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NCT01118026 · ClinicalTrials.gov registry record · Phase 2
Response-Based Therapy Assessed By PET Scan in Treating Patients With Bulky Stage I and Stage II Classical Hodgkin Lymphoma
A Phase 2 study of Lymphoma, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 2
- Development phase
- 101
- Enrollment target
- 20
- Study locations
NCT01118026: Completed Phase 2 study of Lymphoma, sponsored by Alliance for Clinical Trials in Oncology.
NCT01118026 is a Phase 2 study of Lymphoma that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 101 participants, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01118026, a Phase 2 study of Lymphoma, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 101 participants
- Enrollment target
- 20
- Study locations
Study Summary
This research is being done in order to improve treatment outcomes in patients diagnosed with bulky, early stage Hodgkin lymphoma and to reduce the side effects that are associated with use of radiation used in current treatments. The chemotherapy treatment in this study consists of a combination of four drugs approved by the Food and Drug Administration (FDA): doxorubicin, bleomycin, vinblastine, and dacarbazine. This regimen (called ABVD) has been found to be effective in treating patients with Hodgkin lymphoma and is considered the standard of treatment used with radiation therapy in patients with bulky early stage Hodgkin lymphoma. As part of the evaluation of the effectiveness of the chemotherapy treatment, PET scans will be obtained during the course of therapy. The usefulness of this PET scan will be evaluated to determine whether radiation may be left out in the treatment of disease if the PET scan shows that the patient has responded to chemotherapy alone. The plan is to identify a group of patients using early PET scans in order to change to a chemotherapy treatment called BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone). It is one of the most highly effective chemotherapy regimens for Hodgkin lymphoma, but is associated with more side effects than ABVD. Although it has become standard of care in Europe, its use has been more limited in the U.S. because of concerns about toxicity.
Primary Outcome
Progression-free survival (PFS) is defined as the time from first PET/CT scan to disease progression or death. Patients who are alive without disease progression will be censored at the time of their most recent disease evaluation. The Kaplan-Meier three-year (36 month) survival estimates and confidence intervals are presented below.
Conditions Studied
Interventions
- RADIATION radiation therapy
- DRUG ABVD
- DRUG BEACOPP
Study Locations (20)
Delaware
- Beebe Medical Center - Lewes
- Delaware Clinical and Laboratory Physicians PA - Newark
- Christiana Care Health System-Christiana Hospital - Newark
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
- Weiss Memorial Hospital - Chicago
- NorthShore University HealthSystem-Evanston Hospital - Evanston
Minnesota
- Saint John's Hospital - Healtheast - Maplewood
- Park Nicollet Clinic - Saint Louis Park - Saint Louis Park
- Regions Hospital - Saint Paul
California
- Naval Medical Center -San Diego - San Diego
- Saint Helena Hospital - St. Helena
Indiana
- Memorial Regional Cancer Center Day Road - Mishawaka
- Memorial Hospital of South Bend - South Bend
Kansas
- Cancer Center of Kansas - Wichita - Wichita
- Via Christi Regional Medical Center - Wichita
Maryland
- University of Maryland/Greenebaum Cancer Center - Baltimore
- Union Hospital of Cecil County - Elkton
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2010-09 |
| Est. Completion | 2021-09-29 |
| Phase | Phase 2 |
What the finished NCT01118026 record still lists
NCT01118026 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which radiation therapy is the first listed.
NCT01118026 names 20 study sites across 9 states, led by Delaware, Illinois, Minnesota.
Frequently Asked Questions
What is clinical trial NCT01118026 about?
NCT01118026 is a clinical study titled "Response-Based Therapy Assessed By PET Scan in Treating Patients With Bulky Stage I and Stage II Classical Hodgkin Lymphoma". This research is being done in order to improve treatment outcomes in patients diagnosed with bulky, early stage Hodgkin lymphoma and to reduce the side effects that are associated with use of radiation used in current treatments. The chemotherapy treatment in this study consists of a combination of...
What is the current status of trial NCT01118026?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 101 participants. The study started on 2010-09. Estimated completion is 2021-09-29.
What conditions does trial NCT01118026 study?
This clinical trial studies the following conditions: Lymphoma.
What interventions are being tested in trial NCT01118026?
The interventions under investigation include: radiation therapy (RADIATION), ABVD (DRUG), BEACOPP (DRUG).
Who is sponsoring clinical trial NCT01118026?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01118026 being conducted?
This trial has 20 study locations across California, Delaware, District of Columbia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01118026's enrollment target sits among peer trials
101 80th of 299 higher than 220 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma 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.
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