Health Condition 1: null- Locally advanced cancer of the uterine cervix
Conditions
Interventions
Intervention1: Interlace: Neoadjuvant Chemotherapy for weekly tratment for six weeks followed by concurrent chemoradiation.Paclitaxel:80mg/m2 in 250ml of 5% dextrose or0.9%sodium chlorideIV over one h
Sponsors
University College London
Eligibility
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed FIGO stage Ib2- IVa squamous, adeno or adenosquamous carcinoma of the cervix (except those with disease extending to lower third of vagina). Patients with FIGO stage IB1 and positive lymph nodes are also eligible 2.Deemed suitable and fit for radical chemoradiation 3.Medically fit to receive carboplatin and paclitaxel 4.ECOG performance status 0 ââ?¬â?? 1 5.No evidence of active TB 6.Aged 18 and over 7.Adequate renal function, defined as a GFR ââ?°Â¥ 60 ml/min calculated using the Wright equation (or ââ?°Â¥ 50 ml/min for radioisotope GFR assessment) 8.Adequate liver function, as defined by ALT or AST Adequate bone marrow function as defined by ANC ââ?°Â¥1.5 x 109/L, platelets ââ?°Â¥ 100 x 109/L 9.Using adequate contraception precautions if relevant 10.A documented negative HIV test (patients recruited from high risk countries or who have moved within the past 10 years from high risk countries) 11.A documented negative pregnancy test (if applicable) 12.Capable of providing written or witnessed informed consent
Exclusion criteria
Exclusion criteria: 1.Previous pelvic malignancy (regardless of interval since diagnosis) 2.Previous malignancy not affecting the pelvis (except basal cell carcinoma of the skin) where disease free interval is less than 10 years 3.Positive lymph nodes (imaging or histological) above the aortic bifurcation 4.Hydronephrosis which has not undergone ureteric stenting or nephrostomy except where the affected kidney is non-functioning 5.Evidence of distant metastasis i.e. any non-nodal metastasis beyond the pelvis 6.Previous pelvic radiotherapy 7.Prior diagnosis of Crohnââ?¬•s disease or Ulcerative colitis 8.Uncontrolled cardiac disease (defined as cardiac function which would preclude hydration during cisplatin administration and any contraindication to paclitaxel) 9.Pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survivalTimepoint: 30 days after the last patient completes their protocol and enter 5 years followup phase,the end of trail declaration will be submitted. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival Adverse events Quality of life Patterns of relapseTimepoint: 30 days after the last patient completes their protocol and enter 5 years followup phase,the end of trail declaration will be submitted. | — |
Countries
India, Ireland, Italy, Mexico, South Africa, United Kingdom
Contacts
Public ContactAsima Mukhopadhyay
Tata Medical Center
Outcome results
None listed