Status:
COMPLETED
Dose Escalation Study of Simultaneous Boost Intensity-Modulated Radiotherapy for Locally Advanced Cervical Cancer
Lead Sponsor:
Barts & The London NHS Trust
Conditions:
Locally Advanced Cervical Cancer
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
PHASE2
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 locally advanced cervical cance...
Eligibility Criteria
Inclusion
- Histologically confirmed squamous cell carcinoma, adenocarcinoma or poorly differentiated carcinoma of the cervix
- FIGO stage IIB-IVA (any pelvic nodal status) and FIGO stage 1B2 and IIA with pelvic nodal involvement
- Measurable disease on MRI
- Age \> 18 years (no upper limit)
- WHO performance status 0,1
- Adequate renal function with EDTA clearance\> 55ml/min
- Adequate liver function, as defined by ALT or AST less than 2.5 x ULN, and bilirubin less than 1.25 x ULN
- Adequate bone marrow function, defined by WCC \>3.0 x 109/litre, neutrophils \> 1.5 x 109/litre and platelets \> 100 x 109 /litre
- Able to understand and give written informed consent
Exclusion
- Evidence of common iliac or para-aortic nodal involvement, or distant metastases
- Previous history of cancer except skin tumour
- Previous pelvic radiotherapy or surgery other than toparoscopic node disection
- Previous history of pelvic adhesions, inflammatory bowel disease, pelvic inflammatory disease or diabetes mellitus
- 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.
- Females must not be pregnant or breastfeeding
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01230996
Start Date
July 1 2010
End Date
July 1 2018
Last Update
April 24 2019
Active Locations (4)
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1
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
2
Hammersmith Hospital
London, England, United Kingdom
3
Royal Marsden - London
London, England, United Kingdom
4
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom