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Navelbine And Radiotherapy in Locally Advanced Lung Cancer (NARLAL)

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Navelbine
66 Gy/33F
60 Gy/30F
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Induction chemotherapy, Non-small cell lung cancer, Randomized phase II study, Navelbine Oral (R), 3D-conformal radiotherapy, Chemo-radiotherapy, Local-regionally advanced non-small cell lung cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥18 years
  • Patients with histologically or cytologically documented diagnosis of locally advanced NSCLC stage IIB to IIIB without pleural effusion
  • Performance status 0-1 on the ECOG scale
  • Weight loss ≤10% during the last 6 months
  • Adequate lung function measured as FEV1 ≥1.0
  • Neutrophile count ≥1.5 x 109/L and platelet count ≥100 x 109/L
  • Serum bilirubin ≤1.5 upper limit of normal (ULN)
  • ALAT ≤2 x ULN
  • Able to comply with study and follow-up procedures
  • Patients with reproductive potential must use effective contraception
  • Written (signed) informed consent to participate in the study

Exclusion Criteria:

  • Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease)
  • Any other active malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
  • Prior chemotherapy for lung cancer, including neo- and adjuvant chemotherapy
  • Inability to take oral medication, or requirement of intravenous alimentation
  • Active peptic ulcer disease
  • Nursing mothers

Sites / Locations

  • Department of Oncology, Aalborg University Hospital
  • Department of Oncology, Aarhus University Hospital
  • Department of Oncology, Copenhagen University Hospital Herlev
  • Department of Oncology, Odense University Hospital
  • Laboratory of Radiation Physics
  • Department of Oncology, Vejle Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

B: 66Gy/33F+Navelbine oral 150 mg q3w

A: 60Gy/30F+Navelbine oral 150 mg q3w

Arm Description

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 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

Outcomes

Primary Outcome Measures

Local Failure Free Survival
Local failure free survival 9 month after first RT treatment measured by CT/FDG-CT

Secondary Outcome Measures

Number of Participants Who Experienced Early Toxicity to Concurrent Vinorelbine and Radiotherapy
Local Tumour Control
Loco-regional control
Overall Survival
Overall survival, death of any cause
Late Toxicity
Late toxicity related to concurrent Vinorelbine and radiotherapy
Disease Free Survival
Disease free survival, death of any cause

Full Information

First Posted
April 23, 2009
Last Updated
April 22, 2022
Sponsor
Odense University Hospital
Collaborators
Aarhus University Hospital, Vejle Hospital, Rigshospitalet, Denmark, Aalborg University Hospital, Copenhagen University Hospital at Herlev
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1. Study Identification

Unique Protocol Identification Number
NCT00887783
Brief Title
Navelbine And Radiotherapy in Locally Advanced Lung Cancer
Acronym
NARLAL
Official Title
Induction Chemotherapy With Carboplatin and Navelbine Oral(R) Followed by Concomitant Navelbine Oral(R) and Irradiation in Local-regionally Advanced Non-small Cell Lung Cancer. A Randomized Phase II Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2009 (Actual)
Primary Completion Date
September 1, 2016 (Actual)
Study Completion Date
September 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
Aarhus University Hospital, Vejle Hospital, Rigshospitalet, Denmark, Aalborg University Hospital, Copenhagen University Hospital at Herlev

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Induction chemotherapy, Non-small cell lung cancer, Randomized phase II study, Navelbine Oral (R), 3D-conformal radiotherapy, Chemo-radiotherapy, Local-regionally advanced non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
No blinding after randomization
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B: 66Gy/33F+Navelbine oral 150 mg q3w
Arm Type
Experimental
Arm Description
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
Arm Title
A: 60Gy/30F+Navelbine oral 150 mg q3w
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Navelbine
Other Intervention Name(s)
Vinorelbine
Intervention Description
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks
Intervention Type
Radiation
Intervention Name(s)
66 Gy/33F
Intervention Description
irradiation to 66 Gy (2 Gy x 30, 5 F á weeks)
Intervention Type
Radiation
Intervention Name(s)
60 Gy/30F
Intervention Description
irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)
Primary Outcome Measure Information:
Title
Local Failure Free Survival
Description
Local failure free survival 9 month after first RT treatment measured by CT/FDG-CT
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Number of Participants Who Experienced Early Toxicity to Concurrent Vinorelbine and Radiotherapy
Time Frame
9 months
Title
Local Tumour Control
Description
Loco-regional control
Time Frame
9 months
Title
Overall Survival
Description
Overall survival, death of any cause
Time Frame
72 months
Title
Late Toxicity
Description
Late toxicity related to concurrent Vinorelbine and radiotherapy
Time Frame
48 months
Title
Disease Free Survival
Description
Disease free survival, death of any cause
Time Frame
72 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years Patients with histologically or cytologically documented diagnosis of locally advanced NSCLC stage IIB to IIIB without pleural effusion Performance status 0-1 on the ECOG scale Weight loss ≤10% during the last 6 months Adequate lung function measured as FEV1 ≥1.0 Neutrophile count ≥1.5 x 109/L and platelet count ≥100 x 109/L Serum bilirubin ≤1.5 upper limit of normal (ULN) ALAT ≤2 x ULN Able to comply with study and follow-up procedures Patients with reproductive potential must use effective contraception Written (signed) informed consent to participate in the study Exclusion Criteria: Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease) Any other active malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer) Prior chemotherapy for lung cancer, including neo- and adjuvant chemotherapy Inability to take oral medication, or requirement of intravenous alimentation Active peptic ulcer disease Nursing mothers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olfred Hansen, MD
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology, Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Department of Oncology, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Department of Oncology, Copenhagen University Hospital Herlev
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Department of Oncology, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Laboratory of Radiation Physics
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Department of Oncology, Vejle Hospital
City
Vejle
ZIP/Postal Code
7100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Further studies on toxicity profiles and PET may be performed
Citations:
PubMed Identifier
28410809
Citation
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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Navelbine And Radiotherapy in Locally Advanced Lung Cancer

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