Metastatic Colon CancerPhase 3NCT04416854
The Value of Palliative Primary Tumor Resection in Metastatic Colon Cancer
A Phase 3 study testing resection of primary tumor, XELOX and mFOLFOX6 in people with Metastatic Colon Cancer and Surgery, run by Fudan University at 1 site in China.
Trial summary
The aim of this trial is to evaluate the value of palliative primary tumor resection in colon cancer patients with initially unresectable metastases and a positive response to induction chemotherapy which depends on gene testing. The primary endpoint is to evaluate overall survival. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colon Cancer, Surgery
- What is being tested?
- resection of primary tumor, XELOX and mFOLFOX6
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 627 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 31 Dec 2025
- 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
- 75 years old
- ECOG (Eastern Cooperative Oncology Group) 0-1 and expected survival period for 6 months or more
- Pathological diagnosis of colon cancer adenocarcinoma
- At least one measurable objective tumor lesions which could be evaluated.
- Primary and metastatic tumors exist at the same time, and distant metastases are not resectable
- 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
- No systemic chemotherapy
- Patients with voluntary participation, and sign the informed consent
Who cannot join
- Operation intervention required for perforation, bleeding and obstruction of intestinal cavity
- Multiple primary colorectal carcinoma
- Malignant peritoneal effusion or metastatic carcinoma of the peritoneum
- Uncontrolled pleural effusion
- 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 or meningeal metastasis
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- Pregnancy or breast-feeding women
- Alcohol or drug addictions
- 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 Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xinxiang Li, MD,PhD, +8613918176716, lxx1149@163.com
Qingguo Li, MD,PhD, +8618918298120, qingguoli@fudan.edu.cn
About this study
Official title: The Value of Palliative Primary Tumor Resection in Colon Cancer Patients With Initially Unresectable Metastases After Induction Chemotherapy: a Prospective, Multicenter, Randomized Controlled Clinical Trial
The aim of this trial is to evaluate the value of palliative primary tumor resection in colon cancer patients with initially unresectable metastases and a positive response to induction chemotherapy which depends on gene testing. The primary endpoint is to evaluate overall survival.
- Conditions
- Metastatic Colon Cancer, Surgery
- Being tested
- resection of primary tumor, XELOX, mFOLFOX6
- Keywords
- palliative surgery, stage IV colon cancer, chemotherapy
- 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 tumorProcedure or surgery
resection of primary lesion with unresectablely metastatic colon cancer
XELOXDrug
Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle
mFOLFOX6Drug
Oxaliplatin 85mg/m2, leucovorin 400mg/m2 ivgtt d1 and 5-FU 400 mg/m2 IV bolus d1，2400 mg/m2 CIV 46h, d1
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy plus surgery | Experimental | Chemotherapy plus surgery: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to surgery group. Patients receive palliative resection of Primary tumor. Then the rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated. Receives: Procedure: resection of primary tumor; Drug: XELOX; Drug: mFOLFOX6 |
| Chemotherapy alone | Active comparator | Chemotherapy alone: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to chemotherapy group. The rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated. Receives: Drug: XELOX; Drug: mFOLFOX6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 5-year
Secondary outcomes (7)
Progression-free survival 1
The first progression time after diagnosis
Measured: 3-year
Progression-free survival 2
The first progression time after randomization
Measured: 3-year
The rate of adverse events resulted from chemotherapy
The ratio of the number of patients experienced adverse events to the total patients
Measured: 3-year
The quality of life postoperatively
The European Organization for Research and Treatment (EORTC)-QLQ-C30 HRQL questionnaire was assessed with repeated measures at regular intervals postoperatively at months 3, 6, 9, 12, 18, and 24
Measured: 3-month, 6-month, 9-month, 12-month, 18-month, 24-month
Objective response rate
Measured: 1-year
The rate of postoperative complications
The ratio of the number of patients with postoperative complications to the total patients
Measured: 1-year
The proportion of surgical intervention in control group
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Apr 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 627 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI XIN-XIANG, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416854
- Sponsor's protocol ID
- FDPRMCC
- Status last verified
- Jun 2020
- First submitted
- 26 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Palliative Primary Tumor Resection in Colon Cancer Patients With Initially Unresectable Metastases After Induction Chemotherapy: a Prospective, Multicenter, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04416854
- Acronym / sponsor ID
- FDPRMCC
- Conditions
- Metastatic Colon Cancer, Surgery
- Keywords
- palliative surgery, stage IV colon cancer, chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 627 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Jun 2020 (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.
The aim of this trial is to evaluate the value of palliative primary tumor resection in colon cancer patients with initially unresectable metastases and a positive response to induction chemotherapy which depends on gene testing. The primary endpoint is to evaluate overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy plus surgery | Experimental | Procedure: resection of primary tumor, Drug: XELOX, Drug: mFOLFOX6Chemotherapy plus surgery: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to surgery group. Patients receive palliative resection of Primary tumor. Then the rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated. |
| Chemotherapy alone | Active comparator | Drug: XELOX, Drug: mFOLFOX6Chemotherapy alone: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to chemotherapy group. The rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 75 years old
- ECOG (Eastern Cooperative Oncology Group) 0-1 and expected survival period for 6 months or more
- Pathological diagnosis of colon cancer adenocarcinoma
- At least one measurable objective tumor lesions which could be evaluated.
- Primary and metastatic tumors exist at the same time, and distant metastases are not resectable
Key exclusion criteria (9 listed)
- Operation intervention required for perforation, bleeding and obstruction of intestinal cavity
- Multiple primary colorectal carcinoma
- Malignant peritoneal effusion or metastatic carcinoma of the peritoneum
- Uncontrolled pleural effusion
- 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
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 tumorresection of primary lesion with unresectablely metastatic colon cancer | Procedure or surgery | Chemotherapy plus surgery |
| XELOXOxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle | Drug | Chemotherapy alone, Chemotherapy plus surgery |
| mFOLFOX6Oxaliplatin 85mg/m2, leucovorin 400mg/m2 ivgtt d1 and 5-FU 400 mg/m2 IV bolus d1，2400 mg/m2 CIV 46h, d1 | Drug | Chemotherapy alone, Chemotherapy plus surgery |
Primary outcome
Overall survival
Time frame: 5-year
7 secondary outcomes
Progression-free survival 1
Time frame: 3-year
Progression-free survival 2
Time frame: 3-year
The rate of adverse events resulted from chemotherapy
Time frame: 3-year
The quality of life postoperatively
Time frame: 3-month, 6-month, 9-month, 12-month, 18-month, 24-month
Objective response rate
Time frame: 1-year
The rate of postoperative complications
Time frame: 1-year
The proportion of surgical intervention in control group
Time frame: 1-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
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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 3 study testing resection of primary tumor, XELOX and mFOLFOX6 in people with Metastatic Colon Cancer and Surgery, 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 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: status not confirmed, as of the sponsor's last update on 4 Jun 2020. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinxiang Li (+8613761291659, 1149lxx@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5-year). 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 4 Jun 2020.