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The purpose of this study is to evaluate the safety and efficacy of CT guided 125I seeds implant plus systemic chemotherapy for locally recurrent rectum cancer.
The primary aim of this study is to determined the safety and efficacy of CT guided 125I seeds implant plus systemic chemotherapy for locally recurrent rectum cancer.The patients with recurrence in pelvic or on pelvic wall after rectal resection were treated with 125I seeds implant plus chemotherapy or chemotherapy alone. The side-effect, tumor response and survival data were recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT alone | Active Comparator | Treated with systemic chemotherapy alone (FOLFIRI). |
|
| CT+BT | Experimental | Treated with systemic chemotherapy (FOLFIRI) plus computed tomography guided radioactive seeds implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed tomography guided radioactive seeds implant | Procedure | Computed tomography guided radioactive seeds implant were performed one week before chemotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Progression free survival which is calculated from the start of treatment to disease progression or death | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment related adverse events | Including chemotherapy related side-effect and brachytherapy related adverse events. | Eight weeks |
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Inclusion Criteria:
Exclusion Criteria:
Previous serious cardiac disease
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| Name | Affiliation | Role |
|---|---|---|
| Changping Wu, M.D. | The First People's Hospital of Changzhou | Study Director |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| C480833 | IFL protocol |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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|
| Systemic chemotherapy (FOLFIRI) | Drug | irinotecan 180mg/m2 d1,leucovorin 400mg/m2 d1, 5-fluorouracil 400mg/m2 iv, 2.4g/m2 civ 46h, repeated every 2 weeks |
|
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |