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NCT01399372 · ClinicalTrials.gov registry record · Phase 2
Rituximab, Methotrexate, Vincristine Sulfate, Procarbazine Hydrochloride, and Cytarabine With or Without Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
A Phase 2 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 91
- Enrollment target
NCT01399372: Completed Phase 2 study, sponsored by Radiation Therapy Oncology Group.
NCT01399372 is a Phase 2 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 91 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01399372, a Phase 2 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 91 participants
- Enrollment target
Study 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.
Primary Outcome
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 su
Interventions
- DRUG Vincristine
- BIOLOGICAL Rituximab
- DRUG Cytarabine
- DRUG Methotrexate
- DRUG Procarbazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2011-09 |
| Est. Completion | 2022-05-20 |
| Phase | Phase 2 |
What the finished NCT01399372 record still lists
NCT01399372 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 5 interventions - of which Vincristine is the first listed.
NCT01399372 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01399372 about?
NCT01399372 is a clinical study titled "Rituximab, Methotrexate, Vincristine Sulfate, Procarbazine Hydrochloride, and Cytarabine With or Without Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma". 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...
What is the current status of trial NCT01399372?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2011-09. Estimated completion is 2022-05-20.
What interventions are being tested in trial NCT01399372?
The interventions under investigation include: Vincristine (DRUG), Rituximab (BIOLOGICAL), Cytarabine (DRUG), Methotrexate (DRUG), Procarbazine (DRUG).
Who is sponsoring clinical trial NCT01399372?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01399372's enrollment target sits among peer trials
91 771st of 2000 higher than 1,229 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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