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


Phase 2
N/A
N/A
Not Enrolling
Both
Gastric Cancer

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

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

Authority:

United States: Federal Government

Study ID:

CDR0000067026

NCT ID:

NCT00003862

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

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Ireland Cancer CenterCleveland, Ohio  44106-5065
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
University of Washington Medical CenterSeattle, Washington  98195-6043
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
St. Joseph HospitalDenver, Colorado  80218
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical CenterGrand Junction, Colorado  81502
Rapid City Regional HospitalRapid City, South Dakota  57709
Mount Diablo Medical CenterConcord, California  94524-4110
Wendt Regional Cancer Center of Finley HospitalDubuque, Iowa  52001
McLaren Regional Cancer CenterFlint, Michigan  48432
CCOP - DaytonKettering, Ohio  45429
Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
CCOP - GreenvilleGreenville, South Carolina  29615
Harrington Cancer CenterAmarillo, Texas  79106
LDS HospitalSalt Lake City, Utah  84143
Columbia HospitalMilwaukee, Wisconsin  53211
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Providence Alaska Medical CenterAnchorage, Alaska  99508
Foundation for Cancer Research and EducationPhoenix, Arizona  85013
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
University of California Davis Cancer CenterSacramento, California  95817
Presbyterian-St Luke's Medical CenterDenver, Colorado  80218
CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado  80224
Greenville Hospital SystemGreenville, South Carolina  29605
Fox Chase Virtua Health Cancer Program at Virtua Memorial HospitalMount Holly, New Jersey  08060
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
St. Luke's Hospital Cancer CenterBethlehem, Pennsylvania  18015
Mercy Fitzgerald HospitalDarby, Pennsylvania  19023
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - OmahaOmaha, Nebraska  68114-4199
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
McKay-Dee Hospital CenterOgden, Utah  84403
Leo W. Jenkins Cancer Center of University Health Systems of Eastern CarolinaGreenville, North Carolina  27858-4354
Norris Cotton Cancer Center at Dartmouth Medical SchoolLebanon, New Hampshire  03756-0002
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Fox Chase Cancer Center at St. Francis Medical CenterTrenton, New Jersey  08629
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Northridge Hospital Medical CenterNorthridge, California  91328
Penrose - St. Francis Health ServicesColorado Springs, Colorado  80933
Lutheran General Hospital Cancer Care CenterPark Ridge, Illinois  60068
Ball Memorial Hospital Cancer CenterMuncie, Indiana  47303-3499
Porter Memorial HospitalValparaiso, Indiana  46383
Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wayne Memorial Hospital, Inc.Goldsboro, North Carolina  27533