Description:
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).
Title
- Brief Title: 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)
- Official Title: 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)
Clinical Trial IDs
- ORG STUDY ID:
11-112
- NCT ID:
NCT02057107
Conditions
- Recurrent
- Head and Neck Cancer
Interventions
Drug | Synonyms | Arms |
---|
Cetuximab | Erbitux | SBRT + Cetuximab + Docetaxel followed by Cetuximab + Docetaxel |
Docetaxel | Taxotere | SBRT + Cetuximab + Docetaxel followed by Cetuximab + Docetaxel |
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
SBRT + Cetuximab + Docetaxel followed by Cetuximab + Docetaxel | Other | Previously Treated With Cetuximab - Group A No Previous Cetuximab - Group C | |
SBRT + Cetuximab followed by Cetuximab | Other | Previously Treated with Cetuximab - Group B No Previous Cetuximab - Group D | |
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT)
or other staging studies
- Patients in their reproductive age group should use an effective method of birth
control. Patients who are breast-feeding, or have a positive pregnancy test will be
excluded from the study
- Any co-morbidity or condition of sufficient severity to limit full compliance with the
protocol per assessment by the investigator
- Concurrent serious infection
- History of known hypersensitivity to cetuximab, docetaxel or similar agents
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Locoregional progression-free survival (PFS) of previously-irradiated patients with SCCHN treated with SBRT, cetuximab, and docetaxel |
Time Frame: | 1 Year |
Safety Issue: | |
Description: | Evaluated by PET/CT or CT |
Secondary Outcome Measures
Measure: | Acute and late toxicities associated with the above therapy |
Time Frame: | 3 years |
Safety Issue: | |
Description: | Determined by patient follow up CTCAE criteria |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | David A. Clump, MD, PhD |
Last Updated
August 27, 2020