A phase III randomised trial of sequential chemotherapy followed by radical radiotherapy versus concurrent chemo-radiotherapy followed by chemotherapy in patients with inoperable stage III Non-Small Cell Lung Cancer (NSCLC) and good performance status.

ISRCTN	ISRCTN13746987
DOI	https://doi.org/10.1186/ISRCTN13746987
EudraCT/CTIS number	2004-001920-19
ClinicalTrials.gov number	NCT00309972
Secondary identifying numbers	N/A

Submission date: 13/02/2004
Registration date: 10/03/2004
Last edited: 19/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-to-find-the-best-timing-for-radiotherapy-and-chemotherapy-for-advanced-non-small-cell-lung-cancer

Contact information

Dr Joseph Maguire
Scientific

Clatterbridge Centre for Oncology
Bebington
Wirral
Liverpool
CH63 4JY
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet'
Scientific title	A phase III randomised trial of sequential chemotherapy followed by radical radiotherapy versus concurrent chemo-radiotherapy followed by chemotherapy in patients with inoperable stage III Non-Small Cell Lung Cancer (NSCLC) and good performance status.
Study acronym	SOCCAR - Sequential Or Concurrent Chemotherapy And Radiotherapy
Study objectives	The aim of this trial is to compare concurrent treatment to sequential treatment, to see which works better for advanced Non-Small Cell Lung Cancer (NCSLC).
Ethics approval(s)	Central Manchester LREC, 30/09/2004, REC ref: 04/Q1407/256
Health condition(s) or problem(s) studied	Non Small Cell Lung Cancer (NSCLC)
Intervention	Patients will be randomised to sequential or concurrent chemotherapy and radiotherapy: 1. Sequential arm - patients receive 4 x 21 day cycle of vinorelbine and cisplatin, followed by radical radiotherapy. 2. Concurrent arm - patients receive vinorelbine concurrently with fractions 1, 6, 15 and 20 of radical radiotherapy and cisplatin with fractions 1-4 and 16-19. Four weeks after concurrent treatment is completed patients receive 2 x 21 day cycle of vinorelbine and cisplatin.
Intervention type	Mixed
Primary outcome measure	Compare the overall survival of patients with stage III non-small cell cancer treated with chemotherapy comprising cisplatin and vinorelbine ditartrate (CV) followed by radical radiotherapy versus concurrent CV chemoradiotherapy followed by CV chemotherapy.
Secondary outcome measures	1. Compare the progression-free survival of patients treated with these regimens. 2. Compare the local progression-free survival (local control). 3. Compare the hematological, pulmonary, esophageal, and neurological toxicities. 4. Compare the response. 5. Compare the quality of life. 6. Compare the cost-effectiveness.
Overall study start date	01/12/2005
Completion date	30/04/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	508
Key inclusion criteria	1. Histologically or cytologically confirmed stage III Non-Small Cell Lung Cancer (NSCLC) 2. Performance status - Eastern Cooperative Oncology Group (ECOG) zero or one 3. Life expectancy greater than three months 4. Tumour judged as inoperable by thoracic surgeon or after review by MultiDisciplinary Team (MDT) including thoracic surgeon, using British Thoracic Society guidelines 5. Age 18 or over 6. No prior chemotherapy, radiotherapy or investigational agents 7. Willing and able to give informed consent 8. Willing and able to complete quality of life forms 9. Patient considered able to tolerate platinum based chemotherapy and radical radiotherapy
Key exclusion criteria	1. Stage IIIB disease with pleural effusion cytologically proven to be malignant 2. Superior vena cava obstruction 3. Other previous or current malignant disease likely to interfere with protocol treatment or comparisons 4. Abnormal Liver Function Tests (LFTs) with any of: Alkaline Phosphatase, Gamma Glutamyl Transferase, Transaminases or Bilirubin more than 1.5 times Upper Limit of Normal range (ULN) 5. Hypercalcaemia 6. Evidence of other significant laboratory finding or concurrent uncontrolled medical illness which in the opinion of the investigator would interfere with protocol treatment or results comparison or render the subject at high risk from treatment complications 7. Pregnancy and lactation. Effective contraception is mandatory for all patients (of reproductive potential) if sexually active 8. Active infection
Date of first enrolment	01/12/2005
Date of final enrolment	30/04/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Clatterbridge Centre for Oncology

Liverpool
CH63 4JY
United Kingdom

Sponsor information

Sponsor not defined - Record provided by CRUK and UCL CTC (UK)
Not defined

Stephenson House
158-160 North Gower Street
London
NW1 2ND
United Kingdom

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK) (ref: C11922/A4558)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	01/11/2014		Yes	No

Editorial Notes

19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)