E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Intermediate Stage (TNM Stage II/Stage III) Head and Neck Squamous Cell Carcinoma |
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MedDRA Classification |
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 |
To assess acute toxicity and tolerability of escalated radiotherapy dose with cetuximab |
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E.2.2 | Secondary objectives of the trial |
To assess late toxicity, response rate, loco-regional control, overall survival |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• A histopathological diagnosis of head and neck squamous cell carcinoma • Head and neck subsites of oropharynx, larynx, hypopharynx • Requires radiotherapy as primary treatment • Stage II (T2N0) • Stage III (T1N1, T2N1, T3N0) • WHO performance status 0-2 • Age ≥ 16 and estimated life expectancy > 3 months • Adequate haematological function: Haemoglobin ≥ 10g/dl; WBC ≥ 3.0 x 109/l; ANC ≥ 1.5 x 109/l; platelet count ≥ 100,000/mm3 (prior transfusions for patients with low haemoglobin allowed) • Adequate liver function: total bilirubin ≤ 1.5 x ULN; ALT, AST & ALP ≤ 1.5 x ULN • Adequate renal function with serum urea & creatinine ≤ 1.5 x ULN. • Women of child-bearing potential should have a negative pregnancy test prior to study entry • Women and men of child-bearing potential should be using an adequate contraception method, which must be continued for 3 months after completion of chemotherapy • Capable of giving informed consent • Following types of interventions are allowed: o Neck dissection for suspicious or clinically involved lymph nodes o Tumour excision for diagnostic purpose eg. Tonsillectomy
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E.4 | Principal exclusion criteria |
• Head and neck sub-sites of oral cavity, sinus, nasopharynx, salivary glands, ear • Low risk Stage II o Laryngeal glottic carcinoma T2a • Previous surgical curative resection for primary tumour • Neck lymph nodes clinically or radiologically >2cm without neck dissection • Patients with metastatic disease • Previous radiotherapy within treatment field • Relative contraindication to radiotherapy • Previous administration of EGF monoclonal antibodies, EGFR signal transduction inhibitors or EGFR targeted therapy • History of previous malignancy (except cervical carcinoma in-situ treated by cone-biopsy/resection, non-metastatic basal cell carcinomas of the skin, any early stage (stage I) malignancy adequately resected for cure greater than 5 years previously) • Any disorder likely to impact compliance with the protocol • Pregnancy or breast feeding • Use of any experimental drugs (for any indication) in the previous 4 weeks
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E.5 End points |
E.5.1 | Primary end point(s) |
To assess Acute Toxicity using CTCAE ver 3.0 |
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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 | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.5 | 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 | No |
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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The treatment phase of the study will conclude when the last patient enrolled in the study has received the last protocol directed treatment. The observational phase will conclude when the last patient has been followed up for survival 5 years after concluding the treatment phase. |
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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 | |