Trial · NCT00530088
Photodynamic Therapy Using Porfimer Sodium in Treating Patients With Recurrent Mouth or Throat Dysplasia or Recurrent In Situ Cancer or Stage I Cancer of the Mouth or Throat
NCT00530088, Not applicable, Terminated, Roswell Park Cancer Institute; results first posted 2014-07-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Photodynamic Therapy Using Porfimer Sodium in Treating Patients With Recurrent Mouth or Throat Dysplasia or Recurrent In Situ Cancer or Stage I Cancer of the Mouth or Throat. Trials, record NCT00530088. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00530088
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Photodynamic Therapy Using Porfimer Sodium in Treating Patients With Recurrent Mouth or Throat Dysplasia or Recurrent In Situ Cancer or Stage I Cancer of the Mouth or Throat
- NCT number
- NCT00530088
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 30 participants, actual
- Lead sponsor
- Roswell Park Cancer Institute
- Conditions
- Head and Neck Cancer
- Interventions
- porfimer sodium, Photdynamic Therapy (PDT)
- First posted
- 2007-09-17
- Last updated
- 2014-07-04
- Results first posted
- 2014-07-04
- Limitations and caveats
- Due to the study's early termination, as a result of new competing studies, target accrual was not reached.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response | 2 years | Response Rate 9.0 TUMOR RESPONSE 9.1 Tumor response will be evaluated at each follow-up visit. 9.2 Objective Tumor Response 9.21 Complete Response - CR1 Complete absence of visible lesion and negative biopsy. CR2 Complete absence of visible lesions without biopsy. 9.22 Partial Response. Reduction in the lesion size by 50% or more in the maximum size of the initial lesion or reduction in grade of lesion, e.g. severe -\> mild dysplasia. Patients that have any physical evidence of residual leukoplakia or erythroplasia will require biopsy. 9.23 No Response. All responses less than a Partial Response are considered as No Response. 9.24 Progressive Disease. Any increase in size of the treated lesion or an increase in grade of the treated lesion, i.e. mild to severe dysplasia. |
| Primary | Local Toxicity | 30 days | Number of patients with an adverse event |
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 | Response | 2 years | All treated and eligible patients | percentage of participants | NUMBER |
| PRIMARY | Local Toxicity | 30 days | All treated and eligible patients | 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 |
|---|---|---|---|---|---|
| Response | Porfimer Sodium | 3.5 | 95% Confidence Interval 0 to 10 | percentage of participants | |
| Local Toxicity | Porfimer Sodium | 29 | 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 | Porfimer Sodium | 30 | |
| Overall Study | COMPLETED | Porfimer Sodium | 20 | |
| Overall Study | NOT COMPLETED | Porfimer Sodium | 10 |
Source ClinicalTrials.gov
Adverse events32
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 | Cheilitis | Gastrointestinal disorders | Porfimer Sodium | 1 | 30 | 1 |
| other | Constipation | Gastrointestinal disorders | Porfimer Sodium | 2 | 30 | 2 |
| other | Dysphagia | Gastrointestinal disorders | Porfimer Sodium | 1 | 30 | 1 |
| other | Lip oedema | Gastrointestinal disorders | Porfimer Sodium | 1 | 30 | 1 |
| other | Odynophagia | Gastrointestinal disorders | Porfimer Sodium | 2 | 30 | 2 |
| other | Oedema mouth | Gastrointestinal disorders | Porfimer Sodium | 2 | 30 | 2 |
| other | Oral pain | Gastrointestinal disorders | Porfimer Sodium | 4 | 30 | 5 |
| other | Oral pruritus | Gastrointestinal disorders | Porfimer Sodium | 1 | 30 | 1 |
| other | Face oedema | General disorders | Porfimer Sodium | 2 | 30 | 2 |
| other | Oedema | General disorders | Porfimer Sodium | 14 | 30 | 15 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Porfimer Sodium | ||
| Total, other adverse events | Porfimer Sodium | 29 | 30 |
| Total, serious adverse events | Porfimer Sodium | 3 | 30 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19687399 | 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/NCT00530088
GET https://conductscience.org/api/trials/v1/NCT00530088/events?page=2