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Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer

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ClinicalTrials.gov Identifier: NCT00003298
Recruitment Status : Completed
First Posted : January 23, 2004
Results First Posted : June 23, 2015
Last Update Posted : July 16, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

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, radiation therapy, and surgery may kill more tumor cells. E7296 was conducted to study neoadjuvant chemotherapy and postoperative chemoradiation therapy in patients diagnosed with high-risk gastric cancer using a new neoadjuvant regimen: paclitaxel plus cisplatin. It was hypothesized that this new neoadjuvant chemotherapy followed by surgery and chemoradiation therapy would be well tolerated and would have a high curative resection rate.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: cisplatin Drug: fluorouracil Drug: leucovorin calcium Drug: paclitaxel Procedure: surgery Radiation: radiation therapy Phase 2

Detailed Description:

OBJECTIVES:

Primary objective: To evaluate the tolerability and toxicity of neoadjuvant cisplatin plus paclitaxel and postoperative chemoradiation therapy with fluorouracil plus leucovorin calcium in patients with high-risk gastric cancer.

Secondary objectives: To assess the pathologic response of gastric tumors to neoadjuvant cisplatin plus paclitaxel chemotherapy, and preliminarily assess the patterns of failure and disease free and overall survival.

OUTLINE: Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment. Patients are followed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter.

PROJECTED ACCRUAL: Approximately 30-42 patients will be accrued over 18 months.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Neoadjuvant Paclitaxel - Cisplatin Chemotherapy, Surgery and Adjuvant Radiation Therapy and 5-FU/Leucovorin for Gastric Cancer
Study Start Date : February 1999
Actual Primary Completion Date : February 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Leucovorin

Arm Intervention/treatment
Experimental: Experimental Arm
Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
Drug: cisplatin
Cisplatin was administered as part of the neoadjuvant regimen. It was given at a dose of 75 mg/m² via IV over approximately one hour, on day 1 of each cycle. Three cycles were given.
Other Names:
  • Platinol
  • cis-platinum
  • cisdiamminedichloroplatinum (II)
  • Platinol-AQ
  • DACP
  • platinum
  • CDDP
  • DDP

Drug: fluorouracil
Postoperative regimen 5-FU, along with Leucovorin, was given by IV bolus, with 5-FU given immediately after the Leucovorin
Other Names:
  • 5-Fluorouracil
  • 5-FU
  • Adrucil
  • Efudex

Drug: leucovorin calcium
Both 5-FU and Leucovorin will be given via IV bolus, with Leucovorin given immediately before 5-FU.
Other Names:
  • Leucovorin
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • 5-formyl tetrahydrofolate
  • LV
  • LCV

Drug: paclitaxel
Paclitaxel was administered as part of the neoadjuvant regimen. It was given at a dose of 175 mg/m² as a 3 hour continuous intravenous infusion on day 1. Three cycles were given.
Other Names:
  • Taxol®
  • NSC 125973

Procedure: surgery

The surgical procedure performed involved a radical subtotal or total gastrectomy.

A complete surgical resection was required


Radiation: radiation therapy
Concomitant chemotherapy and radiation therapy course: 5-FU 400 mg/m²/day + Leucovorin 20 mg/m²/day on days 1-4 of week one and days 1-3 of week 5 of XRT. Combined chemotherapy and radiation therapy were to begin 4 weeks after day 1 of the initial course of chemotherapy




Primary Outcome Measures :
  1. Grade 3 or Higher Toxicity Incidence on Step 1 [ Time Frame: assessed at the end of every cycle (cycle=21 days) during treatment (3 cycles in total) ]
    Incidence is defined as proportion of patients with any grade 3 or higher treatment-related toxicities among all treated patients.


Secondary Outcome Measures :
  1. Best Confirmed Response to Neoadjuvant Therapy [ Time Frame: Assessed at surgery time (surgery performed during week 8-10 after registration to the study) ]
    Response was based on pathology at surgery. A patient achieved complete response if no gross or microscopic tumor were identified with the surgical specimen and nodal tissue. Stable response was defined as a response that did not qualify as complete response or progressive disease (PD), where PD indicated metastatic spread. Best confirmed response rate was defined as the proportion of patients with complete response (CR). A patient was considered unevaluable if the patient did not have surgery, the pathologist did not examine at least 15 lymph nodes, or the pathology report was unavailable.

  2. Overall Survival [ Time Frame: assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10 ]
    Overall survival was defined as the time from registration to death, where a subject was censored on date of last record alive.

  3. Progression Free Survival [ Time Frame: assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10 ]
    Progression-free survival (PFS) was defined as time from registration until progression, recurrence, or death, whichever occurred first. If date of death occurred beyond three months from the date of last disease assessment, then PFS was censored at date of last disease assessment. Patients who were alive and progression-free were censored at the date of last disease evaluation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
  • Localized cancer that is potentially curable by surgery (T2, N1-2, M0 or T3-4, any N, M0)
  • No metastatic cancer to the ovaries
  • Age: 18 and over
  • Easter Cooperative Oncology Group (ECOG) performance status 0-2
  • White blood cell (WBC) count at least 4,000 cells/mm3
  • Platelet count at least 150,000/mm3
  • Bilirubin less than 2 mg/dL
  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance greater than 50 mL/min
  • Caloric intake must be at least 1500 kcal/day
  • No prior history of cancer within the past 5 years except for basal cell carcinoma of the skin or in situ carcinoma of the cervix
  • No prior radiation therapy, except for skin cancer
  • Fertile patients must use adequate contraception
  • Met criteria for re-registration after surgery

    • T1N1-2M0, T2N1-2M0 or T3-4NanyM0 at time of initial re-registration.
    • No evidence of metastatic disease from postoperative pathologic staging.
    • ECOG performance status of 0, 1, or 2 at re-registration
    • Curative resection performed
    • Re-registered 4 - 6 weeks from the date of surgery
    • WBC ≥ 4000 cells/mm³, platelets ≥ 150,000/mm³, creatinine ≤ 1.5 mg/dl or creatinine clearance of > 50 ml/min (measured or calculated) and total serum bilirubin < 2 mg/dl, all within four weeks prior to re-registration

Exclusion Criteria:

  • Prior chemotherapy
  • Clinically significant auditory impairment
  • Significant heart disease
  • Pregnant or lactating

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003298


  Hide Study Locations
Locations
United States, Colorado
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, United States, 80209-5031
United States, Georgia
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States, 60611
CCOP - Evanston
Evanston, Illinois, United States, 60201
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States, 46202
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
New England Medical Center Hospital
Boston, Massachusetts, United States, 02111
United States, Michigan
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States, 48106
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68131
United States, New Jersey
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962-1956
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Raritan Bay Medical Center
Perth Amboy, New Jersey, United States, 08861
Somerset Medical Center
Somerville, New Jersey, United States, 08876
United States, New York
Albert Einstein Comprehensive Cancer Center
Bronx, New York, United States, 10461
University of Rochester Cancer Center
Rochester, New York, United States, 14642
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States, 43623-3456
United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
United States, Tennessee
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, United States, 37212
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Wisconsin
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, United States, 54449
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States, 53295
Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
Study Chair: David I. Rosenthal, MD Abramson Cancer Center of the University of Pennsylvania

Publications of Results:
Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT00003298     History of Changes
Other Study ID Numbers: CDR0000066237
E7296 ( Other Identifier: Eastern Cooperative Oncology Group )
U10CA023318 ( U.S. NIH Grant/Contract )
First Posted: January 23, 2004    Key Record Dates
Results First Posted: June 23, 2015
Last Update Posted: July 16, 2015
Last Verified: June 2015

Keywords provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):
stage II gastric cancer
stage III gastric cancer
stage IV gastric cancer
adenocarcinoma of the stomach

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Fluorouracil
Levoleucovorin
Leucovorin
Tetrahydrofolates
Formyltetrahydrofolates
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex