Study on Early Stage Bulky Cervical Cancers
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Concurrent Radical Chemoradiation Paclitaxel(175 mg/sq.m) + Cisplatin (75 mg/sq.m) chemotherapy - 2 cycles of 3 weekly cycle Concurrent Radiotherapy - 50 Gy EBRT + Brachytherapy (7Gy HDR x 3 doses) All to be completed within 8-10 weeks |
Drug: Chemotherapy
cisplatin 75 mg/m2 Paclitaxel 175 mg/m2
Radiation: External Beam Radiotherapy
50 Gy/2 Gy/25 # external beam RT to cervix. four field technique. given concurrently with chemotherapy weeks 1 - 5
Radiation: Brachytherapy
Ir - 192 HDR Brachytherapy - intracavitary. 7Gy x 3#. given after completion of chemoRT.
|
| Experimental: Neoadjuvant Chemoradiation + Radical Hysterectomy Paclitaxel(175 mg/m2) + Cisplatin(75 mg/m2) chemotherapy - 2 cycles of 3 weekly cycle Concurrent Radiotherapy - 50 Gy EBRT - completed within 5 weeks Radical Hysterectomy - 3 weeks after completion of RT All to be completed within 8-10 weeks |
Drug: Chemotherapy
cisplatin 75 mg/m2 Paclitaxel 175 mg/m2
Radiation: External Beam Radiotherapy
50 Gy/2 Gy/25 # external beam RT to cervix. four field technique. given concurrently with chemotherapy weeks 1 - 5
Procedure: Radical Hysterectomy
Type III Radical Hysterectomy + Bilateral Pelvic Node Dissection
|
| Experimental: Neoadjuvant Chemotherapy + Radical Hysterectomy Paclitaxel(175 mg/m2) + Cisplatin (75 mg/m2) chemotherapy - 3 cycles of 3 weekly cycle Radical Hysterectomy - 3 weeks after completion of chemotherapy All to be completed within 8-10 weeks |
Drug: Chemotherapy
cisplatin 75 mg/m2 Paclitaxel 175 mg/m2
Procedure: Radical Hysterectomy
Type III Radical Hysterectomy + Bilateral Pelvic Node Dissection
|
Outcome Measures
Primary Outcome Measures
- Overall and Disease free Survival [3 year]
- Overall and Disease free Survival [5 year]
Secondary Outcome Measures
- 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 Outcome Measures
- Quality of Life [3,5 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with histologically confirmed bulky cervical Squamous cell carcinoma (FIGO stage IB2, II A2, IIB).
-
Age 18-60 years
-
Karnofsky performance status of ≥70%; ECOG PS ≤ 2
Exclusion Criteria:
-
Nonsquamous Histologies
-
Other systemic diseases, comorbidities precluding full participation in the study
-
Concomitant treatment with any experimental drug
-
Pregnant or nursing women
-
Previous or concomitant malignant diseases other than non-melanoma skin cancer
-
Previous radiation to the pelvis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Government Royapettah Hospital | Chennai | Tamil Nadu | India | 600014IndiaNaduI6 |
Sponsors and Collaborators
- Rajkumar Kottayasamy Seenivasagam
Investigators
- Study Chair: Rajaraman Ramamurthy, MS MCh, centre for oncology, Government Royapettah Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GRHCO-01