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13 December 2017 | Posted in: External News

Study Result Update about Phase III, randomized, clinical study for locally advanced cervical carcinoma at the University of the Witwatersrand, Johannesburg, South Africa

Study Result Update about Phase III, randomized, clinical study for locally advanced cervical carcinoma at the University of the Witwatersrand, Johannesburg, South Africa

Oncothermia is usually applied for advanced malignant diseases. To collect a cohort of advanced cases is a complicated task because the diversity of the patients in late disease is more than in the case of naïve, first line applications, however cervix malignancies in South Africa are very common in particular, and frequently connected with HIV infection. Due to this reason Oncotherm had chosen this country for conducting this significant clinical study.

This ongoing phase III randomized clinical trial is being conducted at the Charlotte Maxeke Johannesburg Academic Hospital and the study Principle Investigator is Dr. Kotzen (radiation oncologist, University of the Witwatersrand, Johannesburg) with co-investigator Prof. Dr. Baeyens who is responsible for radiobiology (lab) work and co-supervisor of Dr. Carrie Minnaar PhD candidate in this program. The study is randomised. It is registered on the national trials database in South Africa (http://www.sanctr.gov.za/SAClinicalTrials/tabid/169/Default.aspx) , as well as on the international register (https://clinicaltrials.gov/ct2/show/NCT03332069?term=NCT03332069&rank=1 ) in USA.

A large number of participants (269 patients) have been enrolled in the study. The recruitment is complete, and participants are being followed up for at least 2 years post-treatment, till the study is closed. The study protocol was published in 20131, and interim results are permanently presented at international conferences, as ICHS-2015, ESMO-20162, ESTRO-20173, ESHO-2017 4, SASCRO & SASMO 20175 and SAAPMB-2016 6) by Dr. Carrie Minnaar who is full-time Ph.D radiologist in University of the Witwatersrand, Johannesburg, South Africa7. (For the preliminary study result details please check the links below and the published abstract).

Based on the interim analysis data there is a positive trend in the local disease control in the modulated electro-Hyperthermia group, suggesting that the addition of this form of hyperthermia may be beneficial in locally advanced cervical cancer patients.

Oncotherm in R&D programs does pay special attention to ensure ethically correct and professional clinical trials which serve patients suffering in malignant diseases and provide significant, safe and effective weapon to the medical professionals in the “war against cancer”.

1 study protocol publication: https://www.hindawi.com/archive/2013/293968/

http://www.esmo.org/Conferences/Past-Conferences/ESMO-2016-Congress/Programme

https://www.estro.org/ , https://www.estro.org/congresses-meetings/items/estro-36

4   http://www.esho2017.eu/?c=32&lng=1  

5 http://sscongress2017.co.za/Documents/Programme.pdf

6 http://www.saapmb2016.co.za/images/SAAPMB__Final_Programme.pdf O34, http://www.saapmb2015.co.za/

7 Dr Minaar is former director of medical device company C-Therm

SASCRO SASMO 2017 Abstract: http://oncotherm.org/modulated-electro-hyperhtemia-chemoradiosensitiser-locally-advanced-cervical-cancer

ESTRO 2017 Abstract: http://oncotherm.org/update-phase-iii-randomised-trial-electro-hyperthermia-and-chemoradiation-locally-advanced-cervical 

ESMO 2016 Abstract: http://oncotherm.org/interim-statistical-analysis-phase-iii-randomised-trial-investigating-addition-modulated-electro