A Randomized Study on Postrelapse Disease-Free Survival with Adjuvant Mistletoe versus Oral Etoposide in Osteosarcoma Patients
Table 1
Schedule of events over the study.
Month
−0.5
0
1
2
3
6
9a
12a
Informed consent
X
Inclusion/exclusion criteria
X
Medical history/adverse events
X
X
X
X
X
X
X
X
Physical examination*
X
X
X
X
X
X
X
X
QoL (EORTC/POQOL)
X
X
X
X
X
X
CBC, biochemical profile**
X
X
X
Urine analysis
X
X
Pregnancy test***
X
CT Lungs
X
X
X
X
X
Bone X-ray or CT
X
X
X
Total bone scan
X
X
Ultrasound/CT abdomen
X
X
X
Medication dispense
X
X
X
X
X
X
Return of unused medication
X
X
X
X
X
X
Immunological evaluation
X
X
X
X
X
Full PE on month −0.5 and on exit visit; examination of disease-related findings only at other visits.
**Within two weeks prior to screening or within baseline period.
***For premenopausal women.
aTreatment duration for Viscum: 12 months; for Etoposide: 6 months.
