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

Image Guided Intensity Modulated Reirradiation With Concurrent Cetuximab in the Treatment of Locoregionally Confined Relapsed Squamous Cell Carcinoma of the Head and Neck

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.

Study Overview

• Status: Withdrawn
• Conditions: Squamous Cell Cancer of the Head and Neck
• Intervention / Treatment: Radiation: Radiation; Drug: Cetuximab

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To estimate the incidence rate of acute and late toxicities associated with combined cetuximab and image guided intensity modulated reirradiation in patients with recurrent squamous cell cancer of the head and neck.	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
To estimate the median and one-year, disease-free, and overall survival rates of the treated patients.	5 years
To determine the pattern of disease progression in treated patients.	5 years
To identify the impact of cetuximab and image guided intensity modulated reirradiation on patients' quality of life.	5 years

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Heath B Mackley, MD, Penn State Hershey Cancer Institute

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: July 7, 2009
• First Submitted That Met QC Criteria: July 7, 2009
• First Posted (Estimate): July 8, 2009

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Squamous cell carcinoma, Head and Neck cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Neoplasms, Squamous Cell; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cetuximab
• Other Study ID Numbers: PSHCI 08-066