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Phase 3 N=854 Randomized Treatment

Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma

Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT00003389 ↗
Enrolled (actual)
854
Serious AEs
90.4%
Results posted
Sep 2015
Primary outcome: Primary: Failure-free Survival at 5 Years — 0.74; 0.71 Proportion of patients — p=0.32

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Doxorubicin (Drug); Bleomycin (Drug); Vinblastine (Drug); Dacarbazine (Drug); Vincristine (Drug); Mechlorethamine (Drug); Etoposide (Drug); Prednisone (Drug); Cyclophosphamide (Drug); Radiotherapy (Radiation)
Age
Pediatric, Adult, Older Adult · 16+ yrs
Sex
All
Sponsor
Eastern Cooperative Oncology Group
Primary completion
Sep 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Failure-free Survival at 5 Years		 0.74; 0.71 0.32
SECONDARY
5-year Overall Survival		 0.88; 0.88 0.86
SECONDARY
Incidence of Second Cancers		 15; 19 —

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining more than one drug with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work, with or without radiation therapy, in treating patients with Hodgkin's lymphoma.

Eligibility Criteria

Inclusion criteria

  • Histologically proven previously untreated classical Hodgkin's lymphoma
  • The following stages are eligible:
  • Locally extensive: Stage I-IIA/B with massive mediastinal adenopathy
  • Advanced: Stage III or IV
  • Measurable or evaluable disease
  • Age of 16 and over
  • ECOG Performance status 0-2
  • Disease-free of prior invasive malignancies for >5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  • White blood cell (WBC) at least 4,000/mm³, (unless documented bone marrow involvement)
  • Platelet count at least 100, 000/mm³ (unless documented bone marrow involvement)
  • Bilirubin no greater than 5.0 mg/dL
  • Creatinine no greater than 2.0 mg/dL
  • Ejection fraction determination recommended if over age 50 and/or have a history of cardiac disease
  • Fertile patients must use effective contraception
  • Prior corticosteroids allowed
  • Prior surgery allowed

Exclusion criteria

  • Pregnant or nursing
  • Prior radiotherapy
  • Prior chemotherapy
  • Human immunodeficiency virus (HIV) positive
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00003389). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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