Skip to content
Triangle logo TriangleGet started
← recurrent Oropharyngeal Cancer

NCT02068157 · STUDY IN CONTEXT

Interstitial Photodynamic Therapy in Treating Patients With Recurrent Head and Neck Cancer

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

All treated and eligible patients

→

secondary · POSTED

SADA activity will be correlated with tumor response according to the guidelines of the revised Response Criteria in Solid Tumors 1.1.

The published assay could not be validated in murine samples. As such, no human samples were analyzed.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-oropharyngeal-cancer-recurrent-f3bd66bf
nct id
NCT02068157
trial label
Interstitial Photodynamic Therapy in Treating Patients With Recurrent Head and Neck Cancer
applicability
unclear
applicability note
Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
2
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT02068157
    outcome key
    om-0000
    source section id
    NCT02068157-om-0000
    source outcome index
    0
    endpoint
    Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1
    endpoint definition
    Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
    time origin
    Up to 12 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated and eligible patients
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT02068157
    outcome key
    om-0001
    source section id
    NCT02068157-om-0001
    source outcome index
    1
    endpoint
    Serum Alkaline DNase (SADA) Activity
    endpoint definition
    SADA activity will be correlated with tumor response according to the guidelines of the revised Response Criteria in Solid Tumors 1.1.
    time origin
    Up to 12 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The published assay could not be validated in murine samples. As such, no human samples were analyzed.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT02068157
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Porfimer Sodium, Image-guided I-PDT)
    regimen
    Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2. Laboratory Biomarker Analysis: Correlative studies Photodynamic Therapy: Undergo image-guided I-PDT Porfimer Sodium: Given IV
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02068157-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT02068157
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Porfimer Sodium, Image-guided I-PDT)
    regimen
    Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2. Laboratory Biomarker Analysis: Correlative studies Photodynamic Therapy: Undergo image-guided I-PDT Porfimer Sodium: Given IV
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02068157-om-0001#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT02068157
    harm key
    EG000
    source section id
    NCT02068157-ae
    event group key
    EG000
    event group label
    Treatment (Porfimer Sodium, Image-guided I-PDT)
    serious affected
    1
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    0
    collection period
    Source null
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice