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OpenTrials
Completed

NCT Number: NCT00210379

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

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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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Oncology Institute of Southern Switzerland (IOSI)

Bellinzona, 6500, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age = 18 years.
  • ECOG performance status 0-2
  • Histologically proven primary testicular CD20-positive diffuse large B-cell non-Hodgkin's lymphoma, untreated
  • 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.
  • Bidimensionally measurable or evaluable disease. Patients who have had all disease removed by surgery are eligible.
  • Adequate bone marrow reserve (ANC > 1.000/L, Plt > 100.000/L)
  • Cardiac ejection fraction ≥ 50% by MUGA scan or echocardiography
  • No previous therapy with monoclonal antibody anti-CD20.
  • No psychiatric illness that precludes understanding concepts of the trial or signing informed consent
  • No other major life-threatening illnesses that may preclude chemotherapy
  • 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informed consent prior to any program-specific screening procedure, with the understanding that the consent may be withdrawn by the patient at any time without prejudice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

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

Treatment and study plan

Rituximab

Drug

CHOP

Drug

Intrathecal Methotrexate

Drug

Radiotherapy

Procedure

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

Sponsors and collaborators

Lead sponsor

International Extranodal Lymphoma Study Group (IELSG)

Other

Registry information

Official study title

A Phase II Study of CHOP + Rituximab, With Intrathecal Methotrexate Followed by Radiotherapy in Patients With Primary Testicular Non-Hodgkin's Lymphoma

Important dates

Study start
2000
Primary completion
2004
Study completion
2007
First posted
Sep 21, 2005
Registry last updated
Jul 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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