Clinical research of radiotherapy combined with temozolomide for patients initially diagnosed with primary central nervous system lymphoma

Radiotherapy combined with temozolomide for patients initially diagnosed with primary central nervous system lymphoma: a single arm, randomized, open label study

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OPC-14005409

Enrollment

Unknown

Registered

2014-10-27

Start date

2014-10-31

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Primary central nervous system lymphoma

Interventions

Study group:whole brain radiotherapy and chemotherapy simultaneously

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Patients who meet the following criteria will be eligible for study entry: 1) Patients who have been pathologically diagnosed as primary central nervous system lymphoma by operation or biopsy, without other lymphoma lesions confirmed by the whole body imaging; 2) Intracranial lesion is deep, it is difficult to obtain surgical pathology who integrated clinical and radiographic examination (head MRI + MRS checks are in line with the characteristics of intracranial lymphoma, if necessary, to increase perfusion MR imaging and PET-CT examination). clinical highly consistent with primary central nervous system lymphoma, and thoracic and abdominal imaging tests negative; localized disease diagnosis may first be given radiotherapy, 10Gy / 5f; review the inspection head MRI whole brain radiotherapy and chemotherapy simultaneously investigation showed lesions smaller in size 1/3 above, the clinical diagnosis of primary central nervous system lymphoma patients; 3) Male and female patients aged between 18 and 65 years; 4) KPS at lest more than 40; 5) HIV(-); 6) Expected survival time more than 2 months; 7) Patients who were expected to tolerate chemoradiotherapy according to their laboratory text results and general condition; 8) Patients who signed and agreed to join the study with good compliance.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: The following patients will be excluded from the study: 1) Patients with chronic autoimmune disease; 2) Pregnant or lactating women; 3) Patients who had history of severe nervous system disease, or accompanied with severe neurocognitive dysfunction; 4) Patients with poor compliance, or for other reasons, the researchers considered unsuitable to participate in this clinical study.

Design outcomes

Primary

Measure	Time frame
Objective remission rate;Toxic reaction;	—

Secondary

Measure	Time frame
Progression free survival;	—

Countries

China

Contacts

Public ContactLihua Dong

drlhdong@163.com+86 15843073216

Outcome results

None listed

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