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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02423226
Other study ID # CZ-I125-001
Secondary ID
Status Completed
Phase Phase 2
First received April 16, 2015
Last updated April 21, 2015
Start date October 2008
Est. completion date April 2015

Study information

Verified date April 2015
Source The First People's Hospital of Changzhou
Contact n/a
Is FDA regulated No
Health authority China: Health and Family Planning Commission of Changzhou
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date April 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Computed tomography guided radioactive seeds implant
Computed tomography guided radioactive seeds implant were performed one week before chemotherapy.
Drug:
Systemic chemotherapy (FOLFIRI)
irinotecan 180mg/m2 d1,leucovorin 400mg/m2 d1, 5-fluorouracil 400mg/m2 iv, 2.4g/m2 civ 46h, repeated every 2 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The First People's Hospital of Changzhou

Outcome

Type Measure Description Time frame Safety issue
Primary Progression free survival Progression free survival which is calculated from the start of treatment to disease progression or death One year Yes
Secondary Treatment related adverse events Including chemotherapy related side-effect and brachytherapy related adverse events. Eight weeks Yes
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