Cervical cancer tumor micro-environment immune-profiling and effect on early response to standard chemoradiotherapy in Indian patients

AIIMS0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.FIGO 2008 stage IB2, IIB, IIIB disease.
•2.Age 18 years or older and <65 years
•3.ECOG performance status 0 - 2
•4.Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the cervix
•5.HB > 9 g/dL; ANC > 1000 / mm3; Plt > 1,00,000/ mm3
•6.Bilirubin <= 1.5 x ULN ,
•AST or ALT <= 2.5 x ULN
•7.Adequate renal function: creatinine <= ULN (CTC Grade 0) or calculated creatinine clearance (Cockcroft-Gault Formula) >= 60ml/min or >= 50 ml/min by EDTA creatinine clearance
•8.Written informed consent

•1.Any previous pelvic radiotherapy
•2.Para-aortic nodal involvement above the level of the common iliac nodes or L3/L4 (if biopsy proven or >= 10 mm short axis diameter on CT)
•3.FIGO STAGE IIIA
•4.Patients assessed at presentation as requiring interstitial brachytherapy treatment
•5.Patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfills the required inclusion criteria
•6.Evidence of metastases
•7.Diagnosis of Crohnâ??s disease or ulcerative colitis
•8.Peripheral neuropathy > grade 2 (as per CTCAE)
•9.Patients who have undergone a previous hysterectomy or will have a hysterectomy as part of their initial cervix cancer therapy
•10.Patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years
•11.Patients who are pregnant or lactating
•12.Any contraindication to cisplatin
•13.Serious uncontrolled medical condition
•14.HIV positive

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