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

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ClinicalTrials.gov Identifier: NCT01461850
Recruitment Status : Recruiting
First Posted : October 28, 2011
Last Update Posted : March 29, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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)

Condition or disease Intervention/treatment Phase
Stage IIIC Ovarian Cancer Procedure: Laparoscopy Procedure: Cytoreduction Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm
Study Start Date : September 2011
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Primary 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 e ≤ 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
Procedure: Cytoreduction
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.
Active Comparator: 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 e ≤ 12 randomized in this group will be submitted only to diagnostic laparoscopy followed by neoadjuvant chemotherapy and subsequent Interval Debulking Surgery
Procedure: Laparoscopy
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.


Outcome Measures

Primary Outcome Measures :
  1. Evaluation and comparison of early surgical complications of primary surgery and Interval debulking surgery. [ Time Frame: 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

  2. Evaluation and comparison of late surgical complications of primary surgery and Interval debulking surgery [ Time Frame: six months ]

    Late surgical complication:

    • Death for every reason.
    • Suture dehiscence of laparotomy with opening of the abdominal muscles
    • Fever due to lymphocystis infection

  3. Evaluation of the progression free survival (PFS) [ Time Frame: Thirty-six months ]
    From the last chemotherapy cycle to the first clinical-radiological signs of disease relapse


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Thirty-six months ]
    From the last chemotherapy cycle until death or the last Follow-up.

  2. Evaluation of Quality of life [ Time Frame: 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461850


Locations
Italy
Catholic University of the Sacred Heart Recruiting
Rome, Italy, 00168
Contact: Giovanni Scambia, Professor    +39-06-30156279    clinicaltrials@rm.unicatt.it   
Contact: Lucia Tortorella, MD    +39-06-30156279    luciabianca@hotmail.it   
Sponsors and Collaborators
Catholic University of the Sacred Heart
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Giovanni Scambia, Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01461850     History of Changes
Other Study ID Numbers: 789/11
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders