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A Randomized Phase II Comparison Of Two Cisplatin-Paclitaxel Containing Chemoradiation Regimens In Resected Gastric Cancers


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

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Trial Information

A Randomized Phase II Comparison Of Two Cisplatin-Paclitaxel Containing Chemoradiation Regimens In Resected Gastric Cancers


OBJECTIVES:

- Compare the 2-year disease-free survival in patients with resected stage IB-IIIB
gastric cancer treated with cisplatin, paclitaxel, and radiotherapy with or without
fluorouracil vs therapy in the adjuvant arm of the intergroup adjuvant protocol 0116
(RTOG 90-18). (Arm I closed to accrual as of 6/18/03.)

- Compare the safety and success of these regimens vs therapy in the intergroup adjuvant
study.

- Compare the toxic effects of these regimens vs therapy in the adjuvant arm of the
intergroup study.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor
stage (T1-2 vs T3 vs T4) and by number of involved lymph nodes (none vs 1-3 vs 4 or more).
Patients are randomized to one of two treatment arms. (Arm I closed to accrual as of
6/18/03.)

- Arm I (closed to accrual as of 6/18/03): Patients receive fluorouracil IV continuously
and cisplatin IV over 1 hour on days 1-5 and 29-33 and paclitaxel IV continuously on
days 1 and 29.

At 3-4 weeks after completion of chemotherapy, patients receive radiotherapy once daily and
fluorouracil IV continuously on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also
receive paclitaxel IV over 3 hours on days 1, 8, 15, 22, and 29.

- Arm II: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on
days 1 and 29.

At 3-4 weeks after completion of chemotherapy, patients receive radiotherapy once daily and
paclitaxel IV continuously on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive
cisplatin IV over 1 hour on days 1, 8, 15, 22, and 29.

Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 94 patients will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage IB-IIIB adenocarcinoma of the stomach or
gastroesophageal junction having undergone potentially curative resection of primary
tumor

- No more than 8 weeks since primary tumor resection

- No metastatic disease

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 4,000/mm^3

- Platelet count at least 150,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- AST and ALT no greater than 2.5 times upper limit of normal

Renal:

- BUN less than 30 mg/dL

- Creatinine no greater than 1.4 mg/dL

- Creatinine clearance greater than 50 mL/min

Cardiovascular:

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

- No active angina or myocardial infarction within the past 6 months

- No history of significant ventricular arrhythmia requiring medication with
antiarrhythmics

- No history of clinically significant conduction system abnormality

Other:

- No concurrent serious infection that is uncontrolled or would preclude study
participation

- No nonmalignant medical illness that is uncontrolled or would preclude study
participation

- No psychiatric disorders that would preclude study participation

- No other active malignancy within the past 3 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No clinically significant hearing loss

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy to the treatment field

Surgery:

- See Disease Characteristics

Other:

- No other concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

David Paul Kelsen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068464

NCT ID:

NCT00011960

Start Date:

May 2001

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • stage I gastric cancer
  • stage II gastric cancer
  • stage III gastric cancer
  • stage I esophageal cancer
  • stage II esophageal cancer
  • stage III esophageal cancer
  • adenocarcinoma of the stomach
  • adenocarcinoma of the esophagus
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Ireland Cancer CenterCleveland, Ohio  44106-5065
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
University of Washington Medical CenterSeattle, Washington  98195-6043
St. Luke's Medical CenterMilwaukee, Wisconsin  53215
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
Sutter Health Western Division Cancer Research GroupGreenbrae, California  94904
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
Memorial Hospital Cancer CenterColorado Springs, Colorado  80909
Baptist Hospital of MiamiMiami, Florida  33176-2197
Wendt Regional Cancer Center of Finley HospitalDubuque, Iowa  52001
John F. Kennedy Medical CenterEdison, New Jersey  08818
Community Medical CenterToms River, New Jersey  08755
New York Methodist HospitalBrooklyn, New York  11215-3609
Akron General Medical CenterAkron, Ohio  44302
CCOP - DaytonKettering, Ohio  45429
Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Dixie Regional Medical CenterSaint George, Utah  84770
LDS HospitalSalt Lake City, Utah  84143
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
Columbia HospitalMilwaukee, Wisconsin  53211
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Providence Alaska Medical CenterAnchorage, Alaska  99508
Foundation for Cancer Research and EducationPhoenix, Arizona  85013
University of Utah Health Sciences CenterSalt Lake City, Utah  84132
University of California Davis Cancer CenterSacramento, California  95817
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
Natalie Warren Bryant Cancer CenterTulsa, Oklahoma  74136
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
Fox Chase Virtua Health Cancer Program at Virtua Memorial HospitalMount Holly, New Jersey  08060
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Mercy Fitzgerald HospitalDarby, Pennsylvania  19023
Pocono Cancer CenterEast Stroudsburg, Pennsylvania  18301
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - OmahaOmaha, Nebraska  68114-4199
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Cancer Center at Lexington ClinicLexington, Kentucky  40504
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Highland Hospital of RochesterRochester, New York  14620
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Lima Memorial HospitalLima, Ohio  45804
Firelands Regional Medical CenterSandusky, Ohio  44870
Fulton County Health CenterWauseon, Ohio  43567
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
St. Charles HospitalOregon, Ohio  43616
Medical College of Ohio Cancer InstituteToledo, Ohio  43614
John and Dorothy Morgan Cancer Center at Lehigh Valley HospitalAllentown, Pennsylvania  18105
Flower Hospital - ProMedica Health SystemSylvania, Ohio  43560
Rutherford HospitalRutherfordton, North Carolina  28139
Wayne Memorial Hospital, Inc.Goldsboro, North Carolina  27533
Siteman Cancer CenterSaint Louis, Missouri  63110
Alexian Brothers Cancer Care CenterElk Grove Village, Illinois  60007
Akron City Hospital - Summa Health SystemAkron, Ohio  44304
Cancer Care Center, IncorporatedSalem, Ohio  44460