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The main cause of recurrence after surgical treatment of colon cancer is distant metastasis. Neoadjuvant chemotherapy has potential benefits of improving the effectiveness of chemotherapy. Preoperative chemotherapy may eradicate microscopic metastatic cancer cells earlier than adjuvant chemotherapy, reduce cancer cell spillage during surgery, and lessen the invasiveness of surgical resection. This randomized multicenter phase III trial is assessing whether preoperative chemotherapy improves oncologic outcomes of patients with locally advanced colon cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant FOLFOX | Experimental | 4 cycles of FOLFOX (Folinic acid, fluorouracil and oxaliplatin) neoadjuvant followed by surgery and 8 cycles of FOLFOX |
|
| Conventional adjuvant FOLFOX | Active Comparator | surgery followed by 12 cycles of FOLFOX |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant FOLFOX | Drug | 4 cycles of FOLFOX neoadjuvant chemotherapy and 8 cycles of postoperative chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relapse free survival after randomization | 3 years after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 3 year after randomization | |
| Radiological assessment of response to neoadjuvant treatment | 6 months after surgery | |
| Pathological assessment of response to neoadjuvant treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soo Yeun Park, MD | Kyungpook National University Chilgok Hospital | Study Director |
| Gyu-Seog Choi, MD, PhD | Kyungpook National University Chilgok Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hwasun Hospital | Hwasun | Chonnam | 58128 | South Korea | ||
| Kyungpook National University Chilgok Hospital |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Conventional adjuvant FOLFOX | Drug | 12 cycles of postoperative FOLFOX chemotherapy |
|
Replacement of the tumor by fibrous or fibro-inflammatory granulation tissue |
| 1 months after surgery |
| Surgical complication | 60 days after surgery |
| Length of hospital stay | 60 days after surgery |
| Quality of life (EORTC QLQ-C30) | QLQ (quality of life questionnaire) | before treatment, before surgery, 3 months after surgery, 6 months after surgery, 1 year after surgery |
| Quality of life (EORTC QLQ-C38) | before treatment, before surgery, 3 months after surgery, 6 months after surgery, 1 year after surgery |
| Toxicity of chemotherapy | Toxicity : incidence of chemotherapy-related adverse events according to CTCAE (Common Terminology Criteria for Adverse Events) v4.0 | 1 year |
| Incidence of completion of chemotherapy | 1 year |
| Accuracy of CT staging | 1 year |
| Total cycles of perioperative chemotherapy | 1 year |
| Pathological tumor stage | Colon cancer stage by AJCC 8th edition | 1 month after surgery |
| Daegu |
| 41404 |
| South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| The Catholic Univ. of Korea St. Vincent's Hospital | Suwon | South Korea |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |