Safety and Efficiency of Photodynamic Therapy for Rectal Cancer (PDT-R-01)
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|ClinicalTrials.gov Identifier: NCT01872104|
Recruitment Status : Suspended (Modifying the clinnicaltrials)
First Posted : June 7, 2013
Last Update Posted : June 7, 2013
|Condition or disease||Intervention/treatment||Phase|
|Advanced Rectal Cancer||Procedure: Photodynamic therapy||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Longterm Outcome of Photodynamic Therapy Compared With Chemotherapy Alone in Patients With Advanced Rectal Cancer|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||August 2016|
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).
- Survival rate [ Time Frame: one month ]
- Progression-free survival [ Time Frame: One month ]
- Quality of life [ Time Frame: one month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872104
|The Second Xiangya Hospital of Central South University|
|Changsha, Hunan, China, 410016|