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Short-course HIPEC in Advanced Epithelial Ovarian Cancer

NCT02249013CompletedPHASE2INTERVENTIONAL

Summary

This is an open-label, multicenter, single-arm, feasibility phase 2 trial on safety and efficacy of short-course regimen of intra-operative Hyperthermic Intraperitoneal Chemotherapy (HIPEC) at the time of fast-track interval debulking surgery (IDS) following neoadjuvant chemotherapy (NACT) for high tumor burden epithelial ovarian cancer (EOC).

Key Facts

Lead Sponsor

Professor Fernando Figueira Integral Medicine Institute

Enrollment

Start Date

2015-02-01

Completion Date

2021-02-23

Study Type

INTERVENTIONAL

Official Title

Short-course Hyperthermic IntraPEritoneal Chemotherapy (HIPEC) at Interval Debulking Surgery for High Tumor Burden Ovarian Cancer

Interventions

Cytoreductive Surgery (CRS)Hyperthermic Intraperitoneal Chemotherapy (HIPEC)Neoadjuvant Chemotherapy (NACT)Adjuvant ChemotherapyFast-track recovery strategy

Conditions

Ovarian Cancer

Eligibility

Age Range

18 Years – 70 Years

Sex

ALL

* Inclusion Criteria:

  * Patients with no previous treatment and candidates for elective surgery with histological diagnosis of epithelial ovarian carcinoma;
  * Clinical stage IIIB to IV, without suspicion of extra-abdominal metastasis;
  * No other malignancies in activity;
  * No previous treatments such as radiation, chemotherapy (except neoadjuvant chemotherapy in the study protocol) or major abdominal surgery;
  * Absence of neuro-psychiatric disorders, history of drug allergies, and pregnancy or breast feeding;
  * Aged between 18 and 70 years;
  * Performance status 0-2 (ECOG, Eastern Cooperative Oncology Group) and / or greater than 70 points by the Karnofsky scale;
  * Appropriated cardio-respiratory, hepato-renal and hematological reserves;
  * Signing of the Consent Form.
* Exclusion Criteria:

  * Evidence of extensive retroperitoneal lymph node involvement or unresectable disease (i.e., massive involvement of the small bowel, mesentery, or hepatic pedicle, and ureteral or biliary obstruction) at the time of CRS/HIPEC;
  * Residual disease after the CRS greater than or equal to 2.5 mm (CC-2 and CC-3);
  * Limiting obesity for CRS or HIPEC;
  * Disease progression, apparent or confirmed uncontrolled infection, or health impairment during NACT.

Outcome Measures

Primary Outcomes

PD9

Proportion of patients with disease progression or death occurring within 9 months of IDS plus HIPEC

Time frame: 9 months

Secondary Outcomes

Postoperative 30-day mortality rate

Mortality rates up to 30-day after surgery

Time frame: 30 days

Postoperative complication rates

Complications rates up to 30-day after surgery

Time frame: 30 days

Assessment of quality of life (QLQ-C30/EORTC)

Assessment of quality of life according to the QLQ-C30/EORTC scales.

Time frame: Baseline (i.e., at the time of hospital admission for IDS plus HIPEC); after CRS/HIPEC (i.e., at the time of restarting the systemic chemotherapy); after protocol (i.e., at 3-6 weeks after the last syst

Overall survival (OS)

We defined OS as the time from starting the NACT to death.

Time frame: 24 months

Progression-free Survival (PFS)

We defined PFS as the time from starting the NACT to disease progression.

Time frame: 24 months

Disease-free Survival (DFS)

We defined DFS for patients without no gross residual disease as the time from IDS plus HIPEC to disease progression.

Time frame: 24 months

Linked Papers

2020-07-10

Quality of life in a phase 2 trial of short-course hyperthermic intraperitoneal chemotherapy (HIPEC) at interval debulking surgery for high tumor burden ovarian cancer

ABSTRACT Introduction: to evaluate the effect of short-course (i.e.: 30 minutes) HIPEC on health-related quality of life (HRQoL) in our feasibility study; NCT02249013. Methods: a prespecified secondary end-point of our open-label, multicenter, single-arm, phase 2 trial on safety and efficacy was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30, version 3.0). Patients were required to complete the HRQoL questionnaire at baseline, after HIPEC, and after the end of the treatment. Changes of HRQoL over time were assessed by median scores for each domain and analyzed by Friedman`s test at a significant two-sided level of 0.05. Results: fifteen patients with high tumor burden EOC were recruited from our public health system between February 2015 and July 2019. A baseline EORTC QLQ-C30 questionnaire and at least one follow-up questionnaire was received from all of the patients. No significant difference over time in the QLQC30 summary scores was observed (p>0.05). The transitory impairment on patients HRQoL immediately after the short-course HIPEC trended to return to baseline at the end of the multimodal treatment. Conclusions: we found no significant impairment of short-course HIPEC on patients HRQoL into the context of our comprehensive treatment protocol.

Linked Investigators

ROBERTO JOSÉ COSTA LUSTOSA