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Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy With Aprepitant / Fosaprepitant in Patients With Colorectal Cancer Receiving Oxaliplatin-based Chemotherapy


N/A
20 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy With Aprepitant / Fosaprepitant in Patients With Colorectal Cancer Receiving Oxaliplatin-based Chemotherapy


Inclusion Criteria:



- Age: ≥20 years old

- Sex: Not specified

- Patients with colon/rectal cancer who first underwent FOLFOX, XELOX or SOX regimen
including oxaliplatin at ≥85 mg/m2 (naive patient), or those who had already started
chemotherapy and had nausea of Grade 2 or higher in the last course or an earlier
course (non-naive patient).

- Stage: not specified (neoadjuvant/adjuvant chemotherapy, advanced or recurrent type
are allowed)

- Combination of molecular targeted therapy: allowable

- Written informed consent for participation in the study.

Exclusion Criteria:

- Severe liver or kidney disease

- Nausea/vomiting within 24 hr prior to chemotherapy.

- Treatment with antiemetics within 24 hr prior to chemotherapy.

- Presence of factors causing nausea/vomiting other than chemotherapy (e.g. brain
tumor, gastrointestinal obstruction, active peptic ulcer disease, brain metastasis)

- Presence of a disease precluding 3-day administration of dexamethasone (e.g.
uncontrollable diabetes)

- Pregnant or lactating women, women who plan to become pregnant.

- Current treatment with pimozide.

- Any patient judged to be inappropriate for the study by the investigator.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Patient diary recording nausea, emesis, food ingestion, and rescue therapy

Outcome Time Frame:

From initiating administration of anticancer agents to day 6 (120 hours)

Safety Issue:

Yes

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

SENRI

NCT ID:

NCT01344304

Start Date:

April 2011

Completion Date:

March 2014

Related Keywords:

  • Colorectal Cancer
  • aprepitant therapy
  • fosaprepitant therapy
  • 5HT3-receptor antagonist
  • dexamethasone
  • colorectal cancer
  • FOLFOX
  • XELOX
  • SOX
  • Colorectal Neoplasms

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