IDEAL-CRT: A Phase I/II trial of concurrent chemoradiation with dose-escalated radiotherapy in patients with stage II or stage III non-small cell lung cancer

ISRCTN ISRCTN12155469
DOI https://doi.org/10.1186/ISRCTN12155469
Secondary identifying numbers UCL/08/0201
Submission date
26/10/2009
Registration date
30/11/2009
Last edited
24/03/2022
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://www.cancerhelp.org.uk/trials/a-trial-different-doses-radiotherapy-with-chemotherapy-non-small-cell-lung-cancer-ideal-crt

Contact information

Dr David Landau
Scientific

Guy's & St. Thomas' NHS Trust
Lambeth Palace Road
London
SE1 7UH
United Kingdom

Study information

Study designPhase I/II multicentre interventional study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA phase I/II multicentre interventional trial of concurrent chemoradiation with dose-escalated radiotherapy in patients with stage II or stage III non-small cell lung cancer
Study acronymIDEAL-CRT
Study objectivesThe aim of IDEAL-CRT is to investigate the toxicity, feasibility and potential clinical effectiveness of dose-escalated radiotherapy (RT) with concurrent chemotherapy in stage IIb or stage III non-small cell lung cancer (NSCLC) as a potential experimental arm in future phase III trials. It will also allow the assessment and validation of radiobiological models for predicting tumour control and normal tissue complications.

Please note, as of 03/11/2011 updates have been made to the trial record and can be found under this date in the relevant fields below.
Both start and end dates for this trial have been updated. The dates at time of registration were as follows:
Original start date: 01/12/2009
Original end date: 01/12/2011
Ethics approval(s)Hammersmith and Queen Charlotte's and Chelsea Research Ethics Committee on 27/07/2009 (ref: 09/H0707/38)
Health condition(s) or problem(s) studiedNon-small cell lung cancer
InterventionDose escalation will be through an individual patient-based model, associated with an acceptable level of grade 3 toxicity (from oesophagus or lung).

Radiotherapy (30 single daily fractions to planning target volume [PTV]) for six weeks given concurrently with standard chemotherapy (2 cycles of cisplatin and vinorelbine).

On-treatment assessments:
1. Weekly for 6 weeks

Post-treatment assessments:
2. Weekly until 1 month post RT, then
3. Monthly until 6 months post RT, then
4. 3-monthly until 2 years post RT, then
5. 6-monthly until 3 years post RT, then
6. Annually
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase I/II
Drug / device / biological / vaccine name(s)Cisplatin, vinorelbine
Primary outcome measureCurrent primary outcome measures as of 03/11/2011:
Oesophagitis:
Grade 2-5 according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0 - appendix 1) acute oesophagitis during RT or within 3 months from the first dose of RT for all patients.

Pneumonitis:
Early Radiation Pneumonitis (ERTP) determined by grade 2 - 5 according to CTCAE v4.0 toxicity rates occurring within 6 months from the first dose of RT for all patients.

Previous primary outcome measures:
Oesophagitis:
Grade 2 - 5 according to Common Terminology Criteria For Adverse Events v4.0 (CTCAE v4.0) acute oesophagitis during RT or within 6 months from the first dose of RT rate for all patients. In IDEAL-CRT this will be used for 6 months post-RT.
Secondary outcome measuresCurrent secondary outcome measures as of 03/11/2011:
Oesophagus:
Chronic oesophageal stricture rate: grade 1 - 5 according to Radiation Therapy Oncology Group (RTOG) late toxicity scales from 3 months post-RT for all patients.

Lung:
1. Pneumonitis grades 2 - 5 (CTCAE v4.0) 6 or more months after end of RT for all patients
2. Changes from baseline in FEV1, forced vital capacity (FVC) and DLCO (CTCAE v4.0 grades 2 - 5)
3. Any grade 2 - 5 pulmonary toxicity according to CTCAE v4.0 from start of RT to death

Previous secondary outcome measures:
3. Any grade 2 - 5 pulmonary toxicity according to CTCAE v4.0 from start of RT to 12 months post-RT
Overall study start date01/10/2010
Completion date31/03/2015

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants105
Key inclusion criteria1. Histologically or cytologically confirmed NSCLC
2. Stages: IIa, IIb, IIIa and IIIb (according to International Union Against Cancer Classification of Malignant Tumors [UICC TNM] 7th Edition 2009) (Stage IIa added as of 03/11/2011)
3. World Health Organization (WHO) performance status 0 or 1
4. Life expectancy greater than 6 months
5. Inoperable disease as assessed by a lung cancer multi-disciplinary team (MDT); or operable but MDT agrees that chemoradiotherapy (chemoRT) is a suitable alternative to surgery; or operable but the patient refuses surgery
6. Radiotherapy dose constraints consistent with minimum prescription dose of 63 Gy in 30 fractions
7. Age 18 or over (no upper age limit), either sex
8. No prior thoracic radiotherapy
9. No prior lobectomy/pneumonectomy
10. No prior systemic chemotherapy
11. Willing and able to give informed consent
12. Adequate pulmonary function test (PFT) results:
12.1. Forced expriatory volume in one second (FEV1) greater than or equal to 40% of predicted, or greater than or equal to 1 litre
12.2. Diffusing capacity of the lung for carbon monoxide (DCLO) greater than or equal to 40% of predicted
13. For women with childbearing potential:
13.1. Negative pregnancy test
13.2. Adequate contraceptive precautions during the trial and for 3 months after trial treatment
14. Haematology and biochemistry baselines suitable for cisplatin/vinorelbine chemotherapy
15. Renal function adequate for chemotherapy greater than or equal to 60 ml/min. If glomerular filtration rate (GFR) less than 60 ml/min (Cockroft & Gault-Appendix 7), check GFR with EDTA clearance or equivalent
Added 03/11/2011:
16. In the clinician's view the patient is fit to tolerate the trial treatment without exceptional risk of complications or likelihood of re-planning
Key exclusion criteria1. Radiotherapy dose constraints not consistent with minimum prescription dose of 63 Gy in 30 fractions
2. Clinically diagnosed NSCLC without cytological or histological evidence of non-small cell lung cancer
3. Previous or current malignant disease likely to interfere with the protocol treatment or comparisons
4. Upper lobe tumours if the brachial plexus is within the high-dose volume
5. Medically unstable (e.g. unstable diabetes, uncontrolled arterial hypertension, infection, hypercalcaemia, ischaemic heart disease)
6. Women of childbearing potential who are not practicing adequate contraceptive precautions
7. Women who are pregnant or lactating
8. Chronic liver disease and/or bilirubin greater than 35
9. Chronic renal disease and/or calculated creatinine clearance less than 60 ml/min
10. Connective tissue disorders (e.g. scleroderma, systemic lupus erythematosus)
11. Inability to comply with protocol or trial procedures
12. History of prior malignant tumour, unless the patient has been without evidence of disease for at least 3 years or the tumour was a non-melanoma skin tumour or early cervical cancer
Added as of 03/11/2011:
13. Patients presenting with a collapsed lung or collapse of an entire lobe
14. In the clinician's view there is an exceptional risk of complications or likelihood of re-planning associated with the trial treatment for this patient
Date of first enrolment01/10/2010
Date of final enrolment31/03/2015

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Guy's & St. Thomas' NHS Trust
London
SE1 7UH
United Kingdom

Sponsor information

University College London (UCL) (UK)
University/education

Gower Street
London
WC1E 6BT
England
United Kingdom

Website http://www.ucl.ac.uk/
ROR logo "ROR" https://ror.org/02jx3x895

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK) (ref: C13530/A10424)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2016 Yes No
Results article long-term results 15/03/2020 21/04/2020 Yes No
Plain English results 24/03/2022 No Yes

Editorial Notes

24/03/2022: Plain English results added.
21/04/2020: Publication reference added.
07/12/2017: Publication reference added.