SCORPION: Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm

Sponsor

Catholic University of the Sacred Heart (Other)

Overall Status

Completed

CT.gov ID

NCT01461850

Collaborator

(none)

171

Enrollment

Location

Arms

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Stage IIIC Ovarian Cancer	Drug: Neoadjuvant chemotherapy + Interval Debulking Surgery Procedure: Primary Debulking Surgery + Adjuvant Chemotherapy	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

171 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm

Actual Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Nov 30, 2014

Actual Study Completion Date :

May 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Primary debulking surgery All patients with suspicion of advanced ovarian carcinoma (FIGO stage IIIC) will undergo to a diagnostic laparoscopy in order to obtain a laparoscopic score (PIV) based on seven parameters: omental cake, peritoneal and diaphragmatic extensive carcinosis, mesenteric retraction, bowel and stomach infiltration, spleen and/or liver superficial metastasis, as previously published (Fagotti et al, American Journal of Obstetrics and Gynecology, 2008) Patients with PIV ≥ 8 and ≤ 12 randomized in this group will be submitted to an attempt of primary debulking surgery in order to obtain RT < 1 cm, followed by adjuvant chemotherapy.	Procedure: Primary 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.
Experimental: Interval debulking surgery All patients with suspicion of advanced ovarian carcinoma (FIGO stage IIIC) will undergo to a diagnostic laparoscopy in order to obtain a laparoscopic score (PIV) based on seven parameters: omental cake, peritoneal and diaphragmatic extensive carcinosis, mesenteric retraction, bowel and stomach infiltration, spleen and/or liver superficial metastasis, as previously published (Fagotti et al, American Journal of Obstetrics and Gynecology, 2008) Patients with PIV ≥ 8 and ≤ 12 randomized in this group will be submitted only to diagnostic laparoscopy followed by neoadjuvant chemotherapy and subsequent Interval Debulking Surgery, followed by further cycles of chemotherapy.	Drug: Neoadjuvant 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.

Arm

Intervention/Treatment

Active Comparator: Primary debulking surgery

All patients with suspicion of advanced ovarian carcinoma (FIGO stage IIIC) will undergo to a diagnostic laparoscopy in order to obtain a laparoscopic score (PIV) based on seven parameters: omental cake, peritoneal and diaphragmatic extensive carcinosis, mesenteric retraction, bowel and stomach infiltration, spleen and/or liver superficial metastasis, as previously published (Fagotti et al, American Journal of Obstetrics and Gynecology, 2008) Patients with PIV ≥ 8 and ≤ 12 randomized in this group will be submitted to an attempt of primary debulking surgery in order to obtain RT < 1 cm, followed by adjuvant chemotherapy.

Procedure: Primary 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.

Experimental: Interval debulking surgery

All patients with suspicion of advanced ovarian carcinoma (FIGO stage IIIC) will undergo to a diagnostic laparoscopy in order to obtain a laparoscopic score (PIV) based on seven parameters: omental cake, peritoneal and diaphragmatic extensive carcinosis, mesenteric retraction, bowel and stomach infiltration, spleen and/or liver superficial metastasis, as previously published (Fagotti et al, American Journal of Obstetrics and Gynecology, 2008) Patients with PIV ≥ 8 and ≤ 12 randomized in this group will be submitted only to diagnostic laparoscopy followed by neoadjuvant chemotherapy and subsequent Interval Debulking Surgery, followed by further cycles of chemotherapy.

Drug: Neoadjuvant 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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Catholic University of the Sacred Heart	Rome		Italy	00168

Sponsors and Collaborators

Catholic University of the Sacred Heart

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Giovanni Scambia, Professor, Catholic University of the Sacred Heart

ClinicalTrials.gov Identifier:

NCT01461850

Other Study ID Numbers:

789/11

First Posted:

Oct 28, 2011

Last Update Posted:

Oct 14, 2020

Last Verified:

Oct 1, 2020

Additional relevant MeSH terms:

Neoplasms

Ovarian Neoplasms

Study Results

No Results Posted as of Oct 14, 2020