Where does OCRA's clinical trial data come from?

OCRA indexes clinical trials from ClinicalTrials.gov, the official U.S. registry maintained by the National Library of Medicine. Trials are matched to diseases, investigators, and funded research tracked across the platform.

How do I find clinical trials for ovarian cancer?

Search by condition, treatment type, trial phase, or NCT identifier. Each trial page shows current status, eligibility criteria, study locations, and a direct link to the ClinicalTrials.gov source record.

How often is clinical trial data updated?

Trial data is refreshed through periodic ingestion from the ClinicalTrials.gov v2 API. Status changes, new enrollments, and newly registered trials are captured during each update cycle.

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 Investigators

Anna Fagotti