E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with locally recurrent or second primary SCC of the base tongue, posterior lateral pharyngeal wall, hypopharynx and larynx. |
|
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 compare function status at 4 months after treatment with bleomycin-EPT or surgery in patients with locally recurrent or second primary SCC of the base of tongue, posterior lateral pharyngeal wall, hypopharynx and larynx that have failed primary curative therapy and in whom surgical resection is seen as an option for the disease control. |
|
E.2.2 | Secondary objectives of the trial |
• To evaluate local tumor recurrence, disease free survival and overall survival rates through 2 years after bleomycin-EPT or surgery treatment. • To evaluate the durability of function status outcomes at 8 months after bleomycin-EPT or surgery treatment. • To evaluate pharmacoeconomic parameters through 8 months after bleomycin-EPT or surgery treatment. • To characterize bleomycin systemic absorption and plasma pharmacokinetics following IT bleomycin-EPT administration.
|
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Biopsy confirmed SCC of the base of tongue, posterior lateral pharyngeal wall, hypopharynx and larynx (larynx without invasion through cartilage (i.e. T4a) but including stomal recurrence following laryngectomy). • Recurrent or second primary disease inpatients where surgical resection is seen as an option for disease control. • Lesion must be <= 4 cm in diameter. • Tumor burden must be completely encompassed by surgery or bleomycin-EPT. • Men and women of childbearing potential must use physician prescribed contraceptive methods for 7 days following bleomycin-EPT. • Hematopoietic status: ANC > 1000/uL Platelets > 75,000/qmm PT:INR<= 1.5 (correctable with vitamin K injection) • Blood Chemistry status: Transaminases < 3 times upper limit of normal Total Bilirubin < 2.5 mg/dL Creatinine < 2.5 mg/dL
|
|
E.4 | Principal exclusion criteria |
• Subjects with tumours that involve a 50% or greater encasement of a blood vessel as measured by MRI or CT scan. • Subjects with tumours having bone invasion or invasion through the laryngeal wall (T4a). • Patients with any metallic implants in the treatment field. • Subjects with hypersensitivity to Bleomycin. • Subjects who have received or will exceed a total lifetime dose of Bleomycin greater than 400 International Units. • Subjects deemed unsuitable for general anaesthesia. • Subjects with significant history of emphysema or pulmonary fibrosis. • Subjects with indwelling cardiac pacemakers who cannot tolerate a period with pacemaker turned off • Subjects with a history of uncontrolled cardiac arrhythmia. • Women who are pregnant, or are nursing. Woman must have a negative βHCG test within 7 days of study treatment. • Radiation therapy to the treatment area within 8 weeks of study treatment. • Chemotherapy or other cancer therapy (e.g. surgery, cryotherapy, etc.) to the treatment area within 4 weeks of study treatment.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary end point: Function status, evaluated at 4 months after initiation of treatment by the validated, clinician-rated disease specific, head and neck Performance Status Scale (PSSHN).
Secondary end points: • Durability of the PSSHN function status will be evaluated at 8 months after bleomycin-EPT or surgery treament. • Local tumor recurrence, disease free survival and overall survival rates will be evaluated through two years after bleomycin-EPT or surgery treatment. • Quality of life by the EORTC-QLQ-H&N 35 will be evaluated at 4 and 8 months after bleomycin-EPT or surgery treatment to globally confirm PSSHN function status results and to identify potential quality of life changes not included in the three PSSHN function staus scales. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | No |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
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) | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
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 | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |