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Colorectal cancer (CRC) is one of the most leading causes of cancer death in China. Although multiple treatment modalities including surgery, radiotherapy and chemotherapy have been developed, the prognosis of advanced CRC still remains poor. While around 30% of resectable advanced CRC could be cured. This study is designed to compare perioperative FOLFIRI versus adjuvant FOLFIRI in resectable advanced CRC who exposed to oxaliplatin in open-label, phase III mode.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant therapy arm | Experimental | FOLFIRI * 6 cycles +/- radiotherapy -> surgery -> FOLFIRI * 6 cycles |
|
| Adjuvant therapy arm | Active Comparator | Surgery -> FOLFIRI * 12 cycles +/- radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan | Drug |
| ||
| 5-fluorouracil |
| Measure | Description | Time Frame |
|---|---|---|
| Progress Free Survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 3 Years | |
| R0 Resection Rate | 6 Month | |
| Treatment RelatedToxicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Xiao, MD | Contact | +8613711114566 | xiao_jian@139.com |
| Name | Affiliation | Role |
|---|---|---|
| Ping Lan, MD | Sixth Affiliated Hospital, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 6th Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510655 | China |
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| Drug |
|
| Local radiotherapy | Radiation |
|
| R0 resection | Procedure |
|
Adverse events grade that greater than 3 is considered secondary endpoint, according to the Common Terminology Criteria for Adverse Events Version 3.0.
| 3 Year |
| Life Quality | EORTC QoL Questionaires | 3 Years |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| D009364 | Neoplasm Recurrence, Local |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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