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| Name | Class |
|---|---|
| Peking Union Medical College Hospital | OTHER |
| Peking University People's Hospital | OTHER |
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The purpose of this study is to design a prospective randomized clinical trial to explore whether postoperative adjuvant chemotherapy may provide survival benefit for stage II colon cancer patients with high risk factors.Therefore the investigators can provide high level clinical evidence of indications for patients with colon cancer with stage II colon cancer.
The most controversial of adjuvant chemotherapy for colon cancer is whether stage II colon cancer should receive adjuvant chemotherapy or not. Because of the absolute little benefit of adjuvant chemotherapy after curative resection of stage II colon cancer,NCCN and ESMO guidelines do not recommend routine adjuvant chemotherapy for patients with stage II colon cancer unless combined with high risk factors.
Currently,most studies about stage II colon cancer with high risk factors were retrospective. Some suggested that patients with stage II colon cancer can benefit from adjuvant chemotherapy, however, more got the negative conclusions.
The study was designed as a multicenter, prospective, randomized, controlled trial.Patients who agreed to participate in the study would be randomly assigned to a treatment group of adjuvant chemotherapy or observation with 50% chance by a central randomization system determined by the computer program.
After a follow up of at least 3 years, the disease free survival of the two groups will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adjuvant chemotherapy group | Active Comparator | patients enrolled int the adjuvant chemotherapy group will receive adjuvant chemotherapy[CapeOX(Capecitabine+Oxaliplatin)] by the current guidelines |
|
| observation group | Experimental | patients enrolled int the adjuvant chemotherapy group will not receive adjuvant chemotherapy just for observation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CapeOX(Capecitabine+Oxaliplatin) | Drug | Patients enrolled in the chemotherapy group would receive postoperative chemotherapy CapeOX(Capecitabine+Oxaliplatin)for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease free survival | Disease free survival was defined as the duration after local recurrence or metastasis were found after surgery. Metastasis of any distant organs such as liver, lung, ovary,bone and peritoneum were defined by CT. | At least 3 years after the last patient enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year overall survival | Overall survival was defined as the duration from randomization to death from any cause | At least 3 years after the last patient enrolled |
| Rate of metastasis | Rate of metastasis in different groups |
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Inclusion Criteria:
aged 18 to 75 years;
pathologically confirmed adenocarcinoma of the colon
after curative resection pathological stage was T3-4N0M0;
with at least one of the following factors:
ECOG Performance status 0-1
no evidence of distant metastases
no preoperative chemotherapy or chemoradiation therapy
ANC > 1.5 cells/mm3, HGB > 10.0 g/dL, PLT > 100,000/mm3, total bilirubin ≤ 1.5 xULN, AST≤ 3 x ULN, ALT ≤ 3 x ULN.
Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pengju Chen, M.D. | Contact | +8613811403082 | pengjuchen@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Aiwen Wu, M.D. | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing cancer hospital | Recruiting | Beijing | China |
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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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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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a prospertive randomized clinical trial
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| Observation | Other | Patients enrolled in the observation group would not receive any chemotherapy drugs just for observation |
|
| At least 3 years after the last patient enrolled |
| Relationship between high risk factors and survival | All the high risk factors enrolled in this study will be analyzed one by one to investigate the relationship between high risk factors and survival. | At least 3 years after the last patient enrolled |
| Major adverse events | Toxic reaction in the chemotherapy group.Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | At least 1 years after the last patient enrolled |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |