JCOG1114C: Phase III study of standard chemoradiotherapy with or without temozolomide in newly-diagnosed PCNS
- Conditions
- newly-diagnosed primary Central Nervous System (CNS) lymphoma
- Registration Number
- JPRN-jRCTs031180207
- Lead Sponsor
- ISHIKAWA Ryo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 130
*First registration (after surgery)
(1)Histologically proven diffuse large B-cell lymphoma.
(2)Lymphoma originating from the central nervous system except for the spinal cord. Existence of intraocular lymphoma is eligible.
(3)Both solitary/multiple lesions are eligible.
(4)Both measurable/immeasurable lesions are eligible
(5)No evidence of lymphomatous meningitis confirmed by cerebrospinal fluid cytology or brain/whole spine MRI.
(6)No evidence of lymphomatosis cerebri.
(7)Postoperative date between 3 and 35 days.
(8)Age between 20 and 70 years at the time of study entry
(9)ECOG PS 0-2, or PS 3 caused by neurological deficits associated with tumors.
Following cases are also eligible: PS 0-2 ameliorated by administration of corticosteroids, glycerol, mannitol or corticosteroids.
(10)No prior treatment with chemotherapy or cranial radiotherapy as treatment for other malignancies and malignant lymphoma.
(11)No evidence of lymphoma outside the CNS and the eyes confirmed by CT scanning with contrast enhancement of the chest, abdomen and the pelvis.
(12)Adequate major organ function.
(13)Written informed consent.
*Second registration (after HD-MTX treatment)
(1)At least one cycle of HD-MTX treatment administered
(2)Between 10 and 21 days after the HD-MTX treatment.
(3)ECOG performance status: 0-2 or 3 due to neurological deficits.
(4)Brain MRI with gadolinium enhancement after HD-MTX was implemented.
(5)CSF cytology negative
(6)No evidence of lymphoma outside the CNS and the eyes
(7)Ocular lesions are evaluated by fundus examination under mydriasis and slit lump examination.
(8)No infection or appetite loss of grade 3 or higher. No evidence of pneumonitis of grade 2 or higher.
(9)No fever of 38C or higher suggestive of infection.
(10)Adequate organ function.
First registration (after surgery)
(1)Concurrent malignancies (concurrent double cancer or metachronous cancer within 5 years) excluding basal cell carcinoma of the skin or cervical carcinoma in situ.
(2)Concurrent infectious diseases necessitate systemic treatment.
(3)HIV antibody positive.
(4)HBs antigen positive
(5)HCV antibody positive
(6)Patients with immune deficiency syndrome such as AIDS, X-linked agammaglobulinemia, chronic granulomatous diseases or Wiskott-Aldrich Syndrome.
(7)Organ transplant patients.
(8)Body temperature more than 38C.
(9)Infectious meningitis necessitating treatment.
(10)Pregnant or lactating patients.
(11)Concurrent psychiatric problems.
(12)Those under treatment with continual use of insulin or with the complication of uncontrolled diabetes mellitus.
(13)Evidence of unstable angina (onset within 3 weeks or deteriorating symptoms) or history of cardiac infarction within 6 months.
(14)Concurrent pulmonary fibrosis or interstitial pneumonia.
(15)Patients for whom both gadolinium and iodine contrast media cannot be applied because of allergy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Response rate after HD-MTX, response rate after radiotherapy, complete response rate after HD-MTX, complete response rate after radiotherapy, progression-free survival, adverse events, early deaths, treatment-related deaths, Grade 4 non-hematologic adverse events, proportion of MMSE non-worsening, completion of HD-MTX, completion of radiotherapy, cycles of adjuvant TMZ chemotherapy