Metastatic Colon CancerPhase 2NCT02291744
A Phase Ⅱ Study of XELOX Chemotherapy With or Without Surgery of Primary Lesion for Colon Cancer Patients
A Phase 2 study testing resection of primary lesion and XELOX in people with Metastatic Colon Cancer, run by Fudan University at 1 site in China.
Trial summary
The primary endpoint is to evaluate the TFS (time to failure of strategy). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colon Cancer
- What is being tested?
- resection of primary lesion and XELOX
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Oct 2017
- 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
- 18~75 ears old
- Pathological diagnosis of colon cancer adenocarcinoma
- No systemic chemotherapy for metastatic tumors
- ECOG (Eastern Cooperative Oncology Group) 0-1 and expected survival period for 6 months or more
- At least one measurable objective tumor lesions
- ANC≥1.5*109/L；PLT≥90*109/L；HB≥90g/L；TBI≤1.5(UNL); ALT、AST≤2.5ULN；Cr≤1.0(ULN) screening within 7 days
- Primary and metastatic tumors exist at the same time, and distant metastases are not resectable
- Patients with voluntary participation, and sign the informed consent
Who cannot join
- Operation intervention required for perforation, bleeding and obstruction of intestinal cavity
- With uncontrollable large pleural or peritoneal effusion
- Alcohol or drug addictions
- Malignant tumour of the past five years with other organizations to source, but the full treatment of cervical carcinoma in situ and except skin basal cell carcinoma and squamous cell carcinomas
- With brain metastasis
- Multiple primary colorectal carcinoma
- Pregnancy or breast-feeding women
- There is an important organ failure or other serious diseases, including coronary artery disease, symptomatic cardiovascular disease or myocardial infarction within 12 months; serious neurological or psychiatric history; severe infection; actively disseminated vascula blood coagulation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Wei Jian Guo, PHD
About this study
Official title: A Randomized Phase Ⅱ Study of XELOX Chemotherapy With or Without Surgery of Primary Lesion for Colon Cancer Patients With Unresectable Metastatic Lesions
The primary endpoint is to evaluate the TFS (time to failure of strategy).
Read the detailed description
The primary endpoint is to evaluate the time to failure of strategy, that is the second progression time after induction therapy by the use of XELOX regimen, comparing XELOX regimen chemotherapy combined with or without surgical resection of the primary lesion from the time of randomization to maintenance therapy and reapplication of induction therapy, or time to the use of second line strategy (if no reapplication of induction therapy) or time to no further treatment.
- Conditions
- Metastatic Colon Cancer
- Being tested
- resection of primary lesion, XELOX
- Keywords
- TFS (time to failure of strategy)
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resection of primary lesionProcedure or surgery
Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle, and resection of primary lesion with metastatic colon cancer
XELOXDrug
Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle,
| Study group | Role | What they receive |
|---|---|---|
| XELOX plus surgery | Experimental | Eight cycles of XELOX chemotherapy plus surgery:Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle. After 4 cycles, the patients are randomized to surgery group. Then the rest four cycles are administrated. Receives: Procedure: resection of primary lesion; Drug: XELOX |
| XELOX | Active comparator | Eight cycles of XELOX chemotherapy: Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle Receives: Drug: XELOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
TFS time of failure of strategy (the second progression time after induction therapy, or time to the use of second line strategy (if no reapplication of induction therapy) or time to no further treatment)
Measured: the second progression time after induction therapy, or time to the use of second line strategy (if no reapplication of induction therapy) or time to no further treatment. The average time is three years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colon CancerStudies of the same condition, open and under way.
- More trials run by Fudan 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijian Guo, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291744
- Sponsor's protocol ID
- guoweijian-2014-XELOX
- Status last verified
- Nov 2015
- First submitted
- 4 Nov 2014
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huang M, Yang Y, Li Q, Wang C, Liang L, Zhu X, Zhang W, Chen Z, Huang D, Li W, Zhang X, Zhao X, Qiu L, Geng Q, Yu N, Du W, Sun S, Sheng X, Li X, Guo W. Induction Chemotherapy Followed by Primary Tumor Resection Did Not Bring Survival Benefits in Colon Cancer Patients With Asymptomatic Primary Lesion and Synchronous Unresectable Metastases. Front Oncol. 2022 Jan 31;12:747124. doi: 10.3389/fonc.2022.747124. eCollection 2022.
PubMed 35174078
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase Ⅱ Study of XELOX Chemotherapy With or Without Surgery of Primary Lesion for Colon Cancer Patients With Unresectable Metastatic Lesions
- ClinicalTrials.gov ID
- NCT02291744
- Acronym / sponsor ID
- guoweijian-2014-XELOX
- Conditions
- Metastatic Colon Cancer
- Keywords
- TFS (time to failure of strategy)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 14 Nov 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.
The primary endpoint is to evaluate the TFS (time to failure of strategy).
Detailed description
The primary endpoint is to evaluate the time to failure of strategy, that is the second progression time after induction therapy by the use of XELOX regimen, comparing XELOX regimen chemotherapy combined with or without surgical resection of the primary lesion from the time of randomization to maintenance therapy and reapplication of induction therapy, or time to the use of second line strategy (if no reapplication of induction therapy) or time to no further treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XELOX plus surgery | Experimental | Procedure: resection of primary lesion, Drug: XELOXEight cycles of XELOX chemotherapy plus surgery:Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle. After 4 cycles, the patients are randomized to surgery group. Then the rest four cycles are administrated. |
| XELOX | Active comparator | Drug: XELOXEight cycles of XELOX chemotherapy: Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18~75 ears old
- Pathological diagnosis of colon cancer adenocarcinoma
- No systemic chemotherapy for metastatic tumors
- ECOG (Eastern Cooperative Oncology Group) 0-1 and expected survival period for 6 months or more
- At least one measurable objective tumor lesions
Key exclusion criteria (8 listed)
- Operation intervention required for perforation, bleeding and obstruction of intestinal cavity
- With uncontrollable large pleural or peritoneal effusion
- Alcohol or drug addictions
- Malignant tumour of the past five years with other organizations to source, but the full treatment of cervical carcinoma in situ and except skin basal cell carcinoma and squamous cell carcinomas
- With 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 |
|---|---|---|
| resection of primary lesionOxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle, and resection of primary lesion with metastatic colon cancer | Procedure or surgery | XELOX plus surgery |
| XELOXOxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle, | Drug | XELOX, XELOX plus surgery |
Primary outcome
TFS time of failure of strategy (the second progression time after induction therapy, or time to the use of second line strategy (if no reapplication of induction therapy) or time to no further treatment)
Time frame: the second progression time after induction therapy, or time to the use of second line strategy (if no reapplication of induction therapy) or time to no further treatment. The average time is three years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2015.
- Derived from this study: PubMed 35174078Huang M, Yang Y, Li Q, Wang C, Liang L, Zhu X, Zhang W, Chen Z, Huang D, Li W, Zhang X, Zhao X, Qiu L, Geng Q, Yu N, Du W, Sun S, Sheng X, Li X, Guo W. Induction Chemotherapy Followed by Primary Tumor Resection Did Not Bring Survival Benefits in Colon Cancer Patients With Asymptomatic Primary Lesion and Synchronous Unresectable Metastases. Front Oncol. 2022 Jan 31;12:747124. doi: 10.3389/fonc.2022.747124. eCollection 2022.
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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.
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 resection of primary lesion and XELOX in people with Metastatic Colon Cancer, run by Fudan 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 8 inclusion and 8 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 11 Nov 2015. 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 Weijian Guo, doctor (13816066360, mingzhuhuang0718@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TFS time of failure of strategy (the second progression time after induction therapy, or time to the use of second line strategy (if no reapplication of induction therapy) or time to no further treatment) (time frame: the second progression time after induction therapy, or time to the use of second line strategy (if no reapplication of induction therapy) or time to no further treatment. The average time is three years.). 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 NCT02291744, which also lists 1 linked publication.
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 Nov 2015.