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

NCT00934518 | Withdrawn Phase 2 DMC

• 1 other identifier: PSHCI 08-066
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Squamous cell carcinoma, Head and Neck cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

Radiation and Cetuximab

EXPERIMENTAL

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; Drug: Cetuximab

Interventions

Radiation RADIATION

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

Radiation and Cetuximab

Cetuximab 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

Radiation and Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Cancer Institute

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Head and Neck Neoplasms

Interventions

Radiation; Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Physical Phenomena; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Heath B Mackley, MD

  Penn State Hershey Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 8, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: February 12, 2019

Record last verified: 2019-02

Locations

US (1)