Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
Intervention1: Image guided Adaptive Brachy therapy using information with PET CT: Dose de-escalation to CTV-HR (Total dose up to 85Gy) will be considered if Change in SUVmax more than or equal to 50%
Sponsors
The Jawaharlal Institute of Postgraduate Medical Education Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Treatment naïve, 2. histopathologically proven carcinoma cervix (squamous/adeno/adeno-squamous), 3. International Federation of Gynecology and Obstetrics (FIGO) (2018) stage 1B-IIIC2 patients, 4. age 18-60 years, 5. attending gynecological tumor clinics, with ECOG performance status 0-2, 6. with adequate organ function and planned for definitive treatment with chemoradiotherapy and intracavitary brachytherapy. 7. Adequate organ function at time of participation
Exclusion criteria
Exclusion criteria: 1. Patients with uncontrolled Diabetes mellitus, hypertension 2. Patients with HIV infection, Hepatitis B/C infection/ Active Tuberculosis/ any other systemic infection 3. Previously any pelvic surgery / partial or total hysterectomy 4. Previous pelvic/ abdominal radiotherapy 5. Patients with history of neoadjuvant chemotherapy 6. Patients with history of allergy to iodinated contrast or 18F-FDG 7. Patients requiring ISBT post external beam radiotherapy treatment 8. Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin 9. Pregnancy 10. Patients with bladder or rectal invasion at diagnosis, vesico-vaginal fistula, or recto-vaginal fistula at diagnosis or post EBRT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess proportions of patients achieving hard dose constraints for target and OAR Doses To assess the proportions of patients developing grade 3 acute toxicity during or till 3 months post treatmentTimepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess PET based disease remission status at 3 months To assess the proportions of patients developing more than grade 3 late toxicities at 6 months and at 1 year To assess disease free survival at 1 year To assess proportions of patients achieving soft constraints for target and OAR Doses To assess Change in EORTC-QOL score from baseline to 3 months, 6 months and 1 year post treatment.Timepoint: 1 year | — |
Countries
India
Contacts
Public ContactDr Pooja Sethi
Jawaharlal Institute of Postgraduate Medical Education & Research
Outcome results
None listed