Study on Early Stage Bulky Cervical Cancers
Conditions
Carcinoma Cervix
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
Bulky cervical cancers, Neoadjuvant Chemotherapy, Neoadjuvant Chemoradiotherapy
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Chemotherapy Type: Drug
Name: External Beam Radiotherapy Type: Radiation
Name: Brachytherapy Type: Radiation
Name: Radical Hysterectomy Type: Procedure
Overall Status
Not yet recruiting
Summary
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.
Detailed Description
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 60 Years
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

1. Patients with histologically confirmed bulky cervical Squamous cell carcinoma (FIGO stage IB2, II A2, IIB).

2. Age 18-60 years

3. Karnofsky performance status of ≥70%; ECOG PS ≤ 2

Exclusion Criteria:

1. Nonsquamous Histologies

2. Other systemic diseases, comorbidities precluding full participation in the study

3. Concomitant treatment with any experimental drug

4. Pregnant or nursing women

5. Previous or concomitant malignant diseases other than non-melanoma skin cancer

6. Previous radiation to the pelvis
Location
Government Royapettah Hospital
Chennai, Tamil Nadu, India
Status: Not yet recruiting
Contact: Rajaraman Ramamurthy, MS MCh - +919444046168 - rajaanu1@rediffmail.com
Start Date
August 2013
Completion Date
August 2018
Sponsors
Rajkumar Kottayasamy Seenivasagam
Source
Government Royapettah Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page