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Stage IIIC Ovarian CancerPhase 3SCORPIONNCT01461850

Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm

A Phase 3 study testing Neoadjuvant chemotherapy + Interval Debulking Surgery and Primary Debulking Surgery + Adjuvant Chemotherapy in people with Stage IIIC Ovarian Cancer, run by Catholic University of the Sacred Heart at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Stage IIIC Ovarian Cancer
What is being tested?
Neoadjuvant chemotherapy + Interval Debulking Surgery and Primary Debulking Surgery + Adjuvant Chemotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
171 participants
Where
1 siteItaly
Study dates
1 Oct 2011to 31 May 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Italy1 site

  • Catholic University of the Sacred Heart

    Rome, 00168

Other trials in Italy

About this study

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)

Being tested
Neoadjuvant chemotherapy + Interval Debulking Surgery, Primary Debulking Surgery + Adjuvant Chemotherapy
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neoadjuvant chemotherapy + Interval Debulking SurgeryDrug

    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.

  • Primary Debulking Surgery + Adjuvant ChemotherapyProcedure or surgery

    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.

Study groups in NCT01461850
Study groupRoleWhat they receive
Primary debulking surgeryActive comparatorAll 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.
Receives: Procedure: Primary Debulking Surgery + Adjuvant Chemotherapy
Interval debulking surgeryExperimentalAll 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.
Receives: Drug: Neoadjuvant chemotherapy + Interval Debulking Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: thirty days

  2. 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

    Measured: six months

  3. Evaluation of the progression free survival (PFS)

    Time from randomization until recurrence of tumor or death from any cause.

    Measured: Thirty-six months

Secondary outcomes (2)

  1. Overall Survival

    Time from randomization until death from any cause.

    Measured: Thirty-six months

  2. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2011 (estimated)
  2. Study start1 Oct 2011
  3. Primary completion30 Nov 2014
  4. Study completion31 May 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01461850
Sponsor's protocol ID
789/11
Acronym
SCORPION
Status last verified
Oct 2020
First submitted
19 Oct 2011
Last updated
14 Oct 2020
Results posted
No
Data monitoring committee
No

Publications

  • Vergote I, Trope 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 Cancer-Gynaecological Cancer Group; NCIC Clinical Trials Group. Neoadjuvant chemotherapy or primary surgery in stage IIIC or IV ovarian cancer. N Engl J Med. 2010 Sep 2;363(10):943-53. doi: 10.1056/NEJMoa0908806.

    PubMed 20818904

  • 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. doi: 10.1016/j.ajog.2008.06.052. Epub 2008 Sep 17.

    PubMed 18801470

  • 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. doi: 10.1245/ASO.2006.08.021. Epub 2006 Jun 21.

    PubMed 16791447

  • Fagotti A, Ferrandina MG, Vizzielli G, Pasciuto T, Fanfani F, Gallotta V, Margariti PA, Chiantera V, Costantini B, Gueli Alletti S, Cosentino F, Scambia G. Randomized trial of primary debulking surgery versus neoadjuvant chemotherapy for advanced epithelial ovarian cancer (SCORPION-NCT01461850). Int J Gynecol Cancer. 2020 Nov;30(11):1657-1664. doi: 10.1136/ijgc-2020-001640. Epub 2020 Oct 7.

    PubMed 33028623

  • Fagotti A, Vizzielli G, Fanfani F, Costantini B, Ferrandina G, Gallotta V, Gueli Alletti S, Tortorella L, Scambia G. Introduction of staging laparoscopy in the management of advanced epithelial ovarian, tubal and peritoneal cancer: impact on prognosis in a single institution experience. Gynecol Oncol. 2013 Nov;131(2):341-6. doi: 10.1016/j.ygyno.2013.08.005. Epub 2013 Aug 9.

    PubMed 23938372

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Neoadjuvant chemotherapy + Interval Debulking Surgery and Primary Debulking Surgery + Adjuvant Chemotherapy in people with Stage IIIC Ovarian Cancer, run by Catholic University of the Sacred Heart at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation and comparison of early surgical complications of primary surgery and Interval debulking surgery. (time frame: thirty days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01461850, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.

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