Lapatinib-capecitabine versus capecitabine alone as radiosensitizers in RAS wild-type resectable rectal cancer, an adaptive randomized phase II trial (LaRRC trial): study protocol for a randomized controlled trial

Table 4 Summary of dose modification guidelines

Adverse event (CTCAE v4.0)	Lapatinib	Capecitabine	Radiation
Hematology: neutrophils or platelets
Grade –2:	Continue	Hold 7 days^a	Continue
Grade ≥3:	Continue	Hold 7 days^a	Hold^b
Dermatology: rash
Grade –3:	Hold 7 days^a	Not applicable
Dermatology: irradiated skin
Grade ≥3:	Not applicable		Hold^b
Dermatology: palmar-plantar erythrodysesthesia
Grade ≥2:	Not applicable	Hold 7 days^a	Not applicable
Gastroenteroloy: diarrhea
Grade ≥3:	Discontinue	Hold^a	Hold^b
Respiratory: pneumonitis
Grade ≥3:	Discontinue
Cardiac dysfunction:
Asymptomatic LVEF decrease >20 % from baseline and absolute value below the LLN	Discontinue	Not applicable
Grade –3	Discontinue	Not applicable
Hepatotoxicity:
ALT > 3 × ULN AND ALT < 5 × ULN	Continue	Not applicable
ALT > 3 × ULN AND ALT > 5 × ULN for ≥2 weeks	Discontinue
ALT > 3 × ULN AND ALT < 5 × ULN for > 4 weeks
ALT > 3 × ULN AND bilirubin > 2 × ULN (>35 % direct)
ALT > 3 × ULN AND ALT > 8 × ULN
ALT > 3 x ULN AND signs and symptoms of hepatitis or hypersensitivity

ISSN: 1745-6215