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Trial Title:
Study on Early Stage Bulky Cervical Cancers
NCT ID:
NCT01917695
Condition:
Carcinoma Cervix
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
Bulky cervical cancers
Neoadjuvant Chemotherapy
Neoadjuvant Chemoradiotherapy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
cisplatin 75 mg/m2 Paclitaxel 175 mg/m2
Arm group label:
Concurrent Radical Chemoradiation
Arm group label:
Neoadjuvant Chemoradiation + Radical Hysterectomy
Arm group label:
Neoadjuvant Chemotherapy + Radical Hysterectomy
Intervention type:
Radiation
Intervention name:
External Beam Radiotherapy
Description:
50 Gy/2 Gy/25 # external beam RT to cervix. four field technique. given concurrently with
chemotherapy weeks 1 - 5
Arm group label:
Concurrent Radical Chemoradiation
Arm group label:
Neoadjuvant Chemoradiation + Radical Hysterectomy
Intervention type:
Radiation
Intervention name:
Brachytherapy
Description:
Ir - 192 HDR Brachytherapy - intracavitary. 7Gy x 3#. given after completion of chemoRT.
Arm group label:
Concurrent Radical Chemoradiation
Intervention type:
Procedure
Intervention name:
Radical Hysterectomy
Description:
Type III Radical Hysterectomy + Bilateral Pelvic Node Dissection
Arm group label:
Neoadjuvant Chemoradiation + Radical Hysterectomy
Arm group label:
Neoadjuvant Chemotherapy + Radical Hysterectomy
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:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Government Royapettah Hospital
Address:
City:
Chennai
Zip:
600014IndiaNaduI6
Country:
India
Status:
Recruiting
Contact:
Last name:
Rajaraman Ramamurthy, MS MCh
Phone:
+919444046168
Email:
rajaanu1@rediffmail.com
Contact backup:
Last name:
Subbiah Shanmugam, MS MCh
Phone:
+919360206030
Email:
subbiah_doctor@yahoo.co.uk
Investigator:
Last name:
Rajaraman Ramamurthy, MS MCh
Email:
Principal Investigator
Investigator:
Last name:
Subbiah Shanmugam, MS MCh
Email:
Sub-Investigator
Start date:
August 2013
Completion date:
August 2018
Lead sponsor:
Agency:
Rajkumar Kottayasamy Seenivasagam
Agency class:
Other
Source:
Government Royapettah Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01917695
