A Phase 2 interventional study of Carboplatin AUC-10 in Metastatic Seminoma, sponsored by Barts & The London NHS Trust. Completed at 2 sites in United Kingdom. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-01-25.
Sponsored by Barts & The London NHS Trust · Phase 2, Interventional, and Treatment
This study evaluated the safety, efficacy and toxicity of carboplatin area under the curve (AUC)-10 in metastatic seminoma to see if, by using fluoro-deoxyglucose (FDG) positron emission tomography-computed tomography (PET-CT) to assess metabolic response, the number of patients requiring 4 cycles can be reduced. Carboplatin AUC-10 was given every 21 days. A PET-CT scan was carried out on day 17-21 of the first cycle. If the PET - CT scan showed a complete response patients received 3 cycles of treatment. If the PET - CT scan did not show a complete response patients received 4 cycles of treatment. After treatment, patients were followed up for 2 years.
63 studies on the registry are indexed under Seminoma; 15 are open to participants now.
This study's enrollment of 48 is close to the median of 50 across 47 interventional studies indexed under Seminoma.
Browse Seminoma studies →Barts & The London NHS Trust is the lead sponsor of 151 studies on the registry; 21 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Carboplatin AUC-10
Carboplatin AUC-10 according to the Calvert formula \[10 x (glomerular filtration rate (ml/min) + 25)\]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles.
2 - Year Progression Free Survival
Number of participants progression free 2 years after registration.
Time frame: 2 years
Metabolic Response Rate
Number of participants achieving i) complete metabolic response (CR) and ii) partial metabolic response (PR) after one cycle of treatment.
Time frame: 21 days
Overall Survival
Survival status at 2 years after registration.
Time frame: 2 years
| Milestone | Carboplatin AUC-10 |
|---|---|
| Started | 48 |
| Completed | 47 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
Number of participants progression free 2 years after registration.
| Participants | Carboplatin AUC-10 |
|---|---|
| 2 - Year Progression Free Survival | 46 |
Number of participants achieving i) complete metabolic response (CR) and ii) partial metabolic response (PR) after one cycle of treatment.
| Participants | Carboplatin AUC-10 |
|---|---|
| CR | 21 |
| PR | 26 |
Survival status at 2 years after registration.
| Participants | Carboplatin AUC-10 |
|---|---|
| Alive | 48 |
| Deceased | 0 |
Collected over Start of treatment until 30 days after last dose.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Carboplatin AUC-10 | 0/48 (0%) | 12/48 (25%) | 47/48 (97.9%) |
| Event | Carboplatin AUC-10 |
|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 4/48 |
| NauseaGastrointestinal disorders | 3/48 |
| HeadacheNervous system disorders | 2/48 |
| VomitingGastrointestinal disorders | 2/48 |
| Deep vein thrombosisVascular disorders | 1/48 |
| HypotensionVascular disorders | 1/48 |
| Peripheral ischaemiaVascular disorders | 1/48 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/48 |
| AnaemiaBlood and lymphatic system disorders | 1/48 |
| Hearing impairedEar and labyrinth disorders | 1/48 |
| Event | Carboplatin AUC-10 |
|---|---|
| FatigueGeneral disorders | 44/48 |
| NauseaGastrointestinal disorders | 37/48 |
| Neutrophil count decreasedInvestigations | 34/48 |
| Platelet count decreasedInvestigations | 28/48 |
| AnaemiaBlood and lymphatic system disorders | 27/48 |
| Decreased appetiteMetabolism and nutrition disorders | 22/48 |
| ConstipationGastrointestinal disorders | 17/48 |
| StomatitisGastrointestinal disorders | 16/48 |
| VomitingGastrointestinal disorders | 14/48 |
| TinnitusEar and labyrinth disorders | 13/48 |
| Age, Categorical(Participants) | Carboplatin AUC-10 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 47 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Carboplatin AUC-10 |
|---|---|
| Female | 0 |
| Male | 48 |
| Race and Ethnicity Not Collected(Participants) | Carboplatin AUC-10 |
|---|
| Region of Enrollment(Participants) | Carboplatin AUC-10 |
|---|---|
| United Kingdom | 48 |
| Primary Tumour(Participants) | Carboplatin AUC-10 |
|---|---|
| Testis | 46 |
| Mediastinum | 1 |
| Retroperitoneum | 1 |
| Sites of Metastases(Participants) | Carboplatin AUC-10 |
|---|---|
| Lung | 2 |
| Lymph node | 29 |
| Other | 9 |
| Not recorded | 8 |
| Eastern Cooperative Oncology Group Performance Status (ECOG PS)(Participants) | Carboplatin AUC-10 |
|---|---|
| ECOG PS = 0 | 41 |
| ECOG PS = 1 | 2 |
| ECOG PS = 2 | 0 |
| ECOG PS = 3 | 0 |
| Not recorded | 5 |
| Stage of Disease(Participants) | Carboplatin AUC-10 |
|---|---|
| 2A | 13 |
| 2B | 23 |
| 2C | 11 |
| N/A | 1 |
4 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2012 to primary completion in Oct 2017, 68 months.
Results were first posted in Jan 2019, 1 year 3 months after primary completion.
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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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