Trial · NCT00302003

Combination Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Lymphoma

NCT00302003, Phase 3, Completed, Children's Oncology Group; results first posted 2017-02-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Combination Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Lymphoma. Trials, record NCT00302003. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00302003

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Combination Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Lymphoma
NCT number: NCT00302003
Status: Completed
Phases: Phase 3
Enrollment: 287 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: Childhood Favorable Prognosis Hodgkin Lymphoma, Childhood Lymphocyte Depletion Hodgkin Lymphoma, Childhood Mixed Cellularity Hodgkin Lymphoma, Childhood Nodular Sclerosis Hodgkin Lymphoma, Stage I Childhood Hodgkin Lymphoma, Stage II Childhood Hodgkin Lymphoma
Interventions: radiation therapy, doxorubicin hydrochloride, vincristine sulfate, prednisone, cyclophosphamide, ifosfamide, vinorelbine tartrate, dexamethasone, etoposide phosphate, cisplatin, cytarabine, filgrastim
First posted: 2006-03-13
Last updated: 2021-03-30
Results first posted: 2017-02-09

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 Without Receiving Radiation Therapy (EFSnoRT).	At 60 months	Survival is defined as the minimum time from study entry to requirement for additional chemotherapy and IFRT for retrieval, occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. Patients who achieve less than CR after 3 cycles of AV-PC will require IFRT and hence will satisfy this definition at the time of response evaluation. Patients who achieve a CR but who relapse will receive addition chemotherapy and IFRT or intense retrieval and hence will satisfy this definition at the time of the first relapse of Hodgkin disease. This endpoint will be used to compute event free survival without receiving radiation therapy (EFSnoRT).
Primary	Intensive Therapy Free Survival (ITFS).	At 60 months	Survival is defined as the minimum time from study entry to a relapse of higher risk at any time, any relapse following treatment with protocol mandated IFRT, death from any cause, or the occurrence of a second malignant neoplasm. This will be used to compute intensive therapy free survival (ITFS). Patients without report of such events where censored at last contact. This differs from traditional EFS in that relapse after AVPC\* x3 therapy alone that does not place the patient in a higher risk category is not considered a treatment failure. In this definition, higher-risk relapse refers to relapse involving sites and extent of disease that place the patient in the current COG definition of intermediate or high-risk disease. If a patient with CR who experiences a LR relapse is not retreated with protocol-mandated chemotherapy and IFRT, subsequent disease relapses will nevertheless be counted in the analysis of the treatment strategy.
Primary	Event Free Survival (EFS)	At 60 months	Survival is defined as the minimum time from study entry to a relapse of any kind, death from any cause, or occurrence of a second malignant neoplasm. Patients without report of such events where censored at last contact. This will be used to compute event free survival (EFS).
Secondary	Overall Survival	At 60 months	Survival is defined as time from study entry to death due to any cause. Patients alive at last contact 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 Without Receiving Radiation Therapy (EFSnoRT).	At 60 months	Eligible (n=278) and evaluable response and review of response, n=275. Follow-up for censored patients (n=138) is 76 months (range: 1.8 to 108 months).	Probability of survival	NUMBER
PRIMARY	Intensive Therapy Free Survival (ITFS).	At 60 months	Eligible (n=278) and evaluable response and review of response, n=275. Follow-up for censored patients (n=245) is 76 months (range: 4.7 to 109 months).	Probability of survival	NUMBER
PRIMARY	Event Free Survival (EFS)	At 60 months	Eligible (n=278). Follow-up for censored patients (n=223) is 75 months (range: 4.7 to 108 months).	Probability of survival	NUMBER
SECONDARY	Overall Survival	At 60 months	Eligible (n=278). Follow-up for censored patients (n=277) is 76 months (range: 4.7 to 109 months).	Probability of survival	NUMBER

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Event Free Survival Without Receiving Radiation Therapy (EFSnoRT).	Group 1	0.49	95% Confidence Interval 0.42 to 0.54	Probability of survival
Intensive Therapy Free Survival (ITFS).	Group 1	0.89	95% Confidence Interval 0.84 to 0.92	Probability of survival
Event Free Survival (EFS)	Group 1	0.79	95% Confidence Interval 0.74 to 0.84	Probability of survival
Overall Survival	Group 1	0.99	95% Confidence Interval 0.97 to 1.00	Probability of survival

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim	287
Overall Study	COMPLETED	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim	207
Overall Study	NOT COMPLETED	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim	80

Source ClinicalTrials.gov

Adverse events65

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	Febrile neutropenia	Blood and lymphatic system disorders	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim	18	278	18
other	Hearing impaired	Ear and labyrinth disorders	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim	2	278	2
other	Tinnitus	Ear and labyrinth disorders	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim	2	278	2
other	Delayed puberty	Endocrine disorders	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim	1	278	1
other	Hypothyroidism	Endocrine disorders	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim	1	278	1
other	Eye pain	Eye disorders	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim	1	278	1
other	Optic nerve disorder	Eye disorders	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim	1	278	1
other	Abdominal pain	Gastrointestinal disorders	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim	3	278	3
other	Constipation	Gastrointestinal disorders	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim	3	278	3
other	Enterocolitis	Gastrointestinal disorders	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim	1	278	1

1 to 10 of 65Source ClinicalTrials.gov

See all 65 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
Total, other adverse events	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim	80	278
Total, serious adverse events	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim	2	278

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
35763667	DERIVED	PubMed
37505794	DERIVED	PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00302003

GET https://conductscience.org/api/trials/v1/NCT00302003/events?page=2

API reference For AI assistants