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

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Trial Identification

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

Official Title: A Phase II Study Of Paclitaxel-Based Chemoradiotherapy Regimen With Selective Surgical Salvage For Resectable Locoregionally Advanced Carcinoma Of The Esophagus

Study ID: NCT00069953

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Providence Saint Joseph Medical Center - Burbank, Burbank, California, United States

Saint Rose Hospital, Hayward, California, United States

Providence Holy Cross Cancer Center, Mission Hills, California, United States

CCOP - Bay Area Tumor Institute, Oakland, California, United States

Summit Medical Center, Oakland, California, United States

Valley Care Medical Center, Pleasanton, California, United States

J.C. Robinson, M.D. Regional Cancer Center, San Pablo, California, United States

University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado, United States

Hospital of Saint Raphael, New Haven, Connecticut, United States

Baptist-South Miami Regional Cancer Program, Miami, Florida, United States

Gulf Coast Cancer Treatment Center, Panama City, Florida, United States

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, United States

Mount Sinai Hospital Medical Center, Chicago, Illinois, United States

St. Francis Hospital and Health Centers - Beech Grove Campus, Beech Grove, Indiana, United States

Wendt Regional Cancer Center at Finley Hospital, Dubuque, Iowa, United States

Ochsner Clinic of Baton Rouge, Baton Rouge, Louisiana, United States

CCOP - Ochsner, New Orleans, Louisiana, 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

Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States

Green Bay Oncology, Limited - Escanaba, Escanaba, Michigan, United States

Genesys Hurley Cancer Institute, Flint, Michigan, United States

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States

Green Bay Oncology, Limited - Iron Mountain, Iron Mountain, Michigan, United States

Foote Hospital, Jackson, Michigan, United States

Sparrow Regional Cancer Center, Lansing, Michigan, United States

Seton Cancer Institute - Saginaw, Saginaw, Michigan, United States

St. John Macomb Hospital, Warren, Michigan, United States

Fairview Ridges Hospital, Burnsville, Minnesota, United States

Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States

Fairview Southdale Hospital, Edina, Minnesota, United States

Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States

Virginia Piper Cancer Institute at Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States

Hubert H. Humphrey Cancer Center at North Memorial Medical Center, Robbinsdale, Minnesota, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States

Park Nicollet Health Services, St. Louis Park, Minnesota, United States

United Hospital, St. Paul, Minnesota, United States

Ridgeview Medical Center, Waconia, Minnesota, United States

Hattiesburg Clinic, P.A., Hattiesburg, Mississippi, United States

CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States

St. John's Regional Health Center, Springfield, Missouri, United States

Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri, United States

Siteman Cancer Center at Barnes-Jewish Hospital, St Louis, Missouri, United States

University Medical Center of Southern Nevada, Las Vegas, Nevada, United States

CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada, United States

Monmouth Medical Center, Long Branch, New Jersey, United States

Fox Chase Virtua Health Cancer Program - Marlton, Marlton, New Jersey, United States

Booker Cancer Center at Riverview Medical Center, Red Bank, New Jersey, United States

Community Regional Cancer Center at Community Medical Center, Toms River, New Jersey, United States

Albuquerque Regional Medical Center at Lovelace Sandia Health System, Albuquerque, New Mexico, United States

University of New Mexico Cancer Research and Treatment Center, Albuquerque, New Mexico, United States

SUNY Downstate Medical Center, Brooklyn, New York, United States

Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States

Wayne Radiation Oncology, Goldsboro, North Carolina, United States

Rutherford Hospital, Rutherfordton, North Carolina, United States

Wilmed Radiation Oncology Services, Wilson, North Carolina, United States

Akron City Hospital, Akron, Ohio, United States

Grandview Hospital, Dayton, Ohio, United States

Good Samaritan Hospital, Dayton, Ohio, United States

David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, United States

Samaritan North Cancer Care Center, Dayton, Ohio, United States

Veterans Affairs Medical Center - Dayton, Dayton, Ohio, United States

CCOP - Dayton, Dayton, Ohio, United States

Charles F. Kettering Memorial Hospital, Kettering, Ohio, United States

Middletown Regional Hospital, Middletown, Ohio, United States

Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford, Salem, Ohio, United States

UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio, United States

Cancer Treatment Center, Wooster, Ohio, United States

Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio, United States

Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, United States

Delaware County Regional Cancer Center at Delaware County Memorial Hospital, Drexel Hill, Pennsylvania, United States

Paoli Memorial Hospital, Paoli, Pennsylvania, United States

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Albert Einstein Cancer Center, Philadelphia, Pennsylvania, United States

CCOP - MainLine Health, Wynnewood, Pennsylvania, United States

Lankenau Cancer Center at Lankenau Hospital, Wynnewood, Pennsylvania, United States

Rose Ramer Cancer Clinic at Anderson Area Medical Center, Anderson, South Carolina, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina, United States

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States

M.D. Anderson Cancer Center at University of Texas, Houston, Texas, United States

Cottonwood Hospital Medical Center, Murray, Utah, United States

McKay-Dee Hospital Center, Ogden, Utah, United States

Utah Valley Regional Medical Center - Provo, Provo, Utah, United States

Dixie Regional Medical Center - East Campus, Saint George, Utah, United States

Utah Cancer Specialists at UCS Cancer Center, Salt Lake City, Utah, United States

Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, United States

LDS Hospital, Salt Lake City, Utah, United States

Schiffler Cancer Center at Wheeling Hospital, Wheeling, West Virginia, United States

Green Bay Oncology, Limited at St. Vincent Hospital, Green Bay, Wisconsin, United States

Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin, United States

St. Mary's Hospital Medical Center - Green Bay, Green Bay, Wisconsin, United States

St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States

Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, United States

Green Bay Oncology, Limited - Oconto Falls, Oconto Falls, Wisconsin, United States

Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States

Contact Details

Name: Stephen G. Swisher, MD

Affiliation: M.D. Anderson Cancer Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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