Computed Tomography-guided Brachytherapy Plus Chemotherapy for Locally Recurrent Rectum Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Study of Computed Tomography-guided Brachytherapy Plus Chemotherapy for Locally Recurrent Rectum Cancer

Conditions
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Rectum Cancer

Intervention / Treatment
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* Procedure: Computed tomography guided radioactive seeds implant
* Drug: Systemic chemotherapy (FOLFIRI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Limited locoregional recurrence including solitary recurrence at primary tumor bed, solitary intraabdominal peritoneal recurrence, and single regional lymph node recurrence (no more than 3 lymph nodes) based on diagnosis by CT, and confirmed by percutaneous puncture biopsy Second-line treatment for advanced colorectal cancer,irinotecan was not previously used. Age range 18-70 years old ECOG performance status 0-1 Life expectancy of more than 3 months Adequate organ function Exclusion Criteria: Previous serious cardiac disease History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Pregnant or lactating women Chronic inflammatory bowel disease or intestinal obstruction Serious uncontrolled diseases and intercurrent infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CT alone<br>Treated with systemic chemotherapy alone (FOLFIRI). | Drug: Systemic chemotherapy (FOLFIRI)<br>* irinotecan 180mg/m2 d1,leucovorin 400mg/m2 d1, 5-fluorouracil 400mg/m2 iv, 2.4g/m2 civ 46h, repeated every 2 weeks<br>* Other names: FOLFIRI;|
| Experimental: CT+BT<br>Treated with systemic chemotherapy (FOLFIRI) plus computed tomography guided radioactive seeds implant. | Procedure: Computed tomography guided radioactive seeds implant<br>* Computed tomography guided radioactive seeds implant were performed one week before chemotherapy.<br>* Other names: Brachytherapy;Drug: Systemic chemotherapy (FOLFIRI)<br>* irinotecan 180mg/m2 d1,leucovorin 400mg/m2 d1, 5-fluorouracil 400mg/m2 iv, 2.4g/m2 civ 46h, repeated every 2 weeks<br>* Other names: FOLFIRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment related adverse events | Including chemotherapy related side-effect and brachytherapy related adverse events. | Eight weeks |