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

NCT02423226 | Completed Phase 2

• 1 other identifier: CZ-I125-001
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rectum Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Progression free survival which is calculated from the start of treatment to disease progression or death

  One year

Secondary Outcomes (1)

• Treatment related adverse events

  Eight weeks

Study Arms (2)

CT alone

ACTIVE COMPARATOR

Treated with systemic chemotherapy alone (FOLFIRI).

Drug: Systemic chemotherapy (FOLFIRI)

CT+BT

EXPERIMENTAL

Treated with systemic chemotherapy (FOLFIRI) plus computed tomography guided radioactive seeds implant.

Procedure: Computed tomography guided radioactive seeds implant; Drug: Systemic chemotherapy (FOLFIRI)

Interventions

Computed tomography guided radioactive seeds implant PROCEDURE

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

Also known as: Brachytherapy

CT+BT

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

Also known as: FOLFIRI

CT alone; CT+BT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First People's Hospital of Changzhou: lead

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Brachytherapy; IFL protocol

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Changping Wu, M.D.

  The First People's Hospital of Changzhou

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Science and Education Division

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: April 22, 2015
• Study Start: October 1, 2008
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2015
• Last Updated: April 22, 2015

Record last verified: 2015-04