Image Guided Intensity Modulated Reirradiation (IG-IMRT) With Cetuximab for Locoregionally Confined Recurrent Head and Neck Squamous Cell Carcinoma

NCT ID: NCT00934518

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2011-07-31

Brief Summary

The standard treatment for head and neck cancer relapses in previously irradiated patients is controversial. Reirradiation has had some success, but many patients still die from their disease. Cetuximab is helpful in relapsed head and neck cancer, and it improves the effectiveness of radiation in some head and neck cancer patients. But, it has not been studied with reirradiation. The purpose of this study is to see the effects, both good and bad, of reirradiation with cetuximab.

Conditions

Squamous Cell Cancer of the Head and Neck

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiation and Cetuximab

Radiation Therapy 60 Gy total dose in 30 fractions: 2.0 Gy/fraction once daily five fractions per week

Cetuximab 400 mg/m2 of body surface area over a period of 120 minutes day 1 250 mg/m2 of body surface area over a period of 60 minutes weekly during radiation

Group Type: EXPERIMENTAL

Radiation

Intervention Type: RADIATION

Radiation Therapy 60 Gy total dose in 30 fractions: 2.0 Gy/fraction once daily five fractions per week

Cetuximab

Intervention Type: DRUG

Radiation Therapy 60 Gy total dose in 30 fractions: 2.0 Gy/fraction once daily five fractions per week

Cetuximab 400 mg/m2 of body surface area over a period of 120 minutes day 1 250 mg/m2 of body surface area over a period of 60 minutes weekly during radiation

Interventions

Radiation

Radiation Therapy 60 Gy total dose in 30 fractions: 2.0 Gy/fraction once daily five fractions per week

Intervention Type: RADIATION

Cetuximab

Radiation Therapy 60 Gy total dose in 30 fractions: 2.0 Gy/fraction once daily five fractions per week

Cetuximab 400 mg/m2 of body surface area over a period of 120 minutes day 1 250 mg/m2 of body surface area over a period of 60 minutes weekly during radiation

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients must have a pathologically confirmed recurrence (reappearance of previously cleared) squamous cell cancer in the upper aerodigestive tract or a second squamous cell primary. Patients may have experienced more than one recurrence as long as the first recurrence occurred ≥6 months following the end of the prior RT.
• The recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence).
• The majority (≥75%) of the tumor volume must have been in areas previously irradiated to ≥45 Gy. The previous irradiation must not exceed a maximum of 75 Gy.
• Patients must be at least 6 months from prior radiation therapy.
• If a resection is performed after the diagnosis of recurrence and before enrollment, either microscopic or macroscopic disease must be present (i.e. positive margins or gross residual).
• Karnofsky Performance Status 60-100.
• Granulocytes ≥ 1500/mm3, platelets ≥ 100,000/mm3, bilirubin ≤ 1.5 mg/dl, creatinine ≤ 1.5 mg/dl, within 6 weeks prior to registration.
• Must be able to submit previous radiation records (simulation and portal film if available) in order to assure that cord tolerance is not exceeded.
• Patients must sign a study-specific informed consent form prior to study entry.
• The patient must be between the ages of 18 and 75.

Exclusion Criteria

• Distant metastases.
• Completely resected recurrence with negative margins.
• Other concurrent invasive malignancies.
• Prior invasive malignancy unless disease free for at least two years (prior in situ malignancies are permissible).
• Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival.
• Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns.
• Previous treatment with cetuximab.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Heath Mackley

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heath B Mackley, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State Hershey Cancer Institute

Locations

Penn State Hershey Cancer Institute

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

PSHCI 08-066

Identifier Type: -

Identifier Source: org_study_id