Study Stopped
Modifying the clinnicaltrials
Safety and Efficiency of Photodynamic Therapy for Rectal Cancer
PDT-R-01
Longterm Outcome of Photodynamic Therapy Compared With Chemotherapy Alone in Patients With Advanced Rectal Cancer
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2013
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2013
CompletedFirst Posted
Study publicly available on registry
June 7, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedJune 7, 2013
June 1, 2013
2 years
June 5, 2013
June 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival rate
one month
Secondary Outcomes (1)
Progression-free survival
One month
Other Outcomes (1)
Quality of life
one month
Study Arms (2)
Chemotherapy alone
NO INTERVENTIONGroup that be scheduled to undergo chemothrapy only using FOLFOX4 protocol.
PDT and Chemotherapy
EXPERIMENTALGroup that not only be scheduled to undergo chemothrapy using FOLFOX4 protocol,but also receive colonscopy-assisted PDT.
Interventions
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).
Eligibility Criteria
You may qualify if:
- Patients with advanced rectal cancer 2.Patients are willing to join in this clinical trial.
You may not qualify if:
- Patients with advanced rectal cancer can not suffer PDT procedure. 2.Allergy to photosensitizer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- li xionglead
Study Sites (1)
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410016, China
Related Publications (1)
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.
PMID: 20510306RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
June 5, 2013
First Posted
June 7, 2013
Study Start
August 1, 2013
Primary Completion
August 1, 2015
Study Completion
August 1, 2016
Last Updated
June 7, 2013
Record last verified: 2013-06