A Phase 3 interventional study of radiation therapy in Carcinoma of Unknown Primary, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Completed at 262 sites in 6 countries. Open to female participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2018-07-09.
Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 3, Interventional, and Treatment
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.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 600 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 342 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Irradiation of the ipsilateral level I - V of the neck up to a dose of 60 Gy (30x2Gy in 6 weeks).
Radiation: radiation therapy
Irradiation on the whole mucosa of the larynx, hypopharynx, oropharynx and nasopharynx, and on both sides of the neck (levels I -V) up to a prophylactic dose of 50 Gy (25 x 2 Gy in 5 week).Irradiation of the ipsilateral level I - V of the neck should continue with an additional 10 Gy boost for a total dose of 60 Gy (30 x 2 Gy in 6 weeks).
Radiation: radiation therapy
disease-free survival
Showing the first 100 of 262 sites across 6 countries.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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European Organisation for Research and Treatment of Cancer - EORTC