Condition category
Cancer
Date applied
10/06/2011
Date assigned
10/06/2011
Last edited
04/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Lisette Nixon

ORCID ID

Contact details

6th Floor
Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
+44 (0)29 20687458, ext. 87458
nixonls@cardiff.ac.uk

Additional identifiers

EudraCT number

2010-020075-23

ClinicalTrials.gov number

Protocol/serial number

9703

Study information

Scientific title

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

Acronym

I-START

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

Interventional

Secondary study design

Non 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

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

Intervention

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

Other

Phase

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

01/03/2011

Overall trial end date

01/09/2012

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

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

01/03/2011

Recruitment end date

01/09/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

6th Floor
Cardiff
CF14 4YS
United Kingdom

Sponsor information

Organisation

Velindre NHS Trust (UK)

Sponsor details

Velindre Hospital
Velindre Road
Cardiff
CF14 2TL
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

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