Colorectal CancerNCT01344304
Study of Aprepitant / Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV) in Colorectal Cancer Patients - SENRI Trial
A study testing Aprepitant / Fosaprepitant in people with Colorectal Cancer, run by Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group at 27 sites in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Aprepitant / Fosaprepitant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 413 participants
- Where
- 27 sitesJapan
- Study dates
- Apr 2011to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Japan27 sites
Kansai Rosai Hospital
Amagasaki, Hyōgo, 6600064
Higashiosaka City General Hospital
Higashiosaka, Osaka, 5788588
Saito Yukoukai Hospital
Ibaraki, Osaka, 5670085
Nara Hospital Kinki University Faculty of Medicine
Ikoma, Nara, 6300293
Kinki Central Hospital
Itami, Hyōgo, 6640872
Rinku General Medical Center
Izumisano, Osaka, 5988577
Kaizuka City Hospital
Kaizuka, Osaka, 5970015
Kawasaki Hospital
Kobe, Hyōgo, 6520042
Hannan Chuo Hospital
Matsubara, Osaka, 5800023
Minoh City Hospital
Minoh, Osaka, 5620014
Kenporen Osaka Central Hospital
Osaka, 5300001
Iseikai Hospital
Osaka, 5330022
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, 5378511
National Hospital Organization Osaka National Hospital
Osaka, 5400006
NTT West Osaka Hospital
Osaka, 5430042
Nissay Hospital
Osaka, 5500012
Tane General Hospital
Osaka, 5500024
Osaka Seninhoken Hospital
Osaka, 5520021
Osaka Koseinenkin Hospital
Osaka, 5530003
Osaka General Medical Center
Osaka, 5588558
Sakai City Hospital
Sakai, Osaka, 5900064
Osaka Rosai Hospital
Sakai, Osaka, 5918025
Suita Municipal Hospital
Suita, Osaka, 5640082
Saiseikai Senri Hospital
Suita, Osaka, 5650862
Graduate School of Medicine / Faculty of Medicine, Osaka University
Suita, Osaka
Toyonaka Municipal Hospital
Toyonaka, Osaka, 5608565
Yao Municipal Hospital
Yao, Osaka, 5810069
About this study
Official title: Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy With Aprepitant / Fosaprepitant in Patients With Colorectal Cancer Receiving Oxaliplatin-based Chemotherapy
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.
- Conditions
- Colorectal Cancer
- Being tested
- Aprepitant / Fosaprepitant
- Keywords
- aprepitant therapy, fosaprepitant therapy, 5HT3-receptor antagonist, dexamethasone, colorectal cancer, FOLFOX, XELOX, SOX
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aprepitant / FosaprepitantDrug
Aprepitant:
125 mg PO on day 1 80 mg PO on days 2 to 3
Fosaprepitant:
150 mg IV on day 1
| Study group | Role | What they receive |
|---|---|---|
| Standard therapy | No intervention | The patients are treated with 5HT3-receptor antagonist + dexamethasone during the first course, then treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone |
| Aprepitant / Fosaprepitant therapy | Experimental | The patients are treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone during first and second courses. Receives: Drug: Aprepitant / Fosaprepitant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient diary recording nausea, emesis, food ingestion, and rescue therapy
Measured: From initiating administration of anticancer agents to day 6 (120 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionNov 2013
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344304
- Sponsor's protocol ID
- SENRI
- Status last verified
- Feb 2021
- First submitted
- 27 Apr 2011
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy With Aprepitant / Fosaprepitant in Patients With Colorectal Cancer Receiving Oxaliplatin-based Chemotherapy
- ClinicalTrials.gov ID
- NCT01344304
- Acronym / sponsor ID
- SENRI
- Conditions
- Colorectal Cancer
- Keywords
- aprepitant therapy, fosaprepitant therapy, 5HT3-receptor antagonist, dexamethasone, colorectal cancer, FOLFOX, XELOX, SOX
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment GroupUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 29 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard therapy | No intervention | –The patients are treated with 5HT3-receptor antagonist + dexamethasone during the first course, then treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone |
| Aprepitant / Fosaprepitant therapy | Experimental | Drug: Aprepitant / FosaprepitantThe patients are treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone during first and second courses. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aprepitant / FosaprepitantAprepitant: 125 mg PO on day 1 80 mg PO on days 2 to 3 Fosaprepitant: 150 mg IV on day 1 | Drug | Aprepitant / Fosaprepitant therapy |
Primary outcome
Patient diary recording nausea, emesis, food ingestion, and rescue therapy
Time frame: From initiating administration of anticancer agents to day 6 (120 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aprepitant / Fosaprepitant in people with Colorectal Cancer, run by Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group at 27 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient diary recording nausea, emesis, food ingestion, and rescue therapy (time frame: From initiating administration of anticancer agents to day 6 (120 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.