Postoperative hepatic arterial chemotherapy in high-risk patients as adjuvant treatment after resection of colorectal liver metastases - a randomized phase II/III trial – PACHA-01 (NCT02494973)

Table 1 Plan of the study

VISITS	PRE-RANDOMIZATION WORKUP (maximum 1 month before)		Randomization	Follow-up during treatment					Follow-up
VISITS	PRE-RANDOMIZATION WORKUP (maximum 1 month before)			Every 2 weeks, during at least 3 months					The first three years : every 3 months	From 4 th to 5 th year : every 6 months	From the 6 th year to the8th : Every year
Visits N° Dates (days (D), months (M))	D-28 to D0	D-7 to D-1	D0	V1	V2	V3	V4	Vn	M 3, M6, M9, M12,....	M43, M49, M55, M61
Informed consent signed	X
Inclusion/Exclusion criteria		X
Surgery			X ^c
TREATMENT
- Oxaliplatine IAH or IV				X	X	X	X	X
- LV5FU2 IV				X	X	X	X	X
CLINICAL EXAMINATION
- Weight, BMI, OMS statut		X		X	X	X	X	X	X	X	X
- Treatment toxicity				X	X	X	X	X	X
EXAMS
- Thoraco-Abdomino-pelvic CT scan^d	X								X	X	X
- Electrocardiogram (ECG)		X
- Control of the arterial catheter^a				Every 8 weeks or more frequently if deemed necessary by the physicians
LABORATORY EXAMS^b
- NFS-platelets	X			X	X	X	X
- PT, INR	X
- Ionogram, urea, creatinin level, liver biology	X	X		X	X	X	X
- ACE, CA 19-9	X								X	X	X
- Pregnancy test	X

^aradiological ou angioscintigraphy
^bliver biology: transaminases, alcalin phophatase, gamma glutamyl transferase, bilirubin Within 4 weeks before starting adjuvant chemo
^cPatients are randomized peroperatively or within 6 weeks after surgery
^dcompleted by MRI and/or Petscan according to the physician

ISSN: 1471-2407