Health Condition 1: C538- Malignant neoplasm of overlappingsites of cervix uteri
Conditions
Interventions
Intervention1: Hypofractionated external beam radiotherapy to whole pelvis followed by brachytherapy: Patients will undergo external beam radiotherapy (EBRT) with a prescribed dose of 40 Gy in 16 frac
one fraction daily) with weekly cisplatin 40mg/m2(in patients suitable for chemotherapy) followed by image guided ICBT in 3-4 fractions (7 Gray per fraction, each at least 4-6 days apart).EBRT will b
meeting the dose constraint criteria for target volume (TV) and organ at risks (OARs)
Control Intervention1: NIL: NIL
Sponsors
Dr Ram Manohar Lohia Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Histologically proven squamous carcinoma of the uterine cervix of FIGO(2009) stage IB2-IIIB Patients being treated definitively with radiotherapy Patient willing to sign the informed consent. KPS > 70 Normal complete blood counts, kidney, liver function tests
Exclusion criteria
Exclusion criteria: Stage IV disease Para-aortic nodes +ve History of any other malignancy within the last 5 years Adenocarcinoma of the cervix Patient suffering from active HIV,Hepatitis B or C Pregnancy or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the feasibility and safety in terms of acute toxicity of this regimenTimepoint: Weekly during treatment and monthly thereafter till 3 Months of completion of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the late toxicity and early clinical outcome in terms of loco-regional control at six months for this regimenTimepoint: 2 years from the completion of treatment;To compare the toxicity rates of this regimen to the historical cohort of patients (treated with conventionally fractionated radiotherapy)Timepoint: After completion of the study | — |
Countries
India
Contacts
Public ContactDr Ajeet Kumar Gandhi
Dr Ram Manohar Lohia Institute of Medical Sciences
Outcome results
None listed