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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00069953
First received: October 3, 2003
Last updated: October 8, 2013
Last verified: October 2013
  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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Overall survival [ Time Frame: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of major (grade 4) acute treatment-related toxicities [ Time Frame: From start of chemotherapy to surgery or 2 months after chemoradiation (for patients not undergoing surgery). ] [ Designated as safety issue: Yes ]
  • Frequency of patients with persistent or recurrent disease eligible for surgical salvage resection [ Time Frame: Analysis occurs with the primary outcome measure. ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: September 2003
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Induction chemotherapy-chemoradiation-salvage surgery Biological: filgrastim Biological: pegfilgrastim Drug: cisplatin Drug: fluorouracil Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, California
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Saint Rose Hospital
Hayward, California, United States, 94545
Providence Holy Cross Cancer Center
Mission Hills, California, United States, 91346-9600
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609
Summit Medical Center
Oakland, California, United States, 94609
Valley Care Medical Center
Pleasanton, California, United States, 94588
J.C. Robinson, M.D. Regional Cancer Center
San Pablo, California, United States, 94806
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
Ochsner Clinic of Baton Rouge
Baton Rouge, Louisiana, United States, 708169990
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
United States, Michigan
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Green Bay Oncology, Limited - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Foote Hospital
Jackson, Michigan, United States, 49201
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48909
Seton Cancer Institute - Saginaw
Saginaw, Michigan, United States, 48601
St. John Macomb Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422-2900
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Health Services
St. Louis Park, Minnesota, United States, 55416
United Hospital
St. Paul, Minnesota, United States, 55102
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
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
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
United States, Nevada
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
Fox Chase Virtua Health Cancer Program - Marlton
Marlton, New Jersey, United States, 08053
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
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 Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Wayne Radiation Oncology
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
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
CCOP - Dayton
Dayton, Ohio, United States, 45429
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
Grandview Hospital
Dayton, Ohio, United States, 45405
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Middletown Regional Hospital
Middletown, Ohio, United States, 45044
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
Salem, Ohio, United States, 44460
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Cancer Treatment Center
Wooster, Ohio, United States, 44691
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
United States, Pennsylvania
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
Rose Ramer Cancer Clinic at Anderson Area Medical Center
Anderson, South Carolina, United States, 29621
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
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
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
LDS Hospital
Salt Lake City, Utah, United States, 84143
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States, 84106
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
United States, West Virginia
Schiffler Cancer Center at Wheeling Hospital
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
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
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Stephen G. Swisher, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Swisher S, Winters K, Komaki R, et al.: A phase II study of a paclitaxel based chemoradiation regimen with selective surgical salvage for resectable locoregionally advanced esophageal cancer: initial reporting of RTOG 0246. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-190, S106, 2007.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00069953     History of Changes
Other Study ID Numbers: RTOG-0246, CDR0000306455
Study First Received: October 3, 2003
Last Updated: October 8, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
adenocarcinoma of the esophagus
squamous cell carcinoma of the esophagus
stage II esophageal cancer
stage III esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Fluorouracil
Paclitaxel
Lenograstim
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on July 22, 2014