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Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm

NCT01461850CompletedPHASE3INTERVENTIONAL

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)

Key Facts

Lead Sponsor

Catholic University of the Sacred Heart

Enrollment

171

Start Date

2011-10-01

Completion Date

2014-11-30

Study Type

INTERVENTIONAL

Official Title

Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm

Interventions

Neoadjuvant chemotherapy + Interval Debulking SurgeryPrimary Debulking Surgery + Adjuvant Chemotherapy

Conditions

Stage IIIC Ovarian Cancer

Eligibility

Age Range

18 Years – 75 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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

Time frame: thirty days

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

Time frame: six months

Evaluation of the progression free survival (PFS)

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

Time frame: Thirty-six months

Secondary Outcomes

Overall Survival

Time from randomization until death from any cause.

Time frame: Thirty-six months

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.

Time frame: 12 months

Locations

Catholic University of the Sacred Heart, Rome, Italy

Linked Papers

2020-10-07

Randomized trial of primary debulking surgery versus neoadjuvant chemotherapy for advanced epithelial ovarian cancer (SCORPION-NCT01461850)

To investigate whether neoadjuvant chemotherapy followed by interval debulking surgery is superior to primary debulking surgery in terms of perioperative complications and progression-free survival, in advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients with high tumor load. Patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (stage IIIC-IV) underwent laparoscopy. Patients with high tumor load assessed by a standardized laparoscopic predictive index were randomly assigned (1:1 ratio) to undergo either primary debulking surgery followed by adjuvant chemotherapy (arm A), or neoadjuvant chemotherapy followed by interval debulking surgery and adjuvant chemotherapy (arm B). Co-primary outcome measures were progression-free survival and post-operative complications; secondary outcomes were overall survival, and quality of life. Survival analyses were performed on an intention-to-treat population. 171 patients were randomly assigned to primary debulking surgery (n=84) versus neoadjuvant chemotherapy (n=87). Rates of complete resection (R0) were different between the arms (47.6% in arm A vs 77.0% in arm B; p=0.001). 53 major postoperative complications were registered, mainly distributed in arm A compared with arm B (25.9% vs 7.6%; p=0.0001). All patients were included in the intent-to-treat analysis. With an overall median follow-up of 59 months (95% CI 53 to 64), 142 (83.0%) disease progressions/recurrences and 103 deaths (60.2%) occurred. Median progression-free and overall survival were 15 and 41 months for patients assigned to primary debulking surgery, compared with 14 and 43 months for patients assigned to neoadjuvant chemotherapy, respectively (HR 1.05, 95% CI 0.77 to 1.44, p=0.73; HR 1.12, 95% CI 0.76 to 1.65, p=0.56). Neoadjuvant chemotherapy and primary debulking surgery have the same efficacy when used at their maximal possibilities, but the toxicity profile is different.

Linked Investigators

Anna Fagotti