Spots Global Cancer Trial Database for InductionChemo-Radio-Antibody-Treatment

Study Description

Brief Summary: This is an open-label, randomized, Phase II-study to evaluate the efficacy of a standard-TPF induction chemotherapy (IC) and an alternative TPF induction chemotherapy followed by radio-antibody-therapy, in patients with unresectable LA-SCC of the HN region (oro-hypopharynx carcinoma, cancer of the oral cavity). The primary objective of the study is to assess the feasibility of an experimental 'fractionated' TPF regimen compared to a current standard TPF regimen. Composite endpoint of compliance and feasibility in terms of * response (RECIST1.1) and * hematological acute toxicity (CTCAE v.4.02) * on time application of RAT following an experimental or standard TPF IC. Secondary endpoints are * Treatment intensity achieved * Toxicity (according to CTCAE v.4.02) * Response rates after completion of induction chemotherapy and after completion of entire protocol treatment (RECIST1.1) * Survival (progression-free, metastasis-free, recurrence-free, overall) 1 year after randomisation * Quality of life according to EORTC QoL C30 \& HN35 The study will be conducted at 5-6 investigational sites in Germany recruiting 90 patients in total. Eligible patients will have a diagnosis of histologically confirmed SSC of the HN. Patients will receive one of 2 different regimens of TPF IC followed by cetuximab together with radiotherapy (RAT) or a standard radiochemotherapy(RCT) regimen.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial