N/A Completed N=63 Treatment

Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Source: ClinicalTrials.gov NCT01186978 ↗

Enrolled (actual)

Serious AEs

6.4%

Results posted

Jun 2020

Primary outcomePrimary: Number of Participants With Local Control — 61 Participants

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Local Control	61	—
SECONDARY Percentage of Participants With Progression-free Survival at 5 Years	83	—
SECONDARY Percentage of Participants With Overall Survival	90	—
SECONDARY Number of Participants With Local, Distant, or Local+Distant Failure	1; 6; 0	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01186978). 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. Informational only — not medical advice.