Randomized Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) With Cetuximab +/- Docetaxel Followed by Adjuvant Cetuximab +/- Docetaxel in Recurrent, Previously-Irradiated Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Who is this study for? Adult patients with Recurrent Head and Neck Squamous Cell Carcinoma that have undergone radiotherapy and/or chemotherapy
Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Compare the overall survival of patients with the addition of docetaxel to the overall survival of patients treated with SBRT and cetuximab alone. In addition, we will determine the difference in progression free survival (PFS), the rate of local recurrence (LR) and of distant metastases (DM) across the SBRT and cetuximab + docetaxel arm and the arm receiving SBRT and cetuximab alone. To better resolve the impact of the experimental treatment on PFS, LR, and DM, patients will be stratified by the presence/absence of prior cetuximab treatment and then randomized to either the control arm (cetuximab and SBRT only) or the experimental arm (cetuximab, SBRT, and docetaxel).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Histologically-proven recurrent squamous cell carcinoma of the head and neck (SCCHN), who has received prior radiotherapy with or without chemotherapy. New primary is allowed if location is in a previously irradiated field. Biopsy is recommended for each recurrence but is not mandated per study. This will be at the discretion of the principal investigator.

• Prior radiation dose of at least 50 Gy.

• Disease confined to locoregional site and can be encompassed in a stereotactic body radiosurgery portal

• Tumor must be deemed to be inoperable or unresectable either by clinical or radiographic criteria. These criteria include encasement of great vessels, vertebral invasion or undue peri-operative risk.

• Prior surgery for recurrent or new SCCHN is allowed in previously irradiated patients. A minimum of 4 weeks should elapse between any surgery and treatment on study. However, high-risk pathologic features should be present, such as positive margins, positive lymphadenopathy, perineural or angiolymphatic invasion.

• Karnofsky performance status > 60 (ECOG 0-1)

• Prior treatment with an EGFR Inhibitor is allowed if it was a part of prior curative therapy and was completed at least 30 days prior to commencement of study therapy

• Any number of prior chemotherapy regimens are allowed

• Measurable disease on imaging studies (MRI, CT, PET-CT or physical exam)

• Age > 18

• Estimated life expectancy > 12 weeks

• No prior radiation therapy or chemotherapy within 1 month of study enrollment

• ANC > 1000, PLT>75,000, Serum creatinine<2.5 mg/dL, Bilirubin <1.5 x upper limits of normal (ULN)

• Diabetes must be controlled prior to PET-CT scanning (blood glucose <200 mg/dL)

• Ability to provide written informed consent

Locations
United States
Pennsylvania
UPMC Shadyside Radiation Oncology
Recruiting
Pittsburgh
Contact Information
Primary
Karen D Holeva, BS
holevakd@upmc.edu
412-623-1275
Backup
Dwight E Heron, MD
herond2@upmc.edu
412-623-6720
Time Frame
Start Date: May 2013
Estimated Completion Date: December 2022
Participants
Target number of participants: 92
Treatments
Other: SBRT + Cetuximab + Docetaxel followed by Cetuximab + Docetaxel
Previously Treated With Cetuximab - Group A No Previous Cetuximab - Group C
Other: SBRT + Cetuximab followed by Cetuximab
Previously Treated with Cetuximab - Group B No Previous Cetuximab - Group D
Authors
Sponsors
Leads: David A. Clump, MD, PhD

This content was sourced from clinicaltrials.gov

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