Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

OBJECTIVES:

- Compare the disease-free survival of patients with cervical lymph node metastases of squamous cell carcinoma from an unknown primary treated with selective irradiation vs extensive irradiation.

- Compare the overall survival of patients treated with these regimens.

- Compare the incidence of acute and late side effects in the head and neck region in patients treated with these regimens.

- Compare control of the neck and incidence of subsequent primary in the head and neck region in patients treated with these regimens.

- Compare quality of life of patients treated with these regimens.

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.

- Arm I: Patients undergo selective irradiation of the ipsilateral level of the neck once daily 5 days a week for 6 weeks.

- Arm II: Patients undergo extensive irradiation of the neck (nasopharyngeal, oropharyngeal, hypopharyngeal, and laryngeal mucosa and ipsilateral neck node areas on both sides of the neck) once daily 5 days a week for 6 weeks.

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00047125
Study type Interventional
Source European Organisation for Research and Treatment of Cancer - EORTC
Contact
Status Completed
Phase Phase 3
Start date July 2002

See also
  Status Clinical Trial Phase
Completed NCT00004005 - Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin Phase 2
Completed NCT00003943 - Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Cancer. Phase 2
Recruiting NCT02590055 - Phase 2 Study of Gemcitabine and Docetaxel Combination Chemotherapy in Patients With Carcinoma of Unknown Primary Phase 2
Completed NCT00002507 - Radiation Therapy and Chemotherapy in Treating Patients With Head and Neck Cancer Phase 3
Recruiting NCT03740503 - Genomic Investigation of Unusual Responders
Terminated NCT00148135 - Combination of Carboplatin, Gemcitabine, and Capecitabine in Patients With Carcinoma of Unknown Primary Site Phase 2
Completed NCT00003582 - Radiation Therapy, Combination Chemotherapy, and Amifostine in Treating Patients With Head and Neck Cancer Phase 1/Phase 2
Completed NCT00014456 - Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors Phase 1
Not yet recruiting NCT04985357 - Defining the Clinical Potential of Mass Response as a Biomarker for Patient Tumor Sensitivity to Drugs
Completed NCT00357630 - Gemcitabine in Treating Patients With Metastatic Cancer of Unknown Primary Phase 2
Active, not recruiting NCT01366144 - Veliparib, Paclitaxel, and Carboplatin in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery and Liver or Kidney Dysfunction Phase 1
Completed NCT00004922 - Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors Phase 2
Recruiting NCT05887492 - Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors Phase 1/Phase 2
Withdrawn NCT00119314 - Gemcitabine, Docetaxel, and Capecitabine in Treating Patients With Cancer of Unknown Primary Origin Phase 2
Completed NCT00003657 - High-dose ICE With Amifostine Phase 2
Recruiting NCT05461430 - Mass Response of Tumor Cells as a Biomarker for Rapid Therapy Guidance (TraveraRTGx)
Recruiting NCT02764216 - Elective Mucosal Irradiation in Head-and-Neck Cancer of Unknown Primary Phase 2
Completed NCT00873119 - Belinostat, Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Cancer of Unknown Primary Phase 2
Completed NCT00388024 - PET Scans and CT Scans in Patients With Locally Advanced Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy N/A
Completed NCT00066781 - Gemcitabine and Irinotecan in Treating Patients With Cancer of Unknown Primary Phase 2