A Phase II Trial of Preoperative Radiation and Chemotherapy (Pemetrexed and Carboplatin) for Locally Advanced Esophageal Cancer
OBJECTIVES:
Primary
- Determine the pathologic complete response rate of radiotherapy, pemetrexed disodium,
and carboplatin when administered prior to esophagectomy in patients with locally
advanced esophageal cancer.
Secondary
- Determine the activity, in terms of clinical response rate and adverse event profile of
radiotherapy, pemetrexed disodium, and carboplatin when administered prior to
esophagectomy.
- Determine the overall survival, time-to-progression, and time-to-treatment failure for
patients receiving the above combined modality treatment.
- Determine the surgical outcome for all patients who undergo esophagectomy.
- Determine the time-to-disease recurrence and disease-free survival for patients who
have a curative resection.
- Determine quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy once daily, 5 days a week, for 5 ½ weeks and concurrently
receive pemetrexed disodium IV over 10 minutes and carboplatin IV over 30 minutes on days 1
and 22. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients who are eligible to surgery undergo esophagectomy between 4-12 weeks after
completion of radiotherapy.
Quality of life is assessed at baseline, immediately prior to day 22 of chemotherapy, and
within 2 weeks prior to surgery.
After completion of study treatment, patients are followed periodically for approximately 4
years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Pathologic complete response rate
No
Francis C. Nichols, MD
Mayo Clinic
United States: Federal Government
CDR0000455635
NCT00268437
April 2006
Name | Location |
---|---|
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Foote Hospital | Jackson, Michigan 49201 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
Seton Cancer Institute - Saginaw | Saginaw, Michigan 48601 |
St. John Macomb Hospital | Warren, Michigan 48093 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Duluth Clinic Cancer Center - Duluth | Duluth, Minnesota 55805-1983 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Miller - Dwan Medical Center | Duluth, Minnesota 55805 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
Meeker County Memorial Hospital | Lichfield, Minnesota 55355 |
Minnesota Oncology Hematology, PA - Maplewood | Maplewood, Minnesota 55109 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
HealthEast Cancer Care at St. Joseph's Hospital | St Paul, Minnesota 55102 |
Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota 55125 |
HealthEast Cancer Care at Woodwinds Health Campus | Woodbury, Minnesota 55125 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Eureka Community Hospital | Eureka, Illinois 61530 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
InterCommunity Cancer Center of Western Illinois | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
Hopedale Medical Complex | Hopedale, Illinois 61747 |
Kewanee Hospital | Kewanee, Illinois 61443 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
St. Margaret's Hospital | Spring Valley, Illinois 61362 |
Valley Cancer Center | Spring Valley, Illinois 61362 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Mercy Capitol Hospital | Des Moines, Iowa 50307 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Bismarck Cancer Center | Bismarck, North Dakota 58501 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
St. Anthony's Memorial Hospital | Effingham, Illinois 62401 |
Mid Dakota Clinic, PC | Bismarck, North Dakota 58501 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Galesburg Clinic, PC | Galesburg, Illinois 61401 |
AnMed Cancer Center | Anderson, South Carolina 29621 |
Medcenter One Hospital Cancer Care Center | Bismarck, North Dakota 58501 |
St. Alexius Medical Center Cancer Center | Bismarck, North Dakota 58502 |
Albert Lea Cancer Center at Albert Lea Medical Center | Albert Lea, Minnesota 56007 |