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NCT01872104 Clinical Trial

Safety and Efficiency of Photodynamic Therapy for Rectal Cancer

Advanced Rectal Cancer Clinical Trial

— PDT-R-01  

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

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT01872104
Other study ID # PDT-R-01
Secondary ID PDT-R-01
Status Suspended
Phase Phase 2/Phase 3
First received June 5, 2013
Last updated June 5, 2013
Start date August 2013
Est. completion date August 2016

Study information
Verified date June 2013
Source Central South University
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Suspended
Enrollment 100
Est. completion date August 2016
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
China The Second Xiangya Hospital of Central South University Changsha Hunan

Sponsors (1)
Lead Sponsor Collaborator
li xiong

Country where clinical trial is conducted

China, 

References & 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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other Quality of life one month No
Primary Survival rate one month No
Secondary Progression-free survival One month No
See also
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Active, not recruiting NCT03781323 - Neoadjuvant FOLFOX Therapy With Short Course Radiation and Active Surveillance in Locally Advanced Rectal Cancer Phase 2
Recruiting NCT05228431 - Modified Sandwich Therapeutic Regimen for Locally Advanced Rectal Cancer Phase 2
Active, not recruiting NCT02031939 - Randomized Controlled Study on Optimize Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer Phase 3
Not yet recruiting NCT05359406 - A Combination Therapy Including Anti-PD-1 Immunotherapy in Rectal Cancer With Refractory Distal Metastasis Phase 2
Not yet recruiting NCT05359393 - A Combination Therapy Including Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Distal Metastasis Phase 2

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