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Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) in Ovarian Cancer Recurrence

NCT01539785UNKNOWNNAINTERVENTIONAL

Summary

The purpose of this study is to determine the role of surgery followed by hyperthermic intra-peritoneal chemotherapy (HIPEC) versus surgery alone in patients with platinum-sensitive first recurrence of ovarian cancer. Moreover it is a prospective randomized multicenter trial, aimed to investigate the prognostic role of surgery plus HIPEC versus surgery alone in terms of progression free interval, overall survival, morbidity and mortality, second recurrence pattern, quality of life with EORTC QLQ-C30 and QLQ OV28 questionnaires.

Key Facts

Lead Sponsor

Catholic University of the Sacred Heart

Enrollment

158

Start Date

2012-09-01

Completion Date

2018-09-01

Study Type

INTERVENTIONAL

Official Title

Surgery Plus Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) Versus Surgery Alone in Patients With Platinum-sensitive First Recurrence of Ovarian Cancer: a Prospective Randomized Multicenter Trial.

Interventions

Secondary citoreductionHyperthermic intra-peritoneal chemotherapy (HIPEC)

Conditions

First Recurrence of Ovarian Cancer

Eligibility

Age Range

18 Years – 70 Years

Sex

FEMALE

Inclusion Criteria:

* Age over 18 and under 70 years
* Patients affected by a first recurrence of ovarian cancer with measurable lesions or not, but evaluable (upwards of Ca125 for 2 consecutive assessments).
* ECOG-performance status ≤ 2
* Ovarian cancer limited to the abdominal cavity with or without extraperitoneal spread considered resectable at intraoperative evaluation
* Evidence of tumor recurrence diagnosed after 6 months from primary treatment
* Previous-based chemotherapy of carboplatin and taxanes
* Positive Peritoneal Washing in the presence of other abdominal disease surgically resectable
* Adequate respiratory, hepatic, cardiac, kidney and bone marrow function (absolute neutrophil count \> 1500/mm3, platelets \> 150,000/μl, creatinine clearance \> 60 mL/min according to Cockroft formula)
* Patient-compliant and psychologically able to follow the trial procedures

Exclusion Criteria:

* Non-epithelial ovarian cancer or borderline ovarian tumor
* Pregnancy or breastfeeding
* Patients affected by major depressive disorder even in treatment or minor mood disorders
* Patients with severe impairment of respiratory, hepatic or renal function
* Patients with cardiac, neurological or metabolic uncontrolled pharmacologically disease
* Patients with active infection or other neoplastic disease in progress
* Patients with bowel obstruction
* Inadequate bone marrow, liver, kidney function
* No clear-peritoneal disease at surgical exploration
* Patients with ascites \> 500 ml (the TAC)
* Patients on maintenance therapy with Antiangiogenic drugs
* Patients with secondary or tertiary recurrence, or already submitted to HIPEC
* Patients who have already made the second or third line chemotherapy.

Outcome Measures

Primary Outcomes

Estimate of progression free interval (PFI) in the two trial arms.

The progression-free interval (PFI) will be evaluated from the time of secondary cytoreduction (± HIPEC) to the evidence of a second recurrence of disease.

Time frame: 36 months

Secondary Outcomes

Estimate of overall survival (OS)in the two trial arms.

The overall survival (OS) will be evaluated from the time of secondary cytoreduction ± HIPEC to death or last FU.

Time frame: 36 months

Evaluation of the morbidity and mortality in the two trial arms.

Surgical complications and morbidity will be monitored and recorded in special forms both during surgery and during the period of hospital stay. The following complications should be reported to the coordinating center UCSC within 24 hours Events recorded during surgery and up to 60 days of the latter: transfusion of more than 10 units of blood in 24 hours, re-laparotomy for complications, pulmonary embolism, sepsis, death (regardless of cause), new hospitalization for surgical complication. Events between 60 days and the end of follow-up period: death (regardless of cause).

Time frame: 36 months

Locations

Catholic University of Sacred the Hearth, Rome, Italy

Linked Papers

2024-11-21

Hyperthermic Intraperitoneal Chemotherapy in Platinum-Sensitive Recurrent Ovarian Cancer: A Randomized Trial on Survival Evaluation (HORSE; MITO-18)

PURPOSE To investigate whether the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to secondary cytoreductive surgery (SCS) without neoadjuvant chemotherapy has a benefit on progression-free survival (PFS), as opposed to SCS alone in patients with platinum-sensitive recurrent epithelial ovarian cancer (platinum-free interval, >6 months). METHODS This was a multicenter randomized phase III study. Random assignment was performed at the time of surgery in cases with residual tumor ≤0.25 cm. HIPEC with cisplatin (CDDP) 75 mg/m 2 for 60 minutes at 41.5°C was administered at the end of surgery in the experimental arm. Both groups received postoperative platinum-based chemotherapy. The primary end point was PFS. The safety profile and postrecurrence survival (PRS) were the secondary end points. RESULTS A total of 167 patients underwent random assignment, 82 patients to SCS plus HIPEC (experimental arm) and 85 to SCS alone (control arm). The median follow-up was 83 months (IQR, 64-102). The median PFS was 23 months (95% CI, 17 to 29) in the group that underwent surgery alone and 25 months (95% CI, 18 to 32) in the group that underwent cytoreductive surgery with HIPEC. The probability of PRS at 5 years was 61.6% (95% CI, 50.8 to 72.4) in the SCS group and 75.9% (95% CI, 66.5 to 85.3) in the SCS plus HIPEC group. The incidence of postoperative adverse events of any grade was similar between the two groups. CONCLUSION The addition of HIPEC to complete or nearly complete primary SCS did not confer a benefit in terms of PFS in patients with platinum-sensitive peritoneal recurrence.

Linked Investigators

Anna Fagotti

Barbara Costantini

Diana Giannarelli

Francesco Fanfani

Giorgio Giorda

Giovanni Aletti

Giovanni Scambia

Rita Trozzi

Vanda Salutari

Vito Chiantera