Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
None listed
Sponsors
AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: 1. FIGO 2008 stage IB2, IIB, IIIB disease. 2. Age 18 years or older and 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 AST or ALT 7. Adequate renal function: creatinine = 60ml/min or >= 50 ml/min by EDTA creatinine clearance 8. Written informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a. Categorize locally advanced cervical cancers into immune inflamed and immune suppressed based on immune cell infiltration b. Tumour micro-environment inflammatory cells immune profiling c. Evaluate response rates to standard chemoradiotherapy and progression free survival versus immune cell infiltration Timepoint: Eighteen months and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| N/ATimepoint: N/A | — |
Countries
India
Contacts
Public ContactPritee A Patil
NCI AIIMS New Delhi
Outcome results
None listed