CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,734 enrolled
Drug / intervention
Bleomycin Sulfate +10 morebiological
Likely dose
Dose-intensive chemotherapy regimen with doxorubicin, cisplatin, etoposide, bleomycin, cyclophosphamide, and cytarabine (specific doses not detailed in provided text) plus involved-field radiation therapyAI-extracted
Key inclusion· 6
  • ✓Newly diagnosed, pathologically confirmed Hodgkin disease of all histologies with specific stage eligibility: all Stage IB/IIB regardless of bulk; Stage IA or IIA only if bulk disease present; all Stage IAE/IIAE/IIIA/IIIAE/IIIAS/IVA/IVAE regardless of bulk
  • ✓Cardiac function: ejection fraction at least 50% by MUGA or shortening fraction at least 27% by echocardiogram; no pathologic QTc prolongation on ECG
  • ✓Pulmonary function: FEV1/FVC >60% by pulmonary function test, pulse oximetry >94%, no dyspnea at rest, no exercise intolerance
  • ✓Creatinine ≤1.5 times normal; creatinine clearance >40 mL/min or radioisotope glomerular filtration rate >70 mL/min
Key exclusion· 4
  • ✕Staged by laparotomy alone; surgically staged patients must have presurgical staging documentation
  • ✕Prior chemotherapy
  • ✕Prior radiotherapy
  • ✕Pregnant or nursing; fertile patients must use effective contraception

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00025259
NCT00025259Phase 3Completed
CompareCT.gov

A Phase III Groupwide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents With Newly Diagnosed Intermediate Risk Hodgkin Disease

Children's Oncology Group·interventional·Posted Jan 27, 2003·Updated Apr 12, 2017

In Brief

A Phase 3 clinical trial evaluating Bleomycin Sulfate, Cisplatin, and 9 other interventions for Childhood Lymphocyte-Depleted Classical Hodgkin Lymphoma and 7 related conditions. Completed, enrolled 1,734 participants across 175 sites in 7 countries.

Detailed Summary

This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChildhood 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
CountriesAustralia, Canada, Israel, New Zealand, Puerto Rico, Switzerland, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartSep 1, 2002
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9.9 yearsPosted 23.4 years ago

Interventions

Bleomycin Sulfatebiological

Given IV or SC

Cisplatindrug

Given IV

Cyclophosphamidedrug

Given IV

Cytarabinedrug

Given IV

Dexamethasonedrug

Given IV

Doxorubicin Hydrochloridedrug

Given IV

Etoposidedrug

Given IV

Filgrastimbiological

Given SC

Involved-Field Radiation Therapyradiation

Undergo IFRT

Prednisonedrug

Given orally

Vincristine Sulfate Liposomedrug

Given IV