Trial · NCT01118026
Response-Based Therapy Assessed By PET Scan in Treating Patients With Bulky Stage I and Stage II Classical Hodgkin Lymphoma
NCT01118026, Phase 2, Completed, Alliance for Clinical Trials in Oncology; results first posted 2021-12-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Response-Based Therapy Assessed By PET Scan in Treating Patients With Bulky Stage I and Stage II Classical Hodgkin Lymphoma. Trials, record NCT01118026. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01118026
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Response-Based Therapy Assessed By PET Scan in Treating Patients With Bulky Stage I and Stage II Classical Hodgkin Lymphoma
- NCT number
- NCT01118026
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 101 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Lymphoma
- Interventions
- ABVD, BEACOPP, radiation therapy
- First posted
- 2010-05-06
- Last updated
- 2021-12-01
- Results first posted
- 2021-12-01
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 at 36 Months | Up to 36 months | 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. |
| Secondary | Complete Response | Up to 8 weeks | A Complete Response (CR) is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. For this endpoint, the best response at any time post-baseline was analyzed |
| Other | Comparison of Qualitative and Semiquantitative Fludeoxyglucose-PET Findings/Changes, 2-D and Volumetric CT Changes, and Combinatorial Analyses (PET + Dedicated CT Data) With Molecular Parameters and Conventional Parameters | Up to 3 years | |
| Other | Volumetric vs 2-dimensional (2-D) Measurement Changes for Target Lesions Between Baseline and After Course 2, at the End of Chemotherapy, and After IFRT | Up to 3 years | |
| Other | Determination of the Optimal Cutoff for Absolute Decrease in Maximum SUV Body Weight (SUVbw) and SUV Lean Body Mass (SUVlbm), Relative Uptake in Tumor vs Various Reference Anatomic Sites, IHP Criteria as Well as Various Cutoffs for Post-therapy Maxim ... | Up to 3 years | |
| Other | Standard Uptake Values (SUVs) for Target Sites Measured at Baseline, After Course 2, and After Completion of Therapy | Up to 3 years |
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 at 36 Months | Up to 36 months | Six patients were not eligible for this analysis and one patient was not evaluated for PET status screening. All patients that were eligible and evaluated for PET screening were included in this analysis. | percentage of participants | NUMBER |
| SECONDARY | Complete Response | Up to 8 weeks | All eligible patients patients who were screened for PET status and were evaluated for response are included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Comparison of Qualitative and Semiquantitative Fludeoxyglucose-PET Findings/Changes, 2-D and Volumetric CT Changes, and Combinatorial Analyses (PET + Dedicated CT Data) With Molecular Parameters and Conventional Parameters | Up to 3 years | |||
| OTHER_PRE_SPECIFIED | Volumetric vs 2-dimensional (2-D) Measurement Changes for Target Lesions Between Baseline and After Course 2, at the End of Chemotherapy, and After IFRT | Up to 3 years | |||
| OTHER_PRE_SPECIFIED | Determination of the Optimal Cutoff for Absolute Decrease in Maximum SUV Body Weight (SUVbw) and SUV Lean Body Mass (SUVlbm), Relative Uptake in Tumor vs Various Reference Anatomic Sites, IHP Criteria as Well as Various Cutoffs for Post-therapy Maxim ... | Up to 3 years | |||
| OTHER_PRE_SPECIFIED | Standard Uptake Values (SUVs) for Target Sites Measured at Baseline, After Course 2, and After Completion of Therapy | Up to 3 years |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival at 36 Months | ABVD (PET-negative) | 93.1 | 95% Confidence Interval 87.4 to 99.1 | percentage of participants | |
| Progression-free Survival at 36 Months | ABVD + BEACOPP + Radiation (PET-positive) | 89.7 | 95% Confidence Interval 77.2 to 100 | percentage of participants | |
| Complete Response | ABVD (PET-negative) | 73 | Participants | ||
| Complete Response | ABVD + BEACOPP + Radiation (PET-positive) | 16 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ABVD +/- BEACOPP + Radiation | 101 | |
| Overall Study | COMPLETED | ABVD +/- BEACOPP + Radiation | 101 | |
| Overall Study | NOT COMPLETED | ABVD +/- BEACOPP + Radiation | 0 |
Source ClinicalTrials.gov
Adverse events206
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 | ABVD +/- BEACOPP + Radiation | 75 | 100 | 300 |
| other | Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | ABVD +/- BEACOPP + Radiation | 1 | 100 | 2 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | ABVD +/- BEACOPP + Radiation | 9 | 100 | 11 |
| other | Chest pain - cardiac | Cardiac disorders | ABVD +/- BEACOPP + Radiation | 2 | 100 | 3 |
| other | Sinus tachycardia | Cardiac disorders | ABVD +/- BEACOPP + Radiation | 7 | 100 | 12 |
| other | Supraventricular tachycardia | Cardiac disorders | ABVD +/- BEACOPP + Radiation | 2 | 100 | 4 |
| other | Ventricular tachycardia | Cardiac disorders | ABVD +/- BEACOPP + Radiation | 1 | 100 | 1 |
| other | Ear pain | Ear and labyrinth disorders | ABVD +/- BEACOPP + Radiation | 3 | 100 | 3 |
| other | Cushingoid | Endocrine disorders | ABVD +/- BEACOPP + Radiation | 1 | 100 | 1 |
| other | Blurred vision | Eye disorders | ABVD +/- BEACOPP + Radiation | 2 | 100 | 4 |
1 to 10 of 206Source ClinicalTrials.gov
See all 206 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ABVD +/- BEACOPP + Radiation | 0 | 100 |
| Total, other adverse events | ABVD +/- BEACOPP + Radiation | 100 | 100 |
| Total, serious adverse events | ABVD +/- BEACOPP + Radiation | 0 | 100 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| ABVD (PET-negative) vs ABVD + BEACOPP + Radiation (PET-positive): Complete Response |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
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/NCT01118026
GET https://conductscience.org/api/trials/v1/NCT01118026/events?page=2