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

Phase 2
Not Enrolling
Gastric Cancer

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Trial Information

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


- 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

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

Inclusion Criteria


- 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

- No distant metastases

- No pleural or pericardial effusion

- No peritoneal disease diagnosed by laparoscopy



- Not specified

Performance status:

- Zubrod 0-2

Life expectancy:

- At least 16 weeks


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

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


- Bilirubin no greater than 1.5 mg/dL


- Creatinine less than 1.5 mg/dL


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

- No hypertension


- No cerebrovascular disease

- No diabetic neuropathy

- No mental status abnormalities


- 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


Biologic therapy:

- No prior immunotherapy


- No prior chemotherapy

Endocrine therapy:

- Not specified


- No prior radiotherapy to stomach


- No prior surgery to stomach

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Jaffer A. Ajani, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

November 1999

Completion Date:

Related Keywords:

  • Gastric Cancer
  • stage I gastric cancer
  • stage II gastric cancer
  • stage III gastric cancer
  • stage IV gastric cancer
  • adenocarcinoma of the stomach
  • Adenocarcinoma
  • Stomach Neoplasms



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Ireland Cancer Center Cleveland, Ohio  44106-5065
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
University of Washington Medical Center Seattle, Washington  98195-6043
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis, Indiana  46202
St. Joseph Hospital Denver, Colorado  80218
Rose Medical Center Denver, Colorado  80220
Swedish Medical Center Englewood, Colorado  80110
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Grand Junction, Colorado  81502
Rapid City Regional Hospital Rapid City, South Dakota  57709
Mount Diablo Medical Center Concord, California  94524-4110
Wendt Regional Cancer Center of Finley Hospital Dubuque, Iowa  52001
McLaren Regional Cancer Center Flint, Michigan  48432
CCOP - Dayton Kettering, Ohio  45429
Delaware County Memorial Hospital Drexel Hill, Pennsylvania  19026
Albert Einstein Cancer Center Philadelphia, Pennsylvania  19141
Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
CCOP - Greenville Greenville, South Carolina  29615
Harrington Cancer Center Amarillo, Texas  79106
LDS Hospital Salt Lake City, Utah  84143
Columbia Hospital Milwaukee, Wisconsin  53211
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Utah Valley Regional Medical Center - Provo Provo, Utah  84604
Providence Alaska Medical Center Anchorage, Alaska  99508
Foundation for Cancer Research and Education Phoenix, Arizona  85013
Monmouth Medical Center Long Branch, New Jersey  07740-6395
University of California Davis Cancer Center Sacramento, California  95817
Presbyterian-St Luke's Medical Center Denver, Colorado  80218
CCOP - Colorado Cancer Research Program, Incorporated Denver, Colorado  80224
Greenville Hospital System Greenville, South Carolina  29605
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Mount Holly, New Jersey  08060
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
St. Luke's Hospital Cancer Center Bethlehem, Pennsylvania  18015
Mercy Fitzgerald Hospital Darby, Pennsylvania  19023
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha Omaha, Nebraska  68114-4199
CCOP - Marshfield Clinic Research Foundation Marshfield, Wisconsin  54449
McKay-Dee Hospital Center Ogden, Utah  84403
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina Greenville, North Carolina  27858-4354
Norris Cotton Cancer Center at Dartmouth Medical School Lebanon, New Hampshire  03756-0002
Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
Fox Chase Cancer Center at St. Francis Medical Center Trenton, New Jersey  08629
Bryn Mawr Hospital Bryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau Hospital Wynnewood, Pennsylvania  19096
Northridge Hospital Medical Center Northridge, California  91328
Penrose - St. Francis Health Services Colorado Springs, Colorado  80933
Lutheran General Hospital Cancer Care Center Park Ridge, Illinois  60068
Ball Memorial Hospital Cancer Center Muncie, Indiana  47303-3499
Porter Memorial Hospital Valparaiso, Indiana  46383
Presbyterian Hospital Charlotte, North Carolina  28233-3549
Wayne Memorial Hospital, Inc. Goldsboro, North Carolina  27533