Trial Outcomes & Findings for Navelbine And Radiotherapy in Locally Advanced Lung Cancer (NCT NCT00887783)
NCT ID: NCT00887783
Last Updated: 2022-05-17
Results Overview
Local failure free survival 9 month after first RT treatment measured by CT/FDG-CT
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
117 participants
Primary outcome timeframe
9 months
Results posted on
2022-05-17
Participant Flow
117 included July 2009 to August 2013
Participant milestones
| Measure |
B: 66Gy/33F+Navelbine Oral 150 mg q3w
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 66 Gy (2 Gy x 30, 5 F á weeks).
Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks
66 Gy/33F: irradiation to 66 Gy (2 Gy x 30, 5 F á weeks)
|
A: 60Gy/30F+Navelbine Oral 150 mg q3w
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 60 Gy (2 Gy x 30, 5 F á weeks) Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks
60 Gy/30F: irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
59
|
|
Overall Study
COMPLETED
|
58
|
59
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
B: 66Gy/33F+Navelbine Oral 150 mg q3w
n=58 Participants
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 66 Gy (2 Gy x 30, 5 F á weeks).
Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks
66 Gy/33F: irradiation to 66 Gy (2 Gy x 30, 5 F á weeks)
|
A: 60Gy/30F+Navelbine Oral 150 mg q3w
n=59 Participants
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 60 Gy (2 Gy x 30, 5 F á weeks) Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks
60 Gy/30F: irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=58 Participants
|
0 Participants
n=59 Participants
|
0 Participants
n=117 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=58 Participants
|
22 Participants
n=59 Participants
|
54 Participants
n=117 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=58 Participants
|
37 Participants
n=59 Participants
|
63 Participants
n=117 Participants
|
|
Age, Continuous
|
64.56 years
n=58 Participants
|
66.63 years
n=59 Participants
|
65.53 years
n=117 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=58 Participants
|
36 Participants
n=59 Participants
|
62 Participants
n=117 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=58 Participants
|
23 Participants
n=59 Participants
|
55 Participants
n=117 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Denmark
|
58 Participants
n=58 Participants
|
59 Participants
n=59 Participants
|
117 Participants
n=117 Participants
|
PRIMARY outcome
Timeframe: 9 monthsPopulation: Analyzed as intention to treat
Local failure free survival 9 month after first RT treatment measured by CT/FDG-CT
Outcome measures
| Measure |
B: 66Gy/33F+Navelbine Oral 150 mg q3w
n=58 Participants
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 66 Gy (2 Gy x 30, 5 F á weeks).
Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks
66 Gy/33F: irradiation to 66 Gy (2 Gy x 30, 5 F á weeks)
|
A: 60Gy/30F+Navelbine Oral 150 mg q3w
n=59 Participants
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 60 Gy (2 Gy x 30, 5 F á weeks) Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks
60 Gy/30F: irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)
|
|---|---|---|
|
Local Failure Free Survival
|
9.4 months
Interval 2.8 to 67.0
|
9.9 months
Interval 2.6 to 54.0
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Dysphagia, weight loss ≥20%, pulmonary toxicity grade 3, leucopenia grade 3 or higher
Outcome measures
| Measure |
B: 66Gy/33F+Navelbine Oral 150 mg q3w
n=58 Participants
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 66 Gy (2 Gy x 30, 5 F á weeks).
Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks
66 Gy/33F: irradiation to 66 Gy (2 Gy x 30, 5 F á weeks)
|
A: 60Gy/30F+Navelbine Oral 150 mg q3w
n=59 Participants
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 60 Gy (2 Gy x 30, 5 F á weeks) Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks
60 Gy/30F: irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)
|
|---|---|---|
|
Number of Participants Who Experienced Early Toxicity to Concurrent Vinorelbine and Radiotherapy
Leucopenia g3+
|
4 participants
|
3 participants
|
|
Number of Participants Who Experienced Early Toxicity to Concurrent Vinorelbine and Radiotherapy
Dysphagia g3+
|
7 participants
|
6 participants
|
|
Number of Participants Who Experienced Early Toxicity to Concurrent Vinorelbine and Radiotherapy
Pulmonary tox
|
14 participants
|
11 participants
|
SECONDARY outcome
Timeframe: 9 monthsLoco-regional control
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 72 monthsPopulation: Overall survival, intention to treat
Overall survival, death of any cause
Outcome measures
| Measure |
B: 66Gy/33F+Navelbine Oral 150 mg q3w
n=58 Participants
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 66 Gy (2 Gy x 30, 5 F á weeks).
Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks
66 Gy/33F: irradiation to 66 Gy (2 Gy x 30, 5 F á weeks)
|
A: 60Gy/30F+Navelbine Oral 150 mg q3w
n=59 Participants
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 60 Gy (2 Gy x 30, 5 F á weeks) Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks
60 Gy/30F: irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)
|
|---|---|---|
|
Overall Survival
|
25.3 Months
Interval 3.0 to 68.0
|
23.3 Months
Interval 3.2 to 65.6
|
SECONDARY outcome
Timeframe: 48 monthsLate toxicity related to concurrent Vinorelbine and radiotherapy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 72 monthsDisease free survival, death of any cause
Outcome measures
| Measure |
B: 66Gy/33F+Navelbine Oral 150 mg q3w
n=58 Participants
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 66 Gy (2 Gy x 30, 5 F á weeks).
Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks
66 Gy/33F: irradiation to 66 Gy (2 Gy x 30, 5 F á weeks)
|
A: 60Gy/30F+Navelbine Oral 150 mg q3w
n=59 Participants
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 60 Gy (2 Gy x 30, 5 F á weeks) Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks
60 Gy/30F: irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)
|
|---|---|---|
|
Disease Free Survival
|
8.4 Months
Interval 0.2 to 68.0
|
8.8 Months
Interval 0.2 to 54.0
|
Adverse Events
B: 66Gy/33F+Navelbine Oral 150 mg q3w
Serious events: 18 serious events
Other events: 25 other events
Deaths: 41 deaths
A: 60Gy/30F+Navelbine Oral 150 mg q3w
Serious events: 15 serious events
Other events: 20 other events
Deaths: 44 deaths
Serious adverse events
| Measure |
B: 66Gy/33F+Navelbine Oral 150 mg q3w
n=58 participants at risk
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 66 Gy (2 Gy x 30, 5 F á weeks).
Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks
66 Gy/33F: irradiation to 66 Gy (2 Gy x 30, 5 F á weeks)
|
A: 60Gy/30F+Navelbine Oral 150 mg q3w
n=59 participants at risk
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 60 Gy (2 Gy x 30, 5 F á weeks) Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks
60 Gy/30F: irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.9%
15/58 • Number of events 17 • 5 years, death or recurrence
|
11.9%
7/59 • Number of events 7 • 5 years, death or recurrence
|
|
Gastrointestinal disorders
Dysphagia
|
13.8%
8/58 • Number of events 8 • 5 years, death or recurrence
|
13.6%
8/59 • Number of events 8 • 5 years, death or recurrence
|
|
Skin and subcutaneous tissue disorders
Herpes zoster
|
0.00%
0/58 • 5 years, death or recurrence
|
1.7%
1/59 • Number of events 1 • 5 years, death or recurrence
|
|
Blood and lymphatic system disorders
Atrial fibrilation
|
0.00%
0/58 • 5 years, death or recurrence
|
3.4%
2/59 • Number of events 2 • 5 years, death or recurrence
|
Other adverse events
| Measure |
B: 66Gy/33F+Navelbine Oral 150 mg q3w
n=58 participants at risk
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 66 Gy (2 Gy x 30, 5 F á weeks).
Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks
66 Gy/33F: irradiation to 66 Gy (2 Gy x 30, 5 F á weeks)
|
A: 60Gy/30F+Navelbine Oral 150 mg q3w
n=59 participants at risk
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 60 Gy (2 Gy x 30, 5 F á weeks) Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
Navelbine: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks
60 Gy/30F: irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)
|
|---|---|---|
|
Blood and lymphatic system disorders
Leucopenia
|
6.9%
4/58 • Number of events 4 • 5 years, death or recurrence
|
5.1%
3/59 • Number of events 3 • 5 years, death or recurrence
|
|
Gastrointestinal disorders
Dysphagia
|
12.1%
7/58 • Number of events 7 • 5 years, death or recurrence
|
10.2%
6/59 • Number of events 6 • 5 years, death or recurrence
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
24.1%
14/58 • Number of events 14 • 5 years, death or recurrence
|
18.6%
11/59 • Number of events 11 • 5 years, death or recurrence
|
Additional Information
Dr. Olfred Hansen, Professor, Ph.D.
Dept. Oncology, Odense University Hospital
Phone: +4524241588
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place