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
Protocol serial number	UCL/08/0201
Sponsor	University College London (UCL) (UK)
Funder	Cancer Research UK (CRUK) (UK) (ref: C13530/A10424)

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

Primary study design	Interventional
Study design	Phase I/II multicentre interventional study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A 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 acronym	IDEAL-CRT
Study objectives	The 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) studied	Non-small cell lung cancer
Intervention	Dose 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 type	Drug
Phase	Phase I/II
Drug / device / biological / vaccine name(s)	Cisplatin, vinorelbine
Primary outcome measure(s)	Current 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.
Key secondary outcome measure(s)	Current 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
Completion date	31/03/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	105
Key inclusion criteria	1. 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 criteria	1. 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 enrolment	01/10/2010
Date of final enrolment	31/03/2015

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Guy's & St. Thomas' NHS Trust

London
SE1 7UH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
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.