Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma (DLBCL)

Duke University

Status: Completed

Conditions: Diffuse Large B-cell Lymphoma

Treatments: Radiation: Radiation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01186978

Pro00025164

Details and patient eligibility

About

This study will evaluate whether a reduction in the radiation dose and field size will maintain a high rate of local control while minimizing the risk of acute and late toxicity.

Hypothesis- The radiation dose and treatment volume can be safely reduced from 30 Gy to 20 Gy while maintaining high rates of local control in patients who had a negative PET scan following rituximab-containing chemotherapy.

Enrollment: 63 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologic documentation of diffuse large B-cell lymphoma, or any of its variants as defined in the WHO classification
• Completion of at least 4 cycles of a rituximab-containing, anthracycline-based combination chemotherapy
• Negative post-chemotherapy (or interim) PET scan
• Absolute neutrophil count greater than 1500 and platelet count greater than 40,000
• Negative pregnancy test in women of child-bearing potential

For patients with HIV/AIDS, the following must be true:

• The patient is compliant on combination anti-retroviral therapy (CART)
• The patient has CD4 count ≥ 200 at time of diagnosis

Exclusion criteria

• Any contraindications to irradiation
• Primary CNS lymphoma
• HIV/AIDS

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

63 participants in 1 patient group

Single arm

Other group

Description:

This phase II study will evaluate whether a reduction in the RT dose, concomitant with a decrease in the RT field size, in patients that achieve CR and have a negative post-chemotherapy PET scan following 4 to 6 cycles of rituximab containing chemotherapy, will be associated with a low risk of in-field failure. The goal of this approach is to maintain excellent control rates while minimizing the risk of acute and late toxicity.

Treatment:

Radiation: Radiation Therapy