Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Favorable-Risk Hodgkin Lymphoma

Titre officiel

Reduced Duration Stanford V Chemotherapy With or Without Low-Dose Tailored-Field Radiation Therapy For Favourable Risk Pediatric Hodgkin Lymphoma

Sommaire:

Cet essai de phase II a pour but l’étude de l’efficacité de la polychimiothérapie avec ou sans radiothérapie dans le traitement de jeunes patients avec un lymphome hodgkinien à risques favorables. Les médicaments utilisés en chimiothérapie, comme le chlorhydrate de doxorubicine, la vinblastine, le chlorhydrate de méchloréthamine, le sulfate de vincristine, la bléomycine, l’étoposide et la prednisone, bloquent la croissance des cellules cancéreuses de différentes manières, soit en tuant les cellules, soit en les empêchant de se diviser. Le fait d’administrer plus d’un médicament (polychimiothérapie) pourrait permettre de tuer davantage de cellules cancéreuses. Les rayons X à haute énergie de la radiothérapie sont utilisés pour détruire les cellules cancéreuses résiduelles après la chimiothérapie. Une combinaison de polychimiothérapie et de radiothérapie pourrait tuer plus de cellules cancéreuses et permettre aux médecins de sauver la partie du corps où est né le cancer.

Description de l'essai

Primary Outcome:

• Proportion of patients that will not require any radiation therapy by at least 20% more compared to the favourable risk arm in HOD99

Secondary Outcome:

• Disease failure rate within radiation fields
• Treatment failure patterns for children treated with tailored-field radiation
• Acute hematologic and infectious toxicity incidents as assessed by CTCAE version 3.0
• Comparison of event-free and overall survival distributions, cumulative incidence of local failure, and toxicities of patients treated on this study to outcome and toxicities in the favourable risk group of HOD99
• Comparison of event-free survival distributions between patients that will not be prescribed radiation therapy after 8 weeks Stanford V and those patients on HOD99 that received VAMP without radiation therapy
• Event-free survival distributions of favourable risk patients treated with Stanford V chemotherapy alone and patients treated with Stanford V chemotherapy plus low dose tailored-field radiation

Patients receive doxorubicin hydrochloride intravenously (IV) and vinblastine IV on day 1 of weeks 1, 3, 5, and 7; mechlorethamine hydrochloride IV on day 1 of weeks 1 and 5; vincristine sulfate IV and bleomycin IV on day 1 of weeks 2, 4, 6, and 8; etoposide IV on day 1 of weeks 3 and 7; and prednisone orally (PO) three times daily every other day for 8 weeks. Two to 3 weeks after all chemotherapy is given, patients not achieving a complete response undergo radiation therapy to individual nodal sites (tailored fields).

PRIMARY OBJECTIVES:

• To increase the complete response rate of favourable risk patients (excluding all patients with stage IA nodular lymphocyte predominant Hodgkin lymphoma) after 8 weeks Stanford V by at least 20% compared to favourable risk patients on HOD 99 after 8 weeks vincristine, doxorubicin hydrochloride, methotrexate and prednisone (VAMP).

SECONDARY OBJECTIVES:

• To estimate the disease failure rate within the radiation fields.
• To examine patterns of treatment failure for children treated with low dose tailored field radiation therapy.
• To describe acute hematologic and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia, and hospitalizations, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
• To compare the survival distributions (event-free and overall) and cumulative incidence of local failure and toxicities of favourable risk patients treated with 8 weeks of Stanford V chemotherapy and low-dose tailored-field radiation to those on the favourable risk group of the HOD 99 study that received VAMP and low-dose involved-field radiation.
• To compare the survival distributions between patients that will not be prescribed radiation therapy after 8 weeks Stanford V and those patients on HOD 99 that did not receive radiation therapy after VAMP.
• To estimate the event-free survival distributions of favourable risk patients treated with Stanford V chemotherapy alone and patients treated with Stanford V chemotherapy plus low dose tailored field radiation.

Voir cet essai sur ClinicalTrials.gov