Clinical Trial Results:
Induction chemotherapy with Carboplatin and Navelbine Oral® followed by concomitant Navelbine Oral® and irradiation in local-regionally advanced non-small cell lung cancer.
A randomized phase II study.
Summary
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EudraCT number |
2008-008920-34 |
Trial protocol |
DK |
Global end of trial date |
21 Jul 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
27 Mar 2020
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First version publication date |
27 Mar 2020
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
09.01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00887783 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Odense University Hospital
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Sponsor organisation address |
J. B. Winsløwsvej 2, Indgang 140, kælderen, Odense, Denmark, 5000
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Public contact |
Olfred Hansen, Odense University Hospital, 0045 24241588, olfred.hansen@rsyd.dk
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Scientific contact |
Olfred Hansen, Odense University Hospital, 0045 24241588, olfred.hansen@rsyd.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 Dec 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Dec 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Jul 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The objective of this trial is to test a convenient chemotherapy schedule with an oral formulation of radio-sensitizing Navelbine in concurrent chemo-radiotherapy in radical treatment of inoperable locally advanced non small cell lung cancer (stage IIB-IIIB) with radiotherapy. The trial is a randomized phase II study with two doses of radiotherapy. The primary objective of the study is examine the combination of 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) or 66 Gy (2 Gy x 33, 5 F á week) starting 3 weeks after two cycles of inductions chemotherapy with Navelbine oral and Carboplatin.
Primary endpoint:
- Local failure free survival at 9 months after start of radiotherapy
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Protection of trial subjects |
Strict planning of radiotherapy observing clear constraints on normal tissue. Frequent clinical follow-up within the trial observing any side adverse effects and risk of relapse.
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Background therapy |
. | ||
Evidence for comparator |
. | ||
Actual start date of recruitment |
01 May 2009
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety, Efficacy, Scientific research | ||
Long term follow-up duration |
5 Years | ||
Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 117
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Worldwide total number of subjects |
117
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EEA total number of subjects |
117
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
55
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From 65 to 84 years |
62
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85 years and over |
0
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Recruitment
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Recruitment details |
The inclusion criteria were histologically or cytologically confirmed NSCLC, clinical American Joint Committee of Cancer stage (the seventh edition) IIB–IIIB, performance status (PS) <2 on the ECOG scale, weight | |||||||||
Pre-assignment
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Screening details |
Patients refered to the participating centers was screened for the study. | |||||||||
Period 1
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Period 1 title |
Induction
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||
Blinding implementation details |
Not blinded
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Arms
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Arm title
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Induction chemotherapy | |||||||||
Arm description |
All patients were treated with two cycles of carboplatin day 1 and navelbine day 1 and day 8 | |||||||||
Arm type |
Standard | |||||||||
Investigational medicinal product name |
Navelbine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, soft
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Routes of administration |
Oral use
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Dosage and administration details |
Navelbine 60 mg m2 - possible to increase dose to 80 mg m2
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Investigational medicinal product name |
Carboplatin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
2 cycles of induction therapy - 3 weeks cycles
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Period 2
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Period 2 title |
Randomized
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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60 GY | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Navelbine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, soft
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Routes of administration |
Oral use
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Dosage and administration details |
Radiotherapy 60 GY, concommittant vinorelbin 50mg Sunday, Tuesday and Thursday
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Arm title
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66GY | |||||||||
Arm description |
Radiotherapy 60 GY, concommittant vinorelbin 50mg Sunday, Tuesday and Thursday | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Navelbine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, soft
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Routes of administration |
Oral use
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Dosage and administration details |
50 mg Sunday, Tuesday and Thursday during RT
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Baseline characteristics reporting groups
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Reporting group title |
Induction
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Induction chemotherapy
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Reporting group description |
All patients were treated with two cycles of carboplatin day 1 and navelbine day 1 and day 8 | ||
Reporting group title |
60 GY
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Reporting group description |
- | ||
Reporting group title |
66GY
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Reporting group description |
Radiotherapy 60 GY, concommittant vinorelbin 50mg Sunday, Tuesday and Thursday |
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End point title |
Local progression free interval after start of RT. [1] | |||||
End point description |
Local progression free interval 9 month after start of RT measured on PET CT
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End point type |
Primary
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End point timeframe |
Local progression free interval 9 month after start of RT.
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Analysis in doi.org/10.1016 |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
From randomization until EOT
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Adverse event reporting additional description |
An AE was defined as any adverse medical event in a patient or subject taking a medical treatment regardless of the causal relationship to the trial.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
CTC-AE | |||||||||||||||||||||||||||||||||
Dictionary version |
3.0
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Reporting groups
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Reporting group title |
66GY
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Reporting group description |
Study arm | |||||||||||||||||||||||||||||||||
Reporting group title |
60GY
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Reporting group description |
Study arm | |||||||||||||||||||||||||||||||||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Analysis in doi.org/10.1016 |
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Frequency threshold for reporting non-serious adverse events: 0.05% | ||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
The study was a chemo-radiation study including cancerpatients with an expected 3 years survival 20%. | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/28410809 |