Hyperthermic Intraperitoneal Chemotherapy in the treatment of Ovarian Cancer relapse

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Unicancer, Unicancer

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

26 Apr 2011 → ongoing

Decision date (initial)

2024-09-25

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-517390-24-00

EudraCT number

2010-023035-42

ClinicalTrials.gov

NCT01376752

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacoeconomic

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

Secondary objectives 6

1. To evaluate Relapse-free survival.
2. To evaluate Quality of life and pain: QLQ C30 and FACT O forms (functional assessment of cancer therapy for ovarian cancer) and Visual Analogue Scale (VAS).
3. To evaluate Treatment related toxicities (CTC-AE v4.0) including renal toxicities.
4. To evaluate Morbidity.
5. To perform Medico-economic study: collection of socio-demographic data and patient-related management costs.
6. To perform Pharmacokinetic study: to compare the HIPEC techniques used (open abdomen, and closed abdomen) by analyzing platinum concentrations at peritoneal, plasma and tissue levels.

Conditions and MedDRA coding

Ovarian epithelial cancer : intraperitoneal resectable relapse

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 14

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 > ou = 1.5x109/L, platelets > ou = 100x109/L,
11. No contraindication to general anesthesia for heavy surgery
12. Patient must be informed and the Informed Consent Form signed before any study-specific 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.

Exclusion criteria 17

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The date of death, whatever its cause, will be the main parameter used to evaluate overall survival.

Secondary endpoints 6

1. Relapse-free Survival : 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.
2. 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.
3. Treatment Toxicity, renal toxicity in particular, will be evaluated with the CTC-AE v4.0 scale
4. Morbidity : Morbidity evaluation will be performed until the 60th day after surgery, taking into account: - deaths - severe complications
5. Medico-economic study: collection of socio-demographical data and patient management costs.
6. Pharmacokinetic study: on 50 patients included who received HIPEC (25 in the open method and 25 in the closed method: Analysis of platinum concentrations at the peritoneal, plasma and tissue levels.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Unicancer

Sponsor organisation

Unicancer

Address

101 Rue De Tolbiac

City

Paris

Postcode

75013

Country

France

Scientific contact point

Organisation

Unicancer

Contact name

Nourredine AIT RAHMOUNE

Public contact point

Organisation

Unicancer

Contact name

Nourredine AIT RAHMOUNE

Unicancer

Sponsor organisation

Unicancer

Address

101 Rue De Tolbiac

City

Paris Cedex 13

Postcode

75654

Country

France

Locations

1 EU/EEA country · 32 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications