Randomized phase II study of aprepitant in patients with colorectal cancer receiving FOLFOX, FOLFIRI, or XELOX chemotherapy regimen.

Randomized phase II study of aprepitant in patients with colorectal cancer receiving FOLFOX, FOLFIRI, or XELOX chemotherapy regimen. - The Kagoshima Aprepitant Study for Colorectal Cancer (KASCC)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006773

Enrollment

100

Registered

2011-11-25

Start date

2011-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colon and rectal cancer

Interventions

Aprepitant

125 mg PO on day 1 Aprepitant

80 mg PO on days 2 to 3 5HT3-receptor antagonist

IV on day 1 Dexamethasone

6.6 mg IV on day 1 Dexamethasone

4 mg PO on days 2 to 3 5HT3-receptor antagonist

9.9 mg IV on day 1 Dexamethasone

8 mg PO on days 2 to 3

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Age: 20 years old and over 2) Colorectal cancer patient scheduled to be treated with their first FOLFOX FOLFILI or XELOX chemotherapy, including oxaliplatin at 85 mg/m2 or more, or irinotecan at 150 mg/m2 or more

Exclusion criteria

Exclusion criteria: 1) Patient with a serious hepatic insufficiency or renal failure 2) Patient with nausea or vomiting within 24 hours prior to chemotherapy 3) Patient treated with anti-emetic agents within 24 hours prior to chemotherapy 4) Patient with a risk of nausea or vomiting for other reasons (e.g. central nervous system tumors, gastrointestinal obstruction, active peptic ulcer, brain metastasis) 5) Patient unable to be administered dexamethasone for 3 days due to comorbidity, such as out-of-control diabetes mellitus 6) Pregnant women or Patient with pregnancy desire or Lactating women 7) Patient receiving pimozide 8)Patient judged inappropriate for this study

Design outcomes

Primary

Measure	Time frame
The percentage of patients with complete response (defined as no emetic episode and no rescue therapy)	—

Secondary

Measure	Time frame
1)The percentage of patients with complete protection (defined as no emesis, no rescue therapy and no significant nausea) 2)The percentage of patients with no emesis 3)The percentage of patients with no nausia 4)The percentage of patients with no significant nausea 5)Time to treatment failure (defined as time to first emetic episode or time to first use of rescue therapy)	—

Countries

Japan

Contacts

Public ContactSumiya Ishigami

Kagoshima University Graduate School of Medical and Dental Sciences Department of Digestive Surgery, Breast and Thyroid Surgery

099-275-5360

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026