Concomitant chemoradiotherapy for treatment of non-small cell lung cancer - the Conrad study

ISRCTN	ISRCTN63778716
DOI	https://doi.org/10.1186/ISRCTN63778716
Protocol serial number	Norwegian Social Science Data Services no. 15175; UNN (PVO) no. 0147
Sponsor	Pierre Fabre Pharma Norden AB (Sweden)
Funders	Regional Health Authorities (HELSE NORD) (Norway), Pierre Fabre Pharma Norden AB (Sweden), Please note that the Conrad study was initiated by the Norwegian Lung Cancer Group.

Submission date: 28/04/2009
Registration date: 29/05/2009
Last edited: 21/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Roy Bremnes
Scientific

Oncology Department
University Hospital of North Norway
Tromsø
9038
Norway

Email	roy.bremnes@unn.no

Study information

Primary study design	Interventional
Study design	Open randomised multicentre phase III trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	Conrad
Study objectives	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(s)	1. Regional Ethical Review Board approved on the 19th July 2006 2. Norwegian Social Science Data Services approved on the 7th November 2006
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Overall survival, followed-up for 52 weeks.
Key secondary outcome measure(s)	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
Completion date	15/11/2013

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	352
Key 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.
Key exclusion criteria	1. Other active malignancies 2. Pregnancy or breast feeding
Date of first enrolment	15/11/2006
Date of final enrolment	15/11/2013

Locations

Countries of recruitment

Norway

Study participating centre

Oncology Department

Tromsø
9038
Norway

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	17/09/2013	21/01/2019	Yes	No
Results article	results	01/06/2014	21/01/2019	Yes	No
Results article	results	01/05/2015	21/01/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

21/01/2019: Publication references added