E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx newly diagnosed and eligible for surgery. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10041857 |
E.1.2 | Term | Squamous cell carcinoma of the oral cavity |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10031112 |
E.1.2 | Term | Oropharyngeal squamous cell carcinoma |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021042 |
E.1.2 | Term | Hypopharyngeal cancer |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023856 |
E.1.2 | Term | Laryngeal squamous cell carcinoma |
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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 |
To investigate the safety of neoadjuvant administration of cetuximab in patients with operable head and neck cancer -Phase I part: To determine the safe minimum delay between preoperative cetuximab infusion and surgery (Target delay between cetuximab and surgery = 24 hours) -Phase II part: To investigate the safety of the minimum delay determined in the phase I part
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E.2.2 | Secondary objectives of the trial |
- To investigate the safety of postoperative radiation therapy in combination with cetuximab in patients eligible for postoperative radiation therapy alone after surgery - To investigate the efficacy of cetuximab monotherapy in the pre-operative setting, using FDG-PET and PET/CT scan - To perform translational research
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Age 18 years and over •Histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx •Patients selected for a primary surgical treatment •No distant metastases •No contraindications to cetuximab • No active second malignancy during the last five years except non melanomatous skin cancer or carcinoma in situ of the cervix •No prior or concurrent evidence of uncontrolled severe pathology precluding administration of surgery (i.e. unstable cardiopathy,…) •Life expectancy of 3 months •Not pregnant or nursing: fertile patients must use effective contraception •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial •Signed informed consent. •Performance status ECOG 0-1
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E.4 | Principal exclusion criteria |
•Nasopharynx cancer •Past or current malignancy other than HNSCC, except for: •Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol •Neutrophils count ≤ 1,500/mm3, platelet count ≤ 75,000/mm3, WBC< 3.0/109 L, bilirubin or creatinine > 2 times ULN, ALAT or ALAP > 5 times ULN. •Use of any investigational agent(s) within 4 weeks prior to entry •Previous exposure to EGFR targeting therapy •Known grade 3 or 4 allergic reaction to any of the components of the treatment
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E.5 End points |
E.5.1 | Primary end point(s) |
To investigate the safety of neoadjuvant administration of cetuximab in patients with operable head and neck cancer •Phase I part: To determine the safe minimum delay between preoperative cetuximab infusion and surgery (Target delay between cetuximab and surgery = 24 hours) •Phase II part: To investigate the safety of the minimum delay determined in the phase I part
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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.8.5 | 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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30 days after last visit of the last patient |
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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 | |
E.8.9.1 | In the Member State concerned months | 22 |
E.8.9.1 | In the Member State concerned days | |