Condition category
Cancer
Date applied
13/02/2004
Date assigned
10/03/2004
Last edited
09/11/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Joseph Maguire

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2004-001920-19

ClinicalTrials.gov number

NCT00309972

Protocol/serial number

N/A

Study information

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.

Acronym

SOCCAR - Sequential Or Concurrent Chemotherapy And Radiotherapy

Study hypothesis

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

Central Manchester LREC, 30/09/2004, REC ref: 04/Q1407/256

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

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

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/12/2005

Overall trial end date

30/04/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

508

Participant 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

Recruitment start date

01/12/2005

Recruitment end date

30/04/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clatterbridge Centre for Oncology
Liverpool
CH63 4JY
United Kingdom

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Not defined

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) (ref: C11922/A4558)

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25304298

Publication citations

Additional files

Editorial Notes