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 |
| ClinicalTrials.gov (NCT) | NCT00253591 |
| Clinical Trials Information System (CTIS) | 2004-004438-15 |
| Protocol serial number | LU23 |
| Sponsor | Medical Research Council (UK) |
| Funder | Cancer Research UK (ref: C9759/A4591) |
- 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
Contact information
Dr Matthew Hatton
Scientific
Scientific
Weston Park Hospital
Whitham Road
Sheffield
S10 2SJ
United Kingdom
| Phone | +44 (0)114 226 5080 |
|---|---|
| matthew.hatton@sth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | Cisplatin, vinorelbine ditartrate |
| Primary outcome measure(s) |
Overall survival |
| Key secondary outcome measure(s) |
1. Progession-free survival |
| Completion date | 30/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 46 |
| 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
- United Kingdom
- England
Study participating centre
Weston Park Hospital
Sheffield
S10 2SJ
United Kingdom
S10 2SJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2011 | Yes | No | |
| Plain English results | No | Yes |
Editorial Notes
19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
