Esophageal Cancer Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction

Primary (non-recurrent) disease
Amenable to resection
Stage greater than T1, N0 by endoscopic ultrasound
Must be entirely confined to the esophagus or gastroesophageal junction and periesophageal soft tissue
Tumor may not extend more than 2 cm into the stomach
No multiple primary carcinomas of the esophagus
No cervical esophageal carcinoma or tumors less than 5 cm from cricopharyngeus

No evidence of disseminated cancer

Suggestion of liver metastases by positron emission tomography must be proven negative by biopsy or other imaging studies
Palpable supraclavicular nodes must be negative for cancer by biopsy
Bronchoscopy required for lesions less than 26 cm from the incisors to exclude tracheoesophageal fistula or invasion
No celiac adenopathy greater than 2 cm

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Zubrod 0-1

Life expectancy

Not specified

Hematopoietic

Absolute granulocyte count at least 1,500/mm^3
Platelet count at least 150,000/mm^3
Hemoglobin at least 10 g/dL

Hepatic

Not specified

Renal

Creatinine no greater than 1.5 mg/dL AND/OR
Creatinine clearance at least 65 mL/min
Calcium no greater than 11 mg/dL

Cardiovascular

No uncontrolled heart disease
No uncontrolled hypertension

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Able to comprehend study requirements and considered likely to comply with study parameters
No other malignancy within the past 5 years except curable nonmelanoma skin cancer or carcinoma in situ of the cervix
No uncontrolled diabetes
No hypersensitivity to E. coli-derived products

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

More than 5 years since prior systemic chemotherapy

Endocrine therapy

Not specified

Radiotherapy

No prior chest or upper abdomen radiotherapy

Surgery

No prior esophageal or gastric surgery

Other

No concurrent photodynamic therapy
No other concurrent investigational agents for esophageal carcinoma

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

43

Study ID:

NCT00069953

Recruitment Status:

Completed

Sponsor:

Radiation Therapy Oncology Group

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There are 89 Locations for this study

See Locations Near You

Providence Saint Joseph Medical Center - Burbank
Burbank California, 91505, United States
Saint Rose Hospital
Hayward California, 94545, United States
Providence Holy Cross Cancer Center
Mission Hills California, 91346, United States
CCOP - Bay Area Tumor Institute
Oakland California, 94609, United States
Summit Medical Center
Oakland California, 94609, United States
Valley Care Medical Center
Pleasanton California, 94588, United States
J.C. Robinson, M.D. Regional Cancer Center
San Pablo California, 94806, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora Colorado, 80045, United States
Hospital of Saint Raphael
New Haven Connecticut, 06511, United States
Baptist-South Miami Regional Cancer Program
Miami Florida, 33176, United States
Gulf Coast Cancer Treatment Center
Panama City Florida, 32405, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah Georgia, 31403, United States
Mount Sinai Hospital Medical Center
Chicago Illinois, 60608, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove Indiana, 46107, United States
Wendt Regional Cancer Center at Finley Hospital
Dubuque Iowa, 52001, United States
Ochsner Clinic of Baton Rouge
Baton Rouge Louisiana, 70816, United States
CCOP - Ochsner
New Orleans Louisiana, 70121, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan, 48106, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn Michigan, 48123, United States
Green Bay Oncology, Limited - Escanaba
Escanaba Michigan, 49431, United States
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods Michigan, 48236, United States
Green Bay Oncology, Limited - Iron Mountain
Iron Mountain Michigan, 49801, United States
Foote Hospital
Jackson Michigan, 49201, United States
Sparrow Regional Cancer Center
Lansing Michigan, 48909, United States
Seton Cancer Institute - Saginaw
Saginaw Michigan, 48601, United States
St. John Macomb Hospital
Warren Michigan, 48093, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley Minnesota, 55432, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale Minnesota, 55422, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
Park Nicollet Health Services
St. Louis Park Minnesota, 55416, United States
United Hospital
St. Paul Minnesota, 55102, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
Hattiesburg Clinic, P.A.
Hattiesburg Mississippi, 39401, United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri, 65802, United States
St. John's Regional Health Center
Springfield Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield Missouri, 65807, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis Missouri, 63110, United States
University Medical Center of Southern Nevada
Las Vegas Nevada, 89102, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Monmouth Medical Center
Long Branch New Jersey, 07740, United States
Fox Chase Virtua Health Cancer Program - Marlton
Marlton New Jersey, 08053, United States
Booker Cancer Center at Riverview Medical Center
Red Bank New Jersey, 07701, United States
Community Regional Cancer Center at Community Medical Center
Toms River New Jersey, 08755, United States
Albuquerque Regional Medical Center at Lovelace Sandia Health System
Albuquerque New Mexico, 87102, United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque New Mexico, 87131, United States
SUNY Downstate Medical Center
Brooklyn New York, 11203, United States
Wayne Memorial Hospital, Incorporated
Goldsboro North Carolina, 27534, United States
Wayne Radiation Oncology
Goldsboro North Carolina, 27534, United States
Rutherford Hospital
Rutherfordton North Carolina, 28139, United States
Wilmed Radiation Oncology Services
Wilson North Carolina, 27893, United States
Akron City Hospital
Akron Ohio, 44309, United States
Grandview Hospital
Dayton Ohio, 45405, United States
Good Samaritan Hospital
Dayton Ohio, 45406, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton Ohio, 45409, United States
Samaritan North Cancer Care Center
Dayton Ohio, 45415, United States
Veterans Affairs Medical Center - Dayton
Dayton Ohio, 45428, United States
CCOP - Dayton
Dayton Ohio, 45429, United States
Charles F. Kettering Memorial Hospital
Kettering Ohio, 45429, United States
Middletown Regional Hospital
Middletown Ohio, 45044, United States
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
Salem Ohio, 44460, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy Ohio, 45373, United States
Cancer Treatment Center
Wooster Ohio, 44691, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia Ohio, 45385, United States
Bryn Mawr Hospital
Bryn Mawr Pennsylvania, 19010, United States
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill Pennsylvania, 19026, United States
Paoli Memorial Hospital
Paoli Pennsylvania, 19301, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Albert Einstein Cancer Center
Philadelphia Pennsylvania, 19141, United States
CCOP - MainLine Health
Wynnewood Pennsylvania, 19096, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood Pennsylvania, 19096, United States
Rose Ramer Cancer Clinic at Anderson Area Medical Center
Anderson South Carolina, 29621, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg South Carolina, 29303, United States
M.D. Anderson Cancer Center at University of Texas
Houston Texas, 77030, United States
Cottonwood Hospital Medical Center
Murray Utah, 84107, United States
McKay-Dee Hospital Center
Ogden Utah, 84403, United States
Utah Valley Regional Medical Center - Provo
Provo Utah, 84604, United States
Dixie Regional Medical Center - East Campus
Saint George Utah, 84770, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City Utah, 84106, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City Utah, 84112, United States
LDS Hospital
Salt Lake City Utah, 84143, United States
Schiffler Cancer Center at Wheeling Hospital
Wheeling West Virginia, 26003, United States
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay Wisconsin, 54301, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay Wisconsin, 54303, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay Wisconsin, 54303, United States
St. Vincent Hospital Regional Cancer Center
Green Bay Wisconsin, 54307, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse Wisconsin, 54601, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette Wisconsin, 54143, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls Wisconsin, 54154, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay Wisconsin, 54235, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

43

Study ID:

NCT00069953

Recruitment Status:

Completed

Sponsor:


Radiation Therapy Oncology Group

How clear is this clinincal trial information?

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