Health Condition 1: null- Locally Advanced Carcinoma Cervix
Conditions
Interventions
Intervention1: Twice weekly High dose Rate Brachytherapy: 4.2 Gy per fraction, 2 fractions in a week (on Tuesdays and Fridays), total 6 Fractins
Control Intervention1: Weekly High dose Rate Brachyther
Sponsors
Dr Barnini Ghosh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histopathology confirmed newly diagnosed primary squamous cell carcinoma of cervix 2. Stage of the disease should be between IIB to IVA 3. Patient should have ECOG performance status less than or equal to 2 4. Patient must be medically suitable for concurrent chemoradiation and brachytherapy 5. Patient must sign a study specific informed consent prior to study entry 6. Routine blood reports like complete haemogram, renal function test and liver function test within normal range
Exclusion criteria
Exclusion criteria: 1. Histopathology other than squamous cell carcinoma 2. Evidence of distant metastasis by clinical or radiological examination 3. Previous radiotherapy or concurrent chemoradiation within the intended treatment volume 4. Previous chemotherapy or definitive surgery for the tumour under study other than biopsy 5. Any other serious illness or major organ dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the response rates between the patients in the 2 armsTimepoint: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To detect recurrence, if anyTimepoint: 1.5 years;To determine Acute Toxicities according to the RTOG Criteria and CTCAE version 4Timepoint: 90 days;To determine Late Toxicities according to the RTOG Criteria and CTCAE version 4Timepoint: 1.5 years | — |
Countries
India
Contacts
Public ContactDr Barnini Ghosh
Medical College and Hospital, Kolkata
Outcome results
None listed