The study is a phase II study of induction chemotherapy with docetaxel plus cisplatin and fluorouracil (TPF) followed by radioimmunotherapy with Cetuximab and intensity modulated radiotherapy (IMRT) in combination with a carbon ion boost for locally advanced tumors of the oro- , hypopharynx and laynx (TPF-C-HIT-Study)
Conditions
Interventions
Trade Name: Taxotere, Cisplatin, Fluoruoracil, Erbitux
Pharmaceutical Form:
Sponsors
University of Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: I1. Signed written informed consent, 2. Age of 18 to 70 years, 3. Life expectancy of at least 6 month, 4. Ability of subject to understand character and individual consequences of clinical trial, 5. Histologically confirmed locally advanced (stage III or IV), non-metastatic squamous cell carcinoma of oro-, hypopharynx and larynx (T2-4, any N, M0), 6. Oral cavity or oro- , hypopharynx or laynx as the primary tumor site, 7. At least one uni-measurable lesion according to the RECIST criteria, 8. Karnofsky Performances Status > 70%, 9. Adequate bone marrow function: neutrophils > 1.5 x 109/L, platelets > 100 x 109/L, hemoglobin > 10.0 g/dL§, 10. Adequate liver function: Bilirubin 70 ml/min.§, 12. Negative serum/urine Beta-HCG test in women of childbearing potential, 13. 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 potential are those who are post-menopausal for at least 1 year or sterilized, 14. 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, 15. 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. Nonetheless, he/she may be enrolled in the study. § If in the opinion of the responsible investigator the values excluding a subject from the trial participation are transient, the flagged inclusion criteria may be re-assessed (prior to inclusion). If the control values are within the normal range the subject may be enrolled in the trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Previous systemic chemotherapy, radiotherapy or surgery for carcinoma of the head, neck and larynx, 2. Nasopharyngeal Carcinoma, 3. Prior exposure to EGFR pathway targeting therapy, 4. Evidence of distant metastases. 5. 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, 6. Participation in other interventional trial within the last 30 days§§, 7. Surgery within the last 30 days§§, 8. Known allergic/hypersensitivity reaction to any drugs scheduled for the study treatment, 9. Women: pregnant or breast-feeding, 10. Known drug abuse, 11. 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, 12. Legal incapacity or limited legal capacity, 13. 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. §§ If appropriate, the inclusion of a subject may be postponed to comply with these exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Endpoint Local-Regional Control (LRC) at 1 year ;Secondary Objective: Secondary Endpoints - Disease-free survival, - Progression-free survival, - Overall survival, - Acute radiation effect, - Late radiation effect, - Adverse events, - Proteomics and Genomics. ;Primary end point(s): Primary Endpoint The primary endpoint of the study is the Local-Regional Control (LRC) at 1 year | — |
Countries
Germany
Outcome results
None listed