A Phase 3 interventional study of Control arm (SEQ): and Experimental arm (CON): in Lung Cancer, sponsored by University College, London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-03.
Sponsored by University College, London · Phase 3, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as cisplatin and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving combination chemotherapy followed by radiation therapy is more effective than giving combination chemotherapy together with radiation therapy followed by more chemotherapy in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying combination chemotherapy followed by radiation therapy to see how well it works compared to combination chemotherapy combined with radiation therapy followed by more chemotherapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to clinically important factors. Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline, monthly for 6 months, and then at each follow-up visit.
After completion of study treatment, patients are followed periodically.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 508 patients will be accrued for this study.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 130 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage III non-small cell lung cancer (NSCLC)
PATIENT CHARACTERISTICS:
Hemoglobin > 10.0 g/dL
PRIOR CONCURRENT THERAPY:
Four cycles of cisplatinum/vinorelbine given in a 21 day cycle followed by radical radiotherapy, 55 Gy in 20 once daily fractions in four weeks (2.75 Gy/day).
Drug: Control arm (SEQ):
Concurrent chemo-radiotherapy \[55 Gy in 20 daily fractions in 4 weeks (2.75 Gy/day) with cisplatinum given concurrently with fractions 1-4 and 16-19, and vinorelbine prior to fractions 1, 6, 15 and 20\] followed by two cycles of cisplatinum/vinorelbine.
Drug: Experimental arm (CON):
Four cycles of cisplatinum/vinorelbine given in a 21 day cycle followed by radical radiotherapy, 55 Gy in 20 once daily fractions in four weeks (2.75 Gy/day).
concurrent chemo-radiotherapy \[55 Gy in 20 daily fractions in 4 weeks (2.75 Gy/day) with cisplatinum given concurrently with fractions 1-4 and 16-19, and vinorelbine prior to fractions 1, 6, 15 and 20\] followed by two cycles of cisplatinum/vinorelbine.
Treatment related mortality (any cause)
Time frame: from randomization till death
Hematological, pulmonary, esophageal, and neurological toxicities
Time frame: From randomisation to the first 6 months
Quality of life
Time frame: at baseline, every 3 weeks for the first 6 months, then 3 monthly until 2 years, 6 monthly until 3 years, and annually thereafter
Cost effectiveness
Time frame: at baseline, every 3 weeks for the first 6 months, then 3 monthly until 2 years, 6 monthly until 3 years, and annually thereafter
Overall survival and progression-free survival.
Time frame: Overall Survival is the time between date of randomisation and date of death of any cause. Progression-free survival will be calculated from the date of randomisation to the date of first clinical evidence of progressive disease, or death.
Local progression-free survival (local control)
Time frame: From the date of randomisation to the date of first clinical evidence of progressive disease at the primary site, or death
Response
Time frame: proportion of patients in each treatment group whose best response in the first 6 months from randomisation is complete or partial will be reported.
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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University College, London