Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Radiation Therapy Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00069953
First received: October 3, 2003
Last updated: April 23, 2011
Last verified: February 2006
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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: | 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:
Drug Information available for:
Fluorouracil
Cisplatin
Paclitaxel
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
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 |
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
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Hide Study LocationsLocations
| 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.
| ClinicalTrials.gov Identifier: | NCT00069953 History of Changes |
| Other Study ID Numbers: | CDR0000306455, RTOG-0246 |
| Study First Received: | October 3, 2003 |
| Last Updated: | April 23, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the esophagus squamous cell carcinoma of the esophagus stage II esophageal cancer stage III esophageal cancer |
Additional relevant MeSH terms:
|
Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms 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 June 17, 2013