Carcinoma Cervix Clinical Trial
Official title:
Randomised Phase III Clinical Trial on Concurent Chemoradiation vs. Neoadjuvant Chemoradiation and Surgery vs. Neoadjuvant Chemotherapy and Surgery in Early Stage Bulky Cervical Cancers (FIGO Stages IB2, IIA2 and IIB)
The aim of this study is to establish the role of neoadjuvant chemotherapy and chemo irradiation in carcinoma cervix and to compare its results with the concurrent chemo irradiation in terms of overall survival, disease free survival and quality of life.
Early stage bulky cancers of the cervix, (defined as FIGO Stages IB2, IIA2 and IIB) form a
distinctive subset of "curable" cervical cancers with good 5 year survival rates with
adequate treatment. Concurrent chemo radiation with or without salvage surgery is at present
the standard of care for this group of cervical cancers. However, when pelvic recurrences
occur, the morbidity of salvage surgery after radiotherapy, especially brachytherapy is
often higher than the morbidity of salvage radiotherapy following radical surgery. The
advantages of downsizing the disease without the use of brachytherapy are tempting and open
a completely new philosophy in radical treatment for "curable" early stage bulky cancers of
the cervix. This approach is appealing especially in developing countries where the load of
cervical cancers is high and radiotherapy (brachytherapy) resources are scarce.
The results of two Phase II trials conducted at Govt. Royapettah Hospital, Chennai
(Neoadjuvant Chemotherapy followed by Radical Hysterectomy: Cisplatin + 5FU vs. Cisplatin
+Paclitaxel) and at Govt. General Hospital,Chennai (Neoadjuvant Chemoradiation with weekly
cisplatin and 50 EBRT followed by radical Hysterectomy) and one retrospective study (
Preoperative 50 GY EBRT followed by Radical Hysterectomy) have shown similar response rates
and acceptable toxicity profiles when compared to concurrent chemoradiation (EBRT +
Brachytherapy+ Chemotherapy). Similar studies have been published elsewhere with similar
results.
With this in mind we are planning to conduct a Phase III Randomised control trial comparing
Neoadjuvant Chemotherapy + Radical Hysterectomy and Neoadjuvant Chemoradiation + Radical
Hysterectomy with concurrent chemoradiation in this subset of cervical cancers
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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