Navelbine And Radiotherapy in Locally Advanced Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00887783
• Other study ID #: 09.01
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2009
• Est. completion date: September 1, 2016

Study information

• Verified date: April 2022
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: September 1, 2016
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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

Radiation:
• 66 Gy/33F
irradiation to 66 Gy (2 Gy x 30, 5 F á weeks)
• 60 Gy/30F
irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)

Locations

Country	Name	City	State
Denmark	Department of Oncology, Aalborg University Hospital	Aalborg
Denmark	Department of Oncology, Aarhus University Hospital	Aarhus
Denmark	Department of Oncology, Copenhagen University Hospital Herlev	Herlev
Denmark	Department of Oncology, Odense University Hospital	Odense
Denmark	Laboratory of Radiation Physics	Odense
Denmark	Department of Oncology, Vejle Hospital	Vejle

Sponsors (6)

Lead Sponsor	Collaborator
Odense University Hospital	Aalborg University Hospital, Aarhus University Hospital, Copenhagen University Hospital at Herlev, Rigshospitalet, Denmark, Vejle Hospital

Country where clinical trial is conducted

Denmark, 

References & 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 locall — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Failure Free Survival	Local failure free survival 9 month after first RT treatment measured by CT/FDG-CT	9 months
Secondary	Number of Participants Who Experienced Early Toxicity to Concurrent Vinorelbine and Radiotherapy		9 months
Secondary	Local Tumour Control	Loco-regional control	9 months
Secondary	Overall Survival	Overall survival, death of any cause	72 months
Secondary	Late Toxicity	Late toxicity related to concurrent Vinorelbine and radiotherapy	48 months
Secondary	Disease Free Survival	Disease free survival, death of any cause	72 months