mFOLFIRINOX versus mFOLFOX 6 as adjuvant treatment for high-risk stage III colon cancer - the FROST trial: study protocol for a multicenter, randomized controlled, phase II trial

Table 1 Timeline of enrollment, intervention, assessment, and surveillance in FROST trial

Visit¹	Screening	Chemotherapy period			Follow-up period
Visit¹		C1D1	C2–3D1 C5–7D1 C9–11D1	C4D1 C8D1 C12D1	F1–5	F6, F7
Interval			2 weeks (-4 d/+7 d)		4 months (-14/+30 d)	6 months (-14/+30 d)
Informed consent	X
Screening number	X
Complication check²	X
Criteria check	X	X
Randomization		X
Performance status check	X	X	X	X
Medical history and physical examination	X	X	X	X	X	X
Height, weight, BSA³		X	X	X
Vital sign⁴	X	X	X	X
Laboratory test⁵	X	X	X	X	X	X
Pregnancy test ⁶	X		X (even-numbered cycles)
Treatment		X	X		X
CEA⁷	X			X	X	X
Imaging study⁸				X	X	X
Colonoscopy⁹					X	X
Safety assessment		X	X	X
Efficacy assessment				X	X	X

¹The next visit is based on the previous visit date. In the treatment phase, the first day of each treatment cycle (e.g., C1D1, C2D1…) is the reference date
²Postoperative complications: Evaluate complications within 30 d after surgery according to the Clavien-Dindo Classification
³BSA (body surface area)
⁴Vital signs include blood pressure, heart rate, respiratory rate, and body temperature
⁵Laboratory tests include complete blood count, liver and kidney function tests, and electrolytes
⁶Pregnancy test (serum beta-human chorionic gonadotropin test): Performed on even-numbered cycles (C2, 4, 6, 8, 10, 12) only for fertile women
⁷CEA (carcinoembryonic antigen): The first test performed before surgery and during the postoperative screening period
⁸Imaging studies include abdominopelvic computed tomography (CT) and chest radiography (C4, C8, F2, F4, F6) or CT (C12, F1, F3, F5, F7)
⁹Colonoscopy is recommended in F1 and F7

ISSN: 1471-2407