Induction Chemotherapy Followed by Cetuximab and Radiation Therapy for Head and Neck Cancer

Phase 2

Completed

• Conditions: Head and Neck Cancer
• Interventions: Radiation: Radiotherapy; Drug: Leucovorin; Biological: Cetuximab; Drug: Filgrastim; Drug: Erythropoetin; Drug: Cisplatin; Drug: Fluorouracil; Drug: Docetaxel

• Registration Number: NCT01467115
• Lead Sponsor: Drexel University College of Medicine

Brief Summary

More than 50% of Head and Neck cancers are locally advanced at presentation. Although surgery, in combination with other modalities like radiation therapy can achieve 40-50% five year survival rates, resection in the head and neck region can leave patients with poor functional and cosmetic outcomes.

Due to these concerns about quality of life after surgery, there has been a lot of interest in non surgical alternatives of treatment. Various combinations of radiation, chemotherapy and biologics has showed promising results. However, questions still remain about the ideal combination treatment regimen.

Based on assimilation of data from multiple sources, our study tries to identify the role of a potentially highly effective multi-modality regimen based on induction chemotherapy (Cisplatin, Docetaxel and 5 Fluorouracil) followed by combination of a biologic agent, Cetuximab, and radiation therapy.

Detailed Description

Patients will be given two cycles of induction chemotherapy with Cisplatin, Docetaxel and Fluorouracil. This will be followed by six weeks of radiation therapy along with Cetuximab. Patients will get two more cycles of chemotherapy with the same agents after the completion of radiation therapy course. Patients will be watched very closely during the trial period, with close follow up of treatment responses and monitoring of any adverse effects.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2011-11-04
• Study First Submitted QC: 2011-11-04
• Study First Posted: 2011-11-08
• Primary Completion: 2014-06
• Study Completion: 2014-10-07
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Cetuximab	Treatment with induction chemotherapy followed by radiation and cetuximab.
Treatment	Erythropoetin	Treatment with induction chemotherapy followed by radiation and cetuximab.
Treatment	Radiotherapy	Treatment with induction chemotherapy followed by radiation and cetuximab.
Treatment	Leucovorin	Treatment with induction chemotherapy followed by radiation and cetuximab.
Treatment	Filgrastim	Treatment with induction chemotherapy followed by radiation and cetuximab.
Treatment	Fluorouracil	Treatment with induction chemotherapy followed by radiation and cetuximab.
Treatment	Cisplatin	Treatment with induction chemotherapy followed by radiation and cetuximab.
Treatment	Docetaxel	Treatment with induction chemotherapy followed by radiation and cetuximab.

Primary Outcome Measures

Name	Time	Method
Organ Sparing Survival	3 years	to determine whether the intervention will prolong survival without needing salvage surgery (organ sparing survival)

Secondary Outcome Measures

Name	Time	Method
Overall Survival	3 years	we will determine if the intervention prolongs overall survival.

Trial Locations

Locations (1)

Hahnemann University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States