Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
Intervention1: Arm II Experimental arm: Radiation Therapy 37.5 Gy in 15 fractions over 3 weeks with weekly cisplatin 40 mg 3 cycles, with nodal boost to 48 Gy using simultaneous integrated boost follo
Sponsors
Varian Medical Systems
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older with locally advanced cervical cancer suitable for primary treatment with chemoradiotherapy. Pathologically confirmed carcinoma cervix squamous,adenocarcinoma,adeno-squamous carcinoma histology. Patients with stage stage IB3 to IIIB and IIIC1, who have not undergone previous pelvic radiation therapy or surgery and have an Eastern Cooperative Oncology Group performance status of 0-2. Signed informed consent. Adequate end organ function hepatic, renal, cardiac reserve
Exclusion criteria
Exclusion criteria: Patients with stage IIIC2, IVA, or IVB Patients with prior malignancies or active autoimmune diseases will be excluded from the study. Other histology melanoma, small cell, basal cell carcinoma Previous pelvic radiotherapy, hysterectomy, any form of oncological treatment. Contraindications to CEMRI, brachytherapy Age less than 18 years. Uncontrolled medical comorbidity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Locoregional recurrencesTimepoint: At 3 months after completion, every 6 months till 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute toxicityTimepoint: Weekly during chemoradiation, and at completion and 3 months post radiotherapy;Late toxicityTimepoint: Graded using RTOG and EORTC criteria, collected from 3 months after completion of radiotherapy until end of 2 years post chemoradiation | — |
Countries
India
Contacts
Public ContactDR KARUN KAMBOJ
AIIMS New Delhi
Outcome results
None listed