ISRCTN - ISRCTN63027630: 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

Plain English Summary

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

Trial website

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 measures

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

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 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