Trial Outcomes & Findings for Photodynamic Therapy With HPPH Compared to Standard of Care Surgery in Treating Patients With Oral Cavity Cancer (NCT NCT03090412)
NCT ID: NCT03090412
Last Updated: 2022-06-02
Results Overview
Objective tumor response will be tabulated overall.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
At 24 months
Results posted on
2022-06-02
Participant Flow
Participant milestones
| Measure |
Arm I (Surgery)
Patients undergo standard of care surgery on day 1.
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: Undergo standard of care surgery
|
Arm II (HPPH, PDT)
Patients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1.
HPPH: Given IV
Laboratory Biomarker Analysis: Correlative studies
Photodynamic Therapy: Undergo PDT
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Photodynamic Therapy With HPPH Compared to Standard of Care Surgery in Treating Patients With Oral Cavity Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Surgery)
n=1 Participants
Patients undergo standard of care surgery on day 1.
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: Undergo standard of care surgery
|
Arm II (HPPH, PDT)
n=1 Participants
Patients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1.
HPPH: Given IV
Laboratory Biomarker Analysis: Correlative studies
Photodynamic Therapy: Undergo PDT
Quality-of-Life Assessment: Ancillary studies
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Continuous
|
86 years
n=99 Participants
|
55 years
n=107 Participants
|
71 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At 24 monthsPopulation: Due to PI departure and early termination with few patients, only the counts of events have been calculated and no testing was done
Objective tumor response will be tabulated overall.
Outcome measures
| Measure |
Arm I (Surgery)
n=1 Participants
Patients undergo standard of care surgery on day 1.
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: Undergo standard of care surgery
|
Arm II (HPPH, PDT)
n=1 Participants
Patients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1.
HPPH: Given IV
Laboratory Biomarker Analysis: Correlative studies
Photodynamic Therapy: Undergo PDT
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Rate of Tumor Response as Evaluated by Response Evaluation Criteria in Solid Tumors Version 1.1
No evidence of disease
|
1 Participants
|
0 Participants
|
|
Rate of Tumor Response as Evaluated by Response Evaluation Criteria in Solid Tumors Version 1.1
Other
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 24 monthsPopulation: Due to PI departure with few patients, only the counts of events have been calculated and no testing was done..
In the analysis of QoL simple data analyses will initially take place including individual participant-level profile plots and overall mean plots used to examining the mean structure. Formal statistical examination of longitudinal patterns will be done through the use of a mixed model. Once the model is fit, specific linear contrasts based on the estimated model parameters will be constructed and used to test hypotheses concerning between time points and between group comparisons
Outcome measures
| Measure |
Arm I (Surgery)
n=1 Participants
Patients undergo standard of care surgery on day 1.
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: Undergo standard of care surgery
|
Arm II (HPPH, PDT)
n=1 Participants
Patients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1.
HPPH: Given IV
Laboratory Biomarker Analysis: Correlative studies
Photodynamic Therapy: Undergo PDT
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Change in Quality of Life as Measured by the University of Washington Quality of Life Questionnaire Version 4
Outstanding Overall QoL
|
1 Participants
|
0 Participants
|
|
Change in Quality of Life as Measured by the University of Washington Quality of Life Questionnaire Version 4
Very good to Outstanding Overall QoL
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days after administration of HPPHPopulation: Due to PI departure with few patients, only the counts of events have been calculated and no tabulation was done..
The frequency of toxicities will be tabulated by grade.
Outcome measures
| Measure |
Arm I (Surgery)
n=1 Participants
Patients undergo standard of care surgery on day 1.
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: Undergo standard of care surgery
|
Arm II (HPPH, PDT)
n=1 Participants
Patients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1.
HPPH: Given IV
Laboratory Biomarker Analysis: Correlative studies
Photodynamic Therapy: Undergo PDT
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Adverse Events as Graded by CTCAE Version 4.0 Are Reported
|
1 Participants
|
1 Participants
|
Adverse Events
Arm I (Surgery)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm II (HPPH, PDT)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Surgery)
n=1 participants at risk
Patients undergo standard of care surgery on day 1.
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: Undergo standard of care surgery
|
Arm II (HPPH, PDT)
n=1 participants at risk
Patients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1.
HPPH: Given IV
Laboratory Biomarker Analysis: Correlative studies
Photodynamic Therapy: Undergo PDT
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/1 • From administration of study drug or surgery until 30 days after receiving study drug or surgery
|
100.0%
1/1 • Number of events 1 • From administration of study drug or surgery until 30 days after receiving study drug or surgery
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/1 • From administration of study drug or surgery until 30 days after receiving study drug or surgery
|
100.0%
1/1 • Number of events 1 • From administration of study drug or surgery until 30 days after receiving study drug or surgery
|
Other adverse events
| Measure |
Arm I (Surgery)
n=1 participants at risk
Patients undergo standard of care surgery on day 1.
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: Undergo standard of care surgery
|
Arm II (HPPH, PDT)
n=1 participants at risk
Patients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1.
HPPH: Given IV
Laboratory Biomarker Analysis: Correlative studies
Photodynamic Therapy: Undergo PDT
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Gastrointestinal disorders
Odynophagia
|
100.0%
1/1 • Number of events 1 • From administration of study drug or surgery until 30 days after receiving study drug or surgery
|
0.00%
0/1 • From administration of study drug or surgery until 30 days after receiving study drug or surgery
|
|
Gastrointestinal disorders
Tongue coated
|
100.0%
1/1 • Number of events 1 • From administration of study drug or surgery until 30 days after receiving study drug or surgery
|
0.00%
0/1 • From administration of study drug or surgery until 30 days after receiving study drug or surgery
|
|
Gastrointestinal disorders
Tongue exfoliation
|
0.00%
0/1 • From administration of study drug or surgery until 30 days after receiving study drug or surgery
|
100.0%
1/1 • Number of events 1 • From administration of study drug or surgery until 30 days after receiving study drug or surgery
|
|
Gastrointestinal disorders
Tongue oedema
|
0.00%
0/1 • From administration of study drug or surgery until 30 days after receiving study drug or surgery
|
100.0%
1/1 • Number of events 1 • From administration of study drug or surgery until 30 days after receiving study drug or surgery
|
|
General disorders
Face oedema
|
0.00%
0/1 • From administration of study drug or surgery until 30 days after receiving study drug or surgery
|
100.0%
1/1 • Number of events 1 • From administration of study drug or surgery until 30 days after receiving study drug or surgery
|
|
Injury, poisoning and procedural complications
Incision site pain
|
100.0%
1/1 • Number of events 2 • From administration of study drug or surgery until 30 days after receiving study drug or surgery
|
0.00%
0/1 • From administration of study drug or surgery until 30 days after receiving study drug or surgery
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/1 • From administration of study drug or surgery until 30 days after receiving study drug or surgery
|
100.0%
1/1 • Number of events 1 • From administration of study drug or surgery until 30 days after receiving study drug or surgery
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/1 • From administration of study drug or surgery until 30 days after receiving study drug or surgery
|
100.0%
1/1 • Number of events 1 • From administration of study drug or surgery until 30 days after receiving study drug or surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place