Condition category
Cancer
Date applied
25/07/2016
Date assigned
27/07/2016
Last edited
24/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Public

Primary contact

Miss Claire Lawless

ORCID ID

Contact details

Cancer Research UK Clinical Trials Unit
The Beatson West of Scotland Cancer Centre
Level 0
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom

Additional identifiers

EudraCT number

N/A

ClinicalTrials.gov number

Protocol/serial number

ADSCaN2015

Study information

Scientific title

ADSCaN: A Randomised Phase II trial of Accelerated, Dose escalated, Sequential Chemo-radiotherapy in Non small cell lung cancer

Acronym

ADSCaN

Study hypothesis

This trial will take 4 dose escalated accelerated sequential chemo-radiotherapy schedules into a randomized phase II comparison with a UK standard sequential chemo-radiotherapy using state
of-the art radiotherapy. The overall aim of the trial is to identify which of the 4 experimental arms is the best schedule to take forward into a future randomised Phase III study.

Ethics approval

Not provided at time of registration

Study design

Randomised phase II screening/”pick-the-winner” design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Stage III Non-Small Cell Lung Cancer

Intervention

Minimisation incorporating a random factor will be used to allocate patients between treatment arms A:B:C:D:E so that an overall study ratio of 2:1:1:1:1 is achieved. Patients will only be randomised between the arms currently available at their hospital.

Arm A (Standard Arm): Patients will receive one radiotherapy session per day for 4 weeks (55Gy in 20 fractions over 26-28 days)

Arm B CHART-ED: Patients will receive 3 radiotherapy sessions per day for 2½ weeks (54Gy, 36 fractions, 12 days then 10.8Gy, 6 fractions (day 15-17)).

Arm C: IDEAL: Patients will receive one radiotherapy session per day for 5 weeks (Isotoxic radiotherapy 30 fractions, 5 weeks, prescribed dose 63-71Gy).

Arm D: I-START: Patients will receive one radiotherapy session per day for 4 weeks (Isotoxic radiotherapy 20 fractions, 4 weeks total dose of 55 – 65 Gy).

Arm E: Isotoxic IMRT: Patients will receive 2 sessions per day for 4 weeks (Isotoxic regime IMRT, individualised dose escalation to a maximum 79.2Gy in 1.8Gy over 4 weeks BD).

For all trial arms, once patients have completed treatment they will enter follow up and should be reviewed at months - 2, 3, 4, 6, 9, 12, 15, 18, 24 and 36 from randomisation. Thereafter annual visits should be performed until the end of the study period (June 2021). Follow up visits at more frequent intervals should be undertaken at the discretion of the participating Investigator.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Progression free survival (PFS) is determined via RECIST reporting of scans performed at disease evaluation visits during follow-up at months 3, 6, 12, 18, 24 and 36 months

Secondary outcome measures

1. Overall survival (OS) is measured by collecting survival status at each follow up visit (months 2, 3, 4, 6, 9, 12, 15, 18, 21, 24, 36 and annually until the end of the study period (June 2021)). Cause of death and evidence for cause of death will be recorded by participating sites, and is collected from cancer centres, cancer registries and national databases.
2. Time to local-regional failure is determined via RECIST reporting of scans performed at disease evaluation visits during follow-up at months 3, 6, 12, 18, 24 and 36 months
3. Toxicity as assessed by NCI CTCAE v4.03 during treatment and during follow-up at months 3, 6, 12, 18, 24, 36 months and annually until end of study
4. Cost Effectiveness is based on quality adjusted life years calculated using resource-use data (delivery of radiotherapy, hospital inpatient/outpatient/high dependency days) and quality of life (EQ-5D) measured during treatment and follow-up (months 2, 3, 4, 6, 9, 12, 15, 18, 21, 24, 36 and annually until end of study)

Overall trial start date

01/07/2015

Overall trial end date

30/06/2021

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically or cytologically confirmed stage III NSCLC
2. Performance status (PS) – ECOG 0-2
Patients with PS 2 can only be included if the local investigator deems the general condition is explained by disease or the primary chemotherapy treatment
3. Inoperable disease, unsuitable for concurrent chemo-radiotherapy, in the opinion of the treating Oncologist
4. Patients who have had a complete response, partial response or stable disease on CT assessment after 2 cycles of platinum based chemotherapy
5. Willing and able to give written informed consent
6. Aged 16 or over
7. Adequate PFT results: FEV1 and/or KCO ≥ 40% of predicted

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

360

Participant exclusion criteria

1. Previous or current malignant disease likely to interfere with the protocol treatment or comparisons
2. Medically unstable (unstable diabetes, uncontrolled arterial hypertension, infection, hypercalcaemia, ischaemic heart disease)
3. Connective tissue disorders (Scleroderma, Systemic Lupus Erythematosus)
4. Clinically significant interstitial lung disease
5. History of physical or psychiatric disorder that would prevent informed consent and compliance with protocol
6. Pregnant or lactating women
7. Any psychological, familial, sociological or geographical consideration potentially hampering compliance with the trial protocol and follow up schedule

Recruitment start date

01/10/2016

Recruitment end date

30/06/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Weston Park Hospital
Whitham Road
Sheffield
S10 2SJ
United Kingdom

Trial participating centre

The Christie Hospital
Wilmslow Road
Manchester
M20 4BX
United Kingdom

Trial participating centre

Velindre Cancer Centre
Velindre Road
Cardiff
CF14 2TL
United Kingdom

Trial participating centre

Guys Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Trial participating centre

Clatterbridge Cancer Centre
Clatterbridge Road Bebington
Wirral
CH63 4JY
United Kingdom

Trial participating centre

Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom

Trial participating centre

Belfast City Hospital
95 Lisburn Road
Belfast
BT9 7AB
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow & Clyde

Sponsor details

Research and Development Central Office
West Glasgow Ambulatory Care Hospital
Dalnair Street
Glasgow
G3 8SW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Cancer Research 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

Planned publication in a high-impact peer reviewed journal

Intention to publish date

30/06/2022

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/11/2016: Internal review.