Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

Phase 2

Completed

Conditions: Esophageal Cancer

Interventions: Biological: filgrastim
Biological: pegfilgrastim
Drug: cisplatin
Drug: fluorouracil
Drug: paclitaxel
Procedure: conventional surgery
Radiation: radiation therapy

Registration Number: NCT00069953

Lead Sponsor: Radiation Therapy Oncology Group

Brief Summary: RATIONALE: Drugs used in chemotherapy such as paclitaxel, fluorouracil, and cisplatin 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: This phase II trial is studying how well combination chemotherapy followed by chemoradiotherapy, with or without surgery, works in treating patients with resectable locally advanced cancer of the esophagus or gastroesophageal junction.

Detailed Description: OBJECTIVES:

* Determine the feasibility of treatment with paclitaxel, cisplatin, and fluorouracil followed by chemoradiotherapy and possible surgical salvage in patients with resectable locally advanced carcinoma of the esophagus or gastroesophageal junction.

* Determine the overall and disease-free survival of patients treated with this regimen.

* Determine the treatment-related toxicity of this regimen in these patients.

* Determine the tolerance to surgical salvage in patients treated with this regimen.

* Determine the morbidity and mortality of surgical salvage in patients treated with this regimen.

OUTLINE: This is a multicenter study.

* Induction therapy: Patients receive fluorouracil (5-FU) IV continuously over 96 hours beginning on days 1 and 29; cisplatin IV over 1 hour on days 1-5 and 29-33; paclitaxel IV over 2 hours on days 1 and 29; and pegfilgrastim subcutaneously (SC) on days 6 and 34 OR filgrastim (G-CSF) SC on days 6-15 and 34-42. Treatment continues in the absence of unacceptable toxicity.

* Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on days 57-61 and 5-FU IV continuously on days 57-61, 64-68, 71-75, 78-82, 85-89, and 92-96. Patients concurrently undergo external beam radiotherapy on days 57-61, 64-68, 71-75, 78-82, 85-89, and 92-96.

Patients with residual or recurrent esophageal disease 4-6 weeks after completion of chemoradiotherapy may undergo salvage esophagectomy.

Patients are followed periodically.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study within 18 months.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 43

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ChemoRT and selective surgery	paclitaxel	Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
ChemoRT and selective surgery	filgrastim	Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
ChemoRT and selective surgery	pegfilgrastim	Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
ChemoRT and selective surgery	conventional surgery	Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
ChemoRT and selective surgery	radiation therapy	Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
ChemoRT and selective surgery	cisplatin	Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
ChemoRT and selective surgery	fluorouracil	Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.

Primary Outcome Measures

Name	Time	Method
Overall Survival (1-year Rate Reported)	From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year.	One-year survival estimate is reported. Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 1 year. On the basis of a 1-year survival rate of 60% from the Radiation Therapy Oncology Group (RTOG) esophageal database, 38 analyzable patients with a 1-year survival rate of 77.5% or better was needed for this trial to be deemed promising enough for development of a Phase III protocol (type I error of 0.05 and type II error of 0.20).

Secondary Outcome Measures

Name	Time	Method
Frequency of Major (Grade 4) Acute Treatment-related Toxicities	From start of chemotherapy to surgery or 2 months after chemoradiation (for patients not undergoing surgery).
Frequency of Patients With Persistent or Recurrent Disease Eligible for Surgical Salvage Resection	Analysis occurs with the primary outcome measure.

Trial Locations

Locations (97): Providence Saint Joseph Medical Center - Burbank
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Burbank, California, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
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Robbinsdale, Minnesota, United States
Fox Chase Cancer Center
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Philadelphia, Pennsylvania, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Dearborn, Michigan, United States
Foote Hospital
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Jackson, Michigan, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Savannah, Georgia, United States
Fairview Southdale Hospital
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Edina, Minnesota, United States
Mount Sinai Hospital Medical Center
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Chicago, Illinois, United States
Wendt Regional Cancer Center at Finley Hospital
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Dubuque, Iowa, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
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Grosse Pointe Woods, Michigan, United States
Green Bay Oncology, Limited - Iron Mountain
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Iron Mountain, Michigan, United States
Mercy and Unity Cancer Center at Mercy Hospital
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Coon Rapids, Minnesota, United States
Genesys Hurley Cancer Institute
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Flint, Michigan, United States
Saint Rose Hospital
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Hayward, California, United States
J.C. Robinson, M.D. Regional Cancer Center
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San Pablo, California, United States
Green Bay Oncology, Limited - Escanaba
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Escanaba, Michigan, United States
Hulston Cancer Center at Cox Medical Center South
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Springfield, Missouri, United States
Seton Cancer Institute - Saginaw
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Saginaw, Michigan, United States
Wilmed Radiation Oncology Services
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Wilson, North Carolina, United States
Good Samaritan Hospital
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Dayton, Ohio, United States
Gulf Coast Cancer Treatment Center
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Panama City, Florida, United States
Samaritan North Cancer Care Center
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Dayton, Ohio, United States
Green Bay Oncology, Limited at St. Mary's Hospital
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Green Bay, Wisconsin, United States
CCOP - Bay Area Tumor Institute
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Oakland, California, United States
St. John Macomb Hospital
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Warren, Michigan, United States
Valley Care Medical Center
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Pleasanton, California, United States
St. John's Regional Health Center
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Springfield, Missouri, United States
Mercy and Unity Cancer Center at Unity Hospital
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Fridley, Minnesota, United States
CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, United States
CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, United States
Wayne Radiation Oncology
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Goldsboro, North Carolina, United States
Cancer Treatment Center
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Wooster, Ohio, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
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La Crosse, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, United States
Rutherford Hospital
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Rutherfordton, North Carolina, United States
Siteman Cancer Center at Barnes-Jewish Hospital
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St Louis, Missouri, United States
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
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Drexel Hill, Pennsylvania, United States
Akron City Hospital
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Akron, Ohio, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
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Philadelphia, Pennsylvania, United States
CCOP - Dayton
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Dayton, Ohio, United States
Ridgeview Medical Center
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Waconia, Minnesota, United States
Cottonwood Hospital Medical Center
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Murray, Utah, United States
Middletown Regional Hospital
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Middletown, Ohio, United States
Charles F. Kettering Memorial Hospital
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Kettering, Ohio, United States
Wayne Memorial Hospital, Incorporated
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Goldsboro, North Carolina, United States
David L. Rike Cancer Center at Miami Valley Hospital
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Dayton, Ohio, United States
Albert Einstein Cancer Center
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Philadelphia, Pennsylvania, United States
Rose Ramer Cancer Clinic at Anderson Area Medical Center
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Anderson, South Carolina, United States
Veterans Affairs Medical Center - Dayton
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Dayton, Ohio, United States
Utah Valley Regional Medical Center - Provo
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Provo, Utah, United States
Bay Area Cancer Care Center at Bay Area Medical Center
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Marinette, Wisconsin, United States
Green Bay Oncology, Limited at St. Vincent Hospital
🇺🇸
Green Bay, Wisconsin, United States
Paoli Memorial Hospital
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Paoli, Pennsylvania, United States
Dixie Regional Medical Center - East Campus
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Saint George, Utah, United States
Green Bay Oncology, Limited - Sturgeon Bay
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Sturgeon Bay, Wisconsin, United States
Baptist-South Miami Regional Cancer Program
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Miami, Florida, United States
M.D. Anderson Cancer Center at University of Texas
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Houston, Texas, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
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Minneapolis, Minnesota, United States
Utah Cancer Specialists at UCS Cancer Center
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Salt Lake City, Utah, United States
Huntsman Cancer Institute at University of Utah
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Salt Lake City, Utah, United States
LDS Hospital
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Salt Lake City, Utah, United States
Providence Holy Cross Cancer Center
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Mission Hills, California, United States
Summit Medical Center
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Oakland, California, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
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Beech Grove, Indiana, United States
Sparrow Regional Cancer Center
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Lansing, Michigan, United States
Fairview Ridges Hospital
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Burnsville, Minnesota, United States
Park Nicollet Health Services
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St. Louis Park, Minnesota, United States
Albuquerque Regional Medical Center at Lovelace Sandia Health System
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Albuquerque, New Mexico, United States
University of New Mexico Cancer Research and Treatment Center
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Albuquerque, New Mexico, United States
UVMC Cancer Care Center at Upper Valley Medical Center
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Troy, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
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Xenia, Ohio, United States
Bryn Mawr Hospital
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Bryn Mawr, Pennsylvania, United States
CCOP - MainLine Health
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Wynnewood, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
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Wynnewood, Pennsylvania, United States
CCOP - Upstate Carolina
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Spartanburg, South Carolina, United States
McKay-Dee Hospital Center
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Ogden, Utah, United States
Schiffler Cancer Center at Wheeling Hospital
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Wheeling, West Virginia, United States
St. Mary's Hospital Medical Center - Green Bay
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Green Bay, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls
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Oconto Falls, Wisconsin, United States
Fox Chase Virtua Health Cancer Program - Marlton
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Marlton, New Jersey, United States
Community Regional Cancer Center at Community Medical Center
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Toms River, New Jersey, United States
Ochsner Clinic of Baton Rouge
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Baton Rouge, Louisiana, United States
Booker Cancer Center at Riverview Medical Center
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Red Bank, New Jersey, United States
CCOP - Nevada Cancer Research Foundation
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Las Vegas, Nevada, United States
Monmouth Medical Center
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Long Branch, New Jersey, United States
Hattiesburg Clinic, P.A.
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Hattiesburg, Mississippi, United States
University Medical Center of Southern Nevada
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Las Vegas, Nevada, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
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Spartanburg, South Carolina, United States
SUNY Downstate Medical Center
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Brooklyn, New York, United States
United Hospital
🇺🇸
St. Paul, Minnesota, United States
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
🇺🇸
Salem, Ohio, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
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Aurora, Colorado, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
🇺🇸
Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸
Ann Arbor, Michigan, United States
Grandview Hospital
🇺🇸
Dayton, Ohio, United States
Hospital of Saint Raphael
🇺🇸
New Haven, Connecticut, United States
CCOP - Ochsner
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New Orleans, Louisiana, United States