Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309732
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2014-09-09
Brief Title:
GAMEC-II Risk-adapted Protocol for Relapsed Germ Cell Tumours GCT
Sponsor:
Queen Mary University of London
Organization:
Queen Mary University of London
Study Overview
Official Title:
GAMEC-SHORT S GAMEC-ANTHRACYCLINEA Combination Chemotherapy With GCSF Actinomycin-D Methotrexate Etoposide and Cisplatin Risk-adapted Protocol for Relapsed Germ Cell Tumours GCT
Status:
COMPLETED
Status Verified Date:
2024-03
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:
GAMEC-II
Brief Summary:
St Bartholomews hospital completed a study using the regimen GAMEC PEG-filgrastim actinomycin-D methotrexate etoposide cisplatin The results of this study showed that 50 of patients with relapsed testicular cancer could be cured using this treatment These results are very encouraging and compare very favourably to other treatment protocols In reviewing this study it became clear that of the 5 cycles of treatment which were proposed the first 3 seemed to matter and the last 2 did not appear important In addition there was a group of patients who appeared to do particularly well namely patients under the age of 35 and those who had a normal LDH lactate dehydrogenase LDH is a blood test which monitors cancer activity Selecting patients which fill both these criteria this trial aims to see whether the investigators can maintain the good results the investigators have seen but using only 3 cycles of treatment This will therefore shorten the treatment from 10 weeks to 6 weeks thus reducing the side effects
Detailed Description:
GAMEC-II GAMEC -S GAMEC-A is an open-labelled non-randomised clinical trial in patients with relapsed germ cell tumours GCT and its objectives are
1 To establish the response rates to GAMEC-S or GAMEC-A
2 To establish the safety and efficacy of substitution of epirubicin for etoposide GAMEC-A regimen
3 To establish the toxicity of GAMEC-A
4 To establish progression free survival PFS
5 To establish whether shortening GAMEC-S in patients without adverse prognostic factors reduces toxicity without compromising survival
1 To establish the response rates to GAMEC-S or GAMEC-A
2 To establish the safety and efficacy of substitution of epirubicin for etoposide GAMEC-A regimen
3 To establish the toxicity of GAMEC-A
4 To establish progression free survival PFS
5 To establish whether shortening GAMEC-S in patients without adverse prognostic factors reduces toxicity without compromising survival
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 |
|---|---|---|---|
| 2006-001963-52 | EUDRACT_NUMBER | None | None |
| TE 2006-09 | OTHER | Barts and the London NHS Trust | None |