Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Dr Lisette Nixon


Contact details

6th Floor
Neuadd Meirionnydd
Heath Park
CF14 4YS
United Kingdom
+44 (0)29 20687458, ext. 87458

Additional identifiers

EudraCT number

2010-020075-23 number

Protocol/serial number


Study information

Scientific title

A phase I/II trial of isotoxic accelerated radiotherapy in the treatment of patients with non-small cell lung cancer



Study hypothesis

The I-START trial is designed to determine the highest doses of radiotherapy that can safely be used in locally advanced non-small cell lung cancer (NSCLC). Patients with NSCLC who are expected to live longer than three months and are fit to receive radical radiotherapy (radiotherapy given with curative intent) will be eligible to participate. All trial participants will receive 20 doses (called fractions) of radiotherapy.

Phase I will establish the maximum tolerated dose (MTD) that may be safely delivered to the oesophagus in patients where the oesophagus lies within the radiotherapy high dose region. This will establish the maximum dose to the oesophagus for phase II.

Phase II will establish whether this novel radiotherapy regimen is tolerable, safe and sufficiently active in eligible patients to justify its inclusion as an experimental arm in future randomised phase III trials.

Ethics approval

First MREC, 15/09/2010, ref: 10/MRE09/n29

Study design

Non-randomised; Interventional; Design type: Treatment

Primary study design


Secondary study design

Non randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Topic: National Cancer Research Network; Subtopic: Lung Cancer; Disease: Lung (non-small cell)


Phase I will have two groups, each with 6 to 12 particpantss who will be treated at each of up to 4 dose levels until the MTD recommended Phase II dose is identified.

49 patients need to be recruited into Phase II, or which 39 should be toxicity-free at three months for evidence to proceed (base on a Flemming 1 stage design)

Radiotherapy, between 58Gy and 65Gy delivered in 20 fractions; Follow Up Length: 24 month(s); Study Entry : Registration only

Intervention type



Phase I/II

Drug names

Primary outcome measures

Grade 3 or 4 toxicities; Timepoint(s): occuring up to three months after radiotherapy

Secondary outcome measures

1. Dose Limiting Toxicity; Timepoint(s): occuring up to six months after radiotherapy (RT)
2. Estabilsh Maximum Tolerated Dose to the oesophagus; Timepoint(s): acute grade 3 or 4 toxicity occuring up to two months after radiotherapy
3. Local control; Timepoint(s): to the date of first clinical evidence of progressive disease at the primary site, or death
4. Overall Survival; Timepoint(s): date of entry to date of death
5. Tumour response; Timepoint(s): assessed using Response Evaluation Criteria In Solid Tumors (RECIST) at 2 months post RT

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Histologically or cytologically confirmed stage II – IIIb NSCLC (Appendix II)
2. Inoperable disease (as assessed by a lung cancer MDT with thoracic surgical input) or operable but the patient refuses surgery
3. Disease which can be encompassed within a radical radiotherapy treatment plan in keeping with standard practice at the participating centre
4. World Health Organisation (WHO) Performance Status 0 or 1 (Appendix III)
5. Adequate respiratory function: Forced expiratory volume in the first second (FEV1) = 1.0 litre, diffusing capacity of the lung for carbon monoxide (DLCO) (transfer factor) = 40% of predicted and carbon monoxide transfer coefficient (Kco) (Dlco/VA) > 40% predicted on baseline lung function tests
6. Blood haemoglobin should be = 10g/dL
7. No prior thoracic radiotherapy
8. Age more than or equal to 16 years
9. Considered fit to receive trial treatment
10. Estimated life expectancy of more than 3 months
11. Written informed consent obtained
12. Patient consents for electronic CT scan and planning data to be used for future research
13. Patient is available for follow up; Target Gender: Male & Female ; Lower Age Limit 16 years

Participant type


Age group




Target number of participants

Planned Sample Size: 121; UK Sample Size: 121

Participant exclusion criteria

1. Medically unstable (e.g. unstable diabetes, uncontrolled hypertension, infection, hypercalcaemia or very symptomatic ischaemic heart disease)
2. Previous or current malignant disease likely to interfere with protocol treatment
3. Pancoast tumours
4. Connective tissue disorders (e.scleroderma, systemic lupus erythematosus)
5. Interstitial lung disease
6. Women who are pregnant or lactating
7. Women of childbearing potential who are not using adequate contraceptive precautions

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

6th Floor
CF14 4YS
United Kingdom

Sponsor information


Velindre NHS Trust (UK)

Sponsor details

Velindre Hospital
Velindre Road
CF14 2TL
United Kingdom

Sponsor type




Funder type


Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


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