Follow-up of colorectal cancer patients after resection with curative intent-the GILDA trial.
OBJECTIVE
Surgery remains the primary treatment of colorectal cancer. Data are lacking to delineate the optimal surveillance strategy following resection. A large-scale multi-center European study is underway to address this issue (Gruppo Italiano di Lavoro per la Diagnosi Anticipata-GILDA).


METHODS
Following primary surgery with curative intent, stratification, and randomization at GILDA headquarters, colon cancer patients are then assigned to a more intensive or less intensive surveillance regimen. Rectal cancer patients undergoing curative resection are similarly randomized, with their follow-up regimens placing more emphasis on detection of local recurrence. Target recruitment for the study will be 1500 patients to achieve a statistical power of 80% (assuming an alpha of 0.05 and a hazard-rate reduction of >24%).


RESULTS
Since the trial opened in 1998, 985 patients have been randomized from 41 centers as of February 2004. There were 496 patients randomized to the less intensive regimens, and 489 randomized to the more intensive regimens. The mean duration of follow-up is 14 months. 75 relapses (15%) and 32 deaths (7%) had been observed in the two more intensive follow-up arms, while 64 relapses (13%) and 24 deaths (5%) had been observed in the two less intensive arms as of February 2004.


CONCLUSIONS
This trial should provide the first evidence based on an adequately powered randomized trial to determine the optimal follow-up strategy for colorectal cancer patients. This trial is open to US centers, and recruitment continues.
Grossmann
Erik M
EM
Saint Louis University and Saint Louis VA Medical Center, 3635 Vista Avenue, P.O. Box 15250, St. Louis, Missouri 63110-0250, USA. grossmem@slu.edu
Johnson
Frank E
FE
Virgo
Katherine S
KS
Longo
Walter E
WE
Fossati
Rolando
R
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014408:Biomarkers, Tumor / Q000032:analysis; D003113:Colonoscopy; D015179:Colorectal Neoplasms / Q000401:mortality / Q000523:psychology / Q000601:surgery*; D003266:Continuity of Patient Care; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008099:Liver / Q000000981:diagnostic imaging; D008168:Lung / Q000000981:diagnostic imaging; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis / Q000453:epidemiology / Q000523:psychology; D011788:Quality of Life; D011859:Radiography; D013030:Spain / Q000453:epidemiology; D011795:Surveys and Questionnaires; D014463:Ultrasonography; D014481:United States / Q000453:epidemiology
D014408:Biomarkers, Tumor