Trial Title:
Induction Chemotherapy Plus Chemoradiation as First Line Treatment for Locally Advanced Cervical Cancer
NCT ID:
NCT01566240
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Paclitaxel
Carboplatin
Conditions: Keywords:
Cervical Cancer
Chemotherapy
Paclitaxel
Carboplatin
Cisplatin
Radiotherapy
Chemoradiation
Brachytherapy
Stage IB2 Cervical Cancer
Stage IIA Cervical Cancer
Stage IIB Cervical Cancer
Stage IIIB Cervical Cancer
Stage IVA Cervical Cancer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Paclitaxel 80 mg/m2 (capped at 162mg maximum total dose) weekly for 6 weeks i.e. on days
1, 8, 15, 22, 29 & 36.
Arm group label:
Induction Chemotherapy + Chemoradiation
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin AUC 2 (capped at 270mg maximum total dose) weekly for 6 weeks i.e. on day 1,
8, 15, 22, 29, & 36.
Arm group label:
Induction Chemotherapy + Chemoradiation
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
Radiotherapy comprising external beam 40-50.4Gy in 20-28 fractions plus intracavity
brachytherapy to achieve a minimum total EQD2 dose of 78-86Gy.
Arm group label:
Chemoradiation
Arm group label:
Induction Chemotherapy + Chemoradiation
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Cisplatin 40 mg/m2 (capped at 70mg total dose) weekly for five weeks maximum, commencing
in the first week of radiotherapy or as soon as blood counts have recovered from
induction chemotherapy.
Arm group label:
Chemoradiation
Arm group label:
Induction Chemotherapy + Chemoradiation
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Previous pelvic malignancy (regardless of interval since diagnosis)
- Previous malignancy not affecting the pelvis (except basal cell carcinoma of the
skin) where disease free interval is less than 10 years
- 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
- Previous pelvic radiotherapy
- Prior diagnosis of Crohn's disease or Ulcerative colitis
- Uncontrolled cardiac disease (defined as cardiac function which would preclude
hydration during cisplatin administration and any contraindication to paclitaxel)
- Pregnant or lactating * i.e. PET any size, CT/MRI ≥ 15mm
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Instituto do Câncer do Estado de São Paulo
Address:
City:
São Paulo
Zip:
01246-000
Country:
Brazil
Facility:
Name:
Chittaranjan National Cancer Institute (CNCI)
Address:
City:
Kolkata
Country:
India
Facility:
Name:
Saroj Gupta Cancer Centre and Research Institute
Address:
City:
Kolkata
Country:
India
Facility:
Name:
Istituto Europeo di Oncologia
Address:
City:
Milan
Zip:
20141
Country:
Italy
Facility:
Name:
Instituto Nacional de Cancerologia (INCAN)
Address:
City:
Mexico City
Country:
Mexico
Facility:
Name:
North Devon District Hospital
Address:
City:
Barnstaple
Zip:
EX31 4JB
Country:
United Kingdom
Facility:
Name:
University College London Hospital
Address:
City:
London
Zip:
NW1 2BU
Country:
United Kingdom
Facility:
Name:
Weston Park Hospital
Address:
City:
Sheffield
Zip:
S10 2SJ
Country:
United Kingdom
Facility:
Name:
Belfast City Hospital
Address:
City:
Belfast
Country:
United Kingdom
Facility:
Name:
Pilgrim Hospital
Address:
City:
Boston
Country:
United Kingdom
Facility:
Name:
Royal Sussex County Hospital
Address:
City:
Brighton
Country:
United Kingdom
Facility:
Name:
Velindre Cancer Centre
Address:
City:
Cardiff
Country:
United Kingdom
Facility:
Name:
Cheltenham General Hospital
Address:
City:
Cheltenham
Country:
United Kingdom
Facility:
Name:
Royal Derby Hospital
Address:
City:
Derby
Country:
United Kingdom
Facility:
Name:
Royal Devon and Exeter NHS Foundation Trust
Address:
City:
Exeter
Zip:
EX2 5DY
Country:
United Kingdom
Facility:
Name:
Beatson WOSCC
Address:
City:
Glasgow
Country:
United Kingdom
Facility:
Name:
Gloucester Royal Hospital
Address:
City:
Gloucester
Country:
United Kingdom
Facility:
Name:
Grantham and District Hospital
Address:
City:
Grantham
Country:
United Kingdom
Facility:
Name:
Castle Hill Hospital
Address:
City:
Hull
Country:
United Kingdom
Facility:
Name:
Leicester Royal Infirmary
Address:
City:
Leicester
Country:
United Kingdom
Facility:
Name:
Lincoln County Hospital
Address:
City:
Lincoln
Country:
United Kingdom
Facility:
Name:
Guy's and St Thomas' NHS Foundation Trust
Address:
City:
London
Country:
United Kingdom
Facility:
Name:
Imperial College Healthcare NHS Trust
Address:
City:
London
Country:
United Kingdom
Facility:
Name:
St Bart's Hospital
Address:
City:
London
Country:
United Kingdom
Facility:
Name:
The Christie NHS Foundation Trust
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Facility:
Name:
James Cook University Hospital
Address:
City:
Middlesbrough
Country:
United Kingdom
Facility:
Name:
Northampton General Hospital
Address:
City:
Northampton
Country:
United Kingdom
Facility:
Name:
Norfolk and Norwich University Hospital
Address:
City:
Norwich
Country:
United Kingdom
Facility:
Name:
Nottingham University Hospitals NHS Trust
Address:
City:
Nottingham
Zip:
NG5 1PB
Country:
United Kingdom
Facility:
Name:
Derriford Hospital
Address:
City:
Plymouth
Country:
United Kingdom
Facility:
Name:
Southampton General Hospital
Address:
City:
Southampton
Country:
United Kingdom
Facility:
Name:
Royal Stoke University Hospital
Address:
City:
Stoke-On-Trent
Country:
United Kingdom
Facility:
Name:
Royal Cornwall Hospital
Address:
City:
Truro
Country:
United Kingdom
Facility:
Name:
The Clatterbridge Cancer Centre
Address:
City:
Wirral
Country:
United Kingdom
Facility:
Name:
New Cross Hospital
Address:
City:
Wolverhampton
Country:
United Kingdom
Start date:
November 8, 2012
Completion date:
December 2026
Lead sponsor:
Agency:
University College, London
Agency class:
Other
Collaborator:
Agency:
Cancer Research UK
Agency class:
Other
Source:
University College, London
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01566240
