NCT00945724 · OUTCOME

Adverse Events Assessment

Safety and Feasibility Study of Combination of State of Art Chemoimmunotherapy, Intensive Central Nervous System Prophylaxis and Scrotal Irradiation to Treat Primary Diffuse Large B-cell Lymphoma of Testis · Source last updated 2025-05-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From treatment start until the last drug administration, up to week 22 for the 'R-CHOP, Depocyte, Methotrexate' Group, up to 15 weeks (Weeks 1-15) for the 'R-CHOP + Lyposomal Cytarabine' Group, and from week 18-22 for the 'HD-MTX' Group

What was measured

Number of patients who withdrew the treatment due to adverse event

Analysis population: Weeks 1 -15 All patients treated with 6 cycles of R-CHOP (CHOP21) on days 0/1 to 5, to be repeated every 21 days Intratecal (IT) Chemotherapy: liposomal cytarabine on day 0 of cycles 2, 3, 4 and 5 of R-CHOP Weeks 18 - 22 High Dose (HD) Methotrexate (MTX) Days 0 - 4 of two 14 days cycles From Week 25 Scrotal prophylactic radio therapy (RT) to the contralateral testis.

Groups in this outcome

R-CHOP, Depocyte, Methotrexate

Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate: Weeks 1-15: * 6 cycles of CHOP on Days 1 to 5, to be repeated q21 Days * Rituximab 375 mg/m2 on Day 0 or Day 1 of every CHOP cycle * IT chemoth:Depocyte 50 mg on Day 0 of cycles 2,3,4\&5 of R-CHOP Weeks 18-22: • Methotrexate 1.5 g/m2 q14 Days x 2 From Week 24: • Scrotal prophylactic radiotherapy or involved field radiotherapy(but can be planned concomitantly to R-CHOP in pts with bilateral disease)

R-CHOP + Lyposomal Cytarabine

HD-MTX

Weeks 18-22: • Methotrexate 1.5 g/m2 q14 Days x 2

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
R-CHOP, Depocyte, Methotrexate	54
R-CHOP + Lyposomal Cytarabine	54
HD-MTX	48

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
R-CHOP, Depocyte, Methotrexate	6	Not reported	Not reported	Not reported	Not reported
R-CHOP + Lyposomal Cytarabine	3	Not reported	Not reported	Not reported	Not reported
HD-MTX	3	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
6
group Id
OG001
value
3
group Id
OG002
value
3

denoms

counts
group Id
OG000
value
54
group Id
OG001
value
54
group Id
OG002
value
48
units
Participants

description

Number of patients who withdrew the treatment due to adverse event

groups

description
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate: Weeks 1-15: * 6 cycles of CHOP on Days 1 to 5, to be repeated q21 Days * Rituximab 375 mg/m2 on Day 0 or Day 1 of every CHOP cycle * IT chemoth:Depocyte 50 mg on Day 0 of cycles 2,3,4\&5 of R-CHOP Weeks 18-22: • Methotrexate 1.5 g/m2 q14 Days x 2 From Week 24: • Scrotal prophylactic radiotherapy or involved field radiotherapy(but can be planned concomitantly to R-CHOP in pts with bilateral disease)
id
OG000
title
R-CHOP, Depocyte, Methotrexate
description
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate: Weeks 1-15: * 6 cycles of CHOP on Days 1 to 5, to be repeated q21 Days * Rituximab 375 mg/m2 on Day 0 or Day 1 of every CHOP cycle * IT chemoth:Depocyte 50 mg on Day 0 of cycles 2,3,4\&5 of R-CHOP
id
OG001
title
R-CHOP + Lyposomal Cytarabine
description
Weeks 18-22: • Methotrexate 1.5 g/m2 q14 Days x 2
id
OG002
title
HD-MTX

param Type

COUNT_OF_PARTICIPANTS

population Description

Weeks 1 -15 All patients treated with 6 cycles of R-CHOP (CHOP21) on days 0/1 to 5, to be repeated every 21 days Intratecal (IT) Chemotherapy: liposomal cytarabine on day 0 of cycles 2, 3, 4 and 5 of R-CHOP Weeks 18 - 22 High Dose (HD) Methotrexate (MTX) Days 0 - 4 of two 14 days cycles From Week 25 Scrotal prophylactic radio therapy (RT) to the contralateral testis.

reporting Status

POSTED

time Frame

From treatment start until the last drug administration, up to week 22 for the 'R-CHOP, Depocyte, Methotrexate' Group, up to 15 weeks (Weeks 1-15) for the 'R-CHOP + Lyposomal Cytarabine' Group, and from week 18-22 for the 'HD-MTX' Group

title

Adverse Events Assessment

type

PRIMARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice