Colorectal CancerPhase 2NCT02688023
Neoadjuvant Triplet Chemotherapy Regimen in Patients With Resectable Colorectal Cancer
A Phase 2 study testing oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1 in people with Colorectal Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Colorectal cancer is an aggressive malignancy with a poor overall outcome. The purpose of this study is to evaluate the feasibility, safety and efficacy of neoadjuvant oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Mar 2014to Dec 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically verified colorectal cancer
- clinical stage T4N0-2M0、cT1-3N2M0 or M1(liver metastases only)
- age: 18-70 years
- ECOG 0-2
- adequate bone marrow, liver, renal and cardiac function (no history of ischemic heart disease)
- no prior cancer and/or chemotherapy
- signed informed consent
Who cannot join
- patients with a history of prior malignancy
- pregnant or lactating patients
- known or suspected brain metastasis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Jing Huang, M.D., 8610-87788103, huangjingwg@163.com
Zhixiang Zhou, M.D.
About this study
Official title: A Pilot Phase II Study of Triplet Chemotherapy Regimen in Neoadjuvant Chemotherapy of Patients With Resectable Colorectal Cancer
Colorectal cancer is an aggressive malignancy with a poor overall outcome. The purpose of this study is to evaluate the feasibility, safety and efficacy of neoadjuvant oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal cancer.
Read the detailed description
This is a single arm, phase 2 study of neoadjuvant triplet chemotherapy regimen of oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal cancer.Fifty patients will be enrolled in this trial. The primary objective of this study is to determine the 3-year disease-free survival of the patients.
- Conditions
- Colorectal Cancer
- Being tested
- oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1
- Keywords
- 5-fluorouracil, Irinotecan, Oxaliplatin, Colorectal cancer, 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.
oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1Drug
The regimen consisted of irinotecan 150mg/m2 administered as an intravenous infusion on day 1, oxaliplatin 85 mg/m2 administered intravenously on day 2, leucovorin 200 mg intravenously on day 2, 5-fluorouracil 500 mg administered by intravenous bolus,followed by 2400 mg/m2 by 44 h continuous intravenous infusion starting on day 2. S-1 (40-60mg orally twice per day for 10 days) or capecitabine (1000mg/m2 orally twice per day for 10 days) can be substituted for intravenous 5-fluorouracil.14 days as a cycle, up to 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| single-arm Irinotecan-Oxaliplatin-5-Fluorouracil/leucovorin | Experimental | Irinotecan,oxaliplatin and 5-fluorouracil/leucovorin(5-fluorouracil/leucovorin can be substituted with Capecitabine or S-1) Receives: Drug: oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease-free survival
Measured: 5 years
Secondary outcomes (5)
objective response rate
Measured: 2 years
Surgical complete resection rate (R0)
Measured: 2 years
overall survival
Measured: 6 years
Number of participants with adverse events that are related to treatment
Measured: 2 years
Number of participants with surgery complications
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startMar 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Huang, Chinese Academy of Medical Sciences
- Investigators
- Jing Huang, M.D., Principal investigator, Cancer Hospital, CAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688023
- Sponsor's protocol ID
- CH-GI-052
- Status last verified
- Feb 2016
- First submitted
- 11 Feb 2016
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Phase II Study of Triplet Chemotherapy Regimen in Neoadjuvant Chemotherapy of Patients With Resectable Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02688023
- Acronym / sponsor ID
- CH-GI-052
- Conditions
- Colorectal Cancer
- Keywords
- 5-fluorouracil, Irinotecan, Oxaliplatin, Colorectal cancer, neoadjuvant, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- Mar 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 23 Feb 2016 (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.
Colorectal cancer is an aggressive malignancy with a poor overall outcome. The purpose of this study is to evaluate the feasibility, safety and efficacy of neoadjuvant oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal cancer.
Detailed description
This is a single arm, phase 2 study of neoadjuvant triplet chemotherapy regimen of oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal cancer.Fifty patients will be enrolled in this trial. The primary objective of this study is to determine the 3-year disease-free survival of the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-arm Irinotecan-Oxaliplatin-5-Fluorouracil/leucovorin | Experimental | Drug: oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1Irinotecan,oxaliplatin and 5-fluorouracil/leucovorin(5-fluorouracil/leucovorin can be substituted with Capecitabine or S-1) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- histologically verified colorectal cancer
- clinical stage T4N0-2M0、cT1-3N2M0 or M1(liver metastases only)
- age: 18-70 years
- ECOG 0-2
- adequate bone marrow, liver, renal and cardiac function (no history of ischemic heart disease)
Key exclusion criteria (3 listed)
- patients with a history of prior malignancy
- pregnant or lactating patients
- known or suspected brain metastasis
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 |
|---|---|---|
| oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1The regimen consisted of irinotecan 150mg/m2 administered as an intravenous infusion on day 1, oxaliplatin 85 mg/m2 administered intravenously on day 2, leucovorin 200 mg intravenously on day 2, 5-fluorouracil 500 mg administered by intravenous bolus,followed by 2400 mg/m2 by 44 h continuous intravenous infusion starting on day 2. S-1 (40-60mg orally twice per day for 10 days) or capecitabine (1000mg/m2 orally twice per day for 10 days) can be substituted for intravenous 5-fluorouracil.14 days as a cycle, up to 4 cycles. | Drug | single-arm Irinotecan-Oxaliplatin-5-Fluorouracil/leucovorin |
Primary outcome
3-year disease-free survival
Time frame: 5 years
5 secondary outcomes
objective response rate
Time frame: 2 years
Surgical complete resection rate (R0)
Time frame: 2 years
overall survival
Time frame: 6 years
Number of participants with adverse events that are related to treatment
Time frame: 2 years
Number of participants with surgery complications
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 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.
Jing Huang, M.D. principal investigator
Cancer Hospital, CAMS
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 oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1 in people with Colorectal Cancer, run by Chinese Academy of Medical Sciences 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 7 inclusion and 3 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 23 Feb 2016. 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. 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 Jing Huang, M.D. (8610-87788103, huangjingwg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease-free survival (time frame: 5 years). 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 23 Feb 2016.