Contact information
Type
Scientific
Primary contact
Dr Matthew Hatton
ORCID ID
Contact details
Weston Park Hospital
Whitham Road
Sheffield
S10 2SJ
United Kingdom
+44 (0)114 226 5080
matthew.hatton@sth.nhs.uk
Additional identifiers
EudraCT number
2004-004438-15
ClinicalTrials.gov number
NCT00253591
Protocol/serial number
LU23
Study information
Scientific title
A randomised phase II/III trial of induction chemotherapy followed by Continuous Hyperfractionated Accelerated Radiotherapy (CHART) versus CHART alone in patients with inoperable non-small cell lung cancer
Acronym
INCH
Study hypothesis
CHART has been shown to improve survival compared to conventional radical radiotherapy. In addition, the Non Small Cell Lung Cancer meta-analysis suggested a survival benefit with the addition of the chemotherapy to conventional radiotherapy. An important question therefore is whether the addition of chemotherapy to CHART might improve survival still further - adding chemotherapy might improve both local and distant control.
More details can be found at: http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=15
Ethics approval
Northern and Yorkshire MREC, 05/04/2005, REC ref: 04/MRE03/90
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Inoperable non-small cell lung cancer
Intervention
Please note that recruitment to this trial was closed earlier than planned on the 7th December 2007 (initial anticipated end date of recruitment: 12th July 2008) due to poor accrual. 46 patients have been randomised into this trial.
Control arm: CHART alone.
Radiotherapy schedule: 54 Gy in 36 fractions (3 times daily) over 12 consecutive days.
Experimental arm: Induction Chemotherapy followed by CHART. Chemotherapy schedule: 3 x 3 weekly cycles of Cisplatin (80 mg/m^2) on weeks 1, 4, 7, Vinorelbine (25 mg/m^2) on weeks 1, 2, 4, 5, 7 and 8 followed by 4-6 week interval from day 1 of final dose of Cisplatin then CHART (same as control arm).
Intervention type
Drug
Phase
Phase II/III
Drug names
Cisplatin, vinorelbine ditartrate
Primary outcome measure
Overall survival
Secondary outcome measures
1. Progession-free survival
2. Response
3. Toxicity
4. Quality of Life
5. Tumour Control
6. Cost effectiveness
Overall trial start date
01/05/2005
Overall trial end date
30/05/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically or cytologically confirmed stage I-III NSCLC, considered suitable for chemotherapy and CHART
2. Inoperable disease as assessed by a lung cancer MDT with thoracic surgical input
3. Previously untreated by chemotherapy or radiotherapy
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
5. No prior or current malignant disease likely to interfere with protocol treatment
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
As of 14/12/2007: Closed to recruitment. 46 patients have been enrolled; Target number provided at time of registration: 500
Participant exclusion criteria
1. Medically unstable (e.g. unstable diabetes, uncontrolled arterial hypertension, infection, hypercalcaemia or ischaemic heart disease
2. Previous or current malignant disease likely to interfere with protocol or comparisons
3. Women who are pregnant or lactating
4. Women of childbearing potential who are not practising adequate contraceptive precautions
Recruitment start date
01/05/2005
Recruitment end date
14/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Weston Park Hospital
Sheffield
S10 2SJ
United Kingdom
Sponsor information
Organisation
Medical Research Council (UK)
Sponsor details
Ian Viney
MRC Centre London
Stephenson House
158-160 North Gower Street
London
NW1 2DA
United Kingdom
+44 (0)20 7670 4625
iv@centre-london.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (ref: C9759/A4591)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20932667
Publication citations
-
Results
Hatton M, Nankivell M, Lyn E, Falk S, Pugh C, Navani N, Stephens R, Parmar M, Induction chemotherapy and continuous hyperfractionated accelerated radiotherapy (chart) for patients with locally advanced inoperable non-small-cell lung cancer: the MRC INCH randomized trial., Int. J. Radiat. Oncol. Biol. Phys., 2011, 81, 3, 712-718, doi: 10.1016/j.ijrobp.2010.06.053.