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

Primary Purpose

Advanced Rectal Cancer

Status
Suspended
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Photodynamic therapy
Sponsored by
li xiong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Rectal Cancer focused on measuring rectal cancer, rectal adenocarcinoma, photodynamic therapy, chemothrapy

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Second Xiangya Hospital of Central South University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Chemotherapy alone

PDT and Chemotherapy

Arm Description

Group that be scheduled to undergo chemothrapy only using FOLFOX4 protocol.

Group that not only be scheduled to undergo chemothrapy using FOLFOX4 protocol,but also receive colonscopy-assisted PDT.

Outcomes

Primary Outcome Measures

Survival rate

Secondary Outcome Measures

Progression-free survival

Full Information

First Posted
June 5, 2013
Last Updated
June 5, 2013
Sponsor
li xiong
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1. Study Identification

Unique Protocol Identification Number
NCT01872104
Brief Title
Safety and Efficiency of Photodynamic Therapy for Rectal Cancer
Acronym
PDT-R-01
Official Title
Longterm Outcome of Photodynamic Therapy Compared With Chemotherapy Alone in Patients With Advanced Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Suspended
Why Stopped
Modifying the clinnicaltrials
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
li xiong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Rectal Cancer
Keywords
rectal cancer, rectal adenocarcinoma, photodynamic therapy, chemothrapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy alone
Arm Type
No Intervention
Arm Description
Group that be scheduled to undergo chemothrapy only using FOLFOX4 protocol.
Arm Title
PDT and Chemotherapy
Arm Type
Experimental
Arm Description
Group that not only be scheduled to undergo chemothrapy using FOLFOX4 protocol,but also receive colonscopy-assisted PDT.
Intervention Type
Procedure
Intervention Name(s)
Photodynamic therapy
Intervention Description
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 Measure Information:
Title
Survival rate
Time Frame
one month
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
One month
Other Pre-specified Outcome Measures:
Title
Quality of life
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410016
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
20510306
Citation
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.
Results Reference
result

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Safety and Efficiency of Photodynamic Therapy for Rectal Cancer

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