Trial · NCT00003389
Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma
NCT00003389, Phase 3, Completed, Eastern Cooperative Oncology Group; results first posted 2015-09-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma. Trials, record NCT00003389. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00003389
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma
- NCT number
- NCT00003389
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 854 participants, actual
- Lead sponsor
- Eastern Cooperative Oncology Group
- Conditions
- Lymphoma
- Interventions
- Doxorubicin, Bleomycin, Vinblastine, Dacarbazine, Vincristine, Mechlorethamine, Etoposide, Prednisone, Cyclophosphamide, Radiotherapy
- First posted
- 2003-01-27
- Last updated
- 2023-06-29
- Results first posted
- 2015-09-03
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Failure-free Survival at 5 Years | Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5 | Failure-free survival is defined as the time from randomization to the earlier of progression/relapse or death. The 5-year failure-free survival is the probability a patient is failure-free and survives 5 years. Progression is defined as an increase in size of 25% of the sum of the products of the pretreatment measurements or appearance of new lesions. Significant enlargement of the liver or spleen is evidence of progression. A significant increase in size is defined as \> 2.0 cm in distance between costal margin and the inferior margin of either organ. Relapse is defined as the re-appearance of any clinical evidence of Hodgkin's disease in a patient who has had a complete response. Relapse for partial responders is defined as progressive disease relative to disease status during the partial remission. |
| Secondary | 5-year Overall Survival | Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years | Overall survival is defined as the time from randomization to death or last known alive. The 5-year survival rate is the probability a patient survives 5 years. |
| Secondary | Incidence of Second Cancers | Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years | Number of patients who developed second primary cancers |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Failure-free Survival at 5 Years | Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5 | Eligible patients | Proportion of patients | NUMBER |
| SECONDARY | 5-year Overall Survival | Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years | Eligible patients | Proportion of patients | NUMBER |
| SECONDARY | Incidence of Second Cancers | Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Failure-free Survival at 5 Years | Arm A (ABVD) | 0.74 | 95% Confidence Interval 0.69 to 0.79 | Proportion of patients | |
| Failure-free Survival at 5 Years | Arm B (Stanford V) | 0.71 | 95% Confidence Interval 0.66 to 0.76 | Proportion of patients | |
| 5-year Overall Survival | Arm A (ABVD) | 0.88 | 95% Confidence Interval 0.85 to 0.92 | Proportion of patients | |
| 5-year Overall Survival | Arm B (Stanford V) | 0.88 | 95% Confidence Interval 0.84 to 0.91 | Proportion of patients | |
| Incidence of Second Cancers | Arm A (ABVD) | 15 | participants | ||
| Incidence of Second Cancers | Arm B (Stanford V) | 19 | participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (ABVD) | 428 | |
| Overall Study | STARTED | Arm B (Stanford V) | 426 | |
| Overall Study | Treated Pts w/ Toxicity Data Available | Arm A (ABVD) | 414 | |
| Overall Study | Treated Pts w/ Toxicity Data Available | Arm B (Stanford V) | 422 | |
| Overall Study | Eligible Patients | Arm A (ABVD) | 395 | |
| Overall Study | Eligible Patients | Arm B (Stanford V) | 399 | |
| Overall Study | COMPLETED | Arm A (ABVD) | 330 | |
| Overall Study | COMPLETED | Arm B (Stanford V) | 366 | |
| Overall Study | NOT COMPLETED | Arm A (ABVD) | 98 | |
| Overall Study | NOT COMPLETED | Arm B (Stanford V) | 60 |
Source ClinicalTrials.gov
Adverse events322
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 | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Arm A (ABVD) | 24 | 414 | |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Arm B (Stanford V) | 9 | 422 | |
| other | Anemia | Blood and lymphatic system disorders | Arm A (ABVD) | 374 | 414 | |
| other | Anemia | Blood and lymphatic system disorders | Arm B (Stanford V) | 412 | 422 | |
| other | Leukocytes decreased | Investigations | Arm A (ABVD) | 378 | 414 | |
| other | Leukocytes decreased | Investigations | Arm B (Stanford V) | 394 | 422 | |
| other | Lymphopenia | Investigations | Arm A (ABVD) | 319 | 414 | |
| other | Lymphopenia | Investigations | Arm B (Stanford V) | 379 | 422 | |
| other | Neutrophils decreased | Investigations | Arm A (ABVD) | 341 | 414 | |
| other | Neutrophils decreased | Investigations | Arm B (Stanford V) | 354 | 422 |
1 to 10 of 322Source ClinicalTrials.gov
See all 322 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (ABVD) | ||
| Total, all-cause mortality | Arm B (Stanford V) | ||
| Total, other adverse events | Arm A (ABVD) | 413 | 414 |
| Total, other adverse events | Arm B (Stanford V) | 422 | 422 |
| Total, serious adverse events | Arm A (ABVD) | 355 | 414 |
| Total, serious adverse events | Arm B (Stanford V) | 401 | 422 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (ABVD) vs Arm B (Stanford V): Incidence of Second Cancers | Trial comparisons |
| Arm A (ABVD) vs Arm B (Stanford V): serious adverse events | 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/NCT00003389
GET https://conductscience.org/api/trials/v1/NCT00003389/events?page=2