Clinical trial looking at different radiotherapy treatment schedules following chemotherapy for patients with non-small cell lung cancer
| ISRCTN | ISRCTN47674500 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47674500 |
| Integrated Research Application System (IRAS) | 190574 |
| Protocol serial number | IRAS: 190574, ADSCaN2015 |
| Sponsor | NHS Greater Glasgow & Clyde |
| Funder | Cancer Research UK |
- Submission date
- 25/07/2016
- Registration date
- 27/07/2016
- Last edited
- 02/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Contact information
Public
Cancer Research UK Clinical Trials Unit
The Beatson West of Scotland Cancer Centre
Level 0
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
| Phone | +44 141 301 7947 |
|---|---|
| claire.lawless@glasgow.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised phase II screening/”pick-the-winner” design |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | ISRCTN47674500_PIS_v2.0_05Oct2016.pdf |
| Scientific title | ADSCaN: A Randomised Phase II trial of Accelerated, Dose escalated, Sequential Chemo-radiotherapy in Non small cell lung cancer |
| Study acronym | ADSCaN |
| Study objectives | 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(s) | Approved 08/11/2016, West of Scotland REC 1 (Clinical Research & Development, West Glasgow Ambulatory Care Hospital, Dalnair Street, Glasgow, G3 8SW), REC ref: 16/WS/0165 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) | 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 |
| Key secondary outcome measure(s) | 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) |
| Completion date | 12/02/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 360 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 22/08/2017 |
| Date of final enrolment | 26/02/2021 |
Locations
Countries of recruitment
- United Kingdom
- England
- Northern Ireland
- Scotland
- Wales
Study participating centres
Sheffield
S10 2SJ
United Kingdom
Manchester
M20 4BX
United Kingdom
Cardiff
CF14 2TL
United Kingdom
London
SE1 9RT
United Kingdom
Bebington
Wirral
CH63 4JY
United Kingdom
Glasgow
G12 0YN
United Kingdom
Belfast
BT9 7AB
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
Bristol
BS2 8ED
United Kingdom
Cheltenham
GL53 7AN
United Kingdom
Middlesborough
TS4 3BW
United Kingdom
Middlesex
HA6 2RN
United Kingdom
United Kingdom
NE7 7DN
United Kingdom
Nottingham
DG5 1PB
United Kingdom
London
SM2 5PT
United Kingdom
SA2 8QA
United Kingdom
Southampton
SO16 6YD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 29/01/2019 | 30/01/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | Feasibility of isotoxic IMRT regimen | 01/04/2021 | 02/09/2024 | Yes | No |
| Participant information sheet | version 2.0 | 05/10/2016 | 02/09/2024 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
Editorial Notes
02/09/2024: Publication reference and patient information sheet nadded.
04/10/2022: The intention to publish date was changed from 01/10/2022 to 31/03/2023.
08/03/2022: The overall end date was changed from 26/02/2022 to 12/02/2022.
06/04/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2021 to 26/02/2021.
2. The overall end date was changed from 30/06/2021 to 26/02/2022.
3. The intention to publish date was changed from 30/06/2022 to 01/10/2022.
4. The total final enrolment was added.
09/07/2020: The trial contact details have been made publicly visible.
14/04/2020: Due to current public health guidance, recruitment for this study has been paused.
30/01/2020: Publication reference added.
07/01/2020: The following changes have been made:
1. The recruitment start date has been changed from 01/10/2016 to 22/08/2017.
2. The recruitment end date has been changed from 30/06/2020 to 30/04/2021.
3. The ethics approval has been added.
4. The IRAS number has been added.
5. The trial participating centre Addenbrookes Hospital has been added.
6. The trial participating centre Bristol Haematology and Oncology Centre has been added.
7. The trial participating centre Cheltenham General Hospital has been added.
8. The trial participating centre The James Cook University Hospital has been added.
9. The trial participating centre Mount Vernon Cancer Centre, East and North Hertfordshire NHS Trust has been added.
10. The trial participating centre North Wales Cancer Treatment Centre: Glan Clwyd Hospital, Ysbyty Gwyndd Hospital and Wrexham Maelor Hospital has been added.
11. The trial participating centre Northern Centre for Cancer Care, Freeman Hospital has been added.
12. The trial participating centre Nottingham University Hospital has been added.
13. The trial participating centre Royal Marsden NHS Foundation Trust has been added.
14. The trial participating centre South West Wales Cancer Hospital: Singleton Hospital has been added.
15. The trial participating centre University Hospital Southampton has been added.
16/01/2018: Cancer Help UK lay summary link added to plain English summary field.
16/10/2017: Internal review.
22/09/2017: Internal review.
15/09/2017: Internal review.
06/06/2017: Internal review.
