E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
PATIENTS WITH COMPLETE RESECTED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | PT |
E.1.2 | Level | 7.1 |
E.1.2 | Classification code | 10014987 |
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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 |
Primary objective MTD (PHASE I), PROGRESSION FREE SURVIVAL (PHASE II) |
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E.2.2 | Secondary objectives of the trial |
DLT (PHASE I) AND OVERALL SURVIVAL AND LOCOREGIONAL PROGRESSION FREE SURVIVAL (PHASE II) |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. - Patients with histological proof of epidermoid carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx, treated with surgical resection with curative intent. 2. - Surgical resection must have taken place within 8 weeks prior to the patient’s inclusion in the study. 3. - In those patients having clinical regional lymph node involvement radical neck dissection is mandatory. However, radical neck dissection is not an inclusion criterion in patients staged as N0. 4. - Age 18-70 years. 5. - Anticipated life expectancy of ≥ 12 weeks. 6. - Patients should have at least one of the following criteria: Pathological T3-4 tumor stage, apart from T3N0 of the larynx with negative margins Pathological N2-3 nodal stage. Unfavorable pathological findings such as extranodal spread, positive resection margins, perineural and/or vascular involvement. 7. - Written informed consent given by the patient. 8. - Therapeutic compliance of the patient and geographical proximity to the hospital to facilitate appropriate follow-up. 9. - ECOG 0-1. 10. - No distant metastatic disease. 11. - Adequate organ function according to the following criteria: a. Adequate bone marrow reserve: ANC > 1,5 x 10(9) cells/L; Platelet count > 100 x 10(9) cells/L; Hemoglobin > 9 g/dL b. Liver function: Bilirubin < 1.5 x ULN; Alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) < 3.0 x ULN c. Renal function: calculated creatinine clearance (CrCl) > 60ml/min or Creatinine (Cr) < 1.5 ULN of the reference laboratory. d. Serum calcium and alkaline phosphatase must be normal. 12. - Women of child bearing potential must have a negative pregnancy test within the 48h prior to the start of the treatment. 13. - Patients of both genders at a fertile age must follow effective contraceptive measures. 14. - Absence of symptomatic coronary artery disease or acute myocardial infarction within 6 months prior to study. 15. - Patients capable of oral deglutition or requiring gastrostomy. 16. - No problems of intestinal transit such as malabsorption syndrome, chronic inflammatory bowel disease and other diseases, which might impair drug absorption |
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E.4 | Principal exclusion criteria |
1. - Histology other than squamous cell carcinoma. 2. - Presence of macroscopic residual disease. 3. - Previous treatment with chemotherapy or radiotherapy or EGFR-targeted agents. 4. - Incomplete resection of the primary tumor or incomplete neck dissection. 5. - Patients being diagnosed with any other malignant disease, excluding resected nonmelanoma skin cancer or resected uterine cervix carcinoma. 6. - Pregnant or nursing women. 7. - Active infection. 8. - Concomitant severe illness (according to the opinion of the investigator) or whose estimated survival for this concomitant pathology is lower than that estimated for the neoplasm disease. 9. - Uncontrolled psychiatric illness. 10. - Inability to take oral medication, requiring intravenous feeding or prior surgical procedures affecting absorption or having active peptic ulcer. 11. - Impossibility to appropriate follow-up. 12.- Evidence of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding suggesting a condition that contraindicates the use of the study medication (erlotinib, cisplatine, radiotherapy), which might interfere with the analysis of the results or increase the risk of treatment complications. 13.- Any known significant ophthalmologic abnormalities, including severe xerophthalmia, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratopathy or other abnormalities, which may increase the risk of corneal epithelial damage (the use of contact lenses during the study may increase the risk of corneal damage and its use is strongly discouraged. Those patients still using contact lenses will need a closer ophthalmologic follow-up. 14. - Frequent vomiting or medical disorder impairing swallowing of drugs.
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E.5 End points |
E.5.1 | Primary end point(s) |
- Primary objective MTD (PHASE I) defined for a number of patients maximum in the cohort that presents predefined Toxicity Limitant of Dose - PROGRESSION FREE SURVIVAL (PHASE II) defined as the time go by the surgery date and the progression or patient death. |
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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 | Information not present in EudraCT |
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) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
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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 | 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
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 | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 7 |
E.8.9.2 | In all countries concerned by the trial months | 6 |