Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181506
Status:
COMPLETED
Last Update Posted:
2009-06-30
First Post:
2005-09-13
Brief Title:
HI-CHARTFeasibility of High-Dose Accelerated Conformal Radiotherapy
Sponsor:
Maastricht Radiation Oncology
Organization:
Maastricht Radiation Oncology
Study Overview
Official Title:
HI-CHART A Phase III Study on the Feasibility of High-Dose Accelerated Conformal Radiotherapy in Patients With Inoperable Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study we try to increase the radiation dose while reducing or keeping the radiation schedule below 4 weeks
The study hypothesis is that it is feasible to administer hyperfractionated accelerated radiotherapy to patients with inoperable or locally advanced non small cell lung cancer
The study hypothesis is that it is feasible to administer hyperfractionated accelerated radiotherapy to patients with inoperable or locally advanced non small cell lung cancer
Detailed Description:
Non-small cell lung cancer is still the most common cancer and the main cause of cancer death Treatment of choice for these patients is often radiotherapy which results in an overall 5-year survival rate between 5 and 10 The addition of chemotherapy improves survival by a few percentages and is therefore considered standard treatment for patients with stage III disease
However several factors have been identified that have an impact on the local control but also on survival
1 There is a dose-effect relationship A higher dose results in a better survival rate However higher radiation doses are currently not delivered with conventional radiation due to the tolerance of normal tissue
2 The time factor plays an important role in radiotherapy Prolonging the overall treatment time decreases the outcome of radiotherapy Radiobiological modelling of data shows that the overall treatmetn time OTT should be kept below 4 weeks Results from studies support this conclusion
So probably the best results will be achieved when a very high radiation dose can be delivered within 4 weeks without severally damaging normal tissue
In order to achieve this goal an hyperfractionated accelerated treatment regimen together with a technically very advanced radiation technique to avoid as much normal tissue as possible will be used in this study
However several factors have been identified that have an impact on the local control but also on survival
1 There is a dose-effect relationship A higher dose results in a better survival rate However higher radiation doses are currently not delivered with conventional radiation due to the tolerance of normal tissue
2 The time factor plays an important role in radiotherapy Prolonging the overall treatment time decreases the outcome of radiotherapy Radiobiological modelling of data shows that the overall treatmetn time OTT should be kept below 4 weeks Results from studies support this conclusion
So probably the best results will be achieved when a very high radiation dose can be delivered within 4 weeks without severally damaging normal tissue
In order to achieve this goal an hyperfractionated accelerated treatment regimen together with a technically very advanced radiation technique to avoid as much normal tissue as possible will be used in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MEC MAASTRO clinic 0105 | None | None | None |