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

Catholic University of the Sacred Heart

Status and phase: Completed; Phase 3

Conditions: Stage IIIC Ovarian Cancer

Treatments: Procedure: Primary Debulking Surgery + Adjuvant Chemotherapy; Drug: Neoadjuvant chemotherapy + Interval Debulking Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01461850

789/11

Details and patient eligibility

About

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)

Enrollment: 171 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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171 participants in 2 patient groups

Primary debulking surgery

Active Comparator group

Description:

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.

Treatment:

Procedure: Primary Debulking Surgery + Adjuvant Chemotherapy

Interval debulking surgery

Experimental group

Description:

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.

Treatment:

Drug: Neoadjuvant chemotherapy + Interval Debulking Surgery