Induction Chemotherapy With TPF Followed by Radioimmunotherapy With Cetuximab and Intensity Modulated Radiotherapy (IMRT) Plus Carbon Ion Boost for Locally Advanced Tumors of the Oro-, Hypopharynx and Larynx: TPF-C-HIT
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN): Oro-, Hypopharyngeal and Laryngeal Cancer
- Sponsor
- Heidelberg University
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Local-Regional Control (LRC)
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief Summary
TPF-C-HIT investigates the combination of induction chemotherapy with TPF followed by radioimmunotherapy with cetuximab and IMRT plus carbon ion boost with regard to efficacy and toxicity of the combination regimen.
Detailed Description
TPF-C-HIT is a prospective, monocentric phase II trial efficacy, as measured by control and survival rates, as well as toxicity (acute and late effects) of the combined treatment with TPF-induction followed by radioimmunotherapy with the EGFR-antibody cetuximab and carbon ion boost in locally advanced squamous cell carcinoma of the head and neck (SCCHN). As long-term local control remains a therapeutic challenge in advanced head and neck cancer, locoregional control was chosen as the primary endpoint. Secondary endpoints are survival rates (disease-free survival, PFS, OS), acute and late radiation effects as well as adverse events. For development of prognostic markers, proteomic and genomic analyses are also included in the secondary endpoints.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed written informed consent,
- •Age of 18 to 70 years,
- •Life expectancy of at least 6 month,
- •Ability of subject to understand character and individual consequences of clinical trial,
- •Histologically confirmed locally advanced (stage III or IV), non-metastatic squamous cell carcinoma of oro-, hypopharynx and larynx (T2-4, any N, M0),
- •Oral cavity or oro- , hypopharynx or laynx as the primary tumor site,
- •At least one uni-measurable lesion according to the RECIST criteria, Karnofsky Performances Status \> 70%,
- •Adequate bone marrow function: neutrophils \> 1.5 x 109/L, platelets \> 100 x 109/L, hemoglobin \> 10.0 g/dL,
- •Adequate liver function: Bilirubin \< 1.5 mg/dL, SGOT, SGPT \< 3 x ULN, GGT \< 5 x ULN,
- •Adequate renal function: GFR\> 70 ml/min,
Exclusion Criteria
- •Previous systemic chemotherapy, radiotherapy or surgery for carcinoma of the head, neck and larynx,
- •Nasopharyngeal Carcinoma,
- •Prior exposure to EGFR pathway targeting therapy,
- •Evidence of distant metastases.
- •Other serious illness or medical conditions:
- •Unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4,
- •Significant neurologic or psychiatric disorders including dementia or seizures,
- •Active disseminated intravascular coagulation,
- •Other serious underlying medical conditions which in the opinion of investigator could impair the ability of the patient to participate in the study,
- •Symptomatic peripheral neuropathy Common Toxicity Criteria (CTC) grade 2 or higher,
Outcomes
Primary Outcomes
Local-Regional Control (LRC)
Time Frame: 12 months
The primary endpoint of the study is the Local-Regional Control (LRC) at 1 year
Secondary Outcomes
- disease-free survival (DFS)(12 months)
- progression-free survival (PFS)(12 months)
- overall survival (OS)(12 months)
- acute radiation effects(6 weeks post completion of radiotherapy)
- late radiation effects(12 months)
- adverse events(12 months)
- proteomic and genomic analyses(6 measuring points: days 50, 64, 73, 106 of treatment; 6 weeks post completion of radioimmunotherapy; 3 months post completion of radioimmunotherapy)