Carcinoma Cervix
Conditions
Keywords
Bulky cervical cancers, Neoadjuvant Chemotherapy, Neoadjuvant Chemoradiotherapy
Brief 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
Interventions
DRUGChemotherapy
cisplatin 75 mg/m2 Paclitaxel 175 mg/m2
RADIATIONExternal Beam Radiotherapy
50 Gy/2 Gy/25 # external beam RT to cervix. four field technique. given concurrently with chemotherapy weeks 1 - 5
RADIATIONBrachytherapy
Ir - 192 HDR Brachytherapy - intracavitary. 7Gy x 3#. given after completion of chemoRT.
PROCEDURERadical Hysterectomy
Type III Radical Hysterectomy + Bilateral Pelvic Node Dissection
Sponsors
Rajkumar Kottayasamy Seenivasagam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall and Disease free Survival | 3 year |
Secondary
| Measure | Time frame |
|---|---|
| Acute Adverse reactions and complications | Less than 10 weeks |
| SubAcute Adverse reactions and complications | 10 weeks - 6 months |
| Chronic Adverse reactions and complications | 6 months to 5 years |
Other
| Measure | Time frame |
|---|---|
| Quality of Life | 3,5 years |
Countries
India
Contacts
Primary ContactRajaraman Ramamurthy, MS MCh
Backup ContactSubbiah Shanmugam, Ms MCh
Outcome results
None listed