E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001220 |
E.1.2 | Term | Adenoid cystic carcinoma of the oral cavity |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study is to explore the toxicity of the combined modality regimen consisting of heavy ion therapy / IMRT and EGFR antibody immunotherapy, by assessing the rate of patients with mucositis or any other toxicity of severity grade 3 or 4 according to NCI CTCAE V. 4. |
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints include: • Local control rate (i.e. local relapse-free survival) • Distant control rate (i.e. distant relapse-free survival) • Overall disease-free survival • Overall survival • Toxicity according to NCI CTCAE V. 4 (especially mucositis, acneiform skin reactions, hypersensitivity reactions): frequency of occurrence by type and maximum grade; relationship with treatment; SAE
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Histologically proven, or surgically resected adenoid-cystic carcinoma of the head and neck and •macroscopic or microscopic residual tumor (R1/ R2) or •Tumor stage >T3/T4 or •perineural invasion and •M0 stage •Written informed consent •Age between 18 and 70 years •Karnofsky Index ≥ 70% •Adequate bone-marrow, liver, and kidney function: •neutrophils ≥ 1.5 x 109/L, •thrombocytes ≥ 100 x 109/L, •haemoglobin ≥ 10.0 g/dL •bilirubin ≤ 2.0 g/dL •SGOT, SGPT, AP, g-GT ≤ 3 x ULN •serum creatinine ≤ 1.5 mg/dL •Subject (male or female [< 12 months post onset of menopause]) is willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).
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E.4 | Principal exclusion criteria |
•Prior RT or chemotherapy for tumors of the head and neck •R0 resection •M1 (distant metastases) •prior immunotherapy •signs of active infection •other serious illnesses •Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias) •Significant neurologic or psychiatric disorders including dementia or seizures •Active disseminated intravascular coagulopathies •Other serious underlying medical conditions prohibiting the patient’s participation in the trial according to the judgement of the investigators •Active participation in another clinical trial within the past 30 days •Known allergic/ hypersensitivity reactions to non-human proteins •Women: pregnant (Positive serum/ urine β-HCG ) or breast-feeding, •Known drug abuse, •Other previous malignancy within the past 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Rate of patients with mucositis or any other toxicity of severity grade 3 or 4 according to NCI CTCAE V. 4. In order to comply with the statistical model chosen for the trial, the primary endpoint is re-formulated as a “feasibility rate”, i.e. the rate of patients without any grade 3 or 4 toxicity event (1 - toxicity rate). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Cf. section 9.6 of the protocol |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |