Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00589537
Other study ID # MRC-NCRI-TRISST-TE24
Secondary ID CDR0000574037EU-
Status Recruiting
Phase Phase 3
First received December 25, 2007
Last updated August 6, 2013
Start date March 2008

Study information

Verified date July 2009
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 660
Est. completion date
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Male
Age group 16 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
questionnaire administration

Procedure:
computed tomography

magnetic resonance imaging

quality-of-life assessment


Locations

Country Name City State
United Kingdom Aberdeen Royal Infirmary Aberdeen Scotland
United Kingdom Centre for Cancer Research and Cell Biology at Queen's University Belfast Belfast Northern Ireland
United Kingdom Royal Bournemouth Hospital Bournemouth England
United Kingdom Sussex Cancer Centre at Royal Sussex County Hospital Brighton England
United Kingdom Bristol Haematology and Oncology Centre Bristol England
United Kingdom Addenbrooke's Hospital Cambridge England
United Kingdom Velindre Cancer Center at Velindre Hospital Cardiff Wales
United Kingdom Gloucestershire Oncology Centre at Cheltenham General Hospital Cheltenham England
United Kingdom Beatson West of Scotland Cancer Centre Glasgow Scotland
United Kingdom Huddersfield Royal Infirmary Huddersfield, West Yorks England
United Kingdom Leeds Cancer Centre at St. James's University Hospital Leeds England
United Kingdom Leicester Royal Infirmary Leicester England
United Kingdom Lincoln County Hospital Lincoln England
United Kingdom Charing Cross Hospital London England
United Kingdom UCL Cancer Institute London England
United Kingdom University College of London Hospitals London England
United Kingdom Mid Kent Oncology Centre at Maidstone Hospital Maidstone England
United Kingdom Christie Hospital Manchester England
United Kingdom James Cook University Hospital Middlesbrough England
United Kingdom Northern Centre for Cancer Treatment at Newcastle General Hospital Newcastle-Upon-Tyne England
United Kingdom Northampton General Hospital Northampton England
United Kingdom Mount Vernon Cancer Centre at Mount Vernon Hospital Northwood England
United Kingdom Nottingham City Hospital Nottingham England
United Kingdom Churchill Hospital Oxford England
United Kingdom Berkshire Cancer Centre at Royal Berkshire Hospital Reading England
United Kingdom Glan Clwyd Hospital Rhyl, Denbighshire Wales
United Kingdom Cancer Research Centre at Weston Park Hospital Sheffield England
United Kingdom Royal Marsden - Surrey Sutton England
United Kingdom Yeovil District Hospital Yeovil England

Sponsors (1)

Lead Sponsor Collaborator
Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients relapsing with Royal Marsden Hospital stage IIC or greater disease No
Secondary Difference in mean abdominal mass size at relapse between computed tomography (CT) scan and magnetic resonance imaging (MRI) No
Secondary Time on surveillance before detection of relapse No
Secondary Prospective identification of first modality to detect relapse (patient symptom, clinical examination, tumor marker, chest x-ray, cross-sectional image) No
Secondary Extent of relapse according to International Germ Cell Cancer Collaborative Group classification No
Secondary Disease-free survival No
Secondary Overall survival No
Secondary Prospective evaluation of prognostic factors for relapse No
Secondary Number of false positive MRIs No
Secondary Resource use and costs No
See also
  Status Clinical Trial Phase
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Withdrawn NCT00006126 - Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery Phase 1
Completed NCT00003173 - High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors Phase 2
Completed NCT00002596 - Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors Phase 3
Not yet recruiting NCT03448822 - Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour
Completed NCT01433224 - Studying Biomarkers in Samples From Younger Patients With Malignant Germ Cell Tumor Progression N/A
Recruiting NCT01172912 - High-Dose Chemotherapy and Stem Cell Transplant in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to First-Line Therapy Phase 2
Completed NCT00293384 - Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant N/A
Active, not recruiting NCT00003643 - Combination Chemotherapy in Treating Men With Germ Cell Cancer Phase 2/Phase 3
Completed NCT00003107 - Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors Phase 1
Completed NCT00019331 - Vaccine Therapy Plus Biological Therapy in Treating Adults With Metastatic Solid Tumors Phase 2
Completed NCT00002515 - Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer Phase 2
Recruiting NCT06133699 - Sentinel Lymph Node Biopsy in Stage AI-IIA Germ Cell Tumors N/A
Recruiting NCT05670938 - Follow-up After Surgery for Testicular Cancer
Active, not recruiting NCT00104676 - Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors Phase 3
Recruiting NCT00551122 - Gemcitabine, Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Progressive or Relapsed Metastatic Germ Cell Tumors Phase 1/Phase 2
Completed NCT00002508 - Combination Chemotherapy Followed by Bone Marrow or Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Germ Cell Tumors Phase 1/Phase 2
Completed NCT00003800 - Diagnostic Study of Patients With Stage I Testicular Cancer N/A
Terminated NCT05012397 - Milademetan in Advanced/Metastatic Solid Tumors Phase 2
Completed NCT00007813 - Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors Phase 1