Topic: National Cancer Research Network
Conditions
Interventions
Brief summary:
This will be the first study to assess the clinical feasibility of dose escalation with simultaneous integrated boost intensity-modulated radiotherapy for patients with
Sponsors
Barts and The London NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed squamous cell carcinoma, adenocarcinoma or poorly differentiated carcinoma of the cervix 2. International Federation of Gynecology and Obstetrics (FIGO) stage IIB - IVA (any pelvic nodal status) and FIGO stage 1B2 and IIA with pelvic nodal involvement 3. Measurable disease on magnetic resonance imaging (MRI) 4. Aged greater than 18 years (no upper limit), either sex 5. World Health Organisation (WHO) performance status 0 or 1 6. Adequate renal function with ethylenediaminetetraacetic acid (EDTA) clearance greater than 55 ml/min 7. 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 8. Adequate bone marrow function, 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 9. Able to understand and give written informed consent
Exclusion criteria
Exclusion criteria: 1. Evidence of common iliac or para-aortic nodal involvement, or distant metastases 2. Previous history of cancer except skin tumour 3. Previous pelvic radiotherapy or surgery other than toparoscopic node disection 4. Previous history of pelvic adhesions, inflammatory bowel disease, pelvic inflammatory disease or diabetes mellitus 5. Previous history of pelvic adhesions, inflammatory bowel disease, pelvic inflammatory disease or diabetes mellitus 6. Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy if required. Acceptable contraception should be used such as barrier or hormonal methods. 7. Females must not be pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severe gastrointestinal toxicity assessed according to Common Terminology for Adverse Event Criteria (CTCAE) v 3.0, measured within six months of completing radiotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective tumour response rate, measured at 6 months 2. Two year local control rate, measured at 2 years | — |
Countries
United Kingdom
Outcome results
None listed