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Carboplatin AUC-10 With Early PET Scanning in Metastatic Seminoma (Car-PET)

Primary Purpose

Metastatic Seminoma

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Carboplatin AUC-10
Sponsored by
Barts & The London NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Seminoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Barts Health NHS Trust
  • Hillingdon Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Carboplatin AUC-10

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Metabolic Response Rate
Number of participants achieving i) complete metabolic response (CR) and ii) partial metabolic response (PR) after one cycle of treatment.
Overall Survival
Survival status at 2 years after registration.

Full Information

First Posted
November 6, 2012
Last Updated
August 10, 2018
Sponsor
Barts & The London NHS Trust
Collaborators
University College London Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT02272816
Brief Title
Carboplatin AUC-10 With Early PET Scanning in Metastatic Seminoma
Acronym
Car-PET
Official Title
A Multi-Centre Phase II Study Using Carboplatin AUC-10 for Metastatic Seminoma With IGCCCG Good Prognosis Disease-Therapy Directed by Initial Metabolic Response on PET-CT
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 13, 2012 (Actual)
Primary Completion Date
October 13, 2017 (Actual)
Study Completion Date
October 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barts & The London NHS Trust
Collaborators
University College London Hospitals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Seminoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carboplatin AUC-10
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Carboplatin AUC-10
Intervention Description
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.
Primary Outcome Measure Information:
Title
2 - Year Progression Free Survival
Description
Number of participants progression free 2 years after registration.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Metabolic Response Rate
Description
Number of participants achieving i) complete metabolic response (CR) and ii) partial metabolic response (PR) after one cycle of treatment.
Time Frame
21 days
Title
Overall Survival
Description
Survival status at 2 years after registration.
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Metastatic seminoma with International Germ Cell Consensus Classification (IGCCCG) good prognosis. Glomerular filtration rate (GFR) by Ethylenediaminetetraacetic acid (EDTA) clearance over 25 ml/min. Eastern Cooperative Oncology Group (ECOG) Performance status 0-3. Normal Alpha-fetoprotein (All levels of Human chorionic gonadotropin and Lactate dehydrogenase are acceptable). Males aged ≥18 and ≤75 years. Able to give written informed consent prior to study entry. Patients must be sterile or agree to use adequate contraception during the period of therapy. Exclusion Criteria: Metastatic seminoma with any non-pulmonary visceral metastases. Raised Alpha-fetoprotein. Any previous chemotherapy or radiotherapy. Currently enrolled in any other investigational drug study. Other malignancy except basal cell.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Shamash, MD FRCP
Organizational Affiliation
Barts & The London NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barts Health NHS Trust
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Hillingdon Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
HA6 2RN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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11104556
Citation
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Carboplatin AUC-10 With Early PET Scanning in Metastatic Seminoma

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