Colorectal CancerPhase 3NCT02453490
Compare Efficacy and Safety of Raltitrexed-based and 5fu-based Neoadjuvant Chemotherapy for Colorectal Liver Metastasis
A Phase 3 study testing Raltitrexed-based chemotherapy and 5-fluorouracil-based chemotherapy in people with Colorectal Cancer and Liver Metastasis, run by Zhejiang University at 9 sites in China.
Trial summary
This study is a multicenter ,randomization, open control study to evaluate the efficacy and safety of Raltitrexed-based chemotherapy and 5-fluorouracil-based chemotherapy in the peri-operative treatment of patients with Liver Metastasis From colorectal cancer (CRC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Liver Metastasis
- What is being tested?
- Raltitrexed-based chemotherapy and 5-fluorouracil-based chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 9 sitesChina
- Study dates
- 11 Oct 2015to 11 Sep 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed chinese colorectal cancer patients and imaging detection confirmed liver metastasis
- previously no treatment for liver metastasis or Primary tumor had been removed and last additional chemotherapy over one year
- Age of≥18 and ≤75
- Adequate organ functions, as determined by normal bone marrow function (absolute neutrophil count2 x 109/L, platelets 100 x 109/L, White blood cells 4 x 109/L), liver function (serum bilirubin ≤ 2.5 x ULN, serum transaminases ≤2. 5x ULN)
- ECOG≤1
- Life Expectancy>6months
- Signed written informed consent
- Expected adequacy of follow-up
Who cannot join
- Lesion is too small to assess by imaging
- Extrahepatic metastases
- Any anticancer chemotherapy in development within 4 weeks prior to study entry
- Concurrent uncontrolled illness such as infection
- Be allergic to medicines in the study
- Pregnant or nursing patients
Show all 9Show fewer
- Fertile women (< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.
- Not willing or incapable to comply with all study visits and assessments
- Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
The Affiliated Tumor Hospital of Zhongshan University
Guangzhou, Guangdong, 510060
The First Affiliated Hospital of College of Medicine Zhejiang University
Hangzhou, Zhejiang, 310003
Second Affiliated Hospitalof Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
Jinhua People's Hospital
Jinhua, Zhejiang, 321000
The second hospital of Ningbo City
Ningbo, Zhejiang, 315010
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, 200433
Wuhan Union Hospital
Wuhan, Hubei, 430022
Zhongnan Hospital Affiliated to Wuhan University
Wuhan, Hubei, 430071
About this study
Official title: The Second Affiliated Hospital of Zhejiang University
This study is a multicenter ,randomization, open control study to evaluate the efficacy and safety of Raltitrexed-based chemotherapy and 5-fluorouracil-based chemotherapy in the peri-operative treatment of patients with Liver Metastasis From colorectal cancer (CRC).
Read the detailed description
The contrast analysis is separately done on Raltitrexed plus oxaliplatin and 5-fluorouracil plus oxaliplatin;Raltitrexed plus irinotecan and 5-fluorouracil plus irinotecan.To investigate the objective response rate,the R0 resection rate, the early tumor shrinkage （ETS）and depth of response(DPR) and the safety profile.
- Conditions
- Colorectal Cancer, Liver Metastasis
- Being tested
- Raltitrexed-based chemotherapy, 5-fluorouracil-based chemotherapy
- Keywords
- Colorectal Cancer, liver metastasis, neoadjuvant chemotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raltitrexed-based chemotherapyDrug
Also called RTXOX
Raltitrexed: 2.0mg,iv,15min,d1,Oxaliplatin:85mg/m2 iv,d1, q2w
Raltitrexed-based chemotherapyDrug
Also called RTXIRI
Raltitrexed: 2.0mg,iv,15min,d1,Irinotecan:180mg/m2 iv,d1, q2w
5-fluorouracil-based chemotherapyDrug
Also called mFOLFOX6
5-fluorouracil:400mg/m2,ivp,2h,d1,1200mg/m2/d*2d(2400mg/m2,iv46-48h); Oxaliplatin:85mg/m2 iv,d1,q2w
5-fluorouracil-based chemotherapyDrug
Also called FOLFIRI
5-fluorouracil: 400mg/m2,ivp,2h,d1,1200mg/m2/d*2d(2400mg/m2,iv46-48h); Irinotecan:180mg/m2 d1, iv,q2w
| Study group | Role | What they receive |
|---|---|---|
| Raltitrexed-based chemotherapy | Experimental | Raltitrexed plus Oxaliplatin/Raltitrexed plus Irinotecan Receives: Drug: Raltitrexed-based chemotherapy |
| 5-fluorouracil-based chemotherapy | Active comparator | 5-fluorouracil plus Oxaliplatin/5-fluorouracil plus Irinotecan Receives: Drug: 5-fluorouracil-based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: 38 months
Secondary outcomes (1)
R0 resection rate of liver
Measured: 38 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study start11 Oct 2015
- Primary completion11 Sep 2018
- Study completion11 Sep 2019
Why it stopped: difficultly recruiting
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.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Ke-Feng, Zhejiang University
- Investigators
- Ding Ke-Feng, PHD/MD, Study chair, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453490
- Sponsor's protocol ID
- CRCLM-01
- Status last verified
- Jul 2020
- First submitted
- 17 May 2015
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Second Affiliated Hospital of Zhejiang University
- ClinicalTrials.gov ID
- NCT02453490
- Acronym / sponsor ID
- CRCLM-01
- Conditions
- Colorectal Cancer, Liver Metastasis
- Keywords
- Colorectal Cancer, liver metastasis, neoadjuvant chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficultly recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 11 Oct 2015 (actual)
- Primary completion
- 11 Sep 2018 (actual)
- Study completion
- 11 Sep 2019 (actual)
- First posted
- 25 May 2015 (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 is a multicenter ,randomization, open control study to evaluate the efficacy and safety of Raltitrexed-based chemotherapy and 5-fluorouracil-based chemotherapy in the peri-operative treatment of patients with Liver Metastasis From colorectal cancer (CRC).
Detailed description
The contrast analysis is separately done on Raltitrexed plus oxaliplatin and 5-fluorouracil plus oxaliplatin;Raltitrexed plus irinotecan and 5-fluorouracil plus irinotecan.To investigate the objective response rate,the R0 resection rate, the early tumor shrinkage （ETS）and depth of response(DPR) and the safety profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raltitrexed-based chemotherapy | Experimental | Drug: Raltitrexed-based chemotherapyRaltitrexed plus Oxaliplatin/Raltitrexed plus Irinotecan |
| 5-fluorouracil-based chemotherapy | Active comparator | Drug: 5-fluorouracil-based chemotherapy5-fluorouracil plus Oxaliplatin/5-fluorouracil plus Irinotecan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed chinese colorectal cancer patients and imaging detection confirmed liver metastasis
- previously no treatment for liver metastasis or Primary tumor had been removed and last additional chemotherapy over one year
- Age of≥18 and ≤75
- Adequate organ functions, as determined by normal bone marrow function (absolute neutrophil count2 x 109/L, platelets 100 x 109/L, White blood cells 4 x 109/L), liver function (serum bilirubin ≤ 2.5 x ULN, serum transaminases ≤2. 5x ULN)
- ECOG≤1
Key exclusion criteria (9 listed)
- Lesion is too small to assess by imaging
- Extrahepatic metastases
- Any anticancer chemotherapy in development within 4 weeks prior to study entry
- Concurrent uncontrolled illness such as infection
- Be allergic to medicines in the study
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 |
|---|---|---|
| Raltitrexed-based chemotherapyAlso: RTXOXRaltitrexed: 2.0mg,iv,15min,d1,Oxaliplatin:85mg/m2 iv,d1, q2w | Drug | Raltitrexed-based chemotherapy |
| Raltitrexed-based chemotherapyAlso: RTXIRIRaltitrexed: 2.0mg,iv,15min,d1,Irinotecan:180mg/m2 iv,d1, q2w | Drug | Raltitrexed-based chemotherapy |
| 5-fluorouracil-based chemotherapyAlso: mFOLFOX65-fluorouracil:400mg/m2,ivp,2h,d1,1200mg/m2/d*2d(2400mg/m2,iv46-48h); Oxaliplatin:85mg/m2 iv,d1,q2w | Drug | 5-fluorouracil-based chemotherapy |
| 5-fluorouracil-based chemotherapyAlso: FOLFIRI5-fluorouracil: 400mg/m2,ivp,2h,d1,1200mg/m2/d*2d(2400mg/m2,iv46-48h); Irinotecan:180mg/m2 d1, iv,q2w | Drug | 5-fluorouracil-based chemotherapy |
Primary outcome
Objective response rate
Time frame: 38 months
1 secondary outcome
R0 resection rate of liver
Time frame: 38 months
Results and safety
The study was stopped early (reason given: difficultly recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
Related trials for Colorectal Cancer
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.
Ding Ke-Feng, PHD/MD study chair
Zhejiang University
9 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 Raltitrexed-based chemotherapy and 5-fluorouracil-based chemotherapy in people with Colorectal Cancer and Liver Metastasis, run by Zhejiang University at 9 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 8 inclusion and 9 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: stopped early, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. 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 was stopped early (reason given: difficultly recruiting). Results are not available in the source record.
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?
Objective response rate (time frame: 38 months). 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 14 Jul 2020.