Advanced Rectal CancerPhase 2/3PDT-R-01NCT01872104
Safety and Efficiency of Photodynamic Therapy for Rectal Cancer
A Phase 2/3 study testing Photodynamic therapy in people with Advanced Rectal Cancer, run by li xiong at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Advanced Rectal Cancer
- What is being tested?
- Photodynamic therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to Aug 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Patients with advanced rectal cancer 2.Patients are willing to join in this clinical trial.
Who cannot join
- 1.Patients with advanced rectal cancer can not suffer PDT procedure. 2.Allergy to photosensitizer
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410016
About this study
Official title: Longterm Outcome of Photodynamic Therapy Compared With Chemotherapy Alone in Patients With Advanced Rectal Cancer
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.
- Conditions
- Advanced Rectal Cancer
- Being tested
- Photodynamic therapy
- Keywords
- rectal cancer, rectal adenocarcinoma, photodynamic therapy, chemothrapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic therapyProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy alone | No intervention | Group that be scheduled to undergo chemothrapy only using FOLFOX4 protocol. |
| PDT and Chemotherapy | Experimental | Group that not only be scheduled to undergo chemothrapy using FOLFOX4 protocol,but also receive colonscopy-assisted PDT. Receives: Procedure: Photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Measured: one month
Secondary outcomes (1)
Progression-free survival
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2015 (estimated)
- Study completionAug 2016 (estimated)
Why it stopped: Modifying the clinnicaltrials
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- li xiong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, li xiong, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872104
- Sponsor's protocol ID
- PDT-R-01
- Other IDs
- PDT-R-01
- Acronym
- PDT-R-01
- Status last verified
- Jun 2013
- First submitted
- 5 Jun 2013
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20510306
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longterm Outcome of Photodynamic Therapy Compared With Chemotherapy Alone in Patients With Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT01872104
- Acronym / sponsor ID
- PDT-R-01 / PDT-R-01
- Conditions
- Advanced Rectal Cancer
- Keywords
- rectal cancer, rectal adenocarcinoma, photodynamic therapy, chemothrapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Modifying the clinnicaltrials
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- li xiongUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy alone | No intervention | –Group that be scheduled to undergo chemothrapy only using FOLFOX4 protocol. |
| PDT and Chemotherapy | Experimental | Procedure: Photodynamic therapyGroup that not only be scheduled to undergo chemothrapy using FOLFOX4 protocol,but also receive colonscopy-assisted PDT. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Patients with advanced rectal cancer 2.Patients are willing to join in this clinical trial.
Key exclusion criteria (1 listed)
- 1.Patients with advanced rectal cancer can not suffer PDT procedure. 2.Allergy to photosensitizer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photodynamic therapyEach 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). | Procedure or surgery | PDT and Chemotherapy |
Primary outcome
Survival rate
Time frame: one month
1 secondary outcome
Progression-free survival
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2013.
- Results publication: PubMed 20510306Allison 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Photodynamic therapy in people with Advanced Rectal Cancer, run by li xiong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 7 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01872104, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2013.