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• Register: EUCTR
• Last refreshed on: 7 December 2015
• Main ID: EUCTR2010-023035-42-IT
• Date of registration: 23/03/2015
• Prospective Registration: Yes
• Primary sponsor: UNICANCER
• Public title: _
• Scientific title: Randomized phase III study evaluating hyperthermic intraperitoneal chemotherapy in the treatment of ovarian cancer relapse. - CHIPOR
• Date of first enrolment: 30/06/2015
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023035-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Complete surgery Number of treatment arms in the trial: 2

Countries of recruitment

Italy, Spain

Contacts

• Name: Trevor Stanbury
• Affiliation: UNICANCER

• Name: Trevor Stanbury
• Affiliation: UNICANCER

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patient age = 18 years,
2. Performance Status WHO < 2,
3. Previous treatment for epithelial ovarian cancer, tubal peritoneal primitive
4. Patient with intraperitoneal relapse (more than 6 months after the end of the initial treatment), resectable without distant metastasis (with the exception of communicating pleura effusion, sensitive to platine-based second line chemotherapy and resectable
lymph-nodes in the groin or retro peritoneal) ,
5. Second-line platinum-based pre-operatory chemotherapy: carboplatin-paclitaxel or carboplatin-caelix (pegylated liposomal doxorubicine: with gemcitabine, trabectidine, hycamtin authorized)
6. Complete cytoreductive surgery,
7. Delay between the last cycle of second-line chemotherapy and surgery must be between 5 and 12 weeks
8. No hepatic insufficiency (bilirubin = 1.5 the Upper Limit of Normal (ULN), ASAT and ALAT = 3 ULN,
9. No renal insufficiency (creatinine = 1.5 ULN, creatinine clearance >60 ml/min) calculated with MDRD method,
10. Hematological functions : PNN ³ 1.5x109/L, platelets ³ 100x10^9/L,
11. No contraindication to general anesthesia for heavy surgery
12. Patient must be informed and the Informed Consent Form signed before any studyspecific procedures start.
13. Medical/Public Health insurance coverage
14. Women of child-bearing age must use appropriate contraception during treatment and for 6 months after the end of treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 222
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 222

Exclusion criteria:
1) Patient age <18 years,
2) Previous cancer in the last 5 years (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma),
3) Known hypersensitivity to cisplatin,
4) Metastasis,
5) Use of anti-angiogenic treatment within 8 weeks before surgery
6) Patient with other concomitant severe life threatening disease,
7) More than 2 segmental resections concomitant to HIPEC is foreseen,
8) Any progressive disease during the second-line chemotherapy (platine-based),
9) Relapse occurring less than 6 months after the end of the initial treatment,
10) Non-epithelial ovarian tumor,
11) Uncontrolled infection,
12) Patient unwilling or in the incapacity to comply with the medical follow-up required by the trial because of geographic, social or psychological reasons.
13) Clinically significant cardiorespiratory disease contraindicating the hyper hydration required for HIPEC,
14) Patient who has already been treated by HIPEC for ovarian cancer,
15) Persons kept in detention, or incapable of giving consent, or without a Public Health insurance coverage,
16) Pregnant or breastfeeding woman
17) Patient who has already been enrolled in another clinical trial


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Ovarian epithelial cancer : intraperitoneal resectable relapse
MedDRA version: 17.1 Level: PT Classification code 10033160 Term: Ovarian epithelial cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Trade Name: Cisplatine
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: CISPLATIN
CAS Number: 15663271
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-

Primary Outcome(s)

Main Objective: To improve overall survival at 12 months for patients in arm with HIPEC compared with patients in arm without HIPEC.

Primary end point(s): The date of death, whatever its cause, will be the main parameter used to evaluate overall survival.

Secondary Objective: TO EVALUATE:
- Relapse-free survival.
- Quality of life and pain: QLQ C30 and FACT O forms (functional assessment of cancer therapy for ovarian cancer) and Visual Analogue Scale (VAS).
- Treatment related toxicities (CTC-AE v4.0) including renal toxicities.
- Morbidity.

TO PERFORM:
- Medico-economic study: collection of socio-demographic data and patient-related management costs.

Timepoint(s) of evaluation of this end point: _

Secondary Outcome(s)

Secondary end point(s): - Relapse-free Survival
Definition:
Relapse-free survival will be defined as the absence of clinical evidence (presence of mass, or effusion with cytological diagnostic), biological criteria (confirmed elevation of CA 125 markers according to RUSTIN criteria) or medical imaging criteria (detection of measurable mass, with the new RECIST criteria).
The main criteria will be the date at which relapse occurrence is detected.

- Pain and Quality of Life :
Quality of life (QoL) will be studied with the QLQ C30 form from EORTC and FACT O form specific for ovarian cancer (functional assessment of cancer therapy for ovarian cancer).
Pain will be evaluated with VAS. History of chronic pain will be noted and accounted for in the analysis. Pain alleviating treatment such as epidural analgesia, the use of morphine, will be recorded in both arms (with HIPEC and without HIPEC).

- Treatment Toxicity, renal toxicity in particular, will be evaluated with the CTC-AE v4.0 scale.

- Morbidity :
Morbidity evaluation will be performed until the 60th day after surgery, taking into account:
- deaths
- severe complications :
requiring patient placement in intensive care unit or an invasive medical procedure or second intervention,
digestive fistulas due to perforation or suture rupture,
deep abscess,
intra-abdominal hemorrhagic syndrome
pancreatitis
renal toxicity requiring dialysis
any SAE with life-threatening implication or causing permanent
invalidity/disability or severe temporary incapacity.

- Medico-economic study: collection of socio-demographical data and patient management
costs.

Timepoint(s) of evaluation of this end point: _

Secondary ID(s)

UC-0120/1004

2010-023035-42-ES

Source(s) of Monetary Support

Hospital program of clinical research