Condition category
Cancer
Date applied
26/10/2009
Date assigned
30/11/2009
Last edited
27/08/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr David Landau

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UCL/08/0201

Study information

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

Acronym

IDEAL-CRT

Study hypothesis

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

Hammersmith and Queen Charlotte's and Chelsea Research Ethics Committee on 27/07/2009 (ref: 09/H0707/38)

Study design

Phase I/II multicentre interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Cisplatin, vinorelbine

Primary outcome measures

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.

Secondary outcome measures

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

Overall trial start date

01/10/2010

Overall trial end date

31/03/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

105

Participant 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

Recruitment start date

01/10/2010

Recruitment end date

31/03/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University College London (UCL) (UK)

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

http://www.ucl.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) (ref: C13530/A10424)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes