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The investigators conduct this study to evaluate the efficacy and adverse effect of salvage concurrent chemo-proton therapy (CCPT) with or without surgical resection in previously irradiated recurrent rectal cancer.
The obtaining of local control in previously irradiated recurrent rectal cancer is crucial for survival prolongation as well as quality of life of patients. But, it is not easy to get with surgery and/or conventional radiotherapy (RT) because of the limitation of RT dose. Proton therapy has unique advantage showing superior dose distribution focusing tumor escaping surrounding normal tissues using "Bragg-peak".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCPT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concurrent chemo-proton therapy | Radiation | Proton therapy with simultaneous integrated boost technique Gross tumor volume 70.4 gray (Gy)/ 16 fractions and clinical target volume 44.8 Gy/16 fractions Capecitabine twice a day 825 mg/body square meter |
| Measure | Description | Time Frame |
|---|---|---|
| local control rate at 3-year | Local progression will be defined according to the revised Response Evaluation Criteria in Solid Tumor (RECIST version 1.1) | 3-year after CCPT |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | Adverse events will be evaluated with the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. | 3 months after CCPT |
| objective response rate | Local progression will be defined according to the revised Response Evaluation Criteria in Solid Tumor (RECIST version 1.1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hee Cheol Kim | Contact | 82-2-3410-1655 | hc111.kim@samsung.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
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CCPT arm
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|
| 1 and 3 months after CCPT |
| time to local tumor progression | Local progression will be defined according to the revised Response Evaluation Criteria in Solid Tumor (RECIST version 1.1) | 3-year after CCPT |
| progression free survival | Local progression will be defined according to the revised Response Evaluation Criteria in Solid Tumor (RECIST version 1.1) | 3-year after CCPT |
| Core Quality of life (QOL-C) assessment | QOL will be evaluated with European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C) 30. | Baseline, at last week of CCPT, 1 and 3 months after CCPT |
| Colonrectum Quality of life (QOL-CR) assessment | QOL will be evaluated with EORTC QLQ- (colonrectum) CR 29. | Baseline, at last week of CCPT, 1 and 3 months after CCPT |