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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically proven unresectable SCC of the oral cavity, oropharynx and hypopharynx (stage IVA \& IVB)
* Written and signed informed consent
* Karnofsky PS \> 70 %
* Age ≥ 18 years
* Curative treatment intent
* Adequate bone marrow, hepatic and renal functions as evidenced by the following:
Hematology (Bone marrow):
* Neutrophils \> 2.0 109/L
* Platelets \> 100 x 109/L
* Hemoglobin \> 10 g/dL
Hepatic function:
* Total serum bilirubin \< 1 time the UNL of the participating center
* ASAT (SGOT) and ALAT (SGPT) \< 2.5 x UNL
* Alkaline phosphatase \< 5 x UNL
Renal function :
* serum creatinine (SC) \< 120 µmol/L (1.4 mg/dl);
* if values are \> 120 µmol/L, the creatinine clearance should be \> 60 ml/min (actual or calculated by the Cockcroft-Gault method as follows :
weight (kg) x (140 - age) --------------------------------- K x serum creatinine
serum creatinine in mg/dL: K = 72 in man K = 85 in woman serum creatinine in µmol/L: K = 0.814 in man K = 0.96 in woman
• If of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing.
All patients require:
* dental examination and appropriate dental preservation if needed 1 week prior to the beginning of radiotherapy,
* gastric feeding tube and Portal-catheter.
Exclusion Criteria:
* Other neoplasia within the past 5 years with the exception of a controlled skin cancer or "in situ" cervix cancer
* Unknown primary (CUP), nasopharynx, lar…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of an experimental 'fractionated' TPF regimen compared to a current standard TPF regimen.