Locally Advanced Colon CancerPhase 3NCT03125980
Perioperative Versus Postoperative CapOX Chemotherapy for Locally Advanced Colon Cancer
A Phase 3 study testing capecitabine plus oxaliplatin before and after surgery and capecitabine plus oxaliplatin after surgery in people with Locally Advanced Colon Cancer, run by Fudan University at 1 site in China.
Trial summary
Adjuvant chemotherapy has been widely adopted worldwide for locally advanced colon cancer. However, more and more studies have found better efficacy and potential advantages of perioperative or neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Colon Cancer
- What is being tested?
- capecitabine plus oxaliplatin before and after surgery and capecitabine plus oxaliplatin after surgery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,370 participants
- Where
- 1 siteChina
- Study dates
- May 2017to May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2;
- Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: Neutrophil count≥1.5×109/L, Platelet count≥100×109/L, Hemoglobin≥80g/L, Serum bilirubin≤24umol/L, Alanine aminotransferase and aspartate aminotransferase ≤ 60×IU/L, Serum creatinine≤110 umol/L;
- No current pregnancy or breast-feeding, and subjects at childbearing age shall take method of contraception ;
- Be in a condition to receive a surgery/procedure;
- No second tumor at present or in the past 5 years, except skin basal cell carcinoma, skin squamous cell carcinoma, or any in situ cancer;
- No previous systemic chemotherapy for treating colon cancer;
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- No other chemotherapy at the same time;
- Expected lifetime longer than three months;
- Be willing and able to understand the study and to provide written informed consent.
Who cannot join
- End-stage cachexia patients;
- Cardiopulmonary dysfunction or liver and kidney dysfunction, and unable to tolerate CapeOX chemotherapy;
- Metastatic carcinoma;
- Moderate or above anemia caused by serious local tumor bleeding;
- Incomplete or complete intestinal obstruction;
- Known to be allergic to oxaliplatin or capecitabine;
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- Active hepatitis, severe coagulation disorder patients;
- Pregnant or lactating women; or women who have fertility but have not taken at taken adequate contraceptive measures;
- Known to have deficient dihydropyrimidine dehydrogenase (DPD)；
- Have vital organ failure or other severe diseases, including but not limited to coronary heart disease, cardiovascular diseases, or myocardial infarction within 12 months before being included; severe neurological or psychiatric history；severe infection; active disseminated intravascular coagulation;
- Unable or unwilling to abide by the study plan.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Colorectal Surgery Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Sanjun Cai, M.D, +86-21-64175590 ext. 81108, caisanjuncsj@163.com
About this study
Official title: Perioperative CapeOX Chemotherapy Versus Postoperative Chemotherapy for Locally Advanced Resectable Colon Cancer: An Open Label Randomized Controlled Phase III Trial
Adjuvant chemotherapy has been widely adopted worldwide for locally advanced colon cancer. However, more and more studies have found better efficacy and potential advantages of perioperative or neoadjuvant chemotherapy. The sooner the systemic chemotherapy is received, the better suppression it has on activity of tumor growth factors. Pre-operative chemotherapy may eliminate tiny metastases. It may also shrink the invasion of tumor before surgery, and thus reducing operational trauma and expediting recovery. With advances in radiology and tomography, staging before surgery is accurate enough to identify risks and prognosis for patients. The phase II trial conducted by our department has yielded encouraging results (N=47, CapeOX regimen, clinicaltrials.gov NCT02415829): after the neoadjuvant chemotherapy, no subject had disease progression, 68.1% subjects reached complete or partial response. Besides, the toxicity of neoadjuvant CapeOX chemotherapy was acceptable. The present randomized controlled phase III trial will be conducted to further compare efficacy and safety of the neoadjuvant and adjuvant CapeOX chemotherapy for patients with locally advanced resectable colon cancer in China. This study may have two periods, each will last for approximately 5 years. After the first period (n=994), if the results of the test group are better than the control group, the study will be terminated. Otherwise, the study will enter into period 2 (n=376) through selecting out genetically sensitive subjects and repeating the same trial process as period 1.
- Conditions
- Locally Advanced Colon Cancer
- Being tested
- capecitabine plus oxaliplatin before and after surgery, capecitabine plus oxaliplatin after surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabine plus oxaliplatin before and after surgeryDrug
Subjects will receive systemic CapeOX chemotherapy both before and after the radical surgery for at most 4 cycles respectively. They shall have rest after the surgery for at least four weeks before the post-operative chemotherapy. CapOX regimen will be administered as follows:
- Oxaliplatin 130 mg/m2 iv continue for 2 hours.D1
- Capecitabine 1000mg/m2/d PO Bid,once every morning and evening D1-14
- Repeat every 3 weeks (Q3W)
capecitabine plus oxaliplatin after surgeryDrug
Subjects will first receive radical surgery, then have rest for at least four weeks. Thereafter, subjects will receive systemic CapeOX chemotherapy for at most 8 cycles. CapOX regimen will be administered as follows:
- Oxaliplatin 130 mg/m2 iv continue for 2 hours.D1
- Capecitabine 1000mg/m2/d PO Bid,once every morning and evening D1-14
- Q3W
| Study group | Role | What they receive |
|---|---|---|
| Perioperative chemotherapy with CapOX regimen | Experimental | Not described Receives: Drug: capecitabine plus oxaliplatin before and after surgery |
| Postoperative chemotherapy with CapOX regimen | Active comparator | Not described Receives: Drug: capecitabine plus oxaliplatin after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease free survival
Defined as the length of time from the date of randomization until the first documented date of progression or death from any cause, whichever comes first
Measured: 3 years
Secondary outcomes (4)
R0 resection rate
Defined as the rate of patients whose tumors are completely resected with all the margins being negative
Measured: From the date of randomization until the date of the last patient receiving surgery, assessed up to 40 months
Post-operative TRG staging
Defined as the TRG staging of tumor after surgery
Measured: From the date of randomization until the date of the last patients receiving surgery, assessed up to 40 months
Overall survival (OS)
Defined as the length of time from randomization date until the date of death from any cause
Measured: 5 years
Relapse-free survival (RFS)
Defined as the length of time from the date of randomization until the first documented date of relapse.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study startMay 2017 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionMay 2027 (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 Locally Advanced 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
- 1,370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjun Cai, Fudan University
- Investigators
- Ye Xu, M.D, Study director, Department of Colorectal Surgery Fudan University Shanghai Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125980
- Sponsor's protocol ID
- CapeOXcc
- Status last verified
- Apr 2017
- First submitted
- 14 Apr 2017
- Last updated
- 24 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu F, Tong T, Huang D, Yuan W, Li D, Lin J, Cai S, Xu Y, Chen W, Sun Y, Zhuang J. CapeOX perioperative chemotherapy versus postoperative chemotherapy for locally advanced resectable colon cancer: protocol for a two-period randomised controlled phase III trial. BMJ Open. 2019 Jan 29;9(1):e017637. doi: 10.1136/bmjopen-2017-017637.
PubMed 30700474
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative CapeOX Chemotherapy Versus Postoperative Chemotherapy for Locally Advanced Resectable Colon Cancer: An Open Label Randomized Controlled Phase III Trial
- ClinicalTrials.gov ID
- NCT03125980
- Acronym / sponsor ID
- CapeOXcc
- Conditions
- Locally Advanced Colon Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,370 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- May 2017 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 24 Apr 2017 (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.
Adjuvant chemotherapy has been widely adopted worldwide for locally advanced colon cancer. However, more and more studies have found better efficacy and potential advantages of perioperative or neoadjuvant chemotherapy. The sooner the systemic chemotherapy is received, the better suppression it has on activity of tumor growth factors. Pre-operative chemotherapy may eliminate tiny metastases. It may also shrink the invasion of tumor before surgery, and thus reducing operational trauma and expediting recovery. With advances in radiology and tomography, staging before surgery is accurate enough to identify risks and prognosis for patients. The phase II trial conducted by our department has yielded encouraging results (N=47, CapeOX regimen, clinicaltrials.gov NCT02415829): after the neoadjuvant chemotherapy, no subject had disease progression, 68.1% subjects reached complete or partial response. Besides, the toxicity of neoadjuvant CapeOX chemotherapy was acceptable. The present randomized controlled phase III trial will be conducted to further compare efficacy and safety of the neoadjuvant and adjuvant CapeOX chemotherapy for patients with locally advanced resectable colon cancer in China. This study may have two periods, each will last for approximately 5 years. After the first period (n=994), if the results of the test group are better than the control group, the study will be terminated. Otherwise, the study will enter into period 2 (n=376) through selecting out genetically sensitive subjects and repeating the same trial process as period 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perioperative chemotherapy with CapOX regimen | Experimental | Drug: capecitabine plus oxaliplatin before and after surgery |
| Postoperative chemotherapy with CapOX regimen | Active comparator | Drug: capecitabine plus oxaliplatin after surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2;
- Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: Neutrophil count≥1.5×109/L, Platelet count≥100×109/L, Hemoglobin≥80g/L, Serum bilirubin≤24umol/L, Alanine aminotransferase and aspartate aminotransferase ≤ 60×IU/L, Serum creatinine≤110 umol/L;
- No current pregnancy or breast-feeding, and subjects at childbearing age shall take method of contraception ;
- Be in a condition to receive a surgery/procedure;
- No second tumor at present or in the past 5 years, except skin basal cell carcinoma, skin squamous cell carcinoma, or any in situ cancer;
Key exclusion criteria (11 listed)
- End-stage cachexia patients;
- Cardiopulmonary dysfunction or liver and kidney dysfunction, and unable to tolerate CapeOX chemotherapy;
- Metastatic carcinoma;
- Moderate or above anemia caused by serious local tumor bleeding;
- Incomplete or complete intestinal obstruction;
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 |
|---|---|---|
| capecitabine plus oxaliplatin before and after surgerySubjects will receive systemic CapeOX chemotherapy both before and after the radical surgery for at most 4 cycles respectively. They shall have rest after the surgery for at least four weeks before the post-operative chemotherapy. CapOX regimen will be administered as follows: 1. Oxaliplatin 130 mg/m2 iv continue for 2 hours.D1 2. Capecitabine 1000mg/m2/d PO Bid,once every morning and evening D1-14 3. Repeat every 3 weeks (Q3W) | Drug | Perioperative chemotherapy with CapOX regimen |
| capecitabine plus oxaliplatin after surgerySubjects will first receive radical surgery, then have rest for at least four weeks. Thereafter, subjects will receive systemic CapeOX chemotherapy for at most 8 cycles. CapOX regimen will be administered as follows: 1. Oxaliplatin 130 mg/m2 iv continue for 2 hours.D1 2. Capecitabine 1000mg/m2/d PO Bid,once every morning and evening D1-14 3. Q3W | Drug | Postoperative chemotherapy with CapOX regimen |
Primary outcome
3-year disease free survival
Time frame: 3 years
Defined as the length of time from the date of randomization until the first documented date of progression or death from any cause, whichever comes first
4 secondary outcomes
R0 resection rate
Time frame: From the date of randomization until the date of the last patient receiving surgery, assessed up to 40 months
Post-operative TRG staging
Time frame: From the date of randomization until the date of the last patients receiving surgery, assessed up to 40 months
Overall survival (OS)
Time frame: 5 years
Relapse-free survival (RFS)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Derived from this study: PubMed 30700474Liu F, Tong T, Huang D, Yuan W, Li D, Lin J, Cai S, Xu Y, Chen W, Sun Y, Zhuang J. CapeOX perioperative chemotherapy versus postoperative chemotherapy for locally advanced resectable colon cancer: protocol for a two-period randomised controlled phase III trial. BMJ Open. 2019 Jan 29;9(1):e017637. doi: 10.1136/bmjopen-2017-017637.
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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.
Ye Xu, M.D study director
Department of Colorectal Surgery Fudan University Shanghai Cancer Center
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 capecitabine plus oxaliplatin before and after surgery and capecitabine plus oxaliplatin after surgery in people with Locally Advanced 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 9 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 24 Apr 2017. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanjun Cai, M.D (+86-21-64175590 ext. 81108, caisanjuncsj@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: 3 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 NCT03125980, 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 24 Apr 2017.