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

ISRCTN	ISRCTN63027630
DOI	https://doi.org/10.1186/ISRCTN63027630
EudraCT/CTIS number	2004-004438-15
ClinicalTrials.gov number	NCT00253591
Secondary identifying numbers	LU23

Submission date: 02/09/2005
Registration date: 21/09/2005
Last edited: 19/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-chemotherapy-followed-by-chart-radiotherapy-or-chart-radiotherapy-alone-for-non-small-cell-lung-cancer

Contact information

Dr Matthew Hatton
Scientific

Weston Park Hospital
Whitham Road
Sheffield
S10 2SJ
United Kingdom

Phone	+44 (0)114 226 5080
Email	matthew.hatton@sth.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Study acronym	INCH
Study objectives	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(s)	Northern and Yorkshire MREC, 05/04/2005, REC ref: 04/MRE03/90
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase II/III
Drug / device / biological / vaccine name(s)	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 study start date	01/05/2005
Completion date	30/05/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	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
Key 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
Key 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
Date of first enrolment	01/05/2005
Date of final enrolment	14/12/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Weston Park Hospital

Sheffield
S10 2SJ
United Kingdom

Sponsor information

Medical Research Council (UK)
Research council

Ian Viney
MRC Centre London
Stephenson House
158-160 North Gower Street
London
NW1 2DA
United Kingdom

Phone	+44 (0)20 7670 4625
Email	iv@centre-london.mrc.ac.uk
"ROR"	https://ror.org/03x94j517

Funders

Funder type

Charity

Cancer Research UK (ref: C9759/A4591)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	01/11/2011		Yes	No

Editorial Notes

19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)