BridgeMD
Phase III randomized clinical trial evaluating hyperthermic intraperitoneal chemotherapy (HIPEC) in ovarian cancer considering two different settings: Primary Debulking Surgery (PDS) and Interval Debulking Surgery (IDS)
EU CTIS ID: 2024-514706-31-01
What this study is testing
The primary objective of this trial is to assess the efficacy, in terms of disease-free survival (DFS), the use of HIPEC treatment combined with standard care (PDS or IDS) or standard care alone (PDS or IDS alone).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 years and ≤ 76 years
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up
- Signed, IRB-approved written informed consent
- Patient covered by the French or Belgian “Social Security” regime
- Criteria to be checked per-operatively for confirmation of enrolment and randomization : Residual disease after surgery CC-0 (no macroscopic residue) or CC-1 (residue < 2.5 mm)
- Criteria to be checked per-operatively for confirmation of enrolment and randomization : Per-operative hemorrhage < 2.5 L
You likely can't join if
- Benign disease, borderline disease, non epithelial ovarian carcinoma or carcinosarcoma
- Pregnant or breastfeeding woman
- Psychiatric illness or social situation that would limit compliance with study requirement, substantially increase the risk of side effects, or compromise the ability of the patient to give written informed consent
- Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)
- Person under guardianship or curatorship
- Cirrhosis
See the full eligibility criteria
Who can join
- Age ≥18 years and ≤ 76 years
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up
- Signed, IRB-approved written informed consent
- Patient covered by the French or Belgian “Social Security” regime
- Criteria to be checked per-operatively for confirmation of enrolment and randomization : Residual disease after surgery CC-0 (no macroscopic residue) or CC-1 (residue < 2.5 mm)
- Criteria to be checked per-operatively for confirmation of enrolment and randomization : Per-operative hemorrhage < 2.5 L
- Criteria to be checked per-operatively for confirmation of enrolment and randomization : Strictly less than 3 digestive resections (other than appendectomy) performed during surgery
- Criteria to be checked per-operatively for confirmation of enrolment and randomization : Diuresis maintained during surgery, without oliguria or anuria (per-operatory diuresis ≥ 0,5 mL/ kg/ h)
- Histologically proven primary epithelial ovarian carcinoma or fallopian tube carcinoma or peritoneal carcinoma (serous papillary adenocarcinoma, clear-cell carcinoma, mucinous adenocarcinoma and endometrioid carcinoma). In case of Primary Debulking Surgery (PDS), the patient can be included based on an extemporaneous diagnosis of stage III invasive carcinoma.
- Pre-therapeutic FIGO stage III
- Patient eligible for a. Primary Debulking Surgery (PDS) with planned adjuvant chemotherapy +/- bevacizumab or other targeted therapy b. Or Interval Debulking Surgery (IDS) after neo-adjuvant chemotherapy +/- bevacizumab or other targeted therapy, with or without planned adjuvant chemotherapy +/- bevacizumab or other targeted therapy. In case of neo-adjuvant chemotherapy, surgery should be performed in a time interval of 3 to 5 weeks in case of chemotherapy without bevacizumab, and in a time interval of 4 to 6 weeks if chemotherapy is combined with bevacizumab. The patient remains eligible for the trial if surgery is delayed beyond the recommended time interval.
- WHO Performance Status ≤ 2
- Physical status score ASA2 ≤ 2 or ASA = 3 if only related to a BMI ≥ 40 or to malignant ascites
- Adequate bone marrow and renal function, as evidenced by the following tests performed within 7 days prior to surgery: - Absolute Neutrophil Count (ANC) ≥1,500/mm3 - Platelets ≥100,000/mm3 - Aspartate aminotransferase (ALT)/ Alanine aminotransferase (ALT) ≤2.5 × upper normal limit (UNL) (≤5.0 × ULN in case of liver metastases) - Total bilirubin ≤1.5 × ULN (except in case of Gilbert’s disease) - Creatinine clearance ≥ 60 mL/ min/ 1.73m2 (estimated according to MDRD formula)
- Negative serum pregnancy test within 7 days prior to surgery for women of childbearing potential. For non-menopaused women, if no hysterectomy is planned, willing to accept the use of an effective contraceptive regimen3 during the treatment period and at least 6 months after the end of treatment (surgery or adjuvant chemotherapy)
- Absence of contraindication to receive the products used in this study (cisplatin and products used in neo-adjuvant/ adjuvant chemotherapy) according to the most recent SmPC of these products (available at http://base-donnees-publique.medicaments.gouv.fr/)
What rules you out
- Benign disease, borderline disease, non epithelial ovarian carcinoma or carcinosarcoma
- Pregnant or breastfeeding woman
- Psychiatric illness or social situation that would limit compliance with study requirement, substantially increase the risk of side effects, or compromise the ability of the patient to give written informed consent
- Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)
- Person under guardianship or curatorship
- Cirrhosis
- Known hypersensitivity to any of the trial drugs, trial drug classes, or excipients in the formulation
- Auditory impairment (i.e. if hearing aid is fitted or if the patient is complaining. In cases of doubt, an audiogram should be performed.)
- Dehydration or intercurrent disease that contraindicates hyperhydration (including cardio-respiratory disease)
- Other uncontrolled intercurrent disease including, but not limited to: diabetes; hypertension; symptomatic congestive heart or pulmonary failure; renal, hepatic or severe gastrointestinal (associated with diarrhea) chronic disease
- Any unresolved NCI-CTCAE Grade ≥ 2 toxicity from previous anticancer therapy (excluding alopecia), or NCI-CTCAE Grade ≥ 3 for anemia
- Concomitant treatment with prophylactic phenytoin
- Receipt of live attenuated vaccine, including yellow fever vaccine, within 30 days prior to inclusion (and, if patient is enrolled, up to 30 days after the last administration of study treatment)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.