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Study 17 of 2400 for search of: | United States, Kentucky |
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Sponsors and Collaborators: |
European Organization for Research and Treatment of Cancer Radiation Therapy Oncology Group National Cancer Institute of Canada Danish Head and Neck Cancer Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00047125 |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells. It is not yet known which regimen of radiation therapy is more effective in treating patients who have metastases to the lymph nodes in the neck.
PURPOSE: Randomized phase III trial to compare different radiation therapy regimens in treating patients who have metastases to the lymph nodes in the neck from an unknown primary tumor.
Condition | Intervention | Phase |
---|---|---|
Carcinoma of Unknown Primary |
Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | Randomized Phase III Study On The Selection Of The Target Volume In Postoperative Radiotherapy For Cervical Lymph Node Metastases Of Squamous Cell Carcinoma From And Unknown Primary (CUP) |
Study Start Date: | July 2002 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to disease stage (N1-2a vs N2b-3), radiation technique (2D vs 3D conformal vs intensity-modulated), and participating center. Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment continues in the absence of unacceptable toxicity or disease progression.
Quality of life is assessed at baseline, at week 4, on the last day of therapy, and then every 3 months for 1 year.
Patients are followed at day 30, every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 7 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma in cervical lymph node metastasis from an unknown primary tumor
Prior radical, radical modified, or extended radical dissection within the past 8 weeks
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Investigator: | Vincent G. Gregoire, MD, PhD | Cliniques Universitaires Saint-Luc |
Investigator: | Sharon A. Spencer, MD | Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham |
Investigator: | Samy El-Sayed, MD, FFR, FRCR, FRCP | Ottawa Hospital Regional Cancer Centre - General Campus |
Investigator: | Esat M. Ozsahin, MD, PhD | Centre Hospitalier Universitaire Vaudois |
Investigator: | Cai Grau, MD | Aarhus Universitetshospital - Aarhus Sygehus |
Study ID Numbers: | CDR0000257596, EORTC-24001, EORTC-22005, DAHANCA-EORTC-24001, CAN-NCIC-EORTC-24001, RTOG-EORTC-24001 |
Study First Received: | October 3, 2002 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00047125 |
Health Authority: | United States: Federal Government |
newly diagnosed carcinoma of unknown primary squamous cell carcinoma of unknown primary |
Epidermoid carcinoma Neoplasms, Unknown Primary Squamous cell carcinoma Carcinoma, squamous cell Neoplasm Metastasis |
Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Carcinoma |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Histologic Type |