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 |
| ClinicalTrials.gov (NCT) | NCT00551122 |
| Clinical Trials Information System (CTIS) | 2004-004804-19 |
| Protocol serial number | 1447 |
| Sponsor | Southampton University Hospitals NHS Trust (UK) |
| Funder | Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) grant |
- 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
Contact information
Mrs Kelly Cozens
Scientific
Scientific
University of Southampton Clinical Trials Unit, MP 131
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised multicentre interventional treatment trial |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant 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 |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Gemcitabine, paclitaxel, ifosfamide, cisplatin |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
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 |
| Completion date | 04/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 14 |
| 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
- United Kingdom
- England
Study participating centre
University of Southampton Clinical Trials Unit, MP 131
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2018 | 08/03/2019 | Yes | No |
| Abstract results | conference abstract | 01/06/2014 | 08/03/2019 | No | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes | |||
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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.
