Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
None listed
Sponsors
JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patiets with histologically (squamous and adenocarcinoma ) proven cancer of the uterine cervix stage Ib to IVa 2. Karnofsky Performance Score >50 3. Creatinine clearance 4. Patients treated with hypofractionated External Beam radiotherapy of 45Gy in 20 fractions with midline shielding without chemotherapy, followed by standard intracavitary brachytherapy 8.5 Gy in three fractions each in the department since 2016
Exclusion criteria
Exclusion criteria: 1. History of chemotherapy or radiation to abdomen or pelvis. 2. Tumour involving lower third of vagina 3. History of other cancers 4. Expected survival less than 3 months 5. Pregnant women 6. Patients who were FIGO Stage IVB at diagnosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local control according to WHO clinical criteria of locally advanced cancer of uterine cervix after hypofractionation of radiation.Timepoint: at 4 weeks after completion of treatment, 3 monthly till 3 years, 6 monthly till 5 years, yearly thereafter | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival at 5 years 2. Median overall survival in months 3. Recto-sigmoid, bladder, small bowel, skin toxicities as graded by CTCAE , RTOG/ EORTC toxicity grading system in locally advanced cancer of uterine cervix after hypofractionation of radiation. 4. Acute toxicities including skin , upper GI and lower GI toxicities, cystitis, anemia, neutropenia, thrombocytopenia Timepoint: overall survival at 5 years chronic toxicities : every three months till 3 years . every 6 months till 5 years and thereafter yearly follow up. acute toxicities : at 4 weeks and 3 months | — |
Countries
India
Contacts
Public ContactKALARANJANI
Jawaharlal Institute of Postgraduate Medical Education and Research
Outcome results
None listed