84604, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Columbia Hospital

Milwaukee, Wisconsin, 53211, United States

Location

Related 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 modality therapy and pathologic response. J Clin Oncol. 2006 Aug 20;24(24):3953-8. doi: 10.1200/JCO.2006.06.4840.

  PMID: 16921048 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Cisplatin; Fluorouracil; Leucovorin; Paclitaxel; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Combined Modality Therapy; Therapeutics

Study Officials

• Jaffer A. Ajani, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: November 1, 1999
• Primary Completion: November 1, 2004
• Last Updated: October 19, 2020

Record last verified: 2003-09

Locations

US (55)