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Magnetic Resonance Imaging and Computed Tomography in Patients With Stage I Seminoma of the Testicle

Sponsor
Medical Research Council (Other)
Overall Status
Unknown status
CT.gov ID
NCT00589537
Collaborator
(none)
660
Enrollment
29
Locations
22.8
Patients Per Site

Study Details

Study Description

Brief Summary

RATIONALE: Imaging procedures, such as MRI and CT scan, may find recurrent cancer. It is not yet known which MRI or CT scan schedule is more effective in finding recurrent cancer.

PURPOSE: This randomized phase III trial is comparing four different MRI and CT scan schedules in patients with stage I seminoma of the testicle.

Condition or Disease Intervention/Treatment Phase
  • Other: questionnaire administration
  • Procedure: computed tomography
  • Procedure: magnetic resonance imaging
  • Procedure: quality-of-life assessment
 Phase 3

Detailed Description

OBJECTIVES:
  • To assess whether a reduced computed tomography (CT) schedule or magnetic resonance imaging (MRI) could be used as safe and effective alternatives to standard CT-based surveillance in the management of patients with stage I seminoma of the testis.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 4 surveillance arms.

  • Arm I: Patients undergo computed tomography (CT) scan of the abdomen/retroperitoneum* at 6, 12, 18, 24, 36, 48, and 60 months in the absence of disease progression.

  • Arm II: Patients undergo CT scan of the abdomen/retroperitoneum* at 6, 18, and 36 months in the absence of disease progression.

  • Arm III: Patients undergo magnetic resonance imaging (MRI) of the abdomen/retroperitoneum* at 6, 12, 18, 24, 36, 48, and 60 months in the absence of disease progression.

  • Arm IV: Patients undergo MRI of the abdomen/retroperitoneum* at 6, 18, and 36 months in the absence of disease progression.

NOTE: *Patients with a history of ipsilateral inguino-scrotal surgery also undergo imaging of the pelvis.

Patients complete questionnaires at baseline and periodically during study to assess health-related quality of life; utilization and cost of healthcare services (including the cost of CT- or MRI-based surveillance and the management of any recurrence); and acceptability of allocated scanning schedule.

Patients are followed every 3 months for 2 years, every 4 months for 1 year, and then every 6 months for 3 years.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
660 participants
Allocation:
Randomized
Primary Purpose:
Diagnostic
Official Title:
Trial of Imaging and Schedule in Seminoma Testis
Study Start Date :
Mar 1, 2008
Anticipated Primary Completion Date :
Dec 1, 2016

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients relapsing with Royal Marsden Hospital stage IIC or greater disease []

Secondary Outcome Measures

  1. Difference in mean abdominal mass size at relapse between computed tomography (CT) scan and magnetic resonance imaging (MRI) []

  2. Time on surveillance before detection of relapse []

  3. Prospective identification of first modality to detect relapse (patient symptom, clinical examination, tumor marker, chest x-ray, cross-sectional image) []

  4. Extent of relapse according to International Germ Cell Cancer Collaborative Group classification []

  5. Disease-free survival []

  6. Overall survival []

  7. Prospective evaluation of prognostic factors for relapse []

  8. Number of false positive MRIs []

  9. Resource use and costs []

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:

  • Histologically confirmed seminoma of the testis

  • Stage I disease, as determined by clinical examination and CT scan of the chest, abdomen, and pelvis

  • No evidence of any non-seminoma germ cell tumor elements

  • Has undergone orchidectomy within the past 8 weeks

  • Normal serum alpha-fetoprotein pre-orchidectomy and at study randomization

  • Normal serum beta human chorionic gonadotrophin at study randomization (may have been elevated pre-orchidectomy)

  • Not planning to undergo adjuvant therapy

PATIENT CHARACTERISTICS:

  • Able to attend regular surveillance

  • No other malignancy within the past 10 years expect successfully treated nonmelanoma skin cancer

  • No contraindication to MRI (i.e., ferrous metal implants of any type, cardiac pacemaker or defibrillator, or history of injury by metal fragments)

PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics

Contacts and Locations

Locations

Site City State Country Postal Code
1 Royal Bournemouth Hospital Bournemouth England United Kingdom BH7 7DW
2 Sussex Cancer Centre at Royal Sussex County Hospital Brighton England United Kingdom BN2 5BF
3 Bristol Haematology and Oncology Centre Bristol England United Kingdom BS2 8ED
4 Addenbrooke's Hospital Cambridge England United Kingdom CB2 2QQ
5 Gloucestershire Oncology Centre at Cheltenham General Hospital Cheltenham England United Kingdom GL53 7AN
6 Huddersfield Royal Infirmary Huddersfield, West Yorks England United Kingdom HD3 3EA
7 Leeds Cancer Centre at St. James's University Hospital Leeds England United Kingdom LS9 7TF
8 Leicester Royal Infirmary Leicester England United Kingdom LE1 5WW
9 Lincoln County Hospital Lincoln England United Kingdom LN2 5QY
10 UCL Cancer Institute London England United Kingdom NW3 2QG
11 Charing Cross Hospital London England United Kingdom W6 8RF
12 University College of London Hospitals London England United Kingdom WIT 3AA
13 Mid Kent Oncology Centre at Maidstone Hospital Maidstone England United Kingdom ME16 9QQ
14 Christie Hospital Manchester England United Kingdom M20 4BX
15 James Cook University Hospital Middlesbrough England United Kingdom TS4 3BW
16 Northern Centre for Cancer Treatment at Newcastle General Hospital Newcastle-Upon-Tyne England United Kingdom NE4 6BE
17 Northampton General Hospital Northampton England United Kingdom NN1 5BD
18 Mount Vernon Cancer Centre at Mount Vernon Hospital Northwood England United Kingdom HA6 2RN
19 Nottingham City Hospital Nottingham England United Kingdom NG5 1PB
20 Churchill Hospital Oxford England United Kingdom OX3 7LJ
21 Berkshire Cancer Centre at Royal Berkshire Hospital Reading England United Kingdom RG1 5AN
22 Cancer Research Centre at Weston Park Hospital Sheffield England United Kingdom S1O 2SJ
23 Royal Marsden - Surrey Sutton England United Kingdom SM2 5PT
24 Yeovil District Hospital Yeovil England United Kingdom BA21 4AT
25 Centre for Cancer Research and Cell Biology at Queen's University Belfast Belfast Northern Ireland United Kingdom BT9 7BL
26 Aberdeen Royal Infirmary Aberdeen Scotland United Kingdom AB25 2ZN
27 Beatson West of Scotland Cancer Centre Glasgow Scotland United Kingdom G11 6NT
28 Velindre Cancer Center at Velindre Hospital Cardiff Wales United Kingdom CF14 2TL
29 Glan Clwyd Hospital Rhyl, Denbighshire Wales United Kingdom LL 18 5UJ

Sponsors and Collaborators

  • Medical Research Council

Investigators

  • Study Chair: Johnathan Joffe, MD, Huddersfield Royal Infirmary

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00589537
Other Study ID Numbers:
  • MRC-NCRI-TRISST-TE24
  • CDR0000574037
  • EU-20771
  • ISRCTN65987321
First Posted:
Jan 9, 2008
Last Update Posted:
Aug 7, 2013
Last Verified:
Jul 1, 2009
Keywords provided by , ,
testicular seminoma
stage I malignant testicular germ cell tumor
Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Seminoma

Study Results

No Results Posted as of Aug 7, 2013