Carboplatin AUC-10 With Early PET Scanning in Metastatic Seminoma

Phase 2

Completed

• Conditions: Metastatic Seminoma
• Interventions: Drug: Carboplatin AUC-10

• Registration Number: NCT02272816
• Lead Sponsor: Barts & The London NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-13
• Study First Submitted: 2012-11-06
• Study First Submitted QC: 2014-10-21
• Study First Posted: 2014-10-23
• Primary Completion: 2017-10-13
• Study Completion: 2017-10-13
• Status Verified: 2018-08
• Results First Submitted: 2018-08-10
• Results First Submitted QC: 2018-08-10
• Last Update Submitted: 2018-08-10
• Results First Posted: 2019-01-25
• Last Update Posted: 2019-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carboplatin AUC-10	Carboplatin AUC-10	-

Primary Outcome Measures

Name	Time	Method
2 - Year Progression Free Survival	2 years	Number of participants progression free 2 years after registration.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Barts Health NHS Trust; 🇬🇧 London, United Kingdom

Hillingdon Hospitals NHS Foundation Trust; 🇬🇧 London, United Kingdom