Health Condition 1: C530- Malignant neoplasm of endocervix Health Condition 2: C531- Malignant neoplasm of exocervix Health Condition 3: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
Intervention1: Accelerated hypo fractionated EBRT with weekly concurrent cisplatin followed by weekly brachytherapy and response assessment at 3 months post completion of treatment.: 40Gy in 16 fracti
Sponsors
AIIMS, New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Histopathologically confirmed squamous and adenosquamous carcinoma cervix patients, ECOG score of
Exclusion criteria
Exclusion criteria: ECOG score 3-4, Previous radiotherapy to abdomen or pelvis or previous chemotherapy, FIGO Stage IIIC1, IIIC2, IVA and IVB, Synchronous malignancy at any other site or any other malignancy in the past five years, Any uncontrolled comorbidity which may compromise delivery of protocol defined chemotherapy and radiotherapy, Connective tissue disorder, Ineligible to receive cisplatin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical and radiological tumor responseTimepoint: Clinical and radiological tumor response assessment at 3 months of completion of EBRT and HDR brachytherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment related acute and late toxicities Timepoint: During treatment to 3 months for acute toxicities and late toxicity assessment from 3rd month of treatment completion to 1 year;Health-related quality of life (HR-QoL)Timepoint: Baseline/ before starting treatment Immediately, 3 months, 6 months and 12 months after completion of chemoradiotherapy;Disease free survivalTimepoint: 12 months | — |
Countries
India
Contacts
Public ContactDr Sushmita Pathy
Department of Radiation Oncology, AIIMS, New Delhi
Outcome results
None listed