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Melanotan-2

MT-II, Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-NH2

Quick Stats
Studies 3
Trials 100
Completed PHASE2 INTERVENTIONAL NCT00011999

Chemotherapy and Radiation Therapy Following Surgery in Treating Patients With Head and Neck Cancer

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy following surgery may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have undergone surgery for stage III or stage IV head and neck cancer.

Detailed Description

OBJECTIVES: * Determine the feasibility of adjuvant paclitaxel followed by radiotherapy with concurrent paclitaxel and cisplatin in patients undergoing gross complete resection of high-risk stage III or IV squamous cell carcinoma of the head and neck. * Determine the disease-free and overall survival of patients treated with this regimen. * Determine the acute and chronic toxicity of this regimen in these patients. * Determine the patterns of failure in patients treated with this regimen. OUTLINE: Patients receive adjuvant therapy beginning 7-14 days after gross total surgical resection. Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Beginning on approximately day 22, patients undergo radiotherapy once daily 5 days a week for 5.5-6.5 weeks. Patients also receive paclitaxel IV over 1 hour followed by cisplatin IV over 1-3 hours on days 43, 50, and 57. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 11 months.

Interventions

Name: cisplatin
Type: DRUG
Description:
Name: paclitaxel
Type: DRUG
Description:
Name: conventional surgery
Type: PROCEDURE
Description:
Name: radiation therapy
Type: RADIATION
Description:

Primary Outcomes

Measure: Patient tolerance of the treatment regimen
TimeFrame: From registration to end of treatment
Description:

Trial Information

NCT ID

NCT00011999

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Radiation Therapy Oncology Group

Last Updated

December 15, 2025