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A PHASE II STUDY OF CHOP MAS RITUXIMAB WITH INTRATECAL METOTREXATE FOLLOWED BY RADIOTHERAPY IN PATIENTS WITH NON-HODGKIN PRIMARY LYMPHOMA TESTICULAR

A PHASE II STUDY OF CHOP MAS RITUXIMAB WITH INTRATECAL METOTREXATE FOLLOWED BY RADIOTHERAPY IN PATIENTS WITH NON-HODGKIN PRIMARY LYMPHOMA TESTICULAR

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
REPEC
Registry ID
PER-081-03
Enrollment
Unknown
Registered
2004-01-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

- Chemo with CHOP scheme (6 -8 cycles) to be repeated every 21 days. - Rituximab on day 1 of each of the 6 to 8 programmed cycles. - IT Chemotherapy: MTX weekly, in weeks 1,2,3,4 - Prophylactic scrotal radiotherapy. - Radiotherapy in the field involved (diseases with stage II).

Sponsors

INTERNATIONAL EXTRANODAL LYMPHOMA STUDY GROUP,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: NLC Testicular Primary Stage 1 to II Ann Arbor Untreated disease Evaluable, measurable two-dimensionally or without evidence of diseases Age = 18 years ECOG performance status 0-2.

Exclusion criteria

Exclusion criteria: - Impaired renal function (creatinine> 2 mg / day) or liver function (bilimibin> 2mg / di) except due to lymphoma. - Patients with HIV positive - Evolutionary malignancy within 5 years with the exception of cancer Localized skin does not melamomic.

Design outcomes

Primary

MeasureTime frame
Outcome name:Adverse Events Serious. Unacceptable toxicity, defined as unpredictable, irreversible or grade 4. The refusal of the patient to continue therapy. Measure:Therapeutic activity of systematic chemotherapy combined with the addition of Rituximab + Qt. intrathecal + loco-regional radiotherapy in primary testicular DLCL. Timepoints:at month

Secondary

MeasureTime frame
Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated

Countries

Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)