Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm

Stage IIIC Ovarian Cancer Clinical Trial

— SCORPION  

Official title:

Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461850
• Other study ID #: 789/11
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2011
• Est. completion date: May 31, 2016

Study information

• Verified date: October 2020
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: May 31, 2016
• Est. primary completion date: November 30, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Ovarian Neoplasms
• Stage IIIC Ovarian Cancer

Intervention

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.

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.

Locations

Country	Name	City	State
Italy	Catholic University of the Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Fagotti A, Ferrandina G, Fanfani F, Ercoli A, Lorusso D, Rossi M, Scambia G. A laparoscopy-based score to predict surgical outcome in patients with advanced ovarian carcinoma: a pilot study. Ann Surg Oncol. 2006 Aug;13(8):1156-61. Epub 2006 Jun 21. — View Citation

Fagotti A, Ferrandina G, Fanfani F, Garganese G, Vizzielli G, Carone V, Salerno MG, Scambia G. Prospective validation of a laparoscopic predictive model for optimal cytoreduction in advanced ovarian carcinoma. Am J Obstet Gynecol. 2008 Dec;199(6):642.e1-6 — View Citation

Vergote I, Tropé CG, Amant F, Kristensen GB, Ehlen T, Johnson N, Verheijen RH, van der Burg ME, Lacave AJ, Panici PB, Kenter GG, Casado A, Mendiola C, Coens C, Verleye L, Stuart GC, Pecorelli S, Reed NS; European Organization for Research and Treatment of — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation and comparison of early surgical complications of primary surgery and Interval debulking surgery.	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	thirty days
Primary	Evaluation and comparison of late surgical complications of primary surgery and Interval debulking surgery	Late surgical complication: Death for every reason.; Suture dehiscence of laparotomy with opening of the abdominal muscles; Fever due to lymphocystis infection	six months
Primary	Evaluation of the progression free survival (PFS)	Time from randomization until recurrence of tumor or death from any cause.	Thirty-six months
Secondary	Overall Survival	Time from randomization until death from any cause.	Thirty-six months
Secondary	Evaluation of Quality of life	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.	12 months