NeoplasmsPhase 3NCT02203253
Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and Vomiting
A Phase 3 study testing Thalidomide and Palonosetron and Dexamethasone in people with Neoplasms, run by China Medical University, China at 11 sites in China.
Trial summary
This study was aimed to evaluate efficacy and tolerability of thalidomide in improving prevention of chemotherapy-induced delayed nausea and vomiting in chemotherapy-naive patients after highly emetogenic chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neoplasms
- What is being tested?
- Thalidomide and Palonosetron and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 642 participants
- Where
- 11 sitesChina
- Study dates
- Jul 2014to Aug 2016
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18y ≤Age≤70y
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Histologically confirmed solid neoplasm
- No prior chemotherapy
- Laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count ≥1.5×109/L, platelet count ≥85×109/L, creatinine clearance rate (CCr) ≥60ml/min, total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), blood glucose ≤11.1 mmol/L
- Life expectancy of at least 12 weeks
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- Signed informed consent
- For women with child bearing potential, a negative serum or urine pregnancy test result should be obtained before enrollment
- Cancer patients scheduled to receive HEC regimen. The HEC regimen was defined as chemotherapy containing a 50 mg/m2 or higher dose of cisplatin, or cyclophosphamide combination with doxorubicin/epirubicin
Who cannot join
- Diabetic patients
- Pregnant or lactated women
- Patient with history of thrombosis
- Concomitant radiotherapy
- Known hypersensitivity to thalidomide, palonosetron, or dexamethasone.
- Concurrent administration of any other drug which affect antiemetic effect evaluation such as proton pump inhibitor, H2 blocker, amifostine, sedative drugs
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- CHOP regiment or taxanes-based regiment
- Existing emesis within 24 hours before chemotherapy administration
- Symptomatic brain metastasis or suspected clinical brain metastasis
- Serious uncontrolled systemic illness or medical condition: congestive heart failure, unstable angina, history of documented myocardial infarction within 6 months, uncontrolled hypertension and high risk uncontrollable arrhythmias; Obvious neurological or mental abnormalities including mental disorder, epileptic dementia, which affect compliance; Uncontrolled acute infections; Uncontrolled peptic ulcer or other contraindication for corticosteroid therapy.
- Inability to take or absorb oral medicine
- Concurrent administration of any other investigational drug, or have been enrolled in other clinical trial with investigational drug treatment within the 30 days of start of study treatment
- Unsuitable for the study or other chemotherapy determined by investigator
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Anshan Tumor Hospital
Anshan, Liaoning
Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
The First Hospital of Liaoning Medical University
Jinzhou, Liaoning
Liaoyang Central Hospital
Liaoyang, Liaoning
Petrochemical General Hospital of Liaoyang city
Liaoyang, Liaoning
Third People's hospital Liaoyang
Liaoyang, Liaoning
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
General Hospital of Shenyang Military Region
Shenyang, Liaoning
Liaoning Tumor Hospital & Institute
Shenyang, Liaoning
About this study
Official title: Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and Vomiting From Highly Emetogenic Chemotherapy: a Randomized, Multicenter, Double-blind, Placebo-controlled Phase III Trial
This study was aimed to evaluate efficacy and tolerability of thalidomide in improving prevention of chemotherapy-induced delayed nausea and vomiting in chemotherapy-naive patients after highly emetogenic chemotherapy.
Read the detailed description
This is a prospective, randomized, multi-center, double-blind, placebo-controlled clinical trial, aimed to evaluate efficacy and tolerability of thalidomide in improving prevention of chemotherapy-induced delayed nausea and vomiting (CINV) in chemotherapy-naive patients after highly emetogenic chemotherapy(HEC) (cisplatin-based regimen or cyclophosphamide combination with doxorubicin/epirubicin). A total of 820 patients are planned to be enrolled into the study. Patients treating with highly emetogenic chemotherapy will be randomized into two groups, and be treated with Thalidomide+ Palonosetron+ Dexamethasone or Placebo + Palonosetron+ Dexamethasone, respectively. The primary end point is complete response rate (CRR) for delayed CINV, and the secondary end points include the safety and quality of life (QOL).
- Conditions
- Neoplasms
- Being tested
- Thalidomide, Placebo for thalidomide, Palonosetron and Dexamethasone
- Keywords
- solid tumor, chemotherapy-induced delayed nausea and vomiting, thalidomide, prevention
- Medical subject headings
- Neoplasms, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
100 mg by mouth twice a day on days 1-5 after chemotherapy, cycle 1
Placebo for thalidomideDrug
Also called Placebo tablet for thalidomide
Placebo tablet manufactured to mimic Thalidomide 25 mg tablet 100 mg by mouth twice a day on days 1-5 after chemotherapy , cycle 1
Palonosetron and DexamethasoneDrug
Palonosetron 0.25 mg intravenously on day 1; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4; cycle 1.
| Study group | Role | What they receive |
|---|---|---|
| Thalidomide Group | Active comparator | Thalidomide 100 mg by mouth twice a day on days 1-5; Palonosetron 0.25 mg intravenously on day 1; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4; cycle 1. Receives: Drug: Thalidomide; Drug: Palonosetron and Dexamethasone |
| Placebo Group | Placebo comparator | Placebo (for Thalidomide) tablet 100 mg by mouth twice a day on days 1-5; Palonosetron 0.25 mg intravenously on day 1; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4; cycle 1. Receives: Drug: Placebo for thalidomide; Drug: Palonosetron and Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response rate (CRR) for delayed CINV
Measured: 120 hours
Secondary outcomes (2)
Adverse Events
Measured: Up to 3 weeks
quality of life
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 642 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- The First Hospital of Liaoning Medical University, The First Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Dalian Medical University, Liaoning Cancer Hospital & Institute, Shengjing Hospital, General Hospital of Shenyang Military Region, Liaoyang Central Hospital, Third People's hospital Liaoyang, Petrochemical General Hospital of Liaoyang city, Anshan Tumor Hospital
- Responsible party
- Principal investigator, Yunpeng Liu, China Medical University, China
- Investigators
- Yunpeng Liu, MD., PhD, Principal investigator, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203253
- Sponsor's protocol ID
- CLOG1302
- Status last verified
- Aug 2016
- First submitted
- 23 Jul 2014
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and Vomiting From Highly Emetogenic Chemotherapy: a Randomized, Multicenter, Double-blind, Placebo-controlled Phase III Trial
- ClinicalTrials.gov ID
- NCT02203253
- Acronym / sponsor ID
- CLOG1302
- Conditions
- Neoplasms
- Keywords
- solid tumor, chemotherapy-induced delayed nausea and vomiting, thalidomide, prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 642 participants (actual)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Collaborators
- The First Hospital of Liaoning Medical University, The First Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Dalian Medical University, Liaoning Cancer Hospital & Institute, Shengjing Hospital, General Hospital of Shenyang Military Region, Liaoyang Central Hospital, Third People's hospital Liaoyang, Petrochemical General Hospital of Liaoyang city, Anshan Tumor Hospital
- Study start
- Jul 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 29 Jul 2014 (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.
This study was aimed to evaluate efficacy and tolerability of thalidomide in improving prevention of chemotherapy-induced delayed nausea and vomiting in chemotherapy-naive patients after highly emetogenic chemotherapy.
Detailed description
This is a prospective, randomized, multi-center, double-blind, placebo-controlled clinical trial, aimed to evaluate efficacy and tolerability of thalidomide in improving prevention of chemotherapy-induced delayed nausea and vomiting (CINV) in chemotherapy-naive patients after highly emetogenic chemotherapy(HEC) (cisplatin-based regimen or cyclophosphamide combination with doxorubicin/epirubicin). A total of 820 patients are planned to be enrolled into the study. Patients treating with highly emetogenic chemotherapy will be randomized into two groups, and be treated with Thalidomide+ Palonosetron+ Dexamethasone or Placebo + Palonosetron+ Dexamethasone, respectively. The primary end point is complete response rate (CRR) for delayed CINV, and the secondary end points include the safety and quality of life (QOL).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thalidomide Group | Active comparator | Drug: Thalidomide, Drug: Palonosetron and DexamethasoneThalidomide 100 mg by mouth twice a day on days 1-5; Palonosetron 0.25 mg intravenously on day 1; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4; cycle 1. |
| Placebo Group | Placebo comparator | Drug: Placebo for thalidomide, Drug: Palonosetron and DexamethasonePlacebo (for Thalidomide) tablet 100 mg by mouth twice a day on days 1-5; Palonosetron 0.25 mg intravenously on day 1; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4; cycle 1. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18y ≤Age≤70y
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Histologically confirmed solid neoplasm
- No prior chemotherapy
- Laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count ≥1.5×109/L, platelet count ≥85×109/L, creatinine clearance rate (CCr) ≥60ml/min, total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), blood glucose ≤11.1 mmol/L
Key exclusion criteria (13 listed)
- Diabetic patients
- Pregnant or lactated women
- Patient with history of thrombosis
- Concomitant radiotherapy
- Known hypersensitivity to thalidomide, palonosetron, or dexamethasone.
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 |
|---|---|---|
| Thalidomide100 mg by mouth twice a day on days 1-5 after chemotherapy, cycle 1 | Drug | Thalidomide Group |
| Placebo for thalidomideAlso: Placebo tablet for thalidomidePlacebo tablet manufactured to mimic Thalidomide 25 mg tablet 100 mg by mouth twice a day on days 1-5 after chemotherapy , cycle 1 | Drug | Placebo Group |
| Palonosetron and DexamethasonePalonosetron 0.25 mg intravenously on day 1; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4; cycle 1. | Drug | Placebo Group, Thalidomide Group |
Primary outcome
complete response rate (CRR) for delayed CINV
Time frame: 120 hours
2 secondary outcomes
Adverse Events
Time frame: Up to 3 weeks
quality of life
Time frame: up to 7 days
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 24 Aug 2016.
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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.
Yunpeng Liu, MD., PhD principal investigator
China Medical University, China
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thalidomide and Palonosetron and Dexamethasone in people with Neoplasms, run by China Medical University, China at 11 sites in China.
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 9 inclusion and 13 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 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
complete response rate (CRR) for delayed CINV (time frame: 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 24 Aug 2016.