Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
Intervention1: Pelvic and elective paraaortic radiotherapy and concurrent chemotherapy: Patients in intervention arm will receive pelvic and elective para-aortic radiotherapy upto the lower border of
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Age 18 or more Cervical squamous cell carcinoma/adenocarcinoma / adenosquamous cell carcinoma Stage IIIC1r carcinoma cervix diagnosed by MRI pelvis and CECT thorax and abdomen or PET CT or proven pathologically. Highest pelvic node should be 1 cm below the aortic bifurcation. Can undergo concurrent chemoradiation with cisplatin based chemotherapy Eastern Cooperative Oncology Group (ECOG) score 0-2 Women of childbearing age must have a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and they are willing to use appropriate contraceptive methods during the test
Exclusion criteria
Exclusion criteria: Patients with paraaortic node involvement on CT scan (documented by imaging or pathology). Patients with inguinal node involvement confirmed by FNAC. Patients who need elective coverage of the inguinal region. Stage IVA or Stage IVB disease Uncontrolled severe infections Patients with synchronous malignancies who need treatment for another tumor. Patients with prior history of malignancy excluding cervical intra-epithelial neoplasia or basal cell carcinoma of the skin. Liver cirrhosis, decompensated liver disease, chronic renal insufficiency, and renal failure Presence of uncontrolled or severe comorbidities which preclude safe concurrent chemoradiation e.g Myocardial infarction, severe arrhythmia, and grade 2 or more congestive heart failure (NYHA classification). Prior history of renal transplantation Horseshoe kidney or single kidney History of severe allergic reaction to platinum-containing chemotherapy drugs Patients with accompanying diseases or other special circumstances that seriously endanger the safety of patients or affect the completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the para-aortic nodal recurrence rate between the two armsTimepoint: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the progression-free survival (PFS) between the two arms (Time point: 3 years) To compare the distant recurrence rate between the two arms. (Time point: 3 years) To compare the pelvic nodal recurrence rate between the two arms (Time point :3 years) To compare the local failure rate between the two arms (Time point : 3 years) To compare the cumulative incidence of acute and late toxicities between the two arms. Toxicity will be reported using CTCAE V.5.0. To compare the global quality of life, symptom experience, body image scale scores between the two arms at the end of external beam radiotherapy, and at 6 months, 1 year, 2 year and 3 years. EORTC QLQC30 and CX24 modules will be used for evaluating the QOL of patients. Timepoint: 3years | — |
Countries
India
Contacts
Public ContactTapesh Bhattacharyya
Tata Medical Center,Kolkata
Outcome results
None listed