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
ClinicalTrials.gov (NCT) NCT00309972
Clinical Trials Information System (CTIS) 2004-001920-19
Protocol serial number N/A
Sponsor Sponsor not defined - Record provided by CRUK and UCL CTC (UK)
Funder Cancer Research UK (CRUK) (UK) (ref: C11922/A4558)
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

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA 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 acronymSOCCAR - Sequential Or Concurrent Chemotherapy And Radiotherapy
Study objectivesThe 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) studiedNon Small Cell Lung Cancer (NSCLC)
InterventionPatients 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 typeMixed
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

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.

Completion date30/04/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration508
Key inclusion criteria1. 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 criteria1. 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 enrolment01/12/2005
Date of final enrolment30/04/2009

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Clatterbridge Centre for Oncology
Liverpool
CH63 4JY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2014 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Plain English results No Yes

Editorial Notes

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

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