NCT00887783

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P75+ for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started May 2009

Longer than P75 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2009

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

January 8, 2021

Completed
Last Updated

May 17, 2022

Status Verified

April 1, 2022

Enrollment Period

7.3 years

First QC Date

April 23, 2009

Results QC Date

July 21, 2017

Last Update Submit

April 22, 2022

Conditions

Non-small Cell Lung Cancer

Keywords

Induction chemotherapyNon-small cell lung cancerRandomized phase II studyNavelbine Oral (R)3D-conformal radiotherapyChemo-radiotherapyLocal-regionally advanced non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Local Failure Free Survival

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

    9 months

Secondary Outcomes (5)

  • Number of Participants Who Experienced Early Toxicity to Concurrent Vinorelbine and Radiotherapy

    9 months

  • Local Tumour Control

    9 months

  • Overall Survival

    72 months

  • Late Toxicity

    48 months

  • Disease Free Survival

    72 months

Study Arms (2)

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

Drug: NavelbineRadiation: 66 Gy/33F

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

Drug: NavelbineRadiation: 60 Gy/30F

Interventions

NavelbineDRUG

Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks

Also known as: Vinorelbine
A: 60Gy/30F+Navelbine oral 150 mg q3wB: 66Gy/33F+Navelbine oral 150 mg q3w
66 Gy/33FRADIATION

irradiation to 66 Gy (2 Gy x 30, 5 F á weeks)

B: 66Gy/33F+Navelbine oral 150 mg q3w
60 Gy/30FRADIATION

irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)

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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Department of Oncology, Aalborg University Hospital

Aalborg, 9100, Denmark

Location

Department of Oncology, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Department of Oncology, Copenhagen University Hospital Herlev

Herlev, 2730, Denmark

Location

Department of Oncology, Odense University Hospital

Odense, 5000, Denmark

Location

Laboratory of Radiation Physics

Odense, 5000, Denmark

Location

Department of Oncology, Vejle Hospital

Vejle, 7100, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 28410809RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Vinorelbine

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Results Point of Contact

Title
Dr. Olfred Hansen, Professor, Ph.D.
Organization
Dept. Oncology, Odense University Hospital
olfred.hansen@rsyd.dk
+4524241588

Study Officials

  • Olfred Hansen, MD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No blinding after randomization
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor

Study Record Dates

First Submitted

April 23, 2009

First Posted

April 24, 2009

Study Start

May 1, 2009

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

May 17, 2022

Results First Posted

January 8, 2021

Record last verified: 2022-04

Locations

DK(6)