Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm

Phase 3

Completed

• Conditions: Stage IIIC Ovarian Cancer
• Interventions: Drug: Neoadjuvant chemotherapy + Interval Debulking Surgery; Procedure: Primary Debulking Surgery + Adjuvant Chemotherapy

• Registration Number: NCT01461850
• Lead Sponsor: Catholic University of the Sacred Heart

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)

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study Start: 2011-10-01
• Study First Submitted: 2011-10-19
• Study First Submitted QC: 2011-10-26
• Study First Posted: 2011-10-28
• Primary Completion: 2014-11-30
• Study Completion: 2016-05-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-10
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 171

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interval debulking surgery	Neoadjuvant chemotherapy + 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.
Primary debulking surgery	Primary Debulking Surgery + Adjuvant Chemotherapy	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Catholic University of the Sacred Heart; 🇮🇹 Rome, Italy