A Phase 2 interventional study of TORS and Adjuvant Radiation Therapy in Oropharyngeal Cancer, sponsored by Abramson Cancer Center at Penn Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-21.
Sponsored by Abramson Cancer Center at Penn Medicine · Phase 2, Interventional, and Diagnostic
To determine 2-year local (primary tumor site) control and toxicity rates in patients receiving adjuvant RT post-TORS, omitting the primary tumor bed, in patients with completely resected, HPV-positive SCCA of the oropharynx.
To determine acute and long-term toxicity rates in patients receiving adjuvant RT post-TORS, omitting the primary tumor bed, in patients with completely resected, HPV-positive SCCA of the oropharynx.
234 studies on the registry are indexed under Papilloma; 28 are open to participants now.
This study's enrollment of 60 is below the median of 100 across 159 interventional studies indexed under Papilloma.
Browse Papilloma studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Procedure: TORS · Radiation: Adjuvant Radiation Therapy
Percentage of Participants With Local Control
Time frame: 2 years
| Milestone | Single Arm Phase 2 |
|---|---|
| Started | 60 |
| Completed | 60 |
| Not completed | 0 |
| percentage of patients | Single Arm Phase 2 |
|---|---|
| Percentage of Participants With Local Control | 97.9 (86.1 to 99.7) |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Arm Phase 2 | 0/60 (0%) | 18/60 (30%) | 43/60 (71.7%) |
| Event | Single Arm Phase 2 |
|---|---|
| Dermatitis radiationInjury, poisoning and procedural complications | 8/60 |
| Mucositis oralGastrointestinal disorders | 3/60 |
| AspirationRespiratory, thoracic and mediastinal disorders | 2/60 |
| DysphagiaGastrointestinal disorders | 2/60 |
| Esophageal painGastrointestinal disorders | 1/60 |
| Other Gastrointestinal disordersGastrointestinal disorders | 1/60 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 1/60 |
| Event | Single Arm Phase 2 |
|---|---|
| DysgeusiaNervous system disorders | 40/60 |
| Dermatitits radiationInjury, poisoning and procedural complications | 39/60 |
| Dry MouthGastrointestinal disorders | 33/60 |
| Salivary duct inflammationGastrointestinal disorders | 28/60 |
| FatigueGeneral disorders | 26/60 |
| DysphagiaGastrointestinal disorders | 23/60 |
| LymphedemaVascular disorders | 20/60 |
| AnorexiaMetabolism and nutrition disorders | 19/60 |
| AlopeciaSkin and subcutaneous tissue disorders | 18/60 |
| Mucositis oralGastrointestinal disorders | 18/60 |
| Age, Categorical(Participants) | Single Arm Phase 2 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 45 |
| >=65 years | 15 |
| Age, Continuous(years) | Single Arm Phase 2 |
|---|---|
| Mean | 58.51 ± 9.83 |
| Sex: Female, Male(Participants) | Single Arm Phase 2 |
|---|---|
| Female | 10 |
| Male | 50 |
| Ethnicity (NIH/OMB)(Participants) | Single Arm Phase 2 |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 60 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Single Arm Phase 2 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 58 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Single Arm Phase 2 |
|---|---|
| United States | 60 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Abramson Cancer Center at Penn Medicine