Table 1.
Study period | ||||||||
---|---|---|---|---|---|---|---|---|
Enrollment | Allocation | Post allocation | ||||||
Time point | −4 weeks | 0 | Week 0–6 | Week 10 | Weeks 11–34 | Within 2 years | 3–5 years | 5–10 years |
Enrollment: | ||||||||
Eligibility screen | X | |||||||
Informed consent | X | |||||||
Randomization | X | |||||||
Allocation | X | |||||||
Interventions: | ||||||||
RT | X | |||||||
Concurrent TMZ | X | |||||||
Adjuvant TMZ | X | X | ||||||
Assessments: | ||||||||
Physical examination | X | Every 3 months | Every 6 months | Annually | ||||
KPS | X | X | Every 3 months | Every 6 months | Annually | |||
CBC | X | Weekly | X | Weekly | ||||
Serum biochemistry | X | Weekly | X | Weekly | ||||
Postoperative head MRI | X | X | Every 3 months | Every 6 months | Annually | |||
Cognitive function | X | X | Every 3 months | Every 6 months | Annually | |||
Adverse events | X | X | X | Every 3 months | Every 6 months | Annually |
Abbreviations: RT radiation therapy, TMZ temozolomide, KPS Karnofsky performance score, CBC complete blood count, MRI magnetic resonance imaging