Condition category
Cancer
Date applied
28/04/2009
Date assigned
29/05/2009
Last edited
29/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Roy Bremnes

ORCID ID

Contact details

Oncology Department
University Hospital of North Norway
Tromsø
9038
Norway
roy.bremnes@unn.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Norwegian Social Science Data Services no. 15175; UNN (PVO) no. 0147

Study information

Scientific title

A randomised, multicentre phase III trial of combination chemotherapy +/- thoracic radiotherapy in the treatment of patients with stage III non-small cell lung cancer not eligible for radical therapy

Acronym

Conrad

Study hypothesis

That a combination of chemotherapy and thoracic radiation is superior to chemotherapy alone in the treatment of patients with stage III non-small cell lung cancer, non-eligible for radical therapy, with overall survival as primary endpoint.

Protocol can be found at: http://www.nlcg.no/uploads/conrad_protokoll.pdf

Ethics approval

1. Regional Ethical Review Board approved on the 19th July 2006
2. Norwegian Social Science Data Services approved on the 7th November 2006

Study design

Open randomised multicentre phase III trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Can be found at: http://www.nlcg.no/uploads/conrad_protokoll.pdf

Condition

Non-small cell lung cancer

Intervention

The participants will be randomised to the following two arms:
Arm 1: Chemotherapy and thoracic radiation
Arm 2: Chemotherapy alone

Chemotherapy:
All patients will receive 4 cycles of identical regimes of chemotherapy: Oral vinorelbine tablets 60 mg/m^2 orally (per os) day 1 and 8 and intravenous carboplatin AUC = 5 (Calvert's formula) over one hour day 1. However, the doses will be adjusted according to age (patients age greater than 75 year will be given 75% of full dose from cure no.1) and haematological toxicity.

Schedule of radiation therapy:
Simulator planned, two opposing fields with fractionation 2.8 Gy x 15. The radiotherapy should start at the same time as or just after cycle number two. Cycle number three should be given three weeks after cycle number two.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Overall survival, followed-up for 52 weeks.

Secondary outcome measures

1. Health related quality of life, assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) version 3.0 and the lung cancer specific module EORTC QLQ-LC13. The questionnaires will be sent to the patients every month during the treatment period and every second month after the treatment period for a total of 10 questionnaires completed per patient.
2. Time to progression, followed-up for 52 weeks
3. In field relapse, followed-up for 52 weeks
4. Drug related adverse event frequency and severity, followed-up for 52 weeks
5. Health economics, followed-up for 52 weeks

Overall trial start date

15/11/2006

Overall trial end date

15/11/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Chemo-naive patients with non-small cell lung cancer (NSCLC) locally advanced stage III, not candidates for radical radiotherapy and with no pleural effusion
2. Performance status (World Health Organization [WHO]) 0 - 2
3. Ability to understand oral and written study information
4. Both males and females, no age limit
5. S-creatinine less than 1.5 times upper reference limit, bilirubin and S-transaminase levels less than 2 times upper limits. Normal white blood-cell and platelet count.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

352

Participant exclusion criteria

1. Other active malignancies
2. Pregnancy or breast feeding

Recruitment start date

15/11/2006

Recruitment end date

15/11/2013

Locations

Countries of recruitment

Norway

Trial participating centre

Oncology Department
Tromsø
9038
Norway

Sponsor information

Organisation

Pierre Fabre Pharma Norden AB (Sweden)

Sponsor details

Turebergs Torg 1
Sollentuna
SE-191 47
Sweden
tore.aalberg@pierre-fabre.com

Sponsor type

Industry

Website

http://www.pierre-fabre.com

Funders

Funder type

Industry

Funder name

Regional Health Authorities (HELSE NORD) (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Pierre Fabre Pharma Norden AB (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Please note that the Conrad study was initiated by the Norwegian Lung Cancer Group.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes