Safety and Efficiency of Photodynamic Therapy for Rectal Cancer (PDT-R-01)

June 5, 2013 updated by: li xiong

Longterm Outcome of Photodynamic Therapy Compared With Chemotherapy Alone in Patients With Advanced Rectal Cancer

This research is a prospective randomized controlled trial.It aimed to determine longterm outcomes and factors associated with increased survival after photodynamic therapy (PDT) through colonscopy compared with chemotherapy alone in patients presenting with advanced rectal cancer.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410016
        • The second Xiangya Hospital of Central South University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1.Patients with advanced rectal cancer 2.Patients are willing to join in this clinical trial.

Exclusion Criteria:

  • 1.Patients with advanced rectal cancer can not suffer PDT procedure. 2.Allergy to photosensitizer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Chemotherapy alone
Group that be scheduled to undergo chemothrapy only using FOLFOX4 protocol.
Experimental: PDT and Chemotherapy
Group that not only be scheduled to undergo chemothrapy using FOLFOX4 protocol,but also receive colonscopy-assisted PDT.
Procedure: Photodynamic therapy
Each patient to whom PDT was offered underwent a specific, detailed educational process by a dedicated team member(P.B., P.J., or K.E.), after which informed consent was obtained.Porfimer sodium (Photofrin; Axcan Pharma Inc, Quebec, Canada)was used as a photo sensitizing agent, administered intravenously at a dose of 2 mg/kg body weight 48 hours before illumination.A diode laser system (InGaAIP Laser Diode; Diomed Inc, An-dover, MA) with a maximum power output of 2000 mW and a wavelength of 633+-3 nm was used as a light source, delivered through a 3.0-m length fiber having a 2.5-cm-long cylindrical diffuser at its distal end (Pioneer Optics, Windsor Locks, CT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival rate
Time Frame: one month
one month

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: One month
One month

Other Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: one month
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

li xiong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

June 5, 2013

First Submitted That Met QC Criteria

June 5, 2013

First Posted (Estimate)

June 7, 2013

Study Record Updates

Last Update Posted (Estimate)

June 7, 2013

Last Update Submitted That Met QC Criteria

June 5, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDT-R-01 (Other Identifier: Central South University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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