immuno-profiling in cervical cancer
- Conditions
- Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
- Registration Number
- CTRI/2021/10/037690
- Lead Sponsor
- AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method