Low Dose Radiotherapy in Primary Indolent Cutaneous B-cell Lymphoma

NCT07310745 | Active Not Recruiting

• 1 other identifier: 263/2022/OSS/IRCCSRE
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Indolent Cutaneous B-cell Lymphoma

Keywords

Primary indolent cutaneous B-cell Lymphoma; Low dose RT; Primary cutaneous marginal zone lymphoma

Outcome Measures

Primary Outcomes (1)

• Local Progression-Free Interval in Irradiated Field

  Time from the start of low dose radiotherapy (LDRT) to tumor progression within the irradiated field

  12 months

Secondary Outcomes (6)

• Acute toxicity

  4 weeks

• Late toxicity

  12 weeks

• Tumor response in irradated area

  12 weeks

• Overall response rate (ORR)

  12 weeks

• Overall survival (OS)

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

Azienda USL IRCCS di Reggio Emilia - Sc Radioterapia

Reggio Emilia, Italy

Location

Related Publications (6)

• Christensen L, Cooper K, Honda K, Mansur D. Relapse rates in patients with unilesional primary cutaneous B-cell lymphoma treated with radiation therapy: a single-institution experience. Br J Dermatol. 2018 Nov;179(5):1172-1173. doi: 10.1111/bjd.16783. Epub 2018 Jul 27. No abstract available.

  PMID: 29761874 BACKGROUND

• Senff NJ, Noordijk EM, Kim YH, Bagot M, Berti E, Cerroni L, Dummer R, Duvic M, Hoppe RT, Pimpinelli N, Rosen ST, Vermeer MH, Whittaker S, Willemze R; European Organization for Research and Treatment of Cancer; International Society for Cutaneous Lymphoma. European Organization for Research and Treatment of Cancer and International Society for Cutaneous Lymphoma consensus recommendations for the management of cutaneous B-cell lymphomas. Blood. 2008 Sep 1;112(5):1600-9. doi: 10.1182/blood-2008-04-152850. Epub 2008 Jun 20.

  PMID: 18567836 BACKGROUND

• Willemze R, Cerroni L, Kempf W, et al. The 2018 update of the WHO-EORTC classification for primary cutaneous lymphomas. Blood. 2019;133(16):1703-1714. Blood. 2019 Sep 26;134(13):1112. doi: 10.1182/blood.2019002852. No abstract available.

  PMID: 31558559 BACKGROUND

• Willemze R, Hodak E, Zinzani PL, Specht L, Ladetto M; ESMO Guidelines Committee. Primary cutaneous lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018 Oct 1;29(Suppl 4):iv30-iv40. doi: 10.1093/annonc/mdy133. No abstract available.

  PMID: 29878045 BACKGROUND

• Nicolay JP, Wobser M. Cutaneous B-cell lymphomas - pathogenesis, diagnostic workup, and therapy. J Dtsch Dermatol Ges. 2016 Dec;14(12):1207-1224. doi: 10.1111/ddg.13164.

  PMID: 27992127 BACKGROUND

• Dippel E, Assaf C, Becker JC, von Bergwelt-Baildon M, Beyer M, Cozzio A, Eich HT, Follmann M, Grabbe S, Hillen U, Klapper W, Klemke CD, Lamos C, Loquai C, Meiss F, Mestel D, Nashan D, Nicolay JP, Oschlies I, Schlaak M, Stoll C, Vag T, Weichenthal M, Wobser M, Stadler R. S2k Guidelines - Cutaneous Lymphomas Update 2016 - Part 1: Classification and Diagnosis (ICD10 C82 - C86). J Dtsch Dermatol Ges. 2017 Dec;15(12):1266-1273. doi: 10.1111/ddg.13372. Epub 2017 Nov 28. No abstract available.

  PMID: 29193659 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: December 18, 2025
• Primary Completion: December 18, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2025-12

Locations

IT (1)