Prophylactic Para Aortic Irradiation vs Pelvic Radiotherapy in Pelvic node-positive Carcinoma Cervix in the setting of concurrent chemoradiation: A phase II Open-label Multicentric Randomized Controlled Trial (PRO-PARA) - PRO-PARA

Indian Council of Medical Research0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年9月18日

试验速览

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•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

•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

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