Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181532
Status:
COMPLETED
Last Update Posted:
2009-06-30
First Post:
2005-09-13
Brief Title:
Phase II Study of Celecoxib and Concurrent Radiotherapy in Stage II-III NSCLC
Sponsor:
Maastricht Radiation Oncology
Organization:
Maastricht Radiation Oncology
Study Overview
Official Title:
A Multicentre Randomised Double Blind Placebo-Controlled Phase II Study of Celecoxib and Concurrent Radiotherapy in Stage II-III NSCLC An Evaluation of Both Tumor Radiosensitization and Normal Tissue Protection
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:
The purpose of this study is to investigate the effect of the adminstration of celecoxib a cox2-inhibitor in patients with stage II-III non small cell lung cancer receiving radical radiotherapy
The hypothesis is that celecoxib will increase the remission rate of radiotherapy
The hypothesis is that celecoxib will increase the remission rate of radiotherapy
Detailed Description:
Treatment of non-small cell lung cancer NSCLC is difficult even with the best classical radiation and chemotherapy schedule results remain disappointing However there is evidence that increasing the local control rate by delivering radiotherapy either in a short period of time or concomitantly with chemotherapy improves survival Drawback of a higher radiation dose or addition of chemotherapy is a higher incidence of toxicity So radiation dose escalation could lead to further improvements of prognosis but the radiation dose is however limited by radiation-induced lung and esophageal damage
For NSCLC non-toxic agents who both increase the effectiveness of radiotherapy and decrease radiation induced lung and esophageal damage are needed The cox-2-inhibitors seem to be suitable for this purpose In experimental mice tumor models it was already shown that COX-2-inhibitors both inhibit tumor growth and enhance the radio-response of the tumor Moreover anti-inflammatory agents such asCOX-2-inhibitors also lowered the incidence of radiation pneumonitis and esophagitis
In this study the simultaneous favourable effects of COX-2 inhibitors on tumor response and radiation damage in human cancer patients will be investigated
Patients will be randomised to receive Celecoxib or placebo All patients will receive the same radiotherapy treatment Primary outcome measure is tumor response assessed by a CT-scan of the thorax three months after radiotherapy
The tumor response rate of the experimental group will be compared to the tumor response rate of the control group
For NSCLC non-toxic agents who both increase the effectiveness of radiotherapy and decrease radiation induced lung and esophageal damage are needed The cox-2-inhibitors seem to be suitable for this purpose In experimental mice tumor models it was already shown that COX-2-inhibitors both inhibit tumor growth and enhance the radio-response of the tumor Moreover anti-inflammatory agents such asCOX-2-inhibitors also lowered the incidence of radiation pneumonitis and esophagitis
In this study the simultaneous favourable effects of COX-2 inhibitors on tumor response and radiation damage in human cancer patients will be investigated
Patients will be randomised to receive Celecoxib or placebo All patients will receive the same radiotherapy treatment Primary outcome measure is tumor response assessed by a CT-scan of the thorax three months after radiotherapy
The tumor response rate of the experimental group will be compared to the tumor response rate of the control group
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 0205 | None | None | None |
| CKTO 2003-07 | None | None | None |
| IKL 2003-02 | None | None | None |