E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
stage III epithelial ovarian cancer |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
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 determine the beneficial effect of primary cytoreductive surgery (CRS) in combination with HIPEC (treatment arm) compared to primary CRS without HIPEC (standard arm), in patients with FIGO stage III ovarian cancer, who are eligible for primary cytoreductive surgery with no residual disease, or residual disease up to 2.5 mm |
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E.2.2 | Secondary objectives of the trial |
- To show the addition of HIPEC improves recurrence-free survival
- To evaluate the toxicity and morbidity of both treatment arms
- To evaluate the quality of life of the treatment arm compared to the standard arm
- To assess genetic profiles predictive of tumor response in patients with stage III ovarian cancer undergoing primary CRS with or without HIPEC
- To assess an economic- and cost evaluation of the procedure |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- signed and written informed consent
- age ≥18
- candidate for primary CRS, in whom a complete cytoreduction, or cytoreducion with no more than 2.5 mm residual disease is considered feasible
- histological or cytological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer
- fit for major surgery, ASA 1 or ASA 2
- WHO performance status 0 t/m2
- adequate bone marrow, hepatic and renal function
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E.4 | Principal exclusion criteria |
1. history of previous malignancies within 5 years prior to inclusion
2. FIGO stage IV disease
3. if complete primary cytoreduction is impossible
4. patients who received prior treatment for the current malignancy |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
after 1 year of follow up |
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E.5.2 | Secondary end point(s) |
- Recurrence-free survival
- The toxicity and morbidity of both treatment arms
- The quality of life of both treatment arms
- Economic- and cost evaluation of the procedure |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
RFS, QoL and cost effectiveness: after 6 years (after one year of follow up)
safety: after 30 days after last 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 | No |
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) | 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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
HIPEC treatment during surgery or no HIPEC treatment |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 10 |
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 | No |
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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |