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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01872104
Recruitment Status : Suspended (Modifying the clinnicaltrials)
First Posted : June 7, 2013
Last Update Posted : June 7, 2013
Sponsor:
Information provided by (Responsible Party):
li xiong, Central South University

Tracking Information
First Submitted Date  ICMJE June 5, 2013
First Posted Date  ICMJE June 7, 2013
Last Update Posted Date June 7, 2013
Study Start Date  ICMJE August 2013
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2013)
Survival rate [ Time Frame: one month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2013)
Progression-free survival [ Time Frame: One month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 5, 2013)
Quality of life [ Time Frame: one month ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Safety and Efficiency of Photodynamic Therapy for Rectal Cancer
Official Title  ICMJE Longterm Outcome of Photodynamic Therapy Compared With Chemotherapy Alone in Patients With Advanced Rectal Cancer
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Rectal Cancer
Intervention  ICMJE 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).
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Photodynamic therapy
Publications * Allison RR, Sheng C, Cuenca R, Bagnato VS, Austerlitz C, Sibata CH. Photodynamic therapy for anal cancer. Photodiagnosis Photodyn Ther. 2010 Jun;7(2):115-9. doi: 10.1016/j.pdpdt.2010.04.002. Epub 2010 May 7. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: June 5, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2016
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01872104
Other Study ID Numbers  ICMJE PDT-R-01
PDT-R-01 ( Other Identifier: Central South University )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party li xiong, Central South University
Study Sponsor  ICMJE li xiong
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Central South University
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP