Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01011920 · OUTCOME

2 Years Failure Free Survival (FFS) After Second Randomization

Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma · Source last updated 2026-03-19

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Every 3 weeks during treatment and every 3 months thereafter up to 2 years from study entry

What was measured

Percentage of patients alive and free from disease progression, relapse, need for new treatment, after 2 years from study entry. Percentage values are rounded to whole numbers.

Groups in this outcome

Arm D / WBRT 36 Gy +/- Boost 9 Gy

ARM D: WBRT with 36 Gy in the case of CR to primary chemotherapy or the same WBRT dose followed by a tumor-bed boost of 9 Gy with 1-2 cm of margin surrounding enhanced residual lesion (total tumor-bed dose 45 Gy) in patients who achieved a PR or SD after primary chemotherapy. Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions. radiotherapy: Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions. Whole-brain will be irradiated by two opposite lateral fields including the first two cervical vertebras and the posterior two thirds of the orbits, which must be shielded after 30 Gy (after 36 Gy in the case of evident intraocular disease at diagnosis). Tumor-bed (boost or partial-brain RT) will be irradiated by 2 to 4 isocentric treatment fields based on tumor location, with all portals treated per each RT session.

Arm E / BCNU + Thiotepa + APBSCT

Arm E BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6 Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4 Reinfusion of PBSC ≥5 x 106 CD34+ cells/kg day 0 Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4 BCNU: BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6 APBSCT: Autologous peripheral blood stem cell transplant (APBSCT)

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

Analysis denominator · Participants

GroupSource count
Arm D / WBRT 36 Gy +/- Boost 9 Gy55
Arm E / BCNU + Thiotepa + APBSCT58

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm D / WBRT 36 Gy +/- Boost 9 Gy76Not reported6587Not reported
Arm E / BCNU + Thiotepa + APBSCT75Not reported6486Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        65
        upper Limit
        87
        value
        76
      2. group Id
        OG001
        lower Limit
        64
        upper Limit
        86
        value
        75
denoms
  1. counts
    1. group Id
      OG000
      value
      55
    2. group Id
      OG001
      value
      58
    units
    Participants
description
Percentage of patients alive and free from disease progression, relapse, need for new treatment, after 2 years from study entry. Percentage values are rounded to whole numbers.
dispersion Type
95% Confidence Interval
groups
  1. description
    ARM D: WBRT with 36 Gy in the case of CR to primary chemotherapy or the same WBRT dose followed by a tumor-bed boost of 9 Gy with 1-2 cm of margin surrounding enhanced residual lesion (total tumor-bed dose 45 Gy) in patients who achieved a PR or SD after primary chemotherapy. Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions. radiotherapy: Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions. Whole-brain will be irradiated by two opposite lateral fields including the first two cervical vertebras and the posterior two thirds of the orbits, which must be shielded after 30 Gy (after 36 Gy in the case of evident intraocular disease at diagnosis). Tumor-bed (boost or partial-brain RT) will be irradiated by 2 to 4 isocentric treatment fields based on tumor location, with all portals treated per each RT session.
    id
    OG000
    title
    Arm D / WBRT 36 Gy +/- Boost 9 Gy
  2. description
    Arm E BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6 Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4 Reinfusion of PBSC ≥5 x 106 CD34+ cells/kg day 0 Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4 BCNU: BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6 APBSCT: Autologous peripheral blood stem cell transplant (APBSCT)
    id
    OG001
    title
    Arm E / BCNU + Thiotepa + APBSCT
param Type
NUMBER
reporting Status
POSTED
time Frame
Every 3 weeks during treatment and every 3 months thereafter up to 2 years from study entry
title
2 Years Failure Free Survival (FFS) After Second Randomization
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice