NCT01461850: SCORPION

Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm

Completed Phase 3 Last updated 14 October 2020

What this trial tests

Phase 3 trial testing Neoadjuvant chemotherapy + Interval Debulking Surgery in Stage IIIC Ovarian Cancer in 171 participants. Completed in 31 May 2016.

Timeline

1 October 2011

Primary endpoint
30 November 2014

31 May 2016

Quick facts

Lead sponsor	Catholic University of the Sacred Heart
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	171
Start date	1 October 2011
Primary completion	30 November 2014
Estimated completion	31 May 2016
Sites	1 location across Italy

Drugs / interventions tested

• Neoadjuvant chemotherapy + Interval Debulking Surgery — full drug profile →
• Primary Debulking Surgery + Adjuvant Chemotherapy

Conditions studied

• Stage IIIC Ovarian Cancer — all drugs for Stage IIIC Ovarian Cancer →

Sponsor

Catholic University of the Sacred Heart

Who can join

Adults 18 to 75, female only, with Stage IIIC Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Randomized trial of primary debulking surgery versus neoadjuvant chemotherapy for advanced epithelial ovarian cancer (SCORPION-NCT01461850).
   Fagotti A, Ferrandina MG, Vizzielli G, Pasciuto T, et al · · 2020 · cited 267× · PMID 33028623 · DOI 10.1136/ijgc-2020-001640
2. A framework for a personalized surgical approach to ovarian cancer.
   Nick AM, Coleman RL, Ramirez PT, Sood AK. · · 2015 · cited 102× · PMID 25707631 · DOI 10.1038/nrclinonc.2015.26
3. Neoadjuvant chemotherapy before surgery versus surgery followed by chemotherapy for initial treatment in advanced ovarian epithelial cancer.
   Coleridge SL, Bryant A, Kehoe S, Morrison J. · · 2021 · cited 66× · PMID 34328210 · DOI 10.1002/14651858.cd005343.pub6
4. Predictors of optimal cytoreduction in patients with newly diagnosed advanced-stage epithelial ovarian cancer: Time to incorporate laparoscopic assessment into the standard of care.
   Gómez-Hidalgo NR, Martinez-Cannon BA, Nick AM, Lu KH, et al · · 2015 · cited 56× · PMID 25827290 · DOI 10.1016/j.ygyno.2015.03.049
5. Chemotherapy versus surgery for initial treatment in advanced ovarian epithelial cancer.
   Coleridge SL, Bryant A, Kehoe S, Morrison J. · · 2021 · cited 40× · PMID 33543776 · DOI 10.1002/14651858.cd005343.pub5
6. Clinical Value of lncRNA MEG3 in High-Grade Serous Ovarian Cancer.
   Buttarelli M, De Donato M, Raspaglio G, Babini G, et al · · 2020 · cited 28× · PMID 32295169 · DOI 10.3390/cancers12040966
7. Chemotherapy versus surgery for initial treatment in advanced ovarian epithelial cancer.
   Coleridge SL, Bryant A, Lyons TJ, Goodall RJ, et al · · 2019 · cited 23× · PMID 31684686 · DOI 10.1002/14651858.cd005343.pub4
8. Neoadjuvant treatment in ovarian cancer: New perspectives, new challenges.
   Nikolaidi A, Fountzilas E, Fostira F, Psyrri A, et al · · 2022 · cited 21× · PMID 35957909 · DOI 10.3389/fonc.2022.820128