Prospective cohort study: whether or not patients benefit from participation itself in randomized-controlled trials (SELECT BC ECO).
The randomized-controlled trial is widely accepted as a clinical trial to decide a standard therapy. It remains to be concluded whether or not patients benefit from participation itself in a randomized-controlled trial. This study was aimed at comparing prognoses between trial participants and participation-refusers. Concerned randomized trials are 'selection of effective chemotherapy for breast cancer' (SELECT BC) and its successor trial, SELECT BC-CONFIRM. Study subjects are all of metastatic breast cancer patients who are requested by their doctors to participate in these two trials. This trial is a hitherto exceptional prospective study and is suitable to clarify the effects of participation per se in such a trial on prognosis when compared with previous two studies.
*Division of Oncology/Hematology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa-shi, Chiba, Japan. hrmukai@east.ncc.go.jp.
Hirofumi
H
Mukai
Shinji
S
Ohno
Yasuo
Y
Ohashi
D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015331:Cohort Studies; D004338:Drug Combinations; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D010094:Oxonic Acid; D010358:Patient Participation; D018579:Patient Selection; D011379:Prognosis; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D035842:Research Subjects; D015983:Selection Bias; D043823:Taxoids / Q000008:administration & dosage; D005641:Tegafur
D018943:Anthracyclines; D000970:Antineoplastic Agents; D004338:Drug Combinations; D043823:Taxoids; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid
SELECT BC; SELECT BC-CONFIRM; metastatic breast cancer; prospective cohort study