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

Rectum Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02423226
• Other study ID #: CZ-I125-001
• 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

• Rectal Neoplasms
• Rectum Cancer

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