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NCT01359592 · ClinicalTrials.gov registry record · Phase 2
S1001 PET-Directed Therapy in Treating Patients With Limited-Stage Diffuse Large B-Cell Lymphoma
A Phase 2 study, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 2
- Development phase
- 159
- Enrollment target
NCT01359592: Completed Phase 2 study, sponsored by SWOG Cancer Research Network.
NCT01359592 is a Phase 2 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 159 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01359592, a Phase 2 study, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 159 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Comparing results of diagnostic procedures, such as PET scan and CT scan, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This phase II trial studies how well PET-directed chemotherapy works in treating patients with limited-stage diffuse large B-cell lymphoma.
Primary Outcome
Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact. Progressions is defined using the 2007 revised Cheson et. Al. criteria, as ≥50% increase in the sum of the products of diameters (SPD) of target measurable lesions, appearance of any new bone marrow involvement, or appearance of any new lesion \>1.5 cm in the longest axis.
Interventions
- DRUG prednisone
- DRUG cyclophosphamide
- BIOLOGICAL rituximab
- DRUG doxorubicin hydrochloride
- DRUG vincristine sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2011-09 |
| Est. Completion | 2023-12 |
| Phase | Phase 2 |
What the finished NCT01359592 record still lists
NCT01359592 is an interventional study that assigns participants to a tested intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 5 interventions - of which prednisone is the first listed.
NCT01359592 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01359592 about?
NCT01359592 is a clinical study titled "S1001 PET-Directed Therapy in Treating Patients With Limited-Stage Diffuse Large B-Cell Lymphoma". RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells....
What is the current status of trial NCT01359592?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 159 participants. The study started on 2011-09. Estimated completion is 2023-12.
What interventions are being tested in trial NCT01359592?
The interventions under investigation include: prednisone (DRUG), cyclophosphamide (DRUG), rituximab (BIOLOGICAL), doxorubicin hydrochloride (DRUG), vincristine sulfate (DRUG).
Who is sponsoring clinical trial NCT01359592?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01359592's enrollment target sits among peer trials
159 442nd of 2000 higher than 1,558 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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