Metastatic Seminoma
Conditions
Brief summary
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.
Interventions
DRUGCarboplatin 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.
Sponsors
University College London Hospitals
Barts & The London NHS Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Metastatic seminoma with International Germ Cell Consensus Classification (IGCCCG) good prognosis. 2. Glomerular filtration rate (GFR) by Ethylenediaminetetraacetic acid (EDTA) clearance over 25 ml/min. 3. Eastern Cooperative Oncology Group (ECOG) Performance status 0-3. 4. Normal Alpha-fetoprotein (All levels of Human chorionic gonadotropin and Lactate dehydrogenase are acceptable). 5. Males aged ≥18 and ≤75 years. 6. Able to give written informed consent prior to study entry. 7. Patients must be sterile or agree to use adequate contraception during the period of therapy.
Exclusion criteria
1. Metastatic seminoma with any non-pulmonary visceral metastases. 2. Raised Alpha-fetoprotein. 3. Any previous chemotherapy or radiotherapy. 4. Currently enrolled in any other investigational drug study. 5. Other malignancy except basal cell.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2 - Year Progression Free Survival | 2 years | Number of participants progression free 2 years after registration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Response Rate | 21 days | Number of participants achieving i) complete metabolic response (CR) and ii) partial metabolic response (PR) after one cycle of treatment. |
| Overall Survival | 2 years | Survival status at 2 years after registration. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Carboplatin AUC-10 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. | 48 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Carboplatin AUC-10 | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 1 Participants | — |
| Age, Categorical Between 18 and 65 years | 47 Participants | — |
| Eastern Cooperative Oncology Group Performance Status (ECOG PS) ECOG PS = 0 | 41 Participants | — |
| Eastern Cooperative Oncology Group Performance Status (ECOG PS) ECOG PS = 1 | 2 Participants | — |
| Eastern Cooperative Oncology Group Performance Status (ECOG PS) ECOG PS = 2 | 0 Participants | — |
| Eastern Cooperative Oncology Group Performance Status (ECOG PS) ECOG PS = 3 | 0 Participants | — |
| Eastern Cooperative Oncology Group Performance Status (ECOG PS) Not recorded | 5 Participants | — |
| Glomerular Filtration Rate > 120 ml/min | 13 Participants | — |
| Glomerular Filtration Rate 25 - 120 ml/min | 35 Participants | — |
| Primary Tumour Mediastinum | 1 Participants | — |
| Primary Tumour Retroperitoneum | 1 Participants | — |
| Primary Tumour Testis | 46 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 48 Participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 48 Participants | — |
| Sites of Metastases Lung | 2 Participants | — |
| Sites of Metastases Lymph node | 29 Participants | — |
| Sites of Metastases Not recorded | 8 Participants | — |
| Sites of Metastases Other | 9 Participants | — |
| Stage of Disease 2A | 13 Participants | — |
| Stage of Disease 2B | 23 Participants | — |
| Stage of Disease 2C | 11 Participants | — |
| Stage of Disease N/A | 1 Participants | — |
| Tumour Marker: Alpha-fetoprotein Elevated | 0 Participants | — |
| Tumour Marker: Alpha-fetoprotein Normal | 48 Participants | — |
| Tumour Marker: Beta-Human Chorionic Gonadotropin Elevated | 12 Participants | — |
| Tumour Marker: Beta-Human Chorionic Gonadotropin Normal | 36 Participants | — |
| Tumour Marker: Lactate Dehydrogenase Elevated (< 3 x ULN) | 11 Participants | — |
| Tumour Marker: Lactate Dehydrogenase Elevated (≥ 3 x ULN) | 2 Participants | — |
| Tumour Marker: Lactate Dehydrogenase Normal | 34 Participants | — |
| Tumour Marker: Lactate Dehydrogenase Not recorded | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 48 |
| other Total, other adverse events | 47 / 48 |
| serious Total, serious adverse events | 12 / 48 |
Outcome results
Primary
2 - Year Progression Free Survival
Number of participants progression free 2 years after registration.
Time frame: 2 years
Population: All participants who received at least one dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Carboplatin AUC-10 | 2 - Year Progression Free Survival | 46 Participants |
Secondary
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
Population: All participants who completed one cycle of treatment and underwent PET-CT scan on day 17-21.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Carboplatin AUC-10 | Metabolic Response Rate | CR | 21 Participants |
| Carboplatin AUC-10 | Metabolic Response Rate | PR | 26 Participants |
95% CI: [30.2, 59.9]
Secondary
Overall Survival
Survival status at 2 years after registration.
Time frame: 2 years
Population: All participants who received at least one dose of study treatment.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Carboplatin AUC-10 | Overall Survival | Alive | 48 Participants |
| Carboplatin AUC-10 | Overall Survival | Deceased | 0 Participants |
95% CI: [92.6, 100]