HIPEC in Ovarian Carcinoma Clinical Stage IIIC and IV During Interval Laparotomy
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|ClinicalTrials.gov Identifier: NCT03275194|
Recruitment Status : Recruiting
First Posted : September 7, 2017
Last Update Posted : September 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|HPEC Ovarian Cancer Women's Health: Neoplasm of Ovary Chemotherapy Effect||Procedure: HIPEC||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The data will be evaluated for a external person with the groups labeled as "A" and "B" for all outcomes.|
|Official Title:||Hyperthermic Intraperitoneal Chemotherapy in Ovarian Carcinoma Clinical Stage IIIC and IV During Interval Laparotomy. Phase II Study|
|Actual Study Start Date :||September 2, 2017|
|Estimated Primary Completion Date :||December 1, 2020|
|Estimated Study Completion Date :||December 1, 2025|
No Intervention: Control group
After achieving a complete cytoreductive surgery (no visible residual disease), the patient will be randomised and if is assigned to this arm does not receive additional treatment and the procedure will be finished.
Experimental: HIPEC group
After achieving a complete cytoreductive surgery (no visible residual disease), the patient will be randomised and if is assigned to this arm receive a HIPEC procedure with cisplatin and doxorubicin.
Following complete cytoreductive surgery without any evidence of residual disease, the patient will be randomized either HIPEC (intervention) or no-HIPEC (control) in the operative Room. If the arm HIPEC is obtained, then a HIPEC procedure with cisplatin and doxorubicin will be performed. If no-HIPEC (control arm) is assigned then the surgical procedure will be finished.
- Mortality [ Time Frame: Up to 1 year ]To assess the mortality associated with the use of intraperitoneal hyperthermic chemotherapy during interval laparotomy.
- Quality of life [ Time Frame: Up to 1 year ]To evaluate the impact on patients' quality of life, which is undergoing intraperitoneal hyperthermic chemotherapy during interval laparotomy. The scales that will be used will be EORTC QLQ-C30 (Ver. 3) and EORTC QLQ-OV28.
- Morbility [ Time Frame: Up to 1 year ]To assess the morbidity associated with the use of intraperitoneal hyperthermic chemotherapy during interval laparotomy.
- Disease free survival [ Time Frame: Up to 2 years ]Evaluate disease-free survival.
- Overall survival [ Time Frame: up to five years ]Evaluate overall 5 year survival.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03275194
|National Cancer Institute of Mexico||Recruiting|
|Mexico City, Mexico, 14080|
|Contact: Rosa A Salcedo-Hernández, M.Sc 525534265921 email@example.com|
|Contact: Leonardo S Lino-Silva 525534265921 firstname.lastname@example.org|
|Principal Investigator:||Rosa A Salcedo-Hernandez, MSc||Instituto Nacional de Cancerologia, Columbia|