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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Vejle Hospital | OTHER |
| Rigshospitalet, Denmark | OTHER |
| Aalborg University Hospital |
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This study is an open label randomized multi-centre phase II trial in patients with inoperable locally advanced stage IIB-IIIB Non Small Cell Lung Cancer who fulfils the general criteria for curatively intended irradiation. The treatment plan consists of two courses of inductions chemotherapy followed of concomitant therapy chemo-radiotherapy 3 weeks after day 1 of the last induction chemotherapy has been given. The patients will be included in the study after completing the induction chemotherapy. Randomization will take place only if an acceptable dose plan can be obtained.
This study was an open label randomized multi-centre phase II trial in patients with inoperable locally advanced stage IIB-IIIB Non Small Cell Lung Cancer who fulfils the general criteria for curatively intended irradiation. The treatment plan consisted of two courses of inductions chemotherapy followed of concomitant therapy chemo-radiotherapy 3 weeks after day 1 of the last induction chemotherapy has been given. The patients was included in the study after completing the induction chemotherapy. Randomization took place only if an acceptable dose plan could be obtained.
Primary endpoint: local recurrence free interval
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B: 66Gy/33F+Navelbine oral 150 mg q3w | Experimental | 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 |
|
| A: 60Gy/30F+Navelbine oral 150 mg q3w | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navelbine | Drug | Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local Failure Free Survival | Local failure free survival 9 month after first RT treatment measured by CT/FDG-CT | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Early Toxicity to Concurrent Vinorelbine and Radiotherapy | 9 months | |
| Local Tumour Control | Loco-regional control | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olfred Hansen, MD | Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Aalborg University Hospital | Aalborg | 9100 | Denmark | |||
| Department of Oncology, Aarhus University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28410809 | Result | Hansen O, Knap MM, Khalil A, Nyhus CH, McCulloch T, Holm B, Brink C, Hoffmann L, Schytte T. A randomized phase II trial of concurrent chemoradiation with two doses of radiotherapy, 60Gy and 66Gy, concomitant with a fixed dose of oral vinorelbine in locally advanced NSCLC. Radiother Oncol. 2017 May;123(2):276-281. doi: 10.1016/j.radonc.2017.03.017. Epub 2017 Apr 11. |
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Further studies on toxicity profiles and PET may be performed
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117 included July 2009 to August 2013
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Local Failure Free Survival | Local failure free survival 9 month after first RT treatment measured by CT/FDG-CT | Analyzed as intention to treat | Posted | Median | Full Range | months | 9 months |
|
5 years, death or recurrence
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Pneumonitis, pneumonia, embolus |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leucopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Olfred Hansen, Professor, Ph.D. | Dept. Oncology, Odense University Hospital | +4524241588 | olfred.hansen@rsyd.dk |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
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| OTHER |
| Copenhagen University Hospital at Herlev | OTHER |
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No blinding after randomization
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|
| 66 Gy/33F | Radiation | irradiation to 66 Gy (2 Gy x 30, 5 F á weeks) |
|
| 60 Gy/30F | Radiation | irradiation to 60 Gy (2 Gy x 30, 5 F á weeks) |
|
| Overall Survival | Overall survival, death of any cause | 72 months |
| Late Toxicity | Late toxicity related to concurrent Vinorelbine and radiotherapy | 48 months |
| Disease Free Survival | Disease free survival, death of any cause | 72 months |
| Aarhus |
| 8000 |
| Denmark |
| Department of Oncology, Copenhagen University Hospital Herlev | Herlev | 2730 | Denmark |
| Department of Oncology, Odense University Hospital | Odense | 5000 | Denmark |
| Laboratory of Radiation Physics | Odense | 5000 | Denmark |
| Department of Oncology, Vejle Hospital | Vejle | 7100 | Denmark |
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | 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) |
|
|
| Secondary | Number of Participants Who Experienced Early Toxicity to Concurrent Vinorelbine and Radiotherapy | Dysphagia, weight loss ≥20%, pulmonary toxicity grade 3, leucopenia grade 3 or higher | Posted | Number | participants | 9 months |
|
|
|
| Secondary | Local Tumour Control | Loco-regional control | Not Posted | Sep 2022 | 9 months | Participants |
| Secondary | Overall Survival | Overall survival, death of any cause | Overall survival, intention to treat | Posted | Median | Full Range | Months | 72 months |
|
|
|
| Secondary | Late Toxicity | Late toxicity related to concurrent Vinorelbine and radiotherapy | Not Posted | Sep 2022 | 48 months | Participants |
| Secondary | Disease Free Survival | Disease free survival, death of any cause | Posted | Median | Full Range | Months | 72 months |
|
|
|
| 41 |
| 58 |
| 18 |
| 58 |
| 25 |
| 58 |
| EG001 | 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) | 44 | 59 | 15 | 59 | 20 | 59 |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Dysphagia, esophagitis, stenosis, obstipation, nausea |
|
| Herpes zoster | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment | Herpes zoster |
|
| Atrial fibrilation | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Atrial flutter |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pulmonary toxicity | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006571 |
| Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| Leucopenia g3+ |
|