E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
EPITHELIAL OVARIAN/TUBAL CANCER |
CARCINOSI PERITONEALE DA NEOPLASIA EPITELIALE TUBO/OVARICA IN STADIO AVANZATO |
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E.1.1.1 | Medical condition in easily understood language |
OVARIAN CANCER |
CARCINOSI PERITONEALE NEL CANCRO OVARICO |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10033121 |
E.1.2 | Term | Ovarian and fallopian tube cysts and neoplasms |
E.1.2 | System Organ Class | 100000004872 |
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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 compare two-years disease-free survival of CRS and HIPEC (CDDP+Paclitaxel) vs CRS alone in Stage IIIC unresectable epithelial tubal/ovarian cancer with partial or complete response after 3 cycles of 1st line chemotherapy (CBDCA +Paclitaxel). |
valutare il beneficio aggiunto dato dalla chemioipertermia intraperitoneale HIPEC,inteso come sopravvivenza libera da malattia a due anni |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Female adult women (18 to 70 years old) 2.patients, with EOC (FIGO stage IIIc, with a Fagotti modified Laparoscopic Scoring System ≥ 4 3. who will show a complete clinical response (cCR) or partial clinical response (cPR) after 3 cycles (Carboplatin+Paclitaxel) of neoadjuvant chemotherapy; 4. performance status (ECOG) 0, 1 or 2 5. signed informed consent. |
1. donne di età 18-70 anni; 2. tumore tubo/ovarico epiteliale in stadio IIIC/FIGO valutato non resecabile dopo laparoscopia 3. rispondenti completamente o parzialmenti al trattamento neoadiuvante contenete platino 4. performance status (ECOG) 0, 1 o 2 5. firma consenso |
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E.4 | Principal exclusion criteria |
refusing to sign an informed consent; • age > 70 years and age <18 years; • BMI > 35; • impossibility of an adequate follow-up; • presence of other active neoplasms; • active infection or other concurrent medical condition that could interfere in the ability of patients to receive the proposed treatment according to protocol; • extraabdominal metastases (Stage IV) ; • performance status (ECOG)>2; • complete bowel obstruction; • Abnormal bone marrow indices or renal and liver function; • ASA IV or V. |
1. età >7 o < 18 anni 2. BMI >35 3. impossibilità adeguato follow up 4. presenza di altre neoplasie 5. presenza di altre patologie 6. presenza di metastasi extra-addominali (stage IV) 7. performance status (ECOG)>2; • completa ostruzione intestinale; • anormale funzionalità del midollo osseo, della funzione renale o epatica; • ASA IV or V. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The present study will compare CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE) in Stage IIIC inoperable epithelial tubal/ovarian cancer with partial or complete response after neoadjuvant chemotherapy (3 cycles CDDP+Paclitaxel), followed by adjuvant chemotherapy in terms of two-years disease-free survival from the date of randomization. |
valutare il beneficio aggiunto dato dalla chemioipertermia intraperitoneale HIPEC,inteso come sopravvivenza libera da malattia a due anni |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1.to evaluate one-year, three- and five-years disease-free survival from the date of randomization after CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE);
2. to evaluate one month, one-year, three- and five-years overall survival from the date of randomization after CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE);
3.to evaluate toxicity induced by HIPEC using the NCI CTC criteria (APPENDIX 8).
4. to evaluate one month and six months morbidity induced by the CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE) using the Common Terminology Criteria for Adverse Events v4.03 (CTCAE 4.03 - http://evs.nci.nih.gov/ftp1/CTCAE/About.html);
5.to evaluate the duration of operation (minutes) CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE), defined as operating time, anesthesia time, or operating room time;
6. return of bowel function (days) after CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE), subdivided in: time until first stool, introduction of liquid or solid diet;
7. length of hospital stay (days) of CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE);
8. return to normal activity (days), after CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE) i.e. time until return to full activity, work, or sport;
9. six months and one year QOL, using the Standard Form 36 (SF-36 v1.0, APPENDIX 9);
10. percentage of patients in both arms completing the scheduled postoperative chemotherapy;
11. correspondence between pre-randomization clinical/radiologic/laboratory evaluation and intraoperative findings |
1.valutare la sopravvivenza libera da malattia a 1 , 2 e 5 anni dalla data di randomizzazione ai due bracci;
2.valutare la sopravvivenza totale a 1 , 2 e 5 anni dalla data di randomizzazione ai due bracci;
3.valutare la tossicità indotta da intervento + HIPEC;
4.valutare la morbidita' a 1 e 6 mesi per braccio intervento + HIPEC. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
p.to 1: 1-3 e 5 anni
p.to 2: 1-3 e 5 anni |
p.to 1: 1-3 e 5 anni
p.to 2: 1-3 e 5 anni |
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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 |
solo intervento chirurgico |
only surgery |
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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 | 4 |
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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |