E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Inclusion criteria : 1. Histologically confirmed ovarian carcinoma or primary peritoneal carcinoma or Fallopian tube carcinoma. 2. FIGO stage III disease or only pleural stage IV disease 3. Age less than 65 years 4. ECOG performance status 0-1. 5. Adequate bone marrow, hepatic and renal functions. 6. No serious cardiac or respiratory illness
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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 |
Feasibility study evaluating the safety of hyperthermic intraperitoneal chemotherapy (HIPEC) for patients with stage III or only pleural stage IV ovarian carcinoma in first line therapy. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy in terms of progression free survival (PFS) and overall survival (OS) of the treatment to evaluate the morbidity of the treatment
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Histologically confirmed ovarian carcinoma or primary peritoneal carcinoma or Fallopian tube carcinoma. 2. FIGO stage III disease or only pleural stage IV disease 3. Age less than 65 years 4. ECOG performance status 0-1. 5. Adequate bone marrow, hepatic and renal functions. 6. No serious cardiac or respiratory illness 7. No major co morbidity such as diabetes or other condition that might hamper the postoperative recuperation. 8. preoperative chemotherapy with carboplatinum-paclitaxel is recommended for lower surgical morbidity (3 courses). 9. PCI (peritoneal carcinomatosis index) score < 21
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E.4 | Principal exclusion criteria |
1. metastatic disease in other sites than pleural 2. age higher than 65 years 3. ECOG PS 2 or higher 4. serious cardiac or respiratory illness 5. major co morbidity 6. impaired bone marrow, hepatic and renal functions 7. PCI score equal or higher than 21 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety profile : mortality rate of the cytoreductive surgery plus HIPEC treatment |
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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 | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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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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 | |
E.8.9.1 | In the Member State concerned days | |