AzTrials
AzTrials

CancerPhase 4RAPANCT02532634

Ramosetron, Aprepitant, and Dexamethasone Versus Palonosetron, Aprepitant, and Dexamethasone

A Phase 4 study testing ramosetron, aprepitant, dexamethasone and palonosetron, aprepitant, dexamethasone in people with Cancer and Tumors, run by Kangdong Sacred Heart Hospital at 10 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to compare the anti-emetic effect of ramosetron plus aprepitant and dexamethasone with palonosetron plus aprepitant and dexamethasone in patients receiving highly emetogenic chemotherapy. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Cancer, Tumors
What is being tested?
ramosetron, aprepitant, dexamethasone and palonosetron, aprepitant, dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
292 participants
Where
10 sitesSouth Korea
Study dates
19 Aug 2015to 8 May 2018
Phase
Phase 4
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient's age is ≥ 19 years old
  • Histologically or cytologically confirmed solid tumor
  • Patients diagnosed as malignancy who will be treated with highly emetogenic chemotherapeutic agents (NCCN guideline v2.0, 2014 anti-emesis). (Cisplatin dosage is over 50mg/m2, combination therapy is available with other chemotherapeutic agents and including lymphoma)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Available oral administration of study drugs
  • Adequate organ functions as follows: 1) Hematologic - white blood cell count (WBC) ≥ 3000 microliter (microL) or Neutrophil≥ 1500 micro/L, Platelet ≥ 100,000/microL; 2) Serum Creatinine ≤ 1.5 times upper limit of normal; 3) Hepatic function - Total bilirubin, AST, ALT ≤2.5 times upper limit of normal, ALP ≤ 2 times upper limit of normal( except ALP increasing due to bone metastasis
  • Patients with normal range of serum K, Mg and hold serum Ca over lower limit of normal range
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital

Who cannot join

  • Patients with severe Hypertension, severe Heart disease, congenital long QT syndrome, bradyarrhythmia severe kidney disease(serum creatinine≥3㎎/㎗), liver disease (AST, ALT ≥ 2.5 times of upper normal range, ALP ≥ 2 times of upper normal range)
  • Patients with GI obstruction, active gastric ulcer or other diseases that could provoke nausea and vomiting
  • Patients who have nausea and vomiting within 1 week before chemotherapy
  • Patients who should take steroid, antiemetics, antipsychotic agent including benzodiazepine, pimozide, terfenadine, astemizole, cisapride, rifampin, carbamazepine, phenytoin, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir or nelfinavir, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors for the treatment of other diseases
  • Patients with brain tumor, brain metastasis or seizure
  • Patients receiving chemotherapy within 6 months before enrollment
Show all 11Show fewer
  • Patients who need radiation therapy during study period or receiving radiation therapy within 2 weeks before chemotherapy
  • Patients who have known allergy or severe side effect on study drugs(5-HT3 antagonist and aprepitant)
  • Pregnant or lactating women, or women who wish to become pregnant
  • Patients with drug abuse, a mental disease and difficult to communicate with investigators
  • Others whom the investigator judges inappropriate as subjects for this study

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

South Korea10 sites

  • Keimyung University Dongsan Medical Center

    Daegu

  • Chungnam National University Hospita

    Daejeon

  • Pusan National University Hospital

    Pusan

  • Kangbuk Samsung Hospital

    Seoul

  • Kangdong Sacred Heart Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul St. Mary's Hospital

    Seoul

  • Severance Hospital

    Seoul

  • St. Vincent'S Hospital

    Suwon, Gyeonggi-do, 16247

  • Ajou University Hospital

    Suwon

Other trials in South Korea

About this study

Official title: Comparison of Ramosetron, Aprepitant, and Dexamethasone (RAD) With Palonosetron, Aprepitant, and Dexamethasone (PAD) for Prevention of Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy

The purpose of this study is to compare the anti-emetic effect of ramosetron plus aprepitant and dexamethasone with palonosetron plus aprepitant and dexamethasone in patients receiving highly emetogenic chemotherapy.

Read the detailed description

Currently, palonosetron is the clinically preferred antiemetic for Chemotherapy-induced nausea and vomiting (CINV).However the best 5-hydroxytryptamine 3 receptor (5-HT3R) antagonists for use in a triple drug combination for high emetogenic chemotherapy(HEC) has not yet been determined in randomized trials. Previous anti-emetic guidelines stated that the anti-emetic activities of 5-HT3R antagonists were similar at equivalent doses. Based on the meta-analysis of various 5-HT3R antagonists in double regimens, the NCCN guideline has suggested palonosetron as a preferred 5-HT3R antagonist in the triple antiemetic drug combination. But in Asia, RAD is one of the most popular treatments for HEC-treated cancer patients. However, the lack of clinical studies has precluded the recommendation of RAD as a standard regimen for HEC-induced CINV. In two previous studies conducted in Korea, RAD regimen showed significant efficacy for prevention of CINV which is comparable to the efficacy reported from the studies evaluating with PAD regimen. If the efficacy of RAD regimen is evidently proven by this kind of randomized multicenter-trial, RAD regimen can be more recommended as a standard regimen for HEC-induced CINV.

Conditions
Cancer, Tumors
Being tested
ramosetron, aprepitant, dexamethasone, palonosetron, aprepitant, dexamethasone
Keywords
ramosetron, palonosetron, chemotherapy induced nausea and vomiting
Medical subject headings
Neoplasms, Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ramosetron, aprepitant, dexamethasoneDrug

    Also called ramosetron(nasea), aprepitant(emend)

    ramosetron 0.3 mg IV D1 aprepitant 125 mg PO D1, 80 mg PO D2, 80 mg PO D3 dexamethasone 12 mg PO D1, 8 mg PO D2-4

  • palonosetron, aprepitant, dexamethasoneDrug

    Also called palonosetron(aloxi), aprepitant(emend)

    palonosetron 0.25 mg IV D1 aprepitant 125 mg PO D1, 80 mg PO D2, 80 mg PO D3 dexamethasone 12 mg PO D1, 8 mg PO D2-4

Study groups in NCT02532634
Study groupRoleWhat they receive
ramosetron, aprepitant, dexamethasoneExperimental1. Ramosetron 0.3mg IV day1 2. Aprepitant 125mg PO qd day1, 80mg po qd day 2, 3 3. Dexamethasone 12mg IV or PO qd day1, 8mg PO day 2, 3, 4
Receives: Drug: ramosetron, aprepitant, dexamethasone
palonosetron, aprepitant, dexamethasoneActive comparator1. Palonosetron 0.25mg IV day1 2. Aprepitant 125mg PO qd day1, 80mg po qd day 2, 3 3. Dexamethasone 12mg IV or PO qd day1, 8mg PO day 2, 3, 4
Receives: Drug: palonosetron, aprepitant, dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare the overall complete response (CR) of RAD to PAD (Overall CR defined as no emesis, no rescue medication, at cycle 1

    Measured: 0-120 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2015 (estimated)
  2. Study start19 Aug 2015
  3. Primary completion8 May 2018
  4. Study completion8 May 2018

Resources

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 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
292 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02532634
Sponsor's protocol ID
KJH-2015-01
Acronym
RAPA
Status last verified
May 2018
First submitted
23 Aug 2015
Last updated
11 May 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ramosetron, aprepitant, dexamethasone and palonosetron, aprepitant, dexamethasone in people with Cancer and Tumors, run by Kangdong Sacred Heart Hospital at 10 sites in South Korea.

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 8 inclusion and 11 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 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in South Korea. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

To compare the overall complete response (CR) of RAD to PAD (Overall CR defined as no emesis, no rescue medication, at cycle 1 (time frame: 0-120 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02532634.

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 11 May 2018; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in