Clinical Trial to Evaluate Safety and Efficacy of Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) With Mitomycin C Used During Surgery for Treatment of Locally Advanced Colorectal Carcinoma
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|ClinicalTrials.gov Identifier: NCT02614534|
Recruitment Status : Recruiting
First Posted : November 25, 2015
Last Update Posted : September 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: MITOMYCIN-C 40 mg||Phase 3|
The purpose of this study is to determine whether Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma is effective in the treatment of locally advanced colorectal carcinoma.
The Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) is expected to be an effective treatment with minimal side effects, it has already provided clear benefits in terms of overall survival in patients with advanced cancer.
This is an attractive option for the healthcare professionals who face daily to peritoneal recurrence after performing complex surgeries, however its application is difficult due to the cost and resources increase. This leads to the necessity of administering the treatment within a clinical trials and in order to obtain a significant power this clinical trials will be multicenter and it will be performed in several Oncological surgery Units highly specialised and with extensive experience in colorectal carcinoma.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Multicentre, Randomized Clinical Trial to Evaluate Safety and Efficacy of Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) With Mitomycin C Used During Surgery for Treatment of Locally Advanced Colorectal Carcinoma|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||October 2020|
- Locoregional Control (LC) [ Time Frame: 3 years ]Time elapsed from the surgical intervention clinical up to the date the patient is free of clinical and radiological locoregional recurrence
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): NCT02614534
|Contact: Blanca Quijano Ruiz, Pharmacist||(+34) 957 736 firstname.lastname@example.org|
|Hospital Universitario Reina Sofía||Recruiting|
|Córdoba, Spain, 14004|
|Contact: Blanca Quijano Ruiz, Pharmacist (+34) 957 736 484 email@example.com|
|Principal Investigator: Alvaro Arjona, MD|