Trial · NCT01399372
Rituximab, Methotrexate, Vincristine Sulfate, Procarbazine Hydrochloride, and Cytarabine With or Without Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
NCT01399372, Phase 2, Completed, Radiation Therapy Oncology Group; results first posted 2021-05-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Rituximab, Methotrexate, Vincristine Sulfate, Procarbazine Hydrochloride, and Cytarabine With or Without Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma. Trials, record NCT01399372. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01399372
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rituximab, Methotrexate, Vincristine Sulfate, Procarbazine Hydrochloride, and Cytarabine With or Without Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
- NCT number
- NCT01399372
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 91 participants, actual
- Lead sponsor
- Radiation Therapy Oncology Group
- Conditions
- Chemotherapeutic Agent Toxicity, Cognitive/Functional Effects, Lymphoma, Neurotoxicity, Radiation Toxicity
- Interventions
- Rituximab, Cytarabine, Methotrexate, Procarbazine, Vincristine, low-dose whole-brain radiation therapy
- First posted
- 2011-07-21
- Last updated
- 2023-07-20
- Results first posted
- 2021-05-13
- Limitations and caveats
A planned interim efficacy analysis was performed after 42 events (death or progression). The final analysis was planned to occur after 67 events. The Data Monitoring Committee (DMC) recommended releasing the interim results for early reporting and these results are considered the final study results.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | From randomization to last follow-up. Maximum follow-up at time of analysis was 7.3 years. | 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. |
| Secondary | Overall Survival | From randomization to last follow-up. Maximum follow-up at time of analysis was 7.3 years. | Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. |
| Secondary | Percentage of Participants Experiencing Partial Response or Complete Response | After 4th cycle of chemotherapy, approximately 4 months after randomization. | Response was evaluated using the international criteria proposed by the International Primary Central Nervous System Lymphoma (PCNSL) Study Group criteria. Complete Response was defined as no contrast brain enhancement on magnetic resonance imaging (MRI), no corticosteroid use for at least 2 weeks, a normal eye exam, and negative CSF cytology. Partial response was defined as at least 50% decrease in enhancing tumor on MRI compared with baseline imaging, no or minor retinal pigment epithelium (RPE) abnormality, and negative CSF cytology. |
| Secondary | 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. | Global Health Status is calculated from two questions on the EORTC QLQ-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Data through five years after end of protocol treatment is included in the analysis, while summary data is provided only through three years due to very few participants after that timepoint. |
| Secondary | 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. | Neurocognitive failure is defined as cognitive failure on two or more of the following tests: Hopkins Verbal Learning Test - Revised (HVLT-R) Free Recall, HVLT-R Delayed Recall, HVLT-R Delayed Recognition, Trail Making Test Part A, Trail Making Test Part B, and Controlled Oral Word Association. Cognitive failure for each test is defined as a change from baseline in raw score (post baseline score - baseline score) at or exceeding the minimally important difference reported in the literature \[determined by the reliable change index (RCI) method\] of -5, -3, -2,12, 26, and -12, respectively, indicating a worsening of neurocognitive function. Time to neurocognitive failure is defined as time from randomization to date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method and the distributions of failure times are compared between the arms. Two-year estimates are provided here. |
| Secondary | 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. | Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Adverse events reported as definitely, probably, or possibly related to protocol treatment are considered to be related to treatment. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival | From randomization to last follow-up. Maximum follow-up at time of analysis was 7.3 years. | Eligible participants | years | MEDIAN |
| SECONDARY | Overall Survival | From randomization to last follow-up. Maximum follow-up at time of analysis was 7.3 years. | Eligible participants | years | MEDIAN |
| SECONDARY | Percentage of Participants Experiencing Partial Response or Complete Response | After 4th cycle of chemotherapy, approximately 4 months after randomization. | Eligible participants with Cycle 4 disease assessment data | percentage of participants | NUMBER |
| SECONDARY | 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. | Eligible, consented to quality of life study component, and has GHS score for at least one timepoint. | score on a scale | MEAN |
| SECONDARY | 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. | Eligible, consented to neurocognitive function study component and has at least two completed neurocognitive tests at baseline and at least one post baseline visit. | percentage of participants | NUMBER |
| SECONDARY | 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. | Eligible participants who started protocol treatment | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival | Chemotherapy | 2.1 | 95% Confidence Interval 1.0 to NA | years | |
| Progression-free Survival | Chemotherapy + Low-Dose WBRT | NA | 95% Confidence Interval 3.3 to NA | years | |
| Overall Survival | Chemotherapy | NA | 95% Confidence Interval 2.6 to NA | years | |
| Overall Survival | Chemotherapy + Low-Dose WBRT | NA | 95% Confidence Interval 4.5 to NA | years | |
| Percentage of Participants Experiencing Partial Response or Complete Response | Chemotherapy | 83.3 | 95% Confidence Interval 65.3 to 94.4 | percentage of participants | |
| Percentage of Participants Experiencing Partial Response or Complete Response | Chemotherapy + Low-Dose WBRT | 80.6 | 95% Confidence Interval 62.5 to 92.5 | percentage of participants | |
| Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | Chemotherapy | Baseline | 62.78 | Standard Deviation 23.54 | score on a scale |
| Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | Chemotherapy + Low-Dose WBRT | Baseline | 54.90 | Standard Deviation 26.91 | score on a scale |
| Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | Chemotherapy | End of cycle 4 | 67.67 | Standard Deviation 23.97 | score on a scale |
| Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | Chemotherapy + Low-Dose WBRT | End of cycle 4 | 64.58 | Standard Deviation 20.49 | score on a scale |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemotherapy | 47 | |
| Overall Study | STARTED | Chemotherapy + Low-Dose WBRT | 44 | |
| Overall Study | Eligible | Chemotherapy | 44 | |
| Overall Study | Eligible | Chemotherapy + Low-Dose WBRT | 43 | |
| Overall Study | Eligible and Started Protocol Treatment | Chemotherapy | 43 | |
| Overall Study | Eligible and Started Protocol Treatment | Chemotherapy + Low-Dose WBRT | 43 | |
| Overall Study | COMPLETED | Chemotherapy | 44 | |
| Overall Study | COMPLETED | Chemotherapy + Low-Dose WBRT | 43 | |
| Overall Study | NOT COMPLETED | Chemotherapy | 3 | |
| Overall Study | NOT COMPLETED | Chemotherapy + Low-Dose WBRT | 1 |
Source ClinicalTrials.gov
Adverse events352
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Chemotherapy | 34 | 43 | |
| other | Anemia | Blood and lymphatic system disorders | Chemotherapy + Low-Dose WBRT | 30 | 43 | |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Chemotherapy | 3 | 43 | |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Chemotherapy + Low-Dose WBRT | 3 | 43 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Chemotherapy | 0 | 43 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Chemotherapy + Low-Dose WBRT | 3 | 43 | |
| other | Sinus tachycardia | Cardiac disorders | Chemotherapy | 3 | 43 | |
| other | Sinus tachycardia | Cardiac disorders | Chemotherapy + Low-Dose WBRT | 2 | 43 | |
| other | Hearing impaired | Ear and labyrinth disorders | Chemotherapy | 1 | 43 | |
| other | Hearing impaired | Ear and labyrinth disorders | Chemotherapy + Low-Dose WBRT | 4 | 43 |
1 to 10 of 352Source ClinicalTrials.gov
See all 352 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemotherapy | 3 | 44 |
| Total, all-cause mortality | Chemotherapy + Low-Dose WBRT | 1 | 43 |
| Total, other adverse events | Chemotherapy | 42 | 43 |
| Total, other adverse events | Chemotherapy + Low-Dose WBRT | 43 | 43 |
| Total, serious adverse events | Chemotherapy | 22 | 43 |
| Total, serious adverse events | Chemotherapy + Low-Dose WBRT | 21 | 43 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Chemotherapy vs Chemotherapy + Low-Dose WBRT: deaths from any cause | Trial comparisons |
| Chemotherapy vs Chemotherapy + Low-Dose WBRT: serious adverse events | Trial comparisons |
Tests4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01399372
GET https://conductscience.org/api/trials/v1/NCT01399372/results?page=2