Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00193921
Status:
COMPLETED
Last Update Posted:
2014-08-04
First Post:
2005-09-13
Brief Title:
Chemoradiotherapy in Patients With Localised Lung Cancer
Sponsor:
Trans Tasman Radiation Oncology Group
Organization:
Trans Tasman Radiation Oncology Group
Study Overview
Official Title:
A Randomised Phase II Study of Two Regimens of Palliative Chemoradiation Therapy in the Management of Locally Advanced Non Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2014-07
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 study compares 2 different methods of combined chemotherapy and radiotherapy for the treatment of localised lung cancer in patients not suitable for surgery
Hypothesises to be tested
1 Vinorelbine cisplatin high-dose palliative radiotherapy is superior to gemcitabine high dose palliative radiotherapy in terms of efficacy in a multi-institutional setting
2 Vinorelbine cisplatin high-dose palliative radiotherapy is superior to gemcitabine high dose palliative radiotherapy in terms of feasibility in a multi-institutional setting
3 Vinorelbine cisplatin high-dose palliative radiotherapy has a favourable toxicity profile relative to gemcitabine high-dose palliative radiotherapy
Hypothesises to be tested
1 Vinorelbine cisplatin high-dose palliative radiotherapy is superior to gemcitabine high dose palliative radiotherapy in terms of efficacy in a multi-institutional setting
2 Vinorelbine cisplatin high-dose palliative radiotherapy is superior to gemcitabine high dose palliative radiotherapy in terms of feasibility in a multi-institutional setting
3 Vinorelbine cisplatin high-dose palliative radiotherapy has a favourable toxicity profile relative to gemcitabine high-dose palliative radiotherapy
Detailed Description:
A third of patients with non-small cell lung cancer NSCLC present with Stage IIIA or IIIB disease which is not amenable to curative resection Single modality local therapy either surgery or radiation only cures a fraction of such patients
Radical radiation is not feasible for all patients with unresectable Stage IIIA or IIIB non-small cell lung cancer based upon the extent of the loco-regional disease or the medical state of the patient Patients of good performance status receiving protracted high-dose palliative radiotherapy do obtain a survival benefit from this therapy Studies have shown a survival advantage by adding chemotherapy to radical radiation therapy but studies in the high-dose palliative radiotherapy setting are lacking Two regimens of concurrent chemotherapy with high-dose palliative radiotherapy have been developed locally with established MTDs These 2 regimens do warrant a comparative assessment in a phase II trial prior to a phase III trial against high dose palliative radiation alone 36Gy125
This is a randomised phase II trial comprising of 2 arms for randomization as follows
Arm AExternal beam radiation 40 Gy205 per week Plus concurrent Vinorelbine IV 25mgm2 days 1 8 22 and Cisplatin 20mgm2 IV weekly
Arm BExternal beam radiation 30 Gy155 per week Plus concurrentGemcitabine 200mg flat dose IV days 1 8 15
An equal number of patients will be randomised to each arm The randomisation will be carried out by the Princess Alexandra Trial Centre
Patients will be assessed at baseline weekly during treatment and then at 3 weeks 6 weeks and 12 weeks post treatment then 3 monthly thereafter
Radical radiation is not feasible for all patients with unresectable Stage IIIA or IIIB non-small cell lung cancer based upon the extent of the loco-regional disease or the medical state of the patient Patients of good performance status receiving protracted high-dose palliative radiotherapy do obtain a survival benefit from this therapy Studies have shown a survival advantage by adding chemotherapy to radical radiation therapy but studies in the high-dose palliative radiotherapy setting are lacking Two regimens of concurrent chemotherapy with high-dose palliative radiotherapy have been developed locally with established MTDs These 2 regimens do warrant a comparative assessment in a phase II trial prior to a phase III trial against high dose palliative radiation alone 36Gy125
This is a randomised phase II trial comprising of 2 arms for randomization as follows
Arm AExternal beam radiation 40 Gy205 per week Plus concurrent Vinorelbine IV 25mgm2 days 1 8 22 and Cisplatin 20mgm2 IV weekly
Arm BExternal beam radiation 30 Gy155 per week Plus concurrentGemcitabine 200mg flat dose IV days 1 8 15
An equal number of patients will be randomised to each arm The randomisation will be carried out by the Princess Alexandra Trial Centre
Patients will be assessed at baseline weekly during treatment and then at 3 weeks 6 weeks and 12 weeks post treatment then 3 monthly thereafter
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 |
|---|---|---|---|
| PMCC Protocol No 0385 | None | None | None |