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CompletedNCT00210379Updated Jul 22, 2009

Phase II Study of Combined Modality Treatment in Primary Testicular Non-Hodgkin's Lymphoma

A Phase 2 interventional study of rituximab and CHOP in Lymphoma, B Cell, sponsored by International Extranodal Lymphoma Study Group (IELSG). Completed at 1 site in Switzerland. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-07-22.

Sponsored by International Extranodal Lymphoma Study Group (IELSG) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
64
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
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Study summary

The primary objective assess the clinical activity of combination doxorubicin-containing chemotherapy plus monoclonal antibody anti-CD20 (Rituximab) plus intrathecal prophylactic chemotherapy and loco-regional radiotherapy in primary localised testicular DLCL and to assess the toxicity of this therapeutic strategy

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Conditions studied

03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 64 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

International Extranodal Lymphoma Study Group (IELSG) is the lead sponsor of 29 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  1. age = 18 years.
  2. ECOG performance status 0-2
  3. Histologically proven primary testicular CD20-positive diffuse large B-cell non-Hodgkin's lymphoma, untreated
  4. Ann Arbor stage IE or IIE. Bilateral testicular involvement at presentation will not be considered stage IV. In these patients the final Ann Arbor stage will be determined by the extent of nodal involvement.
  5. Bidimensionally measurable or evaluable disease. Patients who have had all disease removed by surgery are eligible.
  6. Adequate bone marrow reserve (ANC > 1.000/L, Plt > 100.000/L)
  7. Cardiac ejection fraction ≥ 50% by MUGA scan or echocardiography
  8. No previous therapy with monoclonal antibody anti-CD20.
  9. No psychiatric illness that precludes understanding concepts of the trial or signing informed consent
  10. No other major life-threatening illnesses that may preclude chemotherapy
  11. Have given written informed consent prior to any program-specific screening procedure, with the understanding that the consent may be withdrawn by the patient at any time without prejudice

Exclusion criteria

Exclusion Criteria:

  1. impairment of renal function (creatinine > 2 mg/dl) or liver function (bilirubin > 2 mg/dl) unless due to lymphoma involvement
  2. HIV positive patients
  3. evolutive malignancy within 5 years with the exception of localized non-melanomatous skin cancer
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
64 participants (actual)

Interventions

  • Drugrituximab
  • DrugCHOP
  • Drugintrathecal methotrexate
  • Procedureradiotherapy
06

What researchers measure

Primary outcomes

  1. Disease-free survival

  2. Progression-free survival

  3. Event-free survival

Secondary outcomes

  1. Overall survival will be a secondary end-point because post-relapse therapy is not specified in this protocol and is expected to be highly variable

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Study locations

1 site
  • Oncology Institute of Southern Switzerland (IOSI)
    Bellinzona, 6500, Switzerland
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00210379
Lead sponsor
International Extranodal Lymphoma Study Group (IELSG)
First posted
Sep 21, 2005
Start date
Nov 2000
Primary completion
Nov 2004
Completion
Mar 2007
Last update
Jul 22, 2009

Study contacts

Andreas Sarris, MD
study chair · International Extranodal Lymphoma Study Group
Emanuele Zucca, MD
study chair · International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland (IOSI)
Mary Gospodarowicz, MD
study chair · Radiation Oncology. Princess Margareth Hospital. Toronto
Umberto Vitolo, MD
study chair · Hematology Division. Ospedale San Giovanni Battista. Torino
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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