Clinical trial · Interventional
Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinosis in Chemosensitive Patients
Prospective Study Assessing the Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinomatosis of Ovarian Origin, Tubal or Primary Peritoneal, in Chemosensitive Patients Treated by Neoadjuvant Chemotherapy.
NCT01905163CI-TRIAL-00028679CILOVEcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective nonrandomized multicenter phase II study, will evaluate the possibility of performing a laparoscopic interval debulking after a minimum of 3 cycles of chemotherapy in highly chemo-sensitive patients with advanced ovarian, tubal cancer or primary peritoneal.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cavity Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor Debulking Surgery by laparoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- laparoscopic management
- description
- Tumor Debulking Surgery by laparoscopy
- interventionNames
- Procedure: Tumor Debulking Surgery by laparoscopy
Primary outcomes (1)
- measure
- the rate of conversion to laparotomy
- timeFrame
- surgery
- description
- Feasibility of the surgical laparoscopic management of interval debulking surgery will be assessed by the rate of conversion to laparotomy.
Secondary outcomes (5)
- measure
- Port site metastases
- timeFrame
- during 1 year post surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> or = 18 years * performance status WHO \< 2 * Epithelial ovarian, fallopian tubes or primary peritoneal carcinoma (histologically confirmed) * Unresectable disease because of FIGO stage IV disease proven by imaging (CT Scan or PET CT) and/or diffuse extensive carcinosis considered unresectable for advanced FIGO stage IIIc; or patients unable to support a radical primary surgery because of age, comorbidities or altered general condition. * No previous debulking surgery before neoadjuvant chemotherapy. * Patients treated with a minimum of 3 cycles of platinum-based neoadjuvant chemotherapy. * Response to chemotherapy was radiologically confirmed (Scan-TAP) prior to interval surgery: No evidence of peritoneal supra-mesocolic carcinomatosis ; Residual pelvic masses smaller than 10 cm ; Absence of suspect supra-centimeter retroperitoneal lymphadenopathy * able to read, write and understand French. * Member of a Social Security scheme. * written informed consent. Exclusion Criteria: * Patient unable to support laparoscopy * psychiatric condition or social or geographic situation that would impede appropriate study participation * Concomitant participation in another clinical trial evaluating surgical treatment (interfering with the evaluation of the main endpoint)
References
Publications (0)
Data not yet available
No reference posted for this study.