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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
Sponsor:
Information provided by (Responsible Party):
li xiong, Central South University

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.

Condition or disease Intervention/treatment Phase
Advanced Rectal Cancer Procedure: Photodynamic therapy Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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).




Primary Outcome Measures :
  1. Survival rate [ Time Frame: one month ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: One month ]

Other Outcome Measures:
  1. Quality of life [ Time Frame: one month ]


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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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China, Hunan
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410016
Sponsors and Collaborators
li xiong

Publications of Results:
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Responsible Party: li xiong, Doctor, Central South University
ClinicalTrials.gov Identifier: NCT01872104     History of Changes
Other Study ID Numbers: PDT-R-01
PDT-R-01 ( Other Identifier: Central South University )
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: June 7, 2013
Last Verified: June 2013

Keywords provided by li xiong, Central South University:
rectal cancer
rectal adenocarcinoma
photodynamic therapy
chemothrapy

Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases