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Metastatic SeminomaPhase 2Car-PETNCT02272816

Carboplatin AUC-10 With Early PET Scanning in Metastatic Seminoma

A Phase 2 study testing Carboplatin AUC-10 in people with Metastatic Seminoma, run by Barts & The London NHS Trust at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, men only
Conditions the study is for
Metastatic Seminoma
What is being tested?
Carboplatin AUC-10
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
2 sitesUnited Kingdom
Study dates
13 Feb 2012to 13 Oct 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Barts Health NHS Trust

    London, EC1A 7BE

  • Hillingdon Hospitals NHS Foundation Trust

    London, HA6 2RN

Other trials in United Kingdom

About this study

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

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.

Being tested
Carboplatin AUC-10
Medical subject headings
Seminoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carboplatin AUC-10Drug

    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.

Study groups in NCT02272816
Study groupRoleWhat they receive
Carboplatin AUC-10ExperimentalNot described
Receives: Drug: Carboplatin AUC-10

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2 - Year Progression Free Survival

    Number of participants progression free 2 years after registration.

    Measured: 2 years

Secondary outcomes (2)

  1. Metabolic Response Rate

    Number of participants achieving i) complete metabolic response (CR) and ii) partial metabolic response (PR) after one cycle of treatment.

    Measured: 21 days

  2. Overall Survival

    Survival status at 2 years after registration.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2014 (estimated)
  2. Study start13 Feb 2012
  3. Primary completion13 Oct 2017
  4. Study completion13 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02272816
Sponsor's protocol ID
007065
Other IDs
2009-009882-33, 2009
Acronym
Car-PET
Status last verified
Aug 2018
First submitted
6 Nov 2012
Last updated
25 Jan 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Horwich A, Oliver RT, Wilkinson PM, Mead GM, Harland SJ, Cullen MH, Roberts JT, Fossa SD, Dearnaley DP, Lallemand E, Stenning SP; MRC Testicular Tumour Working Party. A medical research council randomized trial of single agent carboplatin versus etoposide and cisplatin for advanced metastatic seminoma. MRC Testicular Tumour Working Party. Br J Cancer. 2000 Dec;83(12):1623-9. doi: 10.1054/bjoc.2000.1498.

    PubMed 11104556

  • Bokemeyer C, Kollmannsberger C, Stenning S, Hartmann JT, Horwich A, Clemm C, Gerl A, Meisner C, Ruckerl CP, Schmoll HJ, Kanz L, Oliver T. Metastatic seminoma treated with either single agent carboplatin or cisplatin-based combination chemotherapy: a pooled analysis of two randomised trials. Br J Cancer. 2004 Aug 16;91(4):683-7. doi: 10.1038/sj.bjc.6602020.

    PubMed 15266338

  • Shamash J, McLaren B, LeVay JH, Ong J, Murray P, Asterling S, Oliver RT. Carboplatin AUC8 in combination with etoposide and bleomycin in the treatment of intermediate and poor-risk metastatic germ cell tumours: a phase II study. Cancer Chemother Pharmacol. 2001 Apr;47(4):370-2. doi: 10.1007/s002800000217.

    PubMed 11345655

  • Horwich A, Sleijfer DT, Fossa SD, Kaye SB, Oliver RT, Cullen MH, Mead GM, de Wit R, de Mulder PH, Dearnaley DP, Cook PA, Sylvester RJ, Stenning SP. Randomized trial of bleomycin, etoposide, and cisplatin compared with bleomycin, etoposide, and carboplatin in good-prognosis metastatic nonseminomatous germ cell cancer: a Multiinstitutional Medical Research Council/European Organization for Research and Treatment of Cancer Trial. J Clin Oncol. 1997 May;15(5):1844-52. doi: 10.1200/JCO.1997.15.5.1844.

    PubMed 9164194

  • Gore M, Mainwaring P, A'Hern R, MacFarlane V, Slevin M, Harper P, Osborne R, Mansi J, Blake P, Wiltshaw E, Shepherd J. Randomized trial of dose-intensity with single-agent carboplatin in patients with epithelial ovarian cancer. London Gynaecological Oncology Group. J Clin Oncol. 1998 Jul;16(7):2426-34. doi: 10.1200/JCO.1998.16.7.2426.

    PubMed 9667260

  • Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.

    PubMed 17242396

  • Juweid ME, Stroobants S, Hoekstra OS, Mottaghy FM, Dietlein M, Guermazi A, Wiseman GA, Kostakoglu L, Scheidhauer K, Buck A, Naumann R, Spaepen K, Hicks RJ, Weber WA, Reske SN, Schwaiger M, Schwartz LH, Zijlstra JM, Siegel BA, Cheson BD; Imaging Subcommittee of International Harmonization Project in Lymphoma. Use of positron emission tomography for response assessment of lymphoma: consensus of the Imaging Subcommittee of International Harmonization Project in Lymphoma. J Clin Oncol. 2007 Feb 10;25(5):571-8. doi: 10.1200/JCO.2006.08.2305. Epub 2007 Jan 22.

    PubMed 17242397

  • A'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med. 2001 Mar 30;20(6):859-66. doi: 10.1002/sim.721.

    PubMed 11252008

  • Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.

    PubMed 7165009

  • Shamash J, Syed R, Sarker SJ, Sarwar N, Sharma A, Mutsvangwa K, Coetzee C, Wilson P, Rustin GJ. A phase II study of carboplatin AUC-10 guided by positron emission tomography-defined metabolic response in metastatic seminoma. Eur J Cancer. 2019 Jul;115:128-135. doi: 10.1016/j.ejca.2019.04.013. Epub 2019 May 25.

    PubMed 31136925

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin AUC-10 in people with Metastatic Seminoma, run by Barts & The London NHS Trust at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2 - Year Progression Free Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02272816, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.

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