Concomitant chemoradiotherapy for treatment of non-small cell lung cancer - the Conrad study
| ISRCTN | ISRCTN63778716 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63778716 |
| Secondary identifying numbers | Norwegian Social Science Data Services no. 15175; UNN (PVO) no. 0147 |
- 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
Scientific
Oncology Department
University Hospital of North Norway
Tromsø
9038
Norway
| roy.bremnes@unn.no |
Study information
| Study design | Open randomised multicentre phase III trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Can be found at: http://www.nlcg.no/uploads/conrad_protokoll.pdf |
| 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 | 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 study start date | 15/11/2006 |
| Completion date | 15/11/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 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
9038
Norway
Sponsor information
Pierre Fabre Pharma Norden AB (Sweden)
Industry
Industry
Turebergs Torg 1
Sollentuna
SE-191 47
Sweden
| tore.aalberg@pierre-fabre.com | |
| Website | http://www.pierre-fabre.com |
"ROR" |
https://ror.org/04hdhz511 |
Funders
Funder type
Industry
Regional Health Authorities (HELSE NORD) (Norway)
No information available
Pierre Fabre Pharma Norden AB (Sweden)
No information available
Please note that the Conrad study was initiated by the Norwegian Lung Cancer Group.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
21/01/2019: Publication references added
