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

Sponsor

li xiong (Other)

Overall Status

Suspended

CT.gov ID

NCT01872104

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Rectal Cancer	Procedure: Photodynamic therapy	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated 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 :

Aug 1, 2013

Anticipated Primary Completion Date :

Aug 1, 2015

Anticipated Study Completion Date :

Aug 1, 2016

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Survival rate [one month]

Secondary Outcome Measures

Progression-free survival [One month]

Other Outcome Measures

Quality of life [one month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Xiangya Hospital of Central South University	Changsha	Hunan	China	410016

Sponsors and Collaborators

li xiong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

li xiong, Doctor, Central South University

ClinicalTrials.gov Identifier:

NCT01872104

Other Study ID Numbers:

PDT-R-01
PDT-R-01

First Posted:

Jun 7, 2013

Last Update Posted:

Jun 7, 2013

Last Verified:

Jun 1, 2013

Keywords provided by li xiong, Doctor, Central South University

rectal cancer

rectal adenocarcinoma

photodynamic therapy

chemothrapy

Additional relevant MeSH terms:

Rectal Neoplasms

Study Results

No Results Posted as of Jun 7, 2013