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NCT Number: NCT07310745

Low Dose Radiotherapy in Primary Indolent Cutaneous B-cell Lymphoma

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda USL IRCCS di Reggio Emilia - Sc Radioterapia

Reggio Emilia, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Acute toxicity

    Time frame: 4 weeks

    The occurence and severity of acute adverse events (toxicities)

  2. Late toxicity

    Time frame: 12 weeks

    The occurrence and severity of late adverse events (toxicities)

  3. 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

  4. 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.

  5. 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.

  6. 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

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Acronym: LDRT

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 30, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.