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Completed

NCT Number: NCT02423226

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

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.

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Key information

Conditions

Rectum Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computed tomography guided radioactive seeds implant

Procedure

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

Other names: Brachytherapy

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

Other names: FOLFIRI

Primary outcomes

  1. Progression free survival

    Time frame: One year

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

Secondary outcomes

  1. Treatment related adverse events

    Time frame: Eight weeks

    Including chemotherapy related side-effect and brachytherapy related adverse events.

Sponsors and collaborators

Lead sponsor

The First People's Hospital of Changzhou

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2014
Study completion
2015
First posted
Apr 22, 2015
Registry last updated
Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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