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

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Status and phase: Suspended; Phase 3; Phase 2

Conditions: Advanced Rectal Cancer

Treatments: Procedure: Photodynamic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01872104

PDT-R-01 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Chemotherapy alone

No Intervention group

Description:

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

PDT and Chemotherapy

Experimental group

Description:

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

Treatment:

Procedure: Photodynamic therapy