Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
180 participants
INTERVENTIONAL
2013-08-31
2018-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Gemcitabine and Concurrent Radiation Followed by Adjuvant Hysterectomy in Bulky Stage Ib and IIa Cervical Carcinoma
NCT00184093
Trial of Postoperative Chemoradiotherapy With or Without Consolidation Chemotherapy for Cervical Cancer Patients
NCT01755845
Comparing Study Between Concurrent Chemoradiation and New Combination Treatment in Cervical Cancer Patients
NCT01000415
Neoadjuvant Chemotherapy and Radical Surgery in Stage IIB Cervical Cancer
NCT02595554
A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients
NCT01755897
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Chemotherapy
cisplatin 75 mg/m2 Paclitaxel 175 mg/m2
External Beam Radiotherapy
50 Gy/2 Gy/25 # external beam RT to cervix. four field technique. given concurrently with chemotherapy weeks 1 - 5
Brachytherapy
Ir - 192 HDR Brachytherapy - intracavitary. 7Gy x 3#. given after completion of chemoRT.
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
Chemotherapy
cisplatin 75 mg/m2 Paclitaxel 175 mg/m2
External Beam Radiotherapy
50 Gy/2 Gy/25 # external beam RT to cervix. four field technique. given concurrently with chemotherapy weeks 1 - 5
Radical Hysterectomy
Type III Radical Hysterectomy + Bilateral Pelvic Node Dissection
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
Chemotherapy
cisplatin 75 mg/m2 Paclitaxel 175 mg/m2
Radical Hysterectomy
Type III Radical Hysterectomy + Bilateral Pelvic Node Dissection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Chemotherapy
cisplatin 75 mg/m2 Paclitaxel 175 mg/m2
External Beam Radiotherapy
50 Gy/2 Gy/25 # external beam RT to cervix. four field technique. given concurrently with chemotherapy weeks 1 - 5
Brachytherapy
Ir - 192 HDR Brachytherapy - intracavitary. 7Gy x 3#. given after completion of chemoRT.
Radical Hysterectomy
Type III Radical Hysterectomy + Bilateral Pelvic Node Dissection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age 18-60 years
3. Karnofsky performance status of ≥70%; ECOG PS ≤ 2
Exclusion Criteria
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
18 Years
60 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rajkumar Kottayasamy Seenivasagam
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rajkumar Kottayasamy Seenivasagam
MCh Surgical Oncology trainee
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rajaraman Ramamurthy, MS MCh
Role: STUDY_CHAIR
centre for oncology, Government Royapettah Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Government Royapettah Hospital
Chennai, Tamil Nadu, India
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GRHCO-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.