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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02423226

Enrollment

Registered

2015-04-22

Start date

2008-10-31

Completion date

2015-04-30

Last updated

2015-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectum Cancer

Brief 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.

Detailed 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.

Interventions

PROCEDUREComputed tomography guided radioactive seeds implant

Computed tomography guided radioactive seeds implant were performed one week before chemotherapy.

DRUGSystemic chemotherapy (FOLFIRI)

irinotecan 180mg/m2 d1,leucovorin 400mg/m2 d1, 5-fluorouracil 400mg/m2 iv, 2.4g/m2 civ 46h, repeated every 2 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Progression free survival	One year	Progression free survival which is calculated from the start of treatment to disease progression or death

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026