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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perioperative chemotherapy with CapOX regimen | Experimental |
| |
| Postoperative chemotherapy with CapOX regimen | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capecitabine plus oxaliplatin before and after surgery | Drug | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | Defined as the rate of patients whose tumors are completely resected with all the margins being negative | From the date of randomization until the date of the last patient receiving surgery, assessed up to 40 months |
| Post-operative TRG staging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanjun Cai, M.D | Contact | +86-21-64175590 | 81108 | caisanjuncsj@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ye Xu, M.D | Department of Colorectal Surgery Fudan University Shanghai Cancer Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Colorectal Surgery Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30700474 | Derived | 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. |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D011184 | Postoperative Period |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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Open label
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|
| capecitabine plus oxaliplatin after surgery | Drug | 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:
|
|
Defined as the TRG staging of tumor after surgery |
| 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 | 5 years |
| Relapse-free survival (RFS) | Defined as the length of time from the date of randomization until the first documented date of relapse. | 5 years |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D059035 | Perioperative Period |
| D013514 | Surgical Procedures, Operative |
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |