Trial · NCT00453336
Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer, or Other Disease of the Aerodigestive Tract
NCT00453336, Phase 2, Completed, University of Miami; results first posted 2013-10-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer, or Other Disease of the Aerodigestive Tract. Trials, record NCT00453336. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00453336
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer, or Other Disease of the Aerodigestive Tract
- NCT number
- NCT00453336
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- University of Miami
- Conditions
- Head and Neck Cancer, Precancerous/Nonmalignant Condition
- Interventions
- Porfimer Sodium, Photodynamic Therapy
- First posted
- 2007-03-28
- Last updated
- 2017-02-08
- Results first posted
- 2013-10-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment | 6 months | Number of subjects achieving complete response or partial response to study treatment according to RECIST Criteria version 1.0. |
| Primary | Number of Participants Experiencing Adverse Events | 6 months | Number of participants enrolled experiencing serious adverse events and/or other non-serious events |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment | 6 months | participants | NUMBER | |
| PRIMARY | Number of Participants Experiencing Adverse Events | 6 months | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment | Single Arm | 32 | participants | ||
| Number of Participants Experiencing Adverse Events | Single Arm | 36 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Single Arm | 45 | |
| Overall Study | COMPLETED | Single Arm | 45 | |
| Overall Study | NOT COMPLETED | Single Arm | 0 |
Source ClinicalTrials.gov
Adverse events7
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Mild Skin Irritation | Skin and subcutaneous tissue disorders | Single Arm | 8 | 45 | 8 |
| other | Transient second-degree burn on the back of the hand | Injury, poisoning and procedural complications | Single Arm | 1 | 45 | 1 |
| other | Inflammatory Reaction from Extravasation of Porfimer Sodium at the Intravenous Site | Injury, poisoning and procedural complications | Single Arm | 1 | 45 | 1 |
| other | Transient Aspiration | Surgical and medical procedures | Single Arm | 1 | 45 | 1 |
| other | Temporary edema requiring tracheotomy | Infections and infestations | Single Arm | 1 | 45 | 1 |
| serious | Unfortunate Airway Disaster | Respiratory, thoracic and mediastinal disorders | Single Arm | 1 | 45 | 1 |
| serious | Significant Postoperative Pain for Oral Lesions | General disorders | Single Arm | 23 | 45 | 23 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single Arm | ||
| Total, other adverse events | Single Arm | 12 | 45 |
| Total, serious adverse events | Single Arm | 24 | 45 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23055220 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00453336
GET https://conductscience.org/api/trials/v1/NCT00453336/registered