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Efficacy of Palliative Low-Dose Involved-Field Radiation Therapy for Recurrent Advanced Follicular Lymphoma

NCT02438501 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2015-12-14

No results posted yet for this study

Summary

Many trials that patients with advanced or recurrent indolent lymphoma managed with very low-dose (4Gy) limited-field RT (LD-IFRT) have shown that high response rates and durable remission can be achieved. However, the results of two phase III trials have failed to demonstrate the lasting response rate (RR) with LD-IFRT versus in other approaches. Histology, bulky tumor (\>5 cm), higher number of prior chemotherapy regimens, adoption of rituximab, and age\>65 years have been shown to significantly influence response rates of LD-IFRT. The objectives of this trial investigate the efficacy of palliative low-dose involved-field radiation therapy in patients lower than 65 years of age with recurrent advanced follicular lymphoma.

Conditions

  • Recurrent Follicular Lymphoma

Interventions

RADIATION

Low-dose involved-field radiotherapy

Low-dose involved-field RT (LD-IFRT) is given in 2 daily fractions (2×2 Gy). Involved-field of radiotherapy defined by CALGB is encompassed the prechemotherapy gross tumor.

RADIATION

Involved-field radiotherapy

Involved-field RT (IFRT) is given in 24 Gy in 12 fractions. Radiotherapy field defined by CALGB is encompassed the prechemotherapy gross tumor.

Sponsors & Collaborators

  • Di Deng

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2019-10-31
Completion
2025-10-31

Countries

  • China

Study Locations

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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 NCT02438501 on ClinicalTrials.gov