Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
Conditions
Keywords
Laparoscopy, interval debulking surgery
Brief summary
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.
Interventions
PROCEDURETumor Debulking Surgery by laparoscopy
Sponsors
Centre Jean Perrin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the rate of conversion to laparotomy | surgery | Feasibility of the surgical laparoscopic management of interval debulking surgery will be assessed by the rate of conversion to laparotomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Port site metastases | during 1 year post surgery | — |
| Morbidity: intraoperative and postoperative complications | during surgery and 1 year post surgery | — |
| Pain | during the hospital stay (an expected average of 5 days), at 1 week, 1 month, 3 and 6 months post surgery | — |
| Quality of life using EORTC QLQ-C30 | before surgery (an expected average of 7 days before surgery), 1 week , 1 month, 3 and 6 months post-surgery | — |
| Economic evaluation | 1 year post-surgery | economic evaluation will be assess by a quantification of the additional costs of surgery, duration and cost of hospitalization, number of possible re-interventions or hospitalizations. |
Countries
France
Outcome results
None listed