Testicular Germ Cell TumorPhase 3NCT00003014
Radiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular Cancer
A Phase 3 study testing carboplatin and radiation therapy in people with Testicular Germ Cell Tumor, run by Medical Research Council at 62 sites in 7 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether chemotherapy is more effective than radiation therapy for testicular cancer. Read more about this study
- Who is it for?
- Ages 16 years and older, men only
- Conditions the study is for
- Testicular Germ Cell Tumor
- What is being tested?
- carboplatin and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 62 sitesin 7 countries
- Study dates
- Apr 1998to Jul 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 16 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically confirmed stage I seminomatous germ cell tumor of the testis categorized as either "classical" or "anaplastic"
PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine less than 1.4 mg/dL Other: No concurrent or previously treated malignancy except successfully treated nonmelanoma skin cancer No medical condition or other factor that would preclude study
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: No more than 8 weeks since prior orchidectomy Prior inguino-pelvic or scrotal surgery allowed Must be treated with "dog-leg" field if randomized to radiotherapy If prior vasectomy, choice of fields is at the discretion of the clinician
Trial locations and contacts
62 sites in 7 countries.
62 sites in 7 countries
United Kingdom53 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Ysbyty Gwynedd
Bangor, Wales, LL57 2PW
Royal United Hospital
Bath, England, BA1 3NG
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, BT12 6BE
University of Birmingham
Birmingham, England, B15 2TT
Children's Hospital - Birmingham UK
Birmingham, England, B16 8ET
Bradford Hospitals NHS Trust
Bradford, England, BD9 6RJ
Royal Sussex County Hospital
Brighton, England, BN2 5BE
Bristol Royal Hospital for Sick Children
Bristol, England, BS2 8BJ
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED
Addenbrooke's NHS Trust
Cambridge, England, CB2 2QQ
Kent and Canterbury Hospital
Canterbury, England, CT2 7NR
Walsgrave Hospital
Coventry, England, CV2 2DX
Derbyshire Royal Infirmary
Derby, England, DE1 2QY
Derbyshire Children's Hospital
Derby, England, DE1 3BA
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
Western General Hospital
Edinburgh, Scotland, EH4 9NQ
Royal Hospital for Sick Children
Edinburgh, Scotland
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
Royal Infirmary
Glasgow, Scotland, G4 0SF
Gloucester Royal NHS Trust - Glouchester Royal Hospital
Gloucester, England, GL1 3NN
Royal Surrey County Hospital
Guildford, England, GU2 5XX
Royal Free Hospital
Hampstead, London, England, NW3 2QG
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, HD3 3EA
Cookridge Hospital
Leeds, England, LS16 6QB
St. James's Hospital
Leeds, England, LS9 7TF
University Hospitals of Leicester
Leicester, England, LE1 5WW
Saint Bartholomew's Hospital
London, England, EC1A 7BE
St. Bartholomew's Hospital
London, England, EC1A 7BE
Guy's and St. Thomas' Hospitals Trust
London, England, SE1 7EH
Westminster Hospital
London, England, SW1P 2AP
University College Hospital
London, England, WC1E 6AU
Middlesex Hospital- Meyerstein Institute
London, England, WIT 3AA
Manchester Children's Hospitals (NHS Trust)
Manchester, England, M27 SHA
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, L63 4JY
South Tees Acute Hospitals NHS Trust
Middlesbrough, Cleveland, England, TS4 3BW
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
Newcastle Upon Tyne Hospitals NHS Trust - Freeman Hospital
Newcastle upon Tyne, England, NE7 7DN
Mount Vernon Hospital
Northwood, England, HA6 2RN
Norfolk & Norwich Hospital
Norwich, England, NR1 3SR
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DU
Llandough Hospital
Penarth, Wales, CF6 1XX
Portsmouth Hospitals NHS Trust
Portsmouth, England, P03 6AD
Royal Preston Hospital
Preston, PR2 9HT
Children's Hospital - Sheffield
Sheffield, England, S10 2TH
Weston Park Hospital
Sheffield, England, S1O 2SJ
Royal South Hants Hospital
Southampton, England, SO14 0YG
Southampton General Hospital
Southampton, England, SO16 6YD
Royal Marsden Hospital
Sutton, England, SM2 5PT
Princess Royal Hospital
Telford, England, TF6 6TF
Walsall Manor Hospital
Walsall, England, WS2 9PS
Southend NHS Trust Hospital
Westcliff-on-Sea, England
Canada4 sites
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Mount Sinai Hospital - Toronto
Toronto, Ontario, M5G 1X5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: Carboplatin in the Adjuvant Treatment of Stage I Seminoma: A Radomized Comparison of Single Agent Carboplatin With Radiotherapy in the Adjuvant Treatment of Stage I Seminoma of the Testis, Following Orchidectomy
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether chemotherapy is more effective than radiation therapy for testicular cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin with that of radiation therapy in treating patients who have stage I testicular cancer.
Read the detailed description
OBJECTIVES: I. Compare relapse rates in patients with stage I testicular seminoma treated with adjuvant radiotherapy vs carboplatin. II. Compare quality of life of patients before and after treatment with these regimens. III. Compare the acute and intermediate (1-2 year) side effects of these regimens in these patients. IV. Determine the incidence of late side effects (such as bowel dysfunction) of treatment and second malignancies in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive a single dose of carboplatin IV. Arm II: Patients undergo radiotherapy once daily, 5 days a week. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 800 patients will be accrued for this study within 4 years.
- Conditions
- Testicular Germ Cell Tumor
- Being tested
- carboplatin, radiation therapy
- Keywords
- stage I malignant testicular germ cell tumor, testicular seminoma
- Medical subject headings
- Testicular Germ Cell Tumor, Testicular Neoplasms, Seminoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2004 (estimated)
- Study startApr 1998
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Testicular Germ Cell TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Investigators
- Hans Von Der Maase, MD, Study chair, Aarhus Universitetshospital - Aarhus SygehusR. T. Oliver, MD, Study chair, St. Bartholomew's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003014
- Sponsor's protocol ID
- CDR0000065594
- Other IDs
- MRC-TE19, EORTC-30982, EU-97003
- Status last verified
- Mar 2011
- First submitted
- 1 Nov 1999
- Last updated
- 4 Dec 2013
- Results posted
- No
Publications
Mead GM, Fossa SD, Oliver RT, Joffe JK, Huddart RA, Roberts JT, Pollock P, Gabe R, Stenning SP; MRC/EORTC seminoma trial collaborators. Randomized trials in 2466 patients with stage I seminoma: patterns of relapse and follow-up. J Natl Cancer Inst. 2011 Feb 2;103(3):241-9. doi: 10.1093/jnci/djq525. Epub 2011 Jan 6.
PubMed 21212385Oliver RT, Mason MD, Mead GM, von der Maase H, Rustin GJ, Joffe JK, de Wit R, Aass N, Graham JD, Coleman R, Kirk SJ, Stenning SP; MRC TE19 collaborators and the EORTC 30982 collaborators. Radiotherapy versus single-dose carboplatin in adjuvant treatment of stage I seminoma: a randomised trial. Lancet. 2005 Jul 23-29;366(9482):293-300. doi: 10.1016/S0140-6736(05)66984-X.
PubMed 16039331Oliver RT, Mason M, Von der Masse H, et al.: A randomised comparison of single agent carboplatin with radiotherapy in the adjuvant treatment of stage I seminoma of the testis, following orchidectomy: MRC TE19/EORTC 30982. [Abstract] J Clin Oncol 22 (Suppl 14): A-4517, 386, 2004.
Oliver RT, Mead GM, Rustin GJ, Joffe JK, Aass N, Coleman R, Gabe R, Pollock P, Stenning SP. Randomized trial of carboplatin versus radiotherapy for stage I seminoma: mature results on relapse and contralateral testis cancer rates in MRC TE19/EORTC 30982 study (ISRCTN27163214). J Clin Oncol. 2011 Mar 10;29(8):957-62. doi: 10.1200/JCO.2009.26.4655. Epub 2011 Jan 31.
PubMed 21282539Oliver RT, Mead GM, Fogarty PJ, et al.: Radiotherapy versus carboplatin for stage I seminoma: updated analysis of the MRC/EORTC randomized trial (ISRCTN27163214). [Abstract] J Clin Oncol 26 (Suppl 15): A-1, 2008.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carboplatin in the Adjuvant Treatment of Stage I Seminoma: A Radomized Comparison of Single Agent Carboplatin With Radiotherapy in the Adjuvant Treatment of Stage I Seminoma of the Testis, Following Orchidectomy
- ClinicalTrials.gov ID
- NCT00003014
- Acronym / sponsor ID
- CDR0000065594
- Conditions
- Testicular Germ Cell Tumor
- Keywords
- stage I malignant testicular germ cell tumor, testicular seminoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Medical Research CouncilOther government
- Collaborators
- European Organisation for Research and Treatment of Cancer - EORTC
- Study start
- Apr 1998
- Study completion
- Jul 2005 (actual)
- First posted
- 12 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether chemotherapy is more effective than radiation therapy for testicular cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin with that of radiation therapy in treating patients who have stage I testicular cancer.
Detailed description
OBJECTIVES: I. Compare relapse rates in patients with stage I testicular seminoma treated with adjuvant radiotherapy vs carboplatin. II. Compare quality of life of patients before and after treatment with these regimens. III. Compare the acute and intermediate (1-2 year) side effects of these regimens in these patients. IV. Determine the incidence of late side effects (such as bowel dysfunction) of treatment and second malignancies in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive a single dose of carboplatin IV. Arm II: Patients undergo radiotherapy once daily, 5 days a week. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 800 patients will be accrued for this study within 4 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 16 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carboplatin | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
- Background: PubMed 21212385Mead GM, Fossa SD, Oliver RT, Joffe JK, Huddart RA, Roberts JT, Pollock P, Gabe R, Stenning SP; MRC/EORTC seminoma trial collaborators. Randomized trials in 2466 patients with stage I seminoma: patterns of relapse and follow-up. J Natl Cancer Inst. 2011 Feb 2;103(3):241-9. doi: 10.1093/jnci/djq525. Epub 2011 Jan 6.
- Results publication: PubMed 16039331Oliver RT, Mason MD, Mead GM, von der Maase H, Rustin GJ, Joffe JK, de Wit R, Aass N, Graham JD, Coleman R, Kirk SJ, Stenning SP; MRC TE19 collaborators and the EORTC 30982 collaborators. Radiotherapy versus single-dose carboplatin in adjuvant treatment of stage I seminoma: a randomised trial. Lancet. 2005 Jul 23-29;366(9482):293-300. doi: 10.1016/S0140-6736(05)66984-X.
- Results publicationOliver RT, Mason M, Von der Masse H, et al.: A randomised comparison of single agent carboplatin with radiotherapy in the adjuvant treatment of stage I seminoma of the testis, following orchidectomy: MRC TE19/EORTC 30982. [Abstract] J Clin Oncol 22 (Suppl 14): A-4517, 386, 2004.
- Results publication: PubMed 21282539Oliver RT, Mead GM, Rustin GJ, Joffe JK, Aass N, Coleman R, Gabe R, Pollock P, Stenning SP. Randomized trial of carboplatin versus radiotherapy for stage I seminoma: mature results on relapse and contralateral testis cancer rates in MRC TE19/EORTC 30982 study (ISRCTN27163214). J Clin Oncol. 2011 Mar 10;29(8):957-62. doi: 10.1200/JCO.2009.26.4655. Epub 2011 Jan 31.
- Results publicationOliver RT, Mead GM, Fogarty PJ, et al.: Radiotherapy versus carboplatin for stage I seminoma: updated analysis of the MRC/EORTC randomized trial (ISRCTN27163214). [Abstract] J Clin Oncol 26 (Suppl 15): A-1, 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Von Der Maase, MD study chair
Aarhus Universitetshospital - Aarhus Sygehus
R. T. Oliver, MD study chair
St. Bartholomew's Hospital
62 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing carboplatin and radiation therapy in people with Testicular Germ Cell Tumor, run by Medical Research Council at 62 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United Kingdom, Canada, Brazil, Finland, Netherlands and 2 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003014, which also lists 5 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 4 Dec 2013.