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

Sponsor:	Radiation Therapy Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00069953

Purpose

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.

Condition	Intervention	Phase
Esophageal Cancer	Biological: filgrastim Biological: pegfilgrastim Drug: cisplatin Drug: fluorouracil Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study Of Paclitaxel-Based Chemoradiotherapy Regimen With Selective Surgical Salvage For Resectable Locoregionally Advanced Carcinoma Of The Esophagus

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Surgery

Drug Information available for: Fluorouracil Cisplatin Paclitaxel Filgrastim Pegfilgrastim

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival rate at 1 year [ Designated as safety issue: No ]
Frequency of major (grade 4) acute toxicities [ Designated as safety issue: Yes ]
Frequency of patients with persistent or recurrent disease eligible for surgical salvage resection [ Designated as safety issue: No ]

Study Start Date:

September 2003

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069953

Hide Study Locations

Locations

United States, California
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609
J.C. Robinson, M.D. Regional Cancer Center
San Pablo, California, United States, 94806
Providence Holy Cross Cancer Center
Mission Hills, California, United States, 91346-9600
Summit Medical Center
Oakland, California, United States, 94609
Saint Rose Hospital
Hayward, California, United States, 94545
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Valley Care Medical Center
Pleasanton, California, United States, 94588
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Connecticut
Hospital of Saint Raphael
New Haven, Connecticut, United States, 06511
United States, Florida
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States, 33176
Gulf Coast Cancer Treatment Center
Panama City, Florida, United States, 32405
United States, Georgia
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
United States, Illinois
Mount Sinai Hospital Medical Center
Chicago, Illinois, United States, 60608
United States, Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
United States, Iowa
Wendt Regional Cancer Center at Finley Hospital
Dubuque, Iowa, United States, 52001
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
Ochsner Clinic of Baton Rouge
Baton Rouge, Louisiana, United States, 708169990
United States, Michigan
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Seton Cancer Institute - Saginaw
Saginaw, Michigan, United States, 48601
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Green Bay Oncology, Limited - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Foote Hospital
Jackson, Michigan, United States, 49201
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48909
St. John Macomb Hospital
Warren, Michigan, United States, 48093
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422-2900
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Park Nicollet Health Services
St. Louis Park, Minnesota, United States, 55416
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
United Hospital
St. Paul, Minnesota, United States, 55102
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
United States, Mississippi
Hattiesburg Clinic, P.A.
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Booker Cancer Center at Riverview Medical Center
Red Bank, New Jersey, United States, 07701
Community Regional Cancer Center at Community Medical Center
Toms River, New Jersey, United States, 08755
Fox Chase Virtua Health Cancer Program - Marlton
Marlton, New Jersey, United States, 08053
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
United States, New Mexico
Albuquerque Regional Medical Center at Lovelace Sandia Health System
Albuquerque, New Mexico, United States, 87102
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
United States, North Carolina
Wayne Radiation Oncology
Goldsboro, North Carolina, United States, 27534
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
Wilmed Radiation Oncology Services
Wilson, North Carolina, United States, 27893
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44309-2090
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
Salem, Ohio, United States, 44460
Cancer Treatment Center
Wooster, Ohio, United States, 44691
CCOP - Dayton
Dayton, Ohio, United States, 45429
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Grandview Hospital
Dayton, Ohio, United States, 45405
Middletown Regional Hospital
Middletown, Ohio, United States, 45044
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
United States, Pennsylvania
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
United States, South Carolina
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Rose Ramer Cancer Clinic at Anderson Area Medical Center
Anderson, South Carolina, United States, 29621
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
United States, Utah
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
LDS Hospital
Salt Lake City, Utah, United States, 84143
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States, 84106
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
United States, West Virginia
Schiffler Cancer Center at Wheeling Hospital
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Stephen G. Swisher, MD

M.D. Anderson Cancer Center

Study ID Numbers:	CDR0000306455, RTOG-0246
Study First Received:	October 3, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00069953 History of Changes
Health Authority:	United States: Federal Government