NCT01399372|CompletedPhase 2ResultsDMC

Rituximab, Methotrexate, Vincristine Sulfate, Procarbazine Hydrochloride, and Cytarabine With or Without Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma

Phase II Randomized Study of Rituximab, Methotrexate, Procarbazine, Vincristine, and Cytarabine With and Without Low-Dose Whole-Brain Radiotherapy for Primary Central Nervous System Lymphoma

Radiation Therapy Oncology Group ClinicalTrials.gov

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3 other identifiers

RTOG 1114CDR0000703682NCI-2011-02678

Study Type

interventional

Target

Locations

2 countries

Sites

Timeline

RegisteredJul 2011

StartedSep 2011

CompletionMay 2022

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, vincristine sulfate, procarbazine hydrochloride, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill cancer cells. It is not yet know whether rituximab and combination chemotherapy are more effective when given with or without radiation therapy in treating patients with primary central nervous system lymphoma. PURPOSE: This randomized phase II trial studies how well giving rituximab and combination chemotherapy with or without radiation therapy works in treating patients with primary central nervous system lymphoma.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Sep 2011

Longer than P75 for phase_2

Geographic Reach

2 countries

45 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10.7 years study duration

First Submitted

Initial submission to the registry

July 20, 2011

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2011

Completed

1 month until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed

8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2020

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

May 13, 2021

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2022

Completed

Last Updated

July 20, 2023

Status Verified

May 1, 2023

Enrollment Period

8.6 years

First QC Date

July 20, 2011

Results QC Date

February 15, 2021

Last Update Submit

July 13, 2023

Conditions

Chemotherapeutic Agent Toxicity Cognitive/Functional Effects Lymphoma Neurotoxicity Radiation Toxicity

Keywords

neurotoxicitychemotherapeutic agent toxicityradiation toxicitycognitive/functional effectsprimary central nervous system non-Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

Progression-free Survival
Progression is defined as any of the following: more than 25% increase in the contrast-enhancing lesion seen on magnetic resonance imaging (MRI) compared with baseline or best response; new site of disease (central nervous system or systemic); recurrent or new ocular disease; recurrent or positive cerebrospinal fluid (CSF) cytology. Progression-free survival time is defined as time from randomization to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method.
From randomization to last follow-up. Maximum follow-up at time of analysis was 7.3 years.

Secondary Outcomes (5)

Overall Survival
From randomization to last follow-up. Maximum follow-up at time of analysis was 7.3 years.
Percentage of Participants Experiencing Partial Response or Complete Response
After 4th cycle of chemotherapy, approximately 4 months after randomization.
Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
EORTC QLQ-C30 was administered at baseline, after cycle 4 of treatment (4 months), then every six months after end of treatment (7 months) for five years.
Percentage of Participants With Neurocognitive Failure
Neurocognitive function tests were administered at baseline, after cycle 4 of treatment (4 months), then every six months after end of treatment (7 months) for five years. Two-year rates are provided here.
Distribution of Participants by Highest Grade Adverse Event Related to Protocol Treatment
At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 7.3 years.

Study Arms (2)

Chemotherapy

ACTIVE COMPARATOR

Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.

Biological: RituximabDrug: CytarabineDrug: MethotrexateDrug: ProcarbazineDrug: Vincristine

Chemotherapy + Low-Dose WBRT

EXPERIMENTAL

Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.

Biological: RituximabDrug: CytarabineDrug: MethotrexateDrug: ProcarbazineDrug: VincristineRadiation: low-dose whole-brain radiation therapy