Stage IIIC Ovarian Cancer
Conditions
Brief summary
Patients with advanced ovarian cancer (FIGO stage III C) and highly disseminated tumor will be randomized into two arms: primary debulking surgery followed by adjuvant chemotherapy vs. neoadjuvant chemotherapy followed by interval debulking surgery (IDS). The primary end point is the evaluation and comparison of the surgical complications of primary surgery and IDS and the evaluation of the progression free survival (PFS)
Interventions
DRUGNeoadjuvant chemotherapy + Interval Debulking Surgery
Patients with suspected advanced ovarian cancer (FIGO stage IIIC) will undergo only to diagnostic laparoscopy. Omental cake, diaphragmatic or peritoneal extensive carcinomatosis, tumor diffusion to the small and large curvature of the stomach, large and/or small bowel mesentery disease, spleen and/or liver metastases will be investigated in order to obtain a laparoscopic score. After neoadjuvant chemotherapy interval debulking surgery will be performed: total hysterectomy, bilateral salpingo-oophorectomy, radical omentectomy, appendectomy, pelvic and paraaortic lymphadenectomy, eventual bowel resection, eventual bladder resection, eventual splenectomy, eventual parietal and diaphragmatic peritonectomy, eventual gastric resection, eventual hepatic resection, eventual pancreas resection, eventual cholecystectomy.
PROCEDUREPrimary Debulking Surgery + Adjuvant Chemotherapy
Patients with suspected advanced ovarian cancer (FIGO stage IIIC) will undergo to diagnostic laparoscopy. Omental cake, diaphragmatic or peritoneal extensive carcinomatosis, tumor diffusion to the small and large curvature of the stomach, large and/or small bowel mesentery disease, spleen and/or liver metastases will be investigated in order to obtain a laparoscopic score. Then, an attempt of laparotomic cytoreduction will be performed: total hysterectomy, bilateral salpingo-oophorectomy, radical omentectomy, appendectomy, pelvic and paraaortic lymphadenectomy, eventual bowel resection, eventual bladder resection, eventual splenectomy, eventual parietal and diaphragmatic peritonectomy, eventual gastric resection, eventual hepatic resection, eventual pancreas resection, eventual cholecystectomy.
Sponsors
Catholic University of the Sacred Heart
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomly assigned (1:1 ratio) to undergo either PDS followed by systemic adjuvant chemotherapy, or NACT followed by IDS. Random assignment will be centralised at the Institutional clinical trial center using a block-randomisation computer-generated list (maximum allowable percentage deviation = 10%). Allocation will be concealed to patients and investigators. Patients and investigators will not be masked to group assignment.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with suspected advanced ovarian cancer (FIGO stage IIIC) * PIV ≥ 8, PIV ≤ 12 * Estimated life expectancy of at least 4 weeks. * PS ≤ 2 * Appropriate respiratory, hepatic, cardiological, bone marrow and renal functions (Creatinine Clearance \> 60 mL/min according to Cockcroft formula) * Patient capable of consent.
Exclusion criteria
* Pregnancy or breastfeeding. * Non-appropriate respiratory, hepatic, cardiological, bone marrow and renal functions * Large size mass reaching the xiphoid, occupying all the abdominal cavity and/or infiltrating the abdominal wall. * Mesenteric retraction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation and comparison of early surgical complications of primary surgery and Interval debulking surgery. | thirty days | Early surgical complications: * Blood transfusion * Re-laparotomy * suture dehiscence of laparotomy. * Venous thrombosis * Haemorrhage * Death in the post-operative period * Digestive fistula * Urinary fistula * Lymphocyst * Fever * Infection * Pleural effusion * Pulmonary embolism * Pneumothorax * Pneumonia |
| Evaluation and comparison of late surgical complications of primary surgery and Interval debulking surgery | six months | Late surgical complication: * Death for every reason. * Suture dehiscence of laparotomy with opening of the abdominal muscles * Fever due to lymphocystis infection |
| Evaluation of the progression free survival (PFS) | Thirty-six months | Time from randomization until recurrence of tumor or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Thirty-six months | Time from randomization until death from any cause. |
| Evaluation of Quality of life | 12 months | Quality of life will be assess using the EORTC quality of life questionnaire core-36 (QLQC-30) and the ovarian cancer-specific quality of life questionnaire (QLQ-Ov28). These will be complete at study entry, at the 4th cycle or before IDS (in arm A and arm B, respectively), at the 6th cycle, and 6 months after the last cycle of chemotherapy. |
Countries
Italy
Outcome results
None listed