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Response-Based Therapy Assessed By PET Scan in Treating Patients With Bulky Stage I and Stage II Classical Hodgkin Lymphoma
NCT01118026 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01118026
The ClinicalTrials.gov registry entry for NCT01118026 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01118026 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Delaware, Illinois, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01118026?
The interventions under investigation include: radiation therapy (RADIATION), ABVD (DRUG), BEACOPP (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01118026?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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