Topic: National Cancer Research Network
Conditions
Interventions
Neoadjuvant chemotherapy:
Weekly treatment for six weeks: paclitaxel (80 mg/m^2 IV) followed by carboplatin AUC2 IV on days 1, 8, 15, 22, 29 and 36.
Chemoradiation:
Sponsors
University College London (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed and reviewed at the cancer centre International Federation of Gynaecology and Obstetrics (FIGO) stage Ib2 - IVa squamous, adeno-, or adenosquamous carcinoma of the cervix suitable for radical chemoradiation 2. EUA, cystoscopy and sigmoidoscopy performed by Gynaecological Oncologist +/- Clinical Oncologist to confirm FIGO stage with biopsy of any suspicious lesions in bladder, vagina or rectum 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1 4. Age over 18, no upper limit, providing patient deemed fit by supervising oncologist to receive chemoradiation 5. Adequate renal function, as defined by glomerular filtration rate (GFR) estimated by EDTA or creatinine clearance (24 hour urine) greater than or equal to 60 ml/min 6. Adequate liver function, as defined by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 2.5 upper limit of normal (ULN), and bilirubin less than 1.25 ULN 7. Adequate bone marrow function, as defined by white cell count (WCC) greater than 3.0 x 10^9/litre, neutrophils greater than 1.5 x 10^9/litre, and platelets greater than 100 x 10^9/litre 8. Placement of ureteric stents in all patients with hydronephrosis regardless of renal function 9. Normal electrocardiogram (ECG) 10. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnant or breast feeding patients 2. Previous diagnosis of cancer, except basal cell carcinoma (BCC) skin 3. Active cardiac disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response to both the neoadjuvant combination chemotherapy and the concomitant chemoradiotherapy. 6 week assessment after neoadjuvant chemotherapy by clinical examination and MRI pelvis according to RECIST; 12 week assessment after concomitant chemoradiotherapy by clinical examination, MRI pelvis and CT abdomen by RECIST. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response rate to neoadjuvant chemotherapy 2. The toxicity of neoadjuvant weekly paclitaxel and carboplatin chemotherapy, as defined by Common Toxicity Criteria (CTC) 3. Overall survival 4. Progression free survival Patients will be followed 3 monthly for two years, patients will be evaluated clinically and toxicity assessed. | — |
Countries
United Kingdom
Outcome results
None listed