Elective upper abdominal lymphnode irradiation vs pelvic radiotherapy in pelvic node positive carcinoma cervix: A multicentric phase II trial

Phase 2

Conditions: Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified

Registration Number: CTRI/2023/08/057075

Lead Sponsor: Indian Council of Medical Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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