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R-ABVD vs ABVD-RT in Early Stage Hodgkin's Lymphoma

NCT00992030 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2021-08-19

No results posted yet for this study

Summary

Combined modality therapy has then emerged as the standard of care for limited-stage Hodgkin's lymphoma and doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) chemotherapy that is devoid of alkylating agents and associated with a low potential for gonadal toxicity and leukemogenesis, is currently considered a gold standard. Nevertheless, the disadvantage to combine radiotherapy to ABVD is represented by late cardiovascular events (myocardial dysfunction and coronary or valvular disease), especially when the heart is within the radiation field; bleomycin pulmonary toxicity also is increased in conjunction with RT and secondary tumors, in particular in the RT fields. This study aims at treating patients with limited disease with multiagent chemotherapy alone, without irradiation, and using radiotherapy only for relapses.

Conditions

Interventions

DRUG

Rituximab

I.V. infusion weekly x 6 weeks at a dose of 375 mg/m2

RADIATION

Involved field irradiation

Radiation therapy, limited to initially involved nodal sites, will start within four weeks from the last cycle of ABVD chemotherapy and after complete restaging with TAC total-body and PET total-body. The planned total dose is 30,6 Gy.

Sponsors & Collaborators

  • Fondazione Michelangelo

    lead OTHER

Principal Investigators

  • Alessandro M Gianni, MD · Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • United States
  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00992030 on ClinicalTrials.gov