Back to resultsTransoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer
Primary Purpose
Oropharynx Cancer
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
therapeutic conventional surgery
laboratory biomarker analysis
quality-of-life assessment
intensity-modulated radiation therapy
Cisplatin
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Oropharynx Cancer focused on measuring Papillomavirus Infections, Carcinoma, Squamous Cell, Oropharyngeal Neoplasms, Papilloma, Neoplasms, Glandular and Epithelial, Pharyngeal Neoplasms, Otorhinolaryngologic Neoplasms, Head and Neck Neoplasms, Pharyngeal Diseases, Stomatognathic Diseases, Otorhinolaryngologic Diseases, DNA Virus Infections, Tumor Virus Infections, Antineoplastic Agents, Intensity Modulated Radiotherapy, Carboplatin, Cisplatin, Transoral Surgery
Eligibility Criteria
Inclusion Criteria:
- ECOG performance status of 0 or 1 or Karnofsky score 80-100.
- Newly diagnosed, histologically or cytologically confirmed SCC or undifferentiated carcinoma of the oropharynx and resectable oropharyngeal disease.
- American Joint Committee on Cancer (AJCC, 7th edition (used as a direct comparison to ECOG 3311)) TNM tumor stage III, IV a, or IV b (with no evidence of distant metastases) as determined by imaging studies (performed ≤ 30 days before surgery) and complete neck exam, from the skull base to the clavicles.
- Biopsy-proven p16+ oropharynx cancer; the histologic evidence of invasive squamous cell carcinoma may have been obtained from the primary tumor or metastatic lymph node.
- Carcinoma of the oropharynx associated with HPV as determined by p16 protein expression using immunohistochemistry (IHC) performed by a CLIA approved laboratory.
- No prior radiation above the clavicles.
- Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix, melanoma in-situ (if fully resected), and/or non-melanomatous skin cancer.
- Patients with congestive heart failure > NYHA Class II, CVA/TIA, unstable angina, or myocardial infarction within the last 6 months prior to registration must be evaluated by a cardiologist and/or neurologist.
- Acceptable renal and hepatic function within 4 weeks prior to registration as predefined.
Exclusion Criteria:
- No evidence of extensive or "matted/fixed" pathologic adenopathy on preoperative imaging.
- Women must not be pregnant or breast-feeding due to the teratogenicity of chemotherapy.
- No intercurrent illness likely to interfere with protocol therapy or prevent surgical resection.
- No uncontrolled diabetes, infection despite antibiotics, or hypertension within 30 days prior to registration.
Sites / Locations
- UPMC Hillman Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm S (Low Risk)
Arm RT (Intermediate Risk)
Arm CRT (High Risk)
Arm Description
Low risk patients are defined as T1-T2 AND 0 or 1 metastatic lymph nodes AND <3 cm AND clear (≥3mm) margins AND no extracapsular extension (ECE) AND no perineural invasion AND no lymphovascular invasion. Patients will undergo transoral surgical resection of the oropharyngeal tumor.
Intermediate risk patients are defined as having any of the following features: One or more close (<3mm) margins, OR "minimal" ≤1 mm ECE OR 1 or more metastatic lymph nodes >3 cm in diameter OR 2-4 lymph nodes positive (≤ 6 cm in diameter), OR perineural invasion OR lymphovascular invasion Patients will undergo transoral surgical resection of the oropharyngeal tumor. Following surgery, patients will receive low-dose IMRT five times a week for 3 weeks.
High risk patients are defined as having any of the following features: One or more positive margins OR >1 mm ECE OR ≥ 5 metastatic lymph nodes. Patients will undergo transoral surgical resection of the oropharyngeal tumor. Following surgery, patients will receive low-dose IMRT six times a week and a weekly chemotherapy infusion (cisplatin or carboplatin) during radiation therapy. Patients will receive 2 Gy/fraction, 6 fractions per week with at least a 6-hour interfraction interval between each treatment: PTV-P50 or PTV-N50: 50 Gy in 25 fractions (2 Gy/fx) PTV-N45: 45 Gy in 25 fractions (1.8 Gy/fx) with simultaneous integrated boost to the PTV-P50 volume. PTV-P30 or PTV-N30: 30 Gy in 15 fractions (2 Gy/fx)
Outcomes
Primary Outcome Measures
Recurrence-Free Survival (RFS)
Time to recurrence, defined as local and/or regional progression (identification of disease growth that is present within the area in which it was first located) and/or distant metastasis (identification of disease growth that is present in area(s) distant to that previously located). Local progression is defined as progression at the primary tumor site. Regional progression is defined as progression in the draining lymphatics (typically the cervical, retropharyngeal/retrostyloid and supraclavicular lymph nodes). Distant progression is defined as tumor recurrence in one or more non-local and non-regional sites (e.g., bone, lung, liver, etc.). Recurrent malignancy will be determined based on clinical exam and imaging findings. Patients who are disease-free but who die from other causes will be censored.
Secondary Outcome Measures
Loco-regional control (at 1 year)
Loco-regional control will be evaluated based on the percentage of patients without recurrence (identification of disease growth) in the primary site or regional lymphatics based on imaging and/or clinical exam.
Loco-regional control (at 2 years)
Loco-regional control will be evaluated based on the percentage of patients without recurrence (identification of disease growth) in the primary site or regional lymphatics based on imaging and/or clinical exam.
Time to distant metastasis (at 1 year)
Percentage of patients with distant metastasis (identification of disease growth that is present in area(s) distant to that previously located) evident on imaging and/or clinical exam. Distant metastasis is defined as tumor recurrence in one or more non-local (at the primary tumor) and non-regional (draining lymphatic) sites such as bone, lung, liver, etc.
Time to distant metastasis (at 2 years)
Percentage of patients with distant metastasis (identification of disease growth that is present in area(s) distant to that previously located) evident on imaging and/or clinical exam. Distant metastasis is defined as tumor recurrence in one or more non-local (at the primary tumor) and non-regional (draining lymphatic) sites such as bone, lung, liver, etc.
Overall survival at 1 year
Overall survival will be measured as the time from start of treatment to death from any cause.
Overall survival at 2 years
Overall survival will be measured as the time from start of treatment to death from any cause.
Distribution of patients based on histologic risk features
The percentage of total patients enrolled in the study allocated to low (Arm S), intermediate (Arm RT) and high risk (Arm CRT) groups. Histologic risk features are defined as follows: Low risk (ARM S) - T1-T2 AND 0 or 1 metastatic lymph nodes AND <3 cm AND clear (≥3mm) margins AND no extracapsular extension (ECE) AND no perineural invasion AND no lymphovascular invasion; Intermediate risk (ARM RT) - Any of the following features: One or more close (<3mm) margins, OR "minimal" ≤1 mm ECE OR 1 or more metastatic lymph nodes >3 cm in diameter OR 2-4 lymph nodes positive (≤ 6 cm in diameter), OR perineural invasion OR lymphovascular invasion; High risk (ARM CRT) - Any of the following features: One or more positive margins OR >1 mm ECE OR ≥ 5 metastatic lymph nodes.
Assessment of PEG tube dependence
The percentage of patients that have a feeding tube, by Arm, for the low (Arm S), intermediate (Arm RT) and high risk (Arm CRT) groups following treatment with transoral resection and adjuvant therapy.
Adverse Events Related to Treatment
Number of patients experiencing toxicities related to study treatment per Common Terminology Criteria for Adverse Events (CTCAE v5.0) determined at each follow-up summarized by frequency and grade.
Quality of Life via FACT-HN
FACT-HN is a self-administered questionnaire. Item responses are on a Likert scale score ranging from 0 to 4. Individual responses are summed to compute subscale scores, and the subscales to compute overall total scores. FACT-HN includes 2 parts - FACT-G and FACT-HN. The basic FACT-G (general) is comprised of 27 items, with four subscales including Physical Well-Being (score = 0-28), Social/Family Well-Being (score= 0-28), Emotional Well-Being (score = 0-24), and Functional Well-Being, (score = 0-28), for a total score min/max = 0-108. The FACT-HN is comprised of 12 head and neck specific items (0-48). Thus, the overall total possible score range is 0-156. Analysis will include the FACT Head & Neck Trial Outcome Index, a composite score which includes only physical, functional, and FACT-HN, thus, scores range from 0-104. Higher scores indicate better Quality of Life.
MD Anderson Symptom Inventory-Head & Neck (MDASI-HN)
Patient-reported swallowing perception and performance using MDASI-HN measures treatment related symptom burden in head and neck cancer patients. The 20-item MDASI measures both severity and burden of symptoms and their effect on patients' daily activities, using a numeric rating scale of 0-10. This instrument includes 13 core symptoms and 9 head and neck specific items. Higher scores indicate superior perception of function.
Modified Barium Swallow (MBS) rating
Three swallowing outcomes will be rated by the SLP conducting the MBS study and reported by research staff: 1) laryngeal penetration (yes, no); 2) aspiration (no, sensate, silent), and 3) pharyngeal residue (no, < 50%, > 50%). These have been selected as universal items generally reported by swallowing clinicians that have been shown to significantly predict pneumonia in patients with oropharyngeal cancers. Prevalence of these dysphagia endpoints will be estimated at each time point.
Voice outcomes
Patient-reported voice outcomes will be assessed using the Voice Handicap Index-10 (VHI-10) survey. The VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from "never" to "always"). "Always" response is scored 4 points, a "Never" response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. The patient's values are compared to published norms.
Performance Status Scale (PSS-HN)
The Performance Status Scale (PSS-HN) is a clinician-rated instrument consisting of 3 questions: normalcy of diet, public eating/swallowing, and understandability of speech subscales in patients with head and neck cancer. Each subscale is rated from 0 to 100, with higher scores indicating better performance.
MD Anderson Dysphagia Inventory (MDADI)
Patient-reported swallowing-related quality of life will be measured using the MD Anderson Dysphagia Inventory (MDADI). It evaluates the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. The MDADI is a 20-item questionnaire in which the patient circles the response that best reflects their experience in the past week on a 5-point Likert Scale with answers ranging from "Strongly Agree" (scored as 1 point on all questions except E7 and F2, where it is scored as 5 points) to "Strongly Disagree" (scored as 5 points on all questions except E7 and F2, where it is scored as 1 point). Scores for individual questions are summed and averaged to obtain a composite score ranging from 20 (extremely low swallow functioning) to 100 (high swallow functioning).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05388773
Brief Title
Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer
Official Title
Phase II Trial of Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2022 (Actual)
Primary Completion Date
June 2028 (Anticipated)
Study Completion Date
June 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Heath Skinner
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a trial studying patients with human papilloma virus (HPV) positive oropharyngeal cancer with tumors that can be removed via transoral surgery. Following surgery, patients will be classified as either low, intermediate, or high risk based on the characteristics of the tumors. Low risk patients (Arm S) will receive no further treatment after surgery. Intermediate risk patients (Arm RT) will be treated with Intensity Modulated Radiotherapy (IMRT) after surgery. High risk patients (Arm CRT) will receive a combination of IMRT and chemotherapy after surgery. Patients will be followed for up to five years after the completion of treatment.
Detailed Description
This phase II trial is designed to rationally de-escalate adjuvant (Intensity Modulated Radiotherapy (IMRT) in the post-transoral surgery (TOS) setting in a study population consisting of patients with resectable oropharynx carcinoma, p16+ as confirmed by immunohistochemistry IHC, with a performance status (PS) of 0-1. Patients will be classified into one of three category/treatment groups (low-, intermediate-, and high-risk) according to their highest pathologically risk feature. Radiation will be given via an IMRT technique. For the high-risk patient group, a reduced, but slightly accelerated radiotherapy (RT) fractionation regimen of 50 Gy (HCC 18-034) in conjunction with cisplatin will be used compared to the standard 66 Gy and cisplatin. Low risk patients will transition to observation, intermediate risk patients will receive 30 Gy in 15 fractions of IMRT, and high risk patients will receive 50 Gy in 25 fractions (one day a week will include two treatments) plus 40 mg/m2 Cisplatin for 5 weeks. Patients who are not able to tolerate cisplatin will receive carboplatin instead.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharynx Cancer
Keywords
Papillomavirus Infections, Carcinoma, Squamous Cell, Oropharyngeal Neoplasms, Papilloma, Neoplasms, Glandular and Epithelial, Pharyngeal Neoplasms, Otorhinolaryngologic Neoplasms, Head and Neck Neoplasms, Pharyngeal Diseases, Stomatognathic Diseases, Otorhinolaryngologic Diseases, DNA Virus Infections, Tumor Virus Infections, Antineoplastic Agents, Intensity Modulated Radiotherapy, Carboplatin, Cisplatin, Transoral Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm S (Low Risk)
Arm Type
Experimental
Arm Description
Low risk patients are defined as T1-T2 AND 0 or 1 metastatic lymph nodes AND <3 cm AND clear (≥3mm) margins AND no extracapsular extension (ECE) AND no perineural invasion AND no lymphovascular invasion.
Patients will undergo transoral surgical resection of the oropharyngeal tumor.
Arm Title
Arm RT (Intermediate Risk)
Arm Type
Experimental
Arm Description
Intermediate risk patients are defined as having any of the following features: One or more close (<3mm) margins, OR "minimal" ≤1 mm ECE OR 1 or more metastatic lymph nodes >3 cm in diameter OR 2-4 lymph nodes positive (≤ 6 cm in diameter), OR perineural invasion OR lymphovascular invasion
Patients will undergo transoral surgical resection of the oropharyngeal tumor. Following surgery, patients will receive low-dose IMRT five times a week for 3 weeks.
Arm Title
Arm CRT (High Risk)
Arm Type
Experimental
Arm Description
High risk patients are defined as having any of the following features: One or more positive margins OR >1 mm ECE OR ≥ 5 metastatic lymph nodes.
Patients will undergo transoral surgical resection of the oropharyngeal tumor. Following surgery, patients will receive low-dose IMRT six times a week and a weekly chemotherapy infusion (cisplatin or carboplatin) during radiation therapy.
Patients will receive 2 Gy/fraction, 6 fractions per week with at least a 6-hour interfraction interval between each treatment:
PTV-P50 or PTV-N50: 50 Gy in 25 fractions (2 Gy/fx)
PTV-N45: 45 Gy in 25 fractions (1.8 Gy/fx) with simultaneous integrated boost to the PTV-P50 volume.
PTV-P30 or PTV-N30: 30 Gy in 15 fractions (2 Gy/fx)
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Description
Transoral surgical resection of tumor(s).
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies.
Intervention Type
Radiation
Intervention Name(s)
intensity-modulated radiation therapy
Other Intervention Name(s)
IMRT
Intervention Description
Low-dose IMRT
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
CACP, CDDP, CPDD, DDP
Intervention Description
Given IV.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Recurrence-Free Survival (RFS)
Description
Time to recurrence, defined as local and/or regional progression (identification of disease growth that is present within the area in which it was first located) and/or distant metastasis (identification of disease growth that is present in area(s) distant to that previously located). Local progression is defined as progression at the primary tumor site. Regional progression is defined as progression in the draining lymphatics (typically the cervical, retropharyngeal/retrostyloid and supraclavicular lymph nodes). Distant progression is defined as tumor recurrence in one or more non-local and non-regional sites (e.g., bone, lung, liver, etc.). Recurrent malignancy will be determined based on clinical exam and imaging findings. Patients who are disease-free but who die from other causes will be censored.
Time Frame
Up to 2 years (for cohort)
Secondary Outcome Measure Information:
Title
Loco-regional control (at 1 year)
Description
Loco-regional control will be evaluated based on the percentage of patients without recurrence (identification of disease growth) in the primary site or regional lymphatics based on imaging and/or clinical exam.
Time Frame
Up to 1 year
Title
Loco-regional control (at 2 years)
Description
Loco-regional control will be evaluated based on the percentage of patients without recurrence (identification of disease growth) in the primary site or regional lymphatics based on imaging and/or clinical exam.
Time Frame
Up to 2 year
Title
Time to distant metastasis (at 1 year)
Description
Percentage of patients with distant metastasis (identification of disease growth that is present in area(s) distant to that previously located) evident on imaging and/or clinical exam. Distant metastasis is defined as tumor recurrence in one or more non-local (at the primary tumor) and non-regional (draining lymphatic) sites such as bone, lung, liver, etc.
Time Frame
Up to 1 year
Title
Time to distant metastasis (at 2 years)
Description
Percentage of patients with distant metastasis (identification of disease growth that is present in area(s) distant to that previously located) evident on imaging and/or clinical exam. Distant metastasis is defined as tumor recurrence in one or more non-local (at the primary tumor) and non-regional (draining lymphatic) sites such as bone, lung, liver, etc.
Time Frame
Up to 2 years
Title
Overall survival at 1 year
Description
Overall survival will be measured as the time from start of treatment to death from any cause.
Time Frame
Up to 1 year
Title
Overall survival at 2 years
Description
Overall survival will be measured as the time from start of treatment to death from any cause.
Time Frame
Up to 2 years
Title
Distribution of patients based on histologic risk features
Description
The percentage of total patients enrolled in the study allocated to low (Arm S), intermediate (Arm RT) and high risk (Arm CRT) groups. Histologic risk features are defined as follows: Low risk (ARM S) - T1-T2 AND 0 or 1 metastatic lymph nodes AND <3 cm AND clear (≥3mm) margins AND no extracapsular extension (ECE) AND no perineural invasion AND no lymphovascular invasion; Intermediate risk (ARM RT) - Any of the following features: One or more close (<3mm) margins, OR "minimal" ≤1 mm ECE OR 1 or more metastatic lymph nodes >3 cm in diameter OR 2-4 lymph nodes positive (≤ 6 cm in diameter), OR perineural invasion OR lymphovascular invasion; High risk (ARM CRT) - Any of the following features: One or more positive margins OR >1 mm ECE OR ≥ 5 metastatic lymph nodes.
Time Frame
Up to 3 years
Title
Assessment of PEG tube dependence
Description
The percentage of patients that have a feeding tube, by Arm, for the low (Arm S), intermediate (Arm RT) and high risk (Arm CRT) groups following treatment with transoral resection and adjuvant therapy.
Time Frame
At 1 year (post treatment)
Title
Adverse Events Related to Treatment
Description
Number of patients experiencing toxicities related to study treatment per Common Terminology Criteria for Adverse Events (CTCAE v5.0) determined at each follow-up summarized by frequency and grade.
Time Frame
Up to 5 years
Title
Quality of Life via FACT-HN
Description
FACT-HN is a self-administered questionnaire. Item responses are on a Likert scale score ranging from 0 to 4. Individual responses are summed to compute subscale scores, and the subscales to compute overall total scores. FACT-HN includes 2 parts - FACT-G and FACT-HN. The basic FACT-G (general) is comprised of 27 items, with four subscales including Physical Well-Being (score = 0-28), Social/Family Well-Being (score= 0-28), Emotional Well-Being (score = 0-24), and Functional Well-Being, (score = 0-28), for a total score min/max = 0-108. The FACT-HN is comprised of 12 head and neck specific items (0-48). Thus, the overall total possible score range is 0-156. Analysis will include the FACT Head & Neck Trial Outcome Index, a composite score which includes only physical, functional, and FACT-HN, thus, scores range from 0-104. Higher scores indicate better Quality of Life.
Time Frame
Baseline (before treatment), at 4-8 weeks post-surgery, at 3 months, 6 months, 1 year, up to 2 years following treatment
Title
MD Anderson Symptom Inventory-Head & Neck (MDASI-HN)
Description
Patient-reported swallowing perception and performance using MDASI-HN measures treatment related symptom burden in head and neck cancer patients. The 20-item MDASI measures both severity and burden of symptoms and their effect on patients' daily activities, using a numeric rating scale of 0-10. This instrument includes 13 core symptoms and 9 head and neck specific items. Higher scores indicate superior perception of function.
Time Frame
Baseline (before treatment), at 4-8 weeks post-surgery, at 3 months, 6 months, up to 2 years following treatment
Title
Modified Barium Swallow (MBS) rating
Description
Three swallowing outcomes will be rated by the SLP conducting the MBS study and reported by research staff: 1) laryngeal penetration (yes, no); 2) aspiration (no, sensate, silent), and 3) pharyngeal residue (no, < 50%, > 50%). These have been selected as universal items generally reported by swallowing clinicians that have been shown to significantly predict pneumonia in patients with oropharyngeal cancers. Prevalence of these dysphagia endpoints will be estimated at each time point.
Time Frame
Before treatment, at 4-8 weeks post-surgery, 6 months and 24 months following treatment
Title
Voice outcomes
Description
Patient-reported voice outcomes will be assessed using the Voice Handicap Index-10 (VHI-10) survey. The VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from "never" to "always"). "Always" response is scored 4 points, a "Never" response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. The patient's values are compared to published norms.
Time Frame
Baseline (before treatment), at 4-8 weeks post-surgery, at 1 year, up to 2 years following treatment
Title
Performance Status Scale (PSS-HN)
Description
The Performance Status Scale (PSS-HN) is a clinician-rated instrument consisting of 3 questions: normalcy of diet, public eating/swallowing, and understandability of speech subscales in patients with head and neck cancer. Each subscale is rated from 0 to 100, with higher scores indicating better performance.
Time Frame
Baseline (before treatment), at 4-8 weeks post-surgery, at 3 months, 6 months, 1 year, up to 2 years following treatment
Title
MD Anderson Dysphagia Inventory (MDADI)
Description
Patient-reported swallowing-related quality of life will be measured using the MD Anderson Dysphagia Inventory (MDADI). It evaluates the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. The MDADI is a 20-item questionnaire in which the patient circles the response that best reflects their experience in the past week on a 5-point Likert Scale with answers ranging from "Strongly Agree" (scored as 1 point on all questions except E7 and F2, where it is scored as 5 points) to "Strongly Disagree" (scored as 5 points on all questions except E7 and F2, where it is scored as 1 point). Scores for individual questions are summed and averaged to obtain a composite score ranging from 20 (extremely low swallow functioning) to 100 (high swallow functioning).
Time Frame
Baseline (before treatment), at 4-8 weeks post-surgery, at 1 year, up to 2 years following treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ECOG performance status of 0 or 1 or Karnofsky score 80-100.
Newly diagnosed, histologically or cytologically confirmed SCC or undifferentiated carcinoma of the oropharynx and resectable oropharyngeal disease.
Patients must be deemed eligible for a TOS procedure with no evidence of distant metastasis as determined by imaging studies.
Biopsy-proven p16+ oropharynx cancer; the histologic evidence of invasive squamous cell carcinoma may have been obtained from the primary tumor or metastatic lymph node.
Carcinoma of the oropharynx associated with HPV as determined by p16 protein expression using immunohistochemistry (IHC) performed by a CLIA approved laboratory.
No prior radiation above the clavicles.
Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix, melanoma in-situ (if fully resected), and/or non-melanomatous skin cancer.
Patients with congestive heart failure > NYHA Class II, CVA/TIA, unstable angina, or myocardial infarction within the last 6 months prior to registration must be evaluated by a cardiologist and/or neurologist.
Acceptable renal and hepatic function within 4 weeks prior to registration as predefined.
Exclusion Criteria:
No evidence of extensive or "matted/fixed" pathologic adenopathy on preoperative imaging.
Women must not be pregnant or breast-feeding due to the teratogenicity of chemotherapy.
No intercurrent illness likely to interfere with protocol therapy or prevent surgical resection.
No uncontrolled diabetes, infection despite antibiotics, or hypertension within 30 days prior to registration.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brieana Marino, MS
Phone
412-647-8258
Email
rowlesbm@upmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha Demko, RN, BSN
Phone
412-623-1400
Email
albesl@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heath Skinner, MD, PhD
Organizational Affiliation
UPMC Hillman Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brieana Marino, MS
Phone
412-647-8258
Email
rowlesbm@upmc.edu
First Name & Middle Initial & Last Name & Degree
Samantha Demko, RN, BSN
Phone
412-623-1400
Email
albesl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Heath D Skinner, MD, PhD
First Name & Middle Initial & Last Name & Degree
Umamaheswar Duvvuri, MD, PhD
First Name & Middle Initial & Last Name & Degree
Dan Zandberg, MD
First Name & Middle Initial & Last Name & Degree
Simon Chiosea, MD
First Name & Middle Initial & Last Name & Degree
Robert L Ferris, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer
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