A Single-arm Phase II Study of Post-Transoral Robotic Surgery (TORS) Alone to the Primary Tumor Site and Selective Neck Dissection (SND) Followed by Adjuvant Radiation Therapy (+/- Chemotherapy) to the Regional Nodes for Advanced Stage, Human Papilloma Virus (HPV) Positive, Oropharyngeal Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single Arm Phase 2
|
Procedure: TORS
Radiation: Adjuvant Radiation Therapy
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Local Control [2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients 18 years or older Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, stage IVa, p16-positive on immunohistochemistry Pathologic T1 or T2 disease, resected with negative margins ( 2mm) Pathologic N2a, N2b, or N2c disease ECOG Performance Status 0-1
-
Patients must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits - - - Ability to understand and the willingness to provide written informed consent
Exclusion Criteria
-
Prior radiation therapy to the head and neck Prior chemotherapy within the past 5 years Presence of T3 or T4 disease Presence of close (2 mm) or positive margins PNI on TORS resection of the primary cancer Presence of N0 or N1 disease in neck dissection Presence of distant metastatic (M1) disease
-
Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, connective tissue disease or psychiatric illness/social situations that would limit compliance with study requirements.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Abramson Cancer Center of the University of Pennsylvania
Investigators
- Principal Investigator: Alexander Lin, MD, Abramson Cancer Center of the University of Pennsylvania
Study Documents (Full-Text)
More Information
Publications
None provided.- UPCC 40313
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Single Arm Phase 2 |
|---|---|
| Arm/Group Description | Post-Transoral Robotic Surgery (TORS) Alone to the Primary Tumor Site and Selective Neck Dissection (SND) Followed by Adjuvant Radiation Therapy (+/- Chemotherapy) |
| Period Title: Overall Study | |
| STARTED | 60 |
| COMPLETED | 60 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Single Arm Phase 2 |
|---|---|
| Arm/Group Description | TORS Adjuvant Radiation Therapy |
| Overall Participants | 60 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
45
75%
|
| >=65 years |
15
25%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
58.51
(9.83)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
10
16.7%
|
| Male |
50
83.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
0
0%
|
| Not Hispanic or Latino |
60
100%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
1
1.7%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
1
1.7%
|
| White |
58
96.7%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
60
100%
|
Outcome Measures
| Title | Percentage of Participants With Local Control |
|---|---|
| Description | |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Arm Phase 2 |
|---|---|
| Arm/Group Description | TORS Adjuvant Radiation Therapy |
| Measure Participants | 60 |
| Number (95% Confidence Interval) [percentage of patients] |
97.9
|
Adverse Events
| Time Frame | 2 years | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Single Arm Phase 2 | |
| Arm/Group Description | TORS Adjuvant Radiation Therapy | |
All Cause Mortality |
||
| Single Arm Phase 2 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/60 (0%) | |
Serious Adverse Events |
||
| Single Arm Phase 2 | ||
| Affected / at Risk (%) | # Events | |
| Total | 18/60 (30%) | |
| Gastrointestinal disorders | ||
| Dysphagia | 2/60 (3.3%) | 2 |
| Esophageal pain | 1/60 (1.7%) | 1 |
| Other Gastrointestinal disorders | 1/60 (1.7%) | 1 |
| Mucositis oral | 3/60 (5%) | 3 |
| Injury, poisoning and procedural complications | ||
| Dermatitis radiation | 8/60 (13.3%) | 8 |
| Respiratory, thoracic and mediastinal disorders | ||
| Aspiration | 2/60 (3.3%) | 2 |
| Hypoxia | 1/60 (1.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Single Arm Phase 2 | ||
| Affected / at Risk (%) | # Events | |
| Total | 43/60 (71.7%) | |
| Ear and labyrinth disorders | ||
| Other Ear and labyrinth disorders | 1/60 (1.7%) | 1 |
| Endocrine disorders | ||
| Hypothyroidism | 4/60 (6.7%) | 4 |
| Gastrointestinal disorders | ||
| Constipation | 1/60 (1.7%) | 1 |
| Dry Mouth | 33/60 (55%) | 44 |
| Dysphagia | 23/60 (38.3%) | 36 |
| Esophageal pain | 12/60 (20%) | 17 |
| Other Gastrointestinal disorders | 3/60 (5%) | 3 |
| Lip pain | 1/60 (1.7%) | 1 |
| Mucositis oral | 18/60 (30%) | 24 |
| Nausea | 3/60 (5%) | 3 |
| Oral pain | 2/60 (3.3%) | 2 |
| Salivary duct inflammation | 28/60 (46.7%) | 38 |
| Vomiting | 1/60 (1.7%) | 1 |
| General disorders | ||
| Edema face | 2/60 (3.3%) | 2 |
| Fatigue | 26/60 (43.3%) | 34 |
| Other General disorders and administration site conditions | 1/60 (1.7%) | 1 |
| Neck edema | 4/60 (6.7%) | 4 |
| Pain | 2/60 (3.3%) | 2 |
| Infections and infestations | ||
| Mucosal infection | 11/60 (18.3%) | 25 |
| Injury, poisoning and procedural complications | ||
| Dermatitits radiation | 39/60 (65%) | 79 |
| Investigations | ||
| Weight loss | 3/60 (5%) | 3 |
| Metabolism and nutrition disorders | ||
| Anorexia | 19/60 (31.7%) | 28 |
| Dehydration | 3/60 (5%) | 3 |
| Musculoskeletal and connective tissue disorders | ||
| Other Musculoskeletal and connective tissue disorder | 2/60 (3.3%) | 2 |
| Superficial soft tissue fibrosis | 11/60 (18.3%) | 11 |
| Trismus | 2/60 (3.3%) | 2 |
| Nervous system disorders | ||
| Dizziness | 1/60 (1.7%) | 1 |
| Dysgeusia | 40/60 (66.7%) | 73 |
| Other Nervous system disorders | 1/60 (1.7%) | 1 |
| Psychiatric disorders | ||
| Anxiety | 1/60 (1.7%) | 1 |
| Depression | 2/60 (3.3%) | 2 |
| Respiratory, thoracic and mediastinal disorders | ||
| Aspiration | 4/60 (6.7%) | 5 |
| Hoarseness | 3/60 (5%) | 3 |
| Laryngeal edema | 2/60 (3.3%) | 2 |
| Sore throat | 7/60 (11.7%) | 7 |
| Voice alteration | 18/60 (30%) | 22 |
| Skin and subcutaneous tissue disorders | ||
| Alopecia | 18/60 (30%) | 18 |
| Vascular disorders | ||
| Lymphedema | 20/60 (33.3%) | 24 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Alexander Lin, MD |
|---|---|
| Organization | University of Pennsylvania |
| Phone | (215) 662-3198 |
| alexander.lin@uphs.upenn.edu |
- UPCC 40313