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 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 trial start date
01/12/2005
Overall trial end date
30/04/2009
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25304298