Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
Intervention1: Radiotherapy: 10 Gy BiD, 2 fractions with 6 hours gap. EQD2 85-90 Gy.
Control Intervention1: Standard arm: 5.5 Gy BiD / 5 fractions with 6 hours gap. EQD2 85-90 Gy
Sponsors
Dr Partha Sarathi Bhattacharyya
Eligibility
Inclusion criteria
Inclusion criteria: 1. All biopsy-proven Ca. cervix cases (squamous, adenocarcinoma, adeno-squamous histology) between the age of 18 to 70 years with Karnofsky Performance Status or above 70% will be considered. 2. Patients with carcinoma cervix Stage IIB – IIIB that underwent external beam radiotherapy (EBRT), irrespective of lymph node involvement that are fit for interstitial brachytherapy (ISBT) will be considered.
Exclusion criteria
Exclusion criteria: 1. Diabetes mellitus (DM) 2. Chronic obstructive pulmonary disease (COPD), 3. Ischemic heart disease (IHD) 4. HIV+ 5. HBsAg+ 6. Prior malignancies 7. Mental illness 8. Patients unfit for epidural anesthesia 9. Pregnant and lactating women. 10. Renal dysfunction (S. creatinine >1mg/dl) 11. Hepatic dysfunction (S. bilirubin >1mg/dl)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late toxicities according to Common terminology criteria for adverse events (CTCAE, version 5)Timepoint: Median 2 years of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival Response rateTimepoint: median 2 years 3rd and 6th month | — |
Countries
India
Contacts
Public ContactDr KGK Deepak
Mahatma Gandhi Cancer Hospital and Research Institute
Outcome results
None listed