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NCT Number: NCT01461850

Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm

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)

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Key information

Conditions

Stage IIIC Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Catholic University of the Sacred Heart

Rome, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neoadjuvant chemotherapy + Interval Debulking Surgery

Drug

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 Chemotherapy

Procedure

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.

Primary outcomes

  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

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

Secondary outcomes

  1. Overall Survival

    Time frame: Thirty-six months

    Time from randomization until death from any cause.

  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.

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Acronym: SCORPION

Important dates

Study start
2011
Primary completion
2014
Study completion
2016
First posted
Oct 28, 2011
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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