Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN): Oro-, Hypopharyngeal and Laryngeal Cancer Clinical Trial
— TPF-C-HITOfficial title:
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
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.
| Status | Terminated |
| Enrollment | 8 |
| Est. completion date | November 2013 |
| Est. primary completion date | November 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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, - Negative serum/urine Beta-HCG test in women of childbearing potential, - Women of childbearing potential: willingness to use effective contraceptive method, defined as the concomitant use of either an intrauterine pessary (IUP) or contraceptive pill and in both cases, condoms for the treatment duration and 2 months thereafter. Women of non-childbearing potiential are those who are post-menopausal for at least 1 year or sterilized, - Men of procreative potential: willingness for effective prevention of procreation, defined as a use of condoms and a use of either an intrauterine pessary (IUP) or a contraceptive pill by his partner for the treatment duration and 2 months thereafter, - Subject's consent to collect blood and/or tumor tissue samples for proteomics and genomics. If a patient does not consent, no samples for proteomics and genomics will be taken. Nonetheles, he/she may be enroled in the study 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, - ototoxicity CTC grade 2 or higher, except if due to trauma or mechanical impairment due to tumor mass, - Participation in other interventional trial within the last 30 days§§, - Surgery within the last 30 days, - Known allergic/hypersensitivity reaction to any drugs scheduled for the study treatment, - Women: pregnant or breast-feeding, - Known drug abuse, - Other previous malignancy within 5 years, with exception of a history of a previous, adequately treated, basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix, - Legal incapacity or limited legal capacity, - Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Dept of Radiation Oncology, University of Heidelberg | Heidelberg |
| Lead Sponsor | Collaborator |
|---|---|
| Heidelberg University | University Hospital Heidelberg |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Local-Regional Control (LRC) | The primary endpoint of the study is the Local-Regional Control (LRC) at 1 year | 12 months | No |
| Secondary | disease-free survival (DFS) | 12 months | No | |
| Secondary | progression-free survival (PFS) | 12 months | No | |
| Secondary | overall survival (OS) | 12 months | No | |
| Secondary | acute radiation effects | 6 weeks post completion of radiotherapy | Yes | |
| Secondary | late radiation effects | 12 months | Yes | |
| Secondary | adverse events | includes any adverse events attributable to the combined treatment not otherwise specified | 12 months | Yes |
| Secondary | proteomic and genomic analyses | proteomic and genomic analyses designed to investigate changes during therapy, therefore analyses are carried out at 6 measuring points: days 50, 64, 73, 106 of treatment; 6 weeks post completion of radioimmunotherapy; 3 months post completion of radioimmunotherapy | 6 measuring points: days 50, 64, 73, 106 of treatment; 6 weeks post completion of radioimmunotherapy; 3 months post completion of radioimmunotherapy | No |