Phase I/II multicentre trial of salvage chemotherapy with Gem-TIP for relapsed germ cell cancer

ISRCTN	ISRCTN37453564
DOI	https://doi.org/10.1186/ISRCTN37453564
EudraCT/CTIS number	2004-004804-19
ClinicalTrials.gov number	NCT00551122
Secondary identifying numbers	1447

Submission date: 31/03/2010
Registration date: 31/03/2010
Last edited: 04/04/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-chemotherapy-combination-Gem-TIP-advanced-germ-cell-cancer

Study website

Contact information

Mrs Kelly Cozens
Scientific

University of Southampton Clinical Trials Unit, MP 131
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Study information

Study design	Non-randomised multicentre interventional treatment trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A non-randomised multicentre phase I/II interventional trial of a tolerable salvage chemotherapy regimen for patients with metastatic germ cell cancer who have failed first-line chemotherapy
Study acronym	Gem-TIP
Study objectives	The purpose of this study is to develop a tolerable, highly active, salvage chemotherapy regimen to be used in patients with metastatic germ cell cancer who have failed first-line chemotherapy. On 01/03/2011 the target number of participants was changed from 28 to 14.
Ethics approval(s)	Southampton and South west Hampshire REC A, 05/04/2005, ref: 05/Q1702/22
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network; Subtopic: Testis Cancer; Disease: Testis
Intervention	4 cycles of chemotherapy, 4 cycles of chemotherapy using gemcitabine and paclitaxel, ifosfamide, cisplatin (TIP) regimen. Follow Up Length: 12 month(s) Study Entry : Registration only
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Gemcitabine, paclitaxel, ifosfamide, cisplatin
Primary outcome measure	To assess the maximally tolerated dose of Gem-TIP (+Granulocyte colony-stimulating factor [+GCSF]) when compared with TIP, established in the phase 1 aspect of the trial
Secondary outcome measures	To measure response rates and failure free survival after Gem-TIP alone, assessed at 1, 2, 3, 4, 6, 8 10 and 12 months post-treatment
Overall study start date	11/10/2005
Completion date	04/09/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	14 (28 at time of registration)
Total final enrolment	20
Key inclusion criteria	1. First relapse after single previous cisplatin-containing combination chemotherapy for metastatic extracranial primary germ cell cancer, seminoma and non-seminoma, male or female patients 2. All cases must have either rising serum markers (alphafetoprotein [AFP], human chorionic gonadotropin [HCG]) on sequential measurement, or biopsy-proven unresectable germ cell cancer. Patients with completely resected cancer are not eligible for this study. Patients with late relapse (greater than 2 years post-initial chemotherapy) should be considered for surgery rather than chemotherapy where technically feasible. Patients with cerebral metastases alone are not eligible. Patients with progressive cerebral and systemic disease may be considered for this study. However, it is recommended that cranial irradiation also be considered a component of care. 3. Aged 16 - 60 years 4. Considered medically and psychologically fit to receive this intensive chemotherapy schedule 5. White blood cells (WBC) greater than 3.5 x 10^9/l. Platelets greater than 130 x 10^9/l 6. Glomerular filtration rate (24 hours)
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	11/10/2005
Date of final enrolment	04/09/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Southampton Clinical Trials Unit, MP 131

Southampton
SO16 6YD
United Kingdom

Sponsor information

Southampton University Hospitals NHS Trust (UK)
Hospital/treatment centre

Tremona Road
Southampton
SO16 6YD
England
United Kingdom

Website	http://www.suht.nhs.uk/home.aspx
"ROR"	https://ror.org/0485axj58

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) grant

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Abstract results	conference abstract	01/06/2014	08/03/2019	No	No
Results article	results	01/12/2018	08/03/2019	Yes	No

Editorial Notes

04/04/2022: Total final enrolment added.
11/04/2019: Internal review.
08/03/2019: Publication references added.
26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
16/03/2017: No publications found in PubMed, verifying study status with principal investigator.