A Randomized Phase III 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 and Good Performance Status
18 Years
N/A
Both
Lung Cancer
Trial Information
A Randomized Phase III 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 and Good Performance Status
OBJECTIVES:
Primary
- 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
- Compare the progression-free survival of patients treated with these regimens.
- Compare the local progression-free survival (local control).
- Compare the hematological, pulmonary, esophageal, and neurological toxicities.
- Compare the response.
- Compare the quality of life.
- Compare the cost-effectiveness.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
clinically important factors. Patients are randomized to 1 of 2 treatment arms.
- Arm I (sequential treatment): Patients receive cisplatin IV over 2 hours on day 1 and
vinorelbine ditartrate IV over 5-10 minutes on days 1 and 8. Treatment repeats every 3
weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Beginning in week 15, patients undergo radiotherapy 5 days a week for 4 weeks.
- Arm II (concurrent treatment): Patients undergo radiotherapy as in arm I beginning in
week 1. Patients receive cisplatin IV over 2 hours on days 1-4 and vinorelbine
ditartrate IV over 5-10 minutes on days 1 and 8. Chemotherapy repeats every 3 weeks for
up to 4 courses in the absence of disease progression or unacceptable toxicity.
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed stage III non-small cell lung cancer
(NSCLC)
- Patients with stage IIIB disease must not have a pleural effusion that is
cytologically proven to be malignant
- Inoperable disease
- Disease must be able to be encompassed within a radical radiotherapy treatment volume
PATIENT CHARACTERISTICS:
- ECOG performance status 0 or 1
- Life expectancy > 3 months
- Patient considered able to tolerate platinum-based chemotherapy and radical
radiotherapy
- Glomerular filtration rate ≥ 60 mL/min
- WBC > 3,000/mm³
- Absolute neutrophil count > 1,500/mm³
- Hemoglobin > 10.0 g/dL
- Patients with hemoglobin between 10 and 12 g/dL at randomization require a blood
transfusion to ensure hemoglobin > 12 g/dL before starting radiotherapy
- Platelet count > 100,000/mm³
- FEV_1 ≥ 1.0 L or DLCO (transfer factor) ≥ 50% of predicted
- Alkaline phosphatase ≤ 1.5 times upper limit of normal (ULN)
- Gamma-glutamyl-transferase < 1.5 times ULN
- Transaminases ≤ 1.5 times ULN
- Bilirubin ≤ 1.5 times ULN
- No medically unstable conditions (e.g., unstable diabetes, uncontrolled arterial
hypertension, infection, hypercalcemia, or ischemic heart disease)
- Not pregnant or nursing
- Fertile patients must agree to use effective contraception
- Negative pregnancy test
- No other previous or current malignant disease likely to interfere with protocol
treatment or comparisons
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, radiotherapy, or investigational agents
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Treatment related mortality (any cause)
Outcome Time Frame:
from randomization till death
Safety Issue:
No
Principal Investigator
Joe Maguire, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Clatterbridge Centre for Oncology
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
CDR0000465629
NCT ID:
NCT00309972
Start Date:
December 2005
Completion Date:
December 2012
Related Keywords:
- Lung Cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|
