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

This study has been terminated.
(Inadequate patient accrual)
Sponsor:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00934518
First received: July 7, 2009
Last updated: July 28, 2010
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Squamous Cell Cancer of the Head and Neck
Radiation: Radiation
Drug: Cetuximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Image Guided Intensity Modulated Reirradiation With Concurrent Cetuximab in the Treatment of Locoregionally Confined Relapsed Squamous Cell Carcinoma of the Head and Neck

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • 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. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To estimate the median and one-year, disease-free, and overall survival rates of the treated patients. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To determine the pattern of disease progression in treated patients. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To identify the impact of cetuximab and image guided intensity modulated reirradiation on patients' quality of life. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2009
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934518

Locations
United States, Pennsylvania
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: Heath B Mackley, MD Penn State Hershey Cancer Institute
  More Information

No publications provided

Responsible Party: Heath Mackley, M.D., Principal Investigator, Penn State Hershey Cancer Institute
ClinicalTrials.gov Identifier: NCT00934518     History of Changes
Other Study ID Numbers: PSHCI 08-066
Study First Received: July 7, 2009
Last Updated: July 28, 2010
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Penn State University:
Squamous cell carcinoma, Head and Neck cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Squamous Cell
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Cetuximab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014