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Phase III Multicenter Randomized Controlled Trial of Low-Dose Radiotherapy for Stage I-II Indolent Lymphoma

Phase III Multicenter Randomized Controlled Trial of Low-Dose Radiotherapy for Stage I-II Indolent Lymphoma

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099026
Enrollment
Unknown
Registered
2025-03-18
Start date
2025-03-21
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Indolent Lymphoma

Interventions

Low-dose radiotherapy group:3Gy×4f
Control Group:2Gy×12f

Sponsors

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Histopathologically confirmed FL (grades I-IIIA) or MZL; 2.Ann Arbor stage I-II; 3.Age >= 18 years, no gender restrictions; 4.ECOG performance status < 3; 5.No chemotherapy within 4 weeks prior to radiotherapy; (6) Grade 2 or lower chemotherapy-related hematologic toxicity at the time of enrollment.

Exclusion criteria

Exclusion criteria: 1.History of prior radiotherapy; 2.History of malignancy within the past 3 years (excluding carcinoma in situ and early-stage thyroid cancer); 3.Splenic MZL; 4.Chemotherapy received within 4 weeks prior to radiotherapy; 5.Estimated life expectancy of no more than 3 months.

Design outcomes

Primary

MeasureTime frame
2-year progression free survival;

Secondary

MeasureTime frame
complete response rate;objective response rate;2-year local progression free survival;2year overall survival;Acute toxicity;Late toxicity;quality of life;

Countries

China

Contacts

Public ContactShunan Qi

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

medata@163.com+86 132 6900 0328

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026