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Completed

NCT Number: NCT01344304

Study of Aprepitant / Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV) in Colorectal Cancer Patients - SENRI Trial

The object of this study is to evaluate the superiority of aprepitant therapy with a 5HT3-receptor antagonist, dexamethasone and aprepitant compared to standard therapy with a 5HT3-receptor antagonist and dexamethasone for prevention of nausea and vomiting in first course chemotherapy.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kansai Rosai Hospital, Amagasaki, Hyōgo, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aprepitant / Fosaprepitant

Drug

Aprepitant:

125 mg PO on day 1 80 mg PO on days 2 to 3

Fosaprepitant:

150 mg IV on day 1

Primary outcomes

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

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

Sponsors and collaborators

Lead sponsor

Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Apr 29, 2011
Registry last updated
Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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