NCT01566240Active, not recruitingPhase 3
Induction Chemotherapy Plus Chemoradiation as First Line Treatment for Locally Advanced Cervical Cancer
A Phase III Multicentre Trial of Weekly Induction Chemotherapy Followed by Standard Chemoradiation Versus Standard Chemoradiation Alone in Patients With Locally Advanced Cervical Cancer
Source: ClinicalTrials.gov · Last updated 5 Dec 2024
Brief summary (registry, in English)
Chemoradiation has been the standard treatment for advanced cervical cancer for a decade, but one third of women still die from a failure to control systemic disease. In a recent multicentre phase II trial of 46 women the investigators found that, 68% of women had tumours that responded to weekly induction chemotherapy prior to chemoradiation. The induction chemotherapy had acceptable toxicity and did not compromise the standard chemoradiation treatment. In addition, the overall survival and progression free survival at 3 years was 66% (95% CI 4779). These results, together with acceptable toxicity, provide justification for evaluating induction chemotherapy prior to chemoradiation in a randomised phase III trial. The investigators aim to investigate in a randomised trial whether additional induction chemotherapy given on a weekly schedule immediately before standard chemoradiation leads to an improvement in overall survival. The investigators plan to recruit 770 women with locally advanced cervical cancer who are eligible for standard chemoradiation, they will be randomised to weekly carboplatin and paclitaxel chemotherapy for 6 weeks followed by chemoradiation or to chemoradiation alone. The trial will recruit for 4 years with 5 years of follow up period.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (actual)
- First submitted
- 27 Mar 2012
- Start date
- 8 Nov 2012
- Primary completion date
- Feb 2026
- Lead sponsor
- University College, London
- Diseases
- Cervical cancer
- NCT number
- NCT01566240
- EudraCT number
- 2011-001300-35
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 500
- From 8 Nov 2012 to the primary completion date, Feb 2026
- 35 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pelvic malignancy (regardless of interval since diagnosis)
- Previous pelvic radiotherapy
- Prior diagnosis of Crohn's disease or Ulcerative colitis
Other illness
- Previous malignancy not affecting the pelvis (except basal cell carcinoma of the skin) where disease free interval is less than 10 years
- Uncontrolled cardiac disease (defined as cardiac function which would preclude hydration during cisplatin administration and any contraindication to paclitaxel)
Other
- Positive lymph nodes (imaging or histological) above the aortic bifurcation\*
- Hydronephrosis which has not undergone ureteric stenting or nephrostomy except where the affected kidney is non-functioning
- Evidence of distant metastasis i.e. any non-nodal metastasis beyond the pelvis
- Pregnant or lactating \* i.e. PET any size, CT/MRI ≥ 15mm
Who the study is looking for
- Histologically confirmed FIGO stage Ib2-IVa squamous, adeno or adenosquamous carcinoma of the cervix (except FIGO IIIA). Patients with histologically confirmed FIGO stage IB1 and positive lymph nodes are also eligible
- Deemed suitable and fit for radical chemoradiation
- Medically fit to receive carboplatin and paclitaxel
- ECOG performance status 0 - 1
- No evidence of active TB
- Aged 18 and over
- Adequate renal function, defined as a GFR ≥ 60 ml/min calculated using the Wright equation (or ≥ 50 ml/min for radioisotope GFR assessment)
- Adequate liver function, as defined by ALT or AST \< 2.5 ULN and bilirubin \< 1.25 ULN
- Adequate bone marrow function as defined by ANC ≥1.5 x 109/L, platelets ≥ 100 x 109/L
- Using adequate contraception precautions if relevant
- A documented negative HIV test (patients recruited from high risk countries or who have moved within the past 10 years from high risk countries)
- A documented negative pregnancy test (if applicable)
- Capable of providing written or witnessed informed consent
- Patients with positive (pelvic/para-aortic/both) nodes (either histologically/PET positive ≥15 mm on CT/MRI) at or below the level of the aortic bifurcation may be included in the study provided none of the exclusion criteria apply.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (35)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto do Câncer do Estado de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| North Devon District Hospital Coordinator of this site? Confirm its status | Barnstaple | United Kingdom | Unknown status |
| Belfast City Hospital Coordinator of this site? Confirm its status | Belfast | United Kingdom | Unknown status |
| Pilgrim Hospital Coordinator of this site? Confirm its status | Boston | United Kingdom | Unknown status |
| Royal Sussex County Hospital Coordinator of this site? Confirm its status | Brighton | United Kingdom | Unknown status |
| Velindre Cancer Centre Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Cheltenham General Hospital Coordinator of this site? Confirm its status | Cheltenham | United Kingdom | Unknown status |
| Royal Derby Hospital Coordinator of this site? Confirm its status | Derby | United Kingdom | Unknown status |
| Royal Devon and Exeter NHS Foundation Trust Coordinator of this site? Confirm its status | Exeter | United Kingdom | Unknown status |
| Beatson WOSCC Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Gloucester Royal Hospital Coordinator of this site? Confirm its status | Gloucester | United Kingdom | Unknown status |
| Grantham and District Hospital Coordinator of this site? Confirm its status | Grantham | United Kingdom | Unknown status |
| Castle Hill Hospital Coordinator of this site? Confirm its status | Hull | United Kingdom | Unknown status |
| Leicester Royal Infirmary Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| Lincoln County Hospital Coordinator of this site? Confirm its status | Lincoln | United Kingdom | Unknown status |
| Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University College London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Guy's and St Thomas' NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| St Bart's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| The Christie NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| The Clatterbridge Cancer Centre Coordinator of this site? Confirm its status | Metropolitan Borough of Wirral | United Kingdom | Unknown status |
| James Cook University Hospital Coordinator of this site? Confirm its status | Middlesbrough | United Kingdom | Unknown status |
| Northampton General Hospital Coordinator of this site? Confirm its status | Northampton | United Kingdom | Unknown status |
| Norfolk and Norwich University Hospital Coordinator of this site? Confirm its status | Norwich | United Kingdom | Unknown status |
| Nottingham University Hospitals NHS Trust Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Derriford Hospital Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Weston Park Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| Southampton General Hospital Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| Royal Stoke University Hospital Coordinator of this site? Confirm its status | Stoke-on-Trent | United Kingdom | Unknown status |
| Royal Cornwall Hospital Coordinator of this site? Confirm its status | Truro | United Kingdom | Unknown status |
| New Cross Hospital Coordinator of this site? Confirm its status | Wolverhampton | United Kingdom | Unknown status |
| Chittaranjan National Cancer Institute (CNCI) Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| Saroj Gupta Cancer Centre and Research Institute Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| Istituto Europeo di Oncologia Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Instituto Nacional de Cancerología (INCan) Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.