Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone With Intensity-modulated Radiotherapy (IMRT) for Non Small Cell Lung Cancer (NSCLC) to an Individualised Mean Lung Dose (MLD)
1 other identifier
interventional
300
1 country
1
Brief Summary
Our group has shown that increasing the radiation dose to pre-specified normal tissue dose constraints could lead to increased TCP with the same NTCP in patients with non-concurrent and concurrent chemo-radiation. Here, the investigators want to investigate its efficacy in a prospective study in patients with stage I-III NSCLC, who are selected for high-dose radiotherapy with or without chemotherapy, but treated with IMRT. The latter technique has become standard, but the patterns of recurrence and the possibility for dose-escalation in an individualised setting have never been investigated properly.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2009
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 19, 2010
CompletedFirst Posted
Study publicly available on registry
July 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedMay 23, 2017
May 1, 2017
8 years
July 19, 2010
May 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
2.3 and 5 years
Secondary Outcomes (4)
Progression-free survival
2.3 and 5 years
Dyspnea (CTCAE 4.0)
2.3 and 5 years
Dysphagia (CTCAE 4.0)
2.3 and 5 years
Patterns of recurrence
2.3 and 5 years
Study Arms (1)
Single group
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Histological or cytological proven NSCLC
- IUCC stage I-III, or solitary metastases (\<6), which are amendable for radical local treatment.
- Performance status 0-2
- IMRT technique
You may not qualify if:
- Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma)
- Stage IV, except for solitary (\<6) metastases
- Performance status 3 or more
- No IMRT technique
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MAASTRO clinic
Maastricht, Limburg, 6229 ET, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2010
First Posted
July 20, 2010
Study Start
May 1, 2009
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
May 23, 2017
Record last verified: 2017-05