Low Dose Radiotherapy in Primary Indolent Cutaneous B-cell Lymphoma (LDRT)

April 22, 2026 updated by: Azienda USL Reggio Emilia - IRCCS
Primary indolent cutaneous B cell lymphomas (PCBCL) are rare: although data on outcomes and treatment are limited, traditionally they have been treated with radiation doses in excess of 24 Gy. Recently, some trials that patients with primary cutaneous indolent lymphoma managed with very low dose (4 Gy) RT (LDRT) have shown that high response rates and durable remission can be achieved; unfortunately, given the retrospective nature of these studies, the role of LDRT in indolent PMCL remains undefined. The objective of this retrospective multicentric trial is to investigate the efficacy of low-dose involved-field radiation therapy in patients with primary indolent cutaneous B-cell Lymphoma.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Primary cutaneous B-cell lymphomas (PCBCL) represent approximately 20% of all primary cutaneous lymphoma and are defined by a restricted disease spread to the skin without evidence of extracutaneous involvement at diagnosis. They encompass three main types: primary cutaneous marginal zone lymphoma (PCMZL), primary cutaneous follicle center lymphoma (PCFCL) and primary cutaneous diffuse large B-cell lymphoma, leg type (PCDLBCL, LT), of which the first two entities are indolent. Radiotherapy (RT) is part of the therapeutic mosaic for PCBCL and recommended by both national and international guidelines for a localized disease pattern, conferring high local control rates with a conservative approach . Curative doses cover a range of 18-54 Gy and complete remission is common regardless of which treatment is used. There is accumulating evidence for a possible de-escalation of RT dose while maintaining high response rates and thereby opening a role for low-dose RT (LDRT), which has been successfully shown for other indolent non-Hodgkin lymphoma. However, the rarity of indolent PCBCL and retrospective nature of studies make a definitive dose recommendation troublesome.

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Reggio Emilia, Italy
        • Azienda USL IRCCS di Reggio Emilia - Sc Radioterapia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study involves adult patients with early-stage (I-II) primary cutaneous indolent B-cell lymphoma (PCBCL) treated with low-dose radiotherapy (4 Gy in two sessions). Patients with a confirmed histological diagnosis of indolent B-cell lymphoma (follicular, marginal, NOS) and adequate follow-up are included. Patients with aggressive lymphomas, advanced stages, extracutaneous localisations or radiotherapy doses greater than 4 Gy are excluded.

Description

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Histological diagnosis of indolent B-cell lymphoma (follicular, marginal, NOS)
  • Primary cutaneous location
  • Early stage (I-II)
  • First diagnosis or recurrence
  • Low-dose radiotherapy treatment (4 Gy/2 sessions)

Exclusion Criteria:

  • Aggressive histology lymphomas
  • Advanced stages
  • Extracutaneous localisation
  • Radiotherapy dose administered > 4 Gy
  • Patients without histological typing
  • Patients without follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Progression-Free Interval in Irradiated Field
Time Frame: 12 months
Time from the start of low dose radiotherapy (LDRT) to tumor progression within the irradiated field
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute toxicity
Time Frame: 4 weeks
The occurence and severity of acute adverse events (toxicities)
4 weeks
Late toxicity
Time Frame: 12 weeks
The occurrence and severity of late adverse events (toxicities)
12 weeks
Tumor response in irradated area
Time Frame: 12 weeks
The response of the tumor in the irradiated area will be evaluated based on radiological imaging and/or clinical examination
12 weeks
Overall response rate (ORR)
Time Frame: 12 weeks
The overall response rate is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) in the irradiated sites, as assessed by the investigator using the Lugano classification criteria.
12 weeks
Overall survival (OS)
Time Frame: 24 months
Overall Survival (OS) is defined as the time from the start of LDRT to the date of death from any cause.
24 months
Progression-Free Survival (PFS)
Time Frame: 24 months
Progression-Free Survival (PFS) is defined as the time from the start of Low Dose Radiotherapy (LDRT) to the first observation of disease progression or relapse, or the date of the last follow-up if no progression is observed
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda USL Reggio Emilia - IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2025

Primary Completion (Actual)

December 18, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Actual)

December 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 263/2022/OSS/IRCCSRE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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