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| Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00022139 |
Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy and giving them before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: This phase II trial is studying how well giving radiation therapy together with combination chemotherapy followed by esophagectomy works in treating patients with locally advanced cancer of the esophagus or gastroesophageal junction.
| Condition | Intervention | Phase |
|
Esophageal Cancer Gastric Cancer |
Drug: carboplatin Drug: fluorouracil Drug: paclitaxel Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radiation therapy |
Phase II |
| MedlinePlus related topics: | Cancer Esophageal Cancer Esophagus Disorders Stomach Cancer |
| Drug Information available for: | Carboplatin Paclitaxel Fluorouracil |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Trial of Preoperative Radiation and Chemotherapy (Paclitaxel, Carboplatin, and Continuous Infusion 5-FU) for Locally Advanced Esophageal Cancer |
| Study Start Date: | January 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive carboplatin IV and paclitaxel IV over 3 hours on days 1 and 22 and fluorouracil IV continuously on days 1-42. Beginning on day 1 of chemotherapy, patients undergo radiotherapy to the esophagus 5 days a week for 5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease at 4-8 weeks after completion of radiotherapy undergo esophagectomy and complete dissection of the mediastinal and perigastric lymph nodes. Beginning 8 weeks after surgery, patients who underwent curative resection may receive a maximum of 2 additional courses of paclitaxel and carboplatin in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before chemotherapy on days 1 and 22, and within 2 weeks before surgery.
Patients are followed every 3 months for 4 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (below 20 cm) or gastroesophageal junction
PATIENT CHARACTERISTICS:
Age
Performance status
ECOG 0-2
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Kansas | |||||
| Associates in Womens Health, PA - North Review | |||||
| Wichita, Kansas, United States, 67203 | |||||
| Cancer Center of Kansas, PA - Kingman | |||||
| Kingman, Kansas, United States, 67068 | |||||
| Cancer Center of Kansas, PA - Wichita | |||||
| Wichita, Kansas, United States, 67214 | |||||
| Cancer Center of Kansas, PA - Chanute | |||||
| Chanute, Kansas, United States, 66720 | |||||
| Cancer Center of Kansas, PA - Dodge City | |||||
| Dodge City, Kansas, United States, 67801 | |||||
| Cancer Center of Kansas, PA - El Dorado | |||||
| El Dorado, Kansas, United States, 67042 | |||||
| Cancer Center of Kansas, PA - Medical Arts Tower | |||||
| Wichita, Kansas, United States, 67208 | |||||
| Cancer Center of Kansas, PA - Newton | |||||
| Newton, Kansas, United States, 67114 | |||||
| Wesley Medical Center | |||||
| Wichita, Kansas, United States, 67214 | |||||
| Cancer Center of Kansas, PA - Pratt | |||||
| Pratt, Kansas, United States, 67124 | |||||
| Cancer Center of Kansas, PA - Salina | |||||
| Salina, Kansas, United States, 67042 | |||||
| Cancer Center of Kansas, PA - Wellington | |||||
| Wellington, Kansas, United States, 67152 | |||||
| Cancer Center of Kansas, PA - Winfield | |||||
| Winfield, Kansas, United States, 67156 | |||||
| CCOP - Wichita | |||||
| Wichita, Kansas, United States, 67214 | |||||
| Southwest Medical Center | |||||
| Liberal, Kansas, United States, 67901 | |||||
| Via Christi Cancer Center at Via Christi Regional Medical Center | |||||
| Wichita, Kansas, United States, 67214 | |||||
| Cancer Center of Kansas, PA - Parsons | |||||
| Parsons, Kansas, United States, 67357 | |||||
| United States, Minnesota | |||||
| CCOP - Duluth | |||||
| Duluth, Minnesota, United States, 55805 | |||||
| CCOP - Metro-Minnesota | |||||
| Saint Louis Park, Minnesota, United States, 55416 | |||||
| Duluth Clinic Cancer Center - Duluth | |||||
| Duluth, Minnesota, United States, 55805-1983 | |||||
| Fairview Ridges Hospital | |||||
| Burnsville, Minnesota, United States, 55337 | |||||
| Fairview Southdale Hospital | |||||
| Edina, Minnesota, United States, 55435 | |||||
| Miller - Dwan Medical Center | |||||
| Duluth, Minnesota, United States, 55805 | |||||
| Mercy and Unity Cancer Center at Mercy Hospital | |||||
| Coon Rapids, Minnesota, United States, 55433 | |||||
| Mercy and Unity Cancer Center at Unity Hospital | |||||
| Fridley, Minnesota, United States, 55432 | |||||
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | |||||
| Robbinsdale, Minnesota, United States, 55422-2900 | |||||
| Minnesota Oncology Hematology, PA - Maplewood | |||||
| Maplewood, Minnesota, United States, 55109 | |||||
| Minnesota Oncology Hematology, PA - Woodbury | |||||
| Woodbury, Minnesota, United States, 55125 | |||||
| Park Nicollet Cancer Center | |||||
| St. Louis Park, Minnesota, United States, 55416 | |||||
| Ridgeview Medical Center | |||||
| Waconia, Minnesota, United States, 55387 | |||||
| United Hospital | |||||
| St. Paul, Minnesota, United States, 55102 | |||||
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | |||||
| Minneapolis, Minnesota, United States, 55407 | |||||
| United States, South Dakota | |||||
| Avera Cancer Institute | |||||
| Sioux Falls, South Dakota, United States, 57105 | |||||
| Medical X-Ray Center, PC | |||||
| Sioux Falls, South Dakota, United States, 57105 | |||||
| Sanford Cancer Center at Sanford USD Medical Center | |||||
| Sioux Falls, South Dakota, United States, 57117-5039 | |||||
| North Central Cancer Treatment Group |
| National Cancer Institute (NCI) |
| Study Chair: | Aminah Jatoi, MD | Mayo Clinic |
| Investigator: | Bradley S. Lair, MD | Medical Oncology and Hematology Associates at John Stoddard Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068789, NCCTG-N0044 |
| First Received: | August 10, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00022139 |
| Health Authority: | United States: Federal Government |
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