Trial · NCT00025259
Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease
NCT00025259, Phase 3, Completed, Children's Oncology Group; results first posted 2017-03-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease. Trials, record NCT00025259. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00025259
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease
- NCT number
- NCT00025259
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,734 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
Childhood Lymphocyte-Depleted Classical Hodgkin Lymphoma, Childhood Mixed Cellularity Classical Hodgkin Lymphoma, Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma, Childhood Nodular Sclerosis Classical Hodgkin Lymphoma, Stage I Childhood Hodgkin Lymphoma, Stage II Childhood Hodgkin Lymphoma, Stage III Childhood Hodgkin Lymphoma, Stage IV Childhood Hodgkin Lymphoma
- Interventions
- Bleomycin Sulfate, Cisplatin, Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin Hydrochloride, Etoposide, Filgrastim, Involved-Field Radiation Therapy, Prednisone, Vincristine Sulfate Liposome
- First posted
- 2003-01-27
- Last updated
- 2017-04-12
- Results first posted
- 2017-03-07
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival | 5 years | Probability of event-Free survival which is defined as the time from study entry to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. |
| Secondary | Disease Response Assessed by Modified RECIST Criteria | Protocol therapy: the overall duration of which is: (n=1527) an average of 137.1 days, median 133.0 days, interquartile range: 101.0, 164.0 days. | Number of participants with complete response and very good partial response at the end of protocol therapy. |
| Secondary | Grade 3 or 4 Non-hematologic Toxicity | Protocol therapy: the overall duration of which is: (n=1684) an average of 137.3 days, median 133.0 days, interquartile range: 101.0, 164.0 days. | Occurrence of any grade 4 non-hematologic toxicity or grade 3 non-hematologic toxicity which doesn't respond to treatment within 7 days despite recommended therapy modification, or toxic death, which is any death primarily attributable to treatment. Grade 3 is defined to be severe or medically significant but not immediate life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 refers to toxicities with life-threatening consequences; urgent intervention indicated. |
| Secondary | Overall Survival | 5 years | Probability of overall survival which is defined as the time from study entry to death from any cause. Patients alive where censored at last contact. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-free Survival | 5 years | Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). | Probability of survival | NUMBER |
| SECONDARY | Disease Response Assessed by Modified RECIST Criteria | Protocol therapy: the overall duration of which is: (n=1527) an average of 137.1 days, median 133.0 days, interquartile range: 101.0, 164.0 days. | Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). | Number of participants | NUMBER |
| SECONDARY | Grade 3 or 4 Non-hematologic Toxicity | Protocol therapy: the overall duration of which is: (n=1684) an average of 137.3 days, median 133.0 days, interquartile range: 101.0, 164.0 days. | Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). | Number of participants | NUMBER |
| SECONDARY | Overall Survival | 5 years | Arm V (RER with PD), has been excluded as there were no deaths observed by the Time Frame of 5 years. Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0). | Probability of survival | NUMBER |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-free Survival | Arm I (Patients Off-therapy Before Callback-Induction Only) | 0.89 | 95% Confidence Interval 0.69 to 0.96 | Probability of survival | |
| Event-free Survival | Arm II (RER With CR [ABVE-PC, IFRT]) | 0.87 | 95% Confidence Interval 0.83 to 0.90 | Probability of survival | |
| Event-free Survival | Arm III (RER With CR [ABVE-PC]) | 0.84 | 95% Confidence Interval 0.80 to 0.87 | Probability of survival | |
| Event-free Survival | Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) | 0.87 | 95% Confidence Interval 0.83 to 0.89 | Probability of survival | |
| Event-free Survival | Arm V (RER With PD) | 0.70 | 95% Confidence Interval 0.51 to 0.82 | Probability of survival | |
| Event-free Survival | Arm VI (SER [DECA, ABVE-PC, IFRT]) | 0.79 | 95% Confidence Interval 0.71 to 0.85 | Probability of survival | |
| Event-free Survival | Arm VII (SER [ABVE-PC, IFRT]) | 0.74 | 95% Confidence Interval 0.66 to 0.80 | Probability of survival | |
| Disease Response Assessed by Modified RECIST Criteria | Arm I (Patients Off-therapy Before Callback-Induction Only) | 5 | Number of participants | ||
| Disease Response Assessed by Modified RECIST Criteria | Arm II (RER With CR [ABVE-PC, IFRT]) | 370 | Number of participants | ||
| Disease Response Assessed by Modified RECIST Criteria | Arm III (RER With CR [ABVE-PC]) | 380 | Number of participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Patients Off-therapy Before Callback-Induction Only) | 52 | |
| Overall Study | STARTED | Arm II (RER With CR [ABVE-PC, IFRT]) | 381 | |
| Overall Study | STARTED | Arm III (RER With CR [ABVE-PC]) | 382 | |
| Overall Study | STARTED | Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) | 571 | |
| Overall Study | STARTED | Arm V (RER With PD) | 42 | |
| Overall Study | STARTED | Arm VI (SER [DECA, ABVE-PC, IFRT]) | 153 | |
| Overall Study | STARTED | Arm VII (SER [ABVE-PC, IFRT]) | 153 | |
| Overall Study | COMPLETED | Arm I (Patients Off-therapy Before Callback-Induction Only) | 7 | |
| Overall Study | COMPLETED | Arm II (RER With CR [ABVE-PC, IFRT]) | 292 | |
| Overall Study | COMPLETED | Arm III (RER With CR [ABVE-PC]) | 301 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events896
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 | Arm I (Patients Off-therapy Before Callback-Induction Only) | 4 | 38 | 4 |
| other | Anemia | Blood and lymphatic system disorders | Arm II (RER With CR [ABVE-PC, IFRT]) | 196 | 380 | 196 |
| other | Anemia | Blood and lymphatic system disorders | Arm III (RER With CR [ABVE-PC]) | 162 | 382 | 162 |
| other | Anemia | Blood and lymphatic system disorders | Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) | 245 | 571 | 245 |
| other | Anemia | Blood and lymphatic system disorders | Arm V (RER With PD) | 12 | 36 | 12 |
| other | Anemia | Blood and lymphatic system disorders | Arm VI (SER [DECA, ABVE-PC, IFRT]) | 85 | 153 | 85 |
| other | Anemia | Blood and lymphatic system disorders | Arm VII (SER [ABVE-PC, IFRT]) | 63 | 152 | 63 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm I (Patients Off-therapy Before Callback-Induction Only) | 1 | 38 | 1 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm II (RER With CR [ABVE-PC, IFRT]) | 50 | 380 | 50 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm III (RER With CR [ABVE-PC]) | 35 | 382 | 35 |
1 to 10 of 896Source ClinicalTrials.gov
See all 896 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Patients Off-therapy Before Callback-Induction Only) | ||
| Total, all-cause mortality | Arm II (RER With CR [ABVE-PC, IFRT]) | ||
| Total, all-cause mortality | Arm III (RER With CR [ABVE-PC]) | ||
| Total, all-cause mortality | Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) | ||
| Total, all-cause mortality | Arm V (RER With PD) | ||
| Total, all-cause mortality | Arm VI (SER [DECA, ABVE-PC, IFRT]) | ||
| Total, all-cause mortality | Arm VII (SER [ABVE-PC, IFRT]) | ||
| Total, other adverse events | Arm I (Patients Off-therapy Before Callback-Induction Only) | 23 | 38 |
| Total, other adverse events | Arm II (RER With CR [ABVE-PC, IFRT]) | 341 | 380 |
| Total, other adverse events | Arm III (RER With CR [ABVE-PC]) | 334 | 382 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers6
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 |
|---|---|---|---|---|---|
| U10CA098543 | Children's Oncology Group Chair's Grant | ADAMSON, PETER C. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2003 to 2013 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00025259
GET https://conductscience.org/api/trials/v1/NCT00025259/results?page=2