Colorectal NeoplasmsPhase 2NCT03511170
XELOX and XELIRI Alternative Regimen as First-line Treatment for Advanced Colorectal Cancer
A Phase 2 study testing XELIRI and XELOX in people with Colorectal Neoplasms and Chemotherapy, run by Harbin Medical University at 1 site in China.
Trial summary
Colorectal cancer will be resistant to Chemotherapy drugs after treated for a period of time .In the past, the classical treatment regiment was to change other drug after tumor progressed. In theory, the continuous use of such a drug could shortening the patient's drug resistance time. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Neoplasms, Chemotherapy
- What is being tested?
- XELIRI and XELOX
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 1 Jun 2020
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as colorectal adenocarcinoma by histopathology and/or cytology.
- Patients could not receive surgical resection.
- Never received chemotherapy or radiotherapy.
- According to the RECIST v1.1 guide, at least 1 lesions (never received radiotherapy),accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent as the first choice),the longest diameter was more than 10mm (except for the lymph nodes, the short axis of the lymph nodes must be more than 15mm), repeated measurement.
- Eastern Cooperative Oncology Group Performance Status(ECOG PS):0-1 score
- The main organs function is normal, which meets the following requirements. (1) Blood routine examination,(no blood transfusion within 14 days).
Show all 17Show fewer
- Hemoglobin(HB)≥90g/L;
- Absolute neutrophil count (ANC) ≥1.5×10^9/L;
- Blood platelet (PLT)≥80×10^9/L; (2) Biochemical examination should comply with the following criteria:
- <!-- -->
- Bilirubin(BIL) <1.5 times of the upper limit of normal value (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase(AST)<2.5*ULN (liver metastasis ALT and AST<5*ULN).
- Serum Cr≤1*ULN, creatinine clearance rate≥50ml/min(Cockcroft-Gault formula)
- The expected survival time more than 3 months;
- The physicians plan to use XELOX chemotherapy or XELIRI chemotherapy.
- Patients voluntarily joined the study and signed informed consent form(ICF).
- Childbearing age women must undergo a negative pregnancy test(serum or urine) within 7 days ,and voluntarily adopt appropriate methods for contraception from the period of under observation and within 8 weeks of the last time they are given the drug;As for men, it is necessary to receive surgical sterilization, or agree to adopt appropriate methods for contraception from the period of under observation and within 8 weeks of the last time they are given the drug.
Who cannot join
- There is a case of heart disease in any of the following situations. (1)Recent publications have the following heart disease (within 6 months)
- Acute coronary artery syndrome
- Acute heart failure (grade III or IV of NYHA classification)
- Significant ventricular arrhythmia(sustained ventricular tachycardia, ventricular fibrillation and sudden death after resuscitation).
- (2)The New York Heart Association(NYHA) grade of grade III or IV (3)The patients with severe conduction block, and permanent pacemaker is invalid (two degree and three degree atrioventricular block, sinus arrest) (4)Unexplained syncope occurred within 3 months.
- (5)The researchers identified as uncontrol of severe hypertension, or symptomatic hypertension.
Show all 15Show fewer
- There are many factors that affect the absorption of oral drugs (such as unable to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction).
- ECOG score≥2
- Abnormal coagulation function (INR>1.5*ULN, Activated Partial Thromboplastin Time (APTT)>1.5*ULN), with bleeding tendency.
- There is any history of allergy or hypersensitivity in this research's drug or adjuvant.
- HIV infection and/or active hepatitis B virus infection.
- Any condition that may damage the safety of patients or the integrity of research data, including serious medical risk factors, physical condition and laboratory abnormality.
- The high risk population carrying UGT1A1*28 (7/7) *6 (A/A) genotype or simultaneous carrying of the UGT1A1*28 (6/7) *6 (A/G) genotype (the heterozygous genotype) suggests the exclusion of the Irinotecan
- Pregnant or lactating women;
- Other conditions which the doctor think not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Harbin Medical University
Harbin, Heilongjiang
Yu Han, doctor
About this study
Official title: A Randomized, Open, Controlled, Multicenter,Phase II Clinical Trial of XELOX and XELIRI Alternative Regimen as First-line Treatment for Advanced Colorectal Cancer
Colorectal cancer will be resistant to Chemotherapy drugs after treated for a period of time .In the past, the classical treatment regiment was to change other drug after tumor progressed. In theory, the continuous use of such a drug could shortening the patient's drug resistance time. It has been shown that the alternate use of the two drug combinations is reasonable in clinical. This application can not only further improve the curative effect but also significantly reduce the side effects. So the investigators are going to carry out a prospective phase II clinical study. The control group change to second-line treatment after progression of first-line drugs. The experimental group use the first line and the second line,alternately, for every two cycles. The combination of bevacizumab is a first line development, and the second line can still be used .Objective to compare the clinical value of XELOX and XELIRI alternation regimen in the first-line treatment of advanced colorectal cancer.
- Conditions
- Colorectal Neoplasms, Chemotherapy
- Being tested
- XELIRI, XELOX
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XELIRIDrug
Irinotecan，200mg/㎡,d1;Capecitabine, 850-1250mg/㎡ bid 1-14;every 21 days as a cycle
XELOXDrug
Oxaliplatin ,130mg/㎡,d1;Capecitabine, 1000mg/㎡ bid 1-14;every 21 days as a cycle
| Study group | Role | What they receive |
|---|---|---|
| alternative regiment | Experimental | The first stage:XELOX chemotherapy and XELIRI chemotherapy (alternation of every two cycles) until one of the schemes appears imaging progress or intolerance.And then enter the second stage. The second stage: continue to apply another plan until there is progress or intolerance. Receives: Drug: XELIRI; Drug: XELOX |
| classical regiment | Placebo comparator | Use the XELOX chemotherapy until appears imaging progress or intolerance.And then change to the XELIRI chemotherapy until there is progress or intolerance. Receives: Drug: XELIRI; Drug: XELOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Adverse events will be evaluated according to NCI CTCAE 4.0
Measured: 22 months
time to failure of strategy（TFS）
time from the beginning of the treatment until appear the following events, including death and implementation.the progress of disease
Measured: 22 months
Secondary outcomes (4)
Objective response rate (ORR)
The proportion of patients whose tumor is reduced to a certain amount and maintain a certain period of time.
Measured: 22 months
Disease control rate(DCR)
The rate of cases of remission and stable disease accounts for the total evaluable cases after treatment
Measured: 22 months
Overall Survival (OS)
overall survival time after the beginning of the treatment
Measured: 22 months
time to failure of strategy（TFS）
time from the second beginning of the treatment until appear the following events, including death and implementation.the progress of disease
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start1 Mar 2018
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Fudan University, Sun Yat-sen University, First Affiliated Hospital of Harbin Medical University, The Second Affiliated Hospital of Harbin Medical University, Liaoning Cancer Hospital & Institute, Shengjing Hospital, The First Hospital of Jilin University, The First Affiliated Hospital of Dalian Medical University, Jilin Provincial Tumor Hospital, Jinzhou Medical University
- Responsible party
- Principal investigator, Yu Han, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511170
- Sponsor's protocol ID
- 2018-50-IIT
- Status last verified
- Apr 2018
- First submitted
- 18 Apr 2018
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Controlled, Multicenter,Phase II Clinical Trial of XELOX and XELIRI Alternative Regimen as First-line Treatment for Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03511170
- Acronym / sponsor ID
- 2018-50-IIT
- Conditions
- Colorectal Neoplasms, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Fudan University, Sun Yat-sen University, First Affiliated Hospital of Harbin Medical University, The Second Affiliated Hospital of Harbin Medical University, Liaoning Cancer Hospital & Institute, Shengjing Hospital, The First Hospital of Jilin University, The First Affiliated Hospital of Dalian Medical University, Jilin Provincial Tumor Hospital, Jinzhou Medical University
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 27 Apr 2018 (actual)
- 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.
Colorectal cancer will be resistant to Chemotherapy drugs after treated for a period of time .In the past, the classical treatment regiment was to change other drug after tumor progressed. In theory, the continuous use of such a drug could shortening the patient's drug resistance time. It has been shown that the alternate use of the two drug combinations is reasonable in clinical. This application can not only further improve the curative effect but also significantly reduce the side effects. So the investigators are going to carry out a prospective phase II clinical study. The control group change to second-line treatment after progression of first-line drugs. The experimental group use the first line and the second line,alternately, for every two cycles. The combination of bevacizumab is a first line development, and the second line can still be used .Objective to compare the clinical value of XELOX and XELIRI alternation regimen in the first-line treatment of advanced colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alternative regiment | Experimental | Drug: XELIRI, Drug: XELOXThe first stage:XELOX chemotherapy and XELIRI chemotherapy (alternation of every two cycles) until one of the schemes appears imaging progress or intolerance.And then enter the second stage. The second stage: continue to apply another plan until there is progress or intolerance. |
| classical regiment | Placebo comparator | Drug: XELIRI, Drug: XELOXUse the XELOX chemotherapy until appears imaging progress or intolerance.And then change to the XELIRI chemotherapy until there is progress or intolerance. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Diagnosed as colorectal adenocarcinoma by histopathology and/or cytology.
- Patients could not receive surgical resection.
- Never received chemotherapy or radiotherapy.
- According to the RECIST v1.1 guide, at least 1 lesions (never received radiotherapy),accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent as the first choice),the longest diameter was more than 10mm (except for the lymph nodes, the short axis of the lymph nodes must be more than 15mm), repeated measurement.
- Eastern Cooperative Oncology Group Performance Status(ECOG PS):0-1 score
Key exclusion criteria (15 listed)
- There is a case of heart disease in any of the following situations. (1)Recent publications have the following heart disease (within 6 months)
- (2)The New York Heart Association(NYHA) grade of grade III or IV (3)The patients with severe conduction block, and permanent pacemaker is invalid (two degree and three degree atrioventricular block, sinus arrest) (4)Unexplained syncope occurred within 3 months.
- (5)The researchers identified as uncontrol of severe hypertension, or symptomatic hypertension.
- There are many factors that affect the absorption of oral drugs (such as unable to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction).
- ECOG score≥2
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 |
|---|---|---|
| XELIRIIrinotecan，200mg/㎡,d1;Capecitabine, 850-1250mg/㎡ bid 1-14;every 21 days as a cycle | Drug | alternative regiment, classical regiment |
| XELOXOxaliplatin ,130mg/㎡,d1;Capecitabine, 1000mg/㎡ bid 1-14;every 21 days as a cycle | Drug | alternative regiment, classical regiment |
Primary outcome
Adverse Events
Time frame: 22 months
Adverse events will be evaluated according to NCI CTCAE 4.0
time to failure of strategy（TFS）
Time frame: 22 months
time from the beginning of the treatment until appear the following events, including death and implementation.the progress of disease
4 secondary outcomes
Objective response rate (ORR)
Time frame: 22 months
Disease control rate(DCR)
Time frame: 22 months
Overall Survival (OS)
Time frame: 22 months
time to failure of strategy（TFS）
Time frame: 22 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
Related trials for Colorectal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XELIRI and XELOX in people with Colorectal Neoplasms and Chemotherapy, run by Harbin Medical University at 1 site 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 17 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 1 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 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Han, doctor (+86-451-86298303, hanyuemail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 22 months). The study lists 2 primary outcomes in all. 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 1 May 2018.