Full Text View
Tabular View
No Study Results Posted
Related Studies
Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer
This study has been completed.
Study NCT00003862   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
November 1999
 
 
 
Complete list of historical versions of study NCT00003862 on ClinicalTrials.gov Archive Site
 
 
 
Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer
A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach

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.

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.

Phase II
Interventional
Treatment, Open Label
Gastric Cancer
  • Drug: cisplatin
  • Drug: fluorouracil
  • Drug: leucovorin calcium
  • Drug: paclitaxel
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
  • Radiation: radiation therapy
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003862
 
CDR0000067026, RTOG-9904, RTOG-DEV-1046
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Study Chair: Jaffer A. Ajani, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
September 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP