Trial of De-Intensified Post-operative Chemoradiation Following Robotic Surgery for HPV-positive Oropharyngeal Cancer
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|ClinicalTrials.gov Identifier: NCT04502407|
Recruitment Status : Recruiting
First Posted : August 6, 2020
Last Update Posted : April 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|HPV Positive Oropharyngeal Squamous Cell Carcinoma||Radiation: Cisplatin-based Radiation Therapy Drug: Cisplatin Chemotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||IIT2019-20-Zumsteg-HPVOPC: Phase II Trial of De-Intensified Post-operative Chemoradiation Following Robotic Surgery for HPV-positive Oropharyngeal Cancer|
|Actual Study Start Date :||February 16, 2021|
|Estimated Primary Completion Date :||September 15, 2023|
|Estimated Study Completion Date :||September 15, 2025|
Experimental: De-intensified Cisplatin-based Chemoradiation
This is a non-randomized study, with all patients undergoing de-intensified post-operative cisplatin-based chemoradiation. Dosage level and duration of administration will be determined by whether the patient is high risk or not as assessed by the treating investigator.
Radiation: Cisplatin-based Radiation Therapy
Drug: Cisplatin Chemotherapy
- 2-Year Progression-Free Survival (PFS) [ Time Frame: 2 years ]Proportion of patients alive and without evidence of local, regional, or distant recurrence at 2 years from study enrollment.
- Overall Survival (OS) [ Time Frame: 2 years ]Proportion of patients alive, based on time from enrollment to death from any cause.
- Local Control [ Time Frame: 2 years ]Proportion of patients without recurrence at the primary site, based on time from enrollment to local recurrence, irrespective of prior regional or distant recurrence. Death from causes unrelated to cancer is a competing event.
- Regional Control [ Time Frame: 2 years ]Proportion of patients without recurrence in the cervical lymph nodes, based on time from enrollment to regional recurrence, irrespective of prior local or distant recurrence. Death from causes unrelated to cancer is a competing event.
- Locoregional Control [ Time Frame: 2 years ]Proportion of patients without local recurrence or regional recurrence, as defined above, based on the time from enrollment to the first evidence of either local or regional recurrence, irrespective of prior distant recurrence. Death from causes unrelated to cancer is a competing event.
- Distant Control [ Time Frame: 2 years ]Proportion of patients without distant recurrence, based on time from enrollment to distant recurrence, irrespective of prior local or regional recurrence. Distant metastasis includes any recurrent disease outside of the head and neck, cervical lymph nodes, or retropharyngeal lymph nodes. Death from causes unrelated to cancer is a competing event.
- Cause-specific Survival [ Time Frame: 2 years ]Proportion of patients without oropharyngeal cancer-related or treatment-related death, based on time from enrollment to death from oropharyngeal cancer or treatment. Death from other causes is a competing event.
- Mean change in patient-reported outcomes using Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [ Time Frame: 2 years ]PRO-CTCAE responses are scored from 0 to 4 (or 0/1 for absent/present), with lower scoring indicating an absence of symptoms to higher scoring reflecting higher severity of symptoms.
- Mean change in patient-reported outcomes using Hearing Handicap Inventory for Adults (HHIA-S) [ Time Frame: 2 years ]The scale ranges from 0 to 4 (0 - no, 2 - sometimes, 4- yes) for each question identifying problems with hearing loss, as self-reported by patients. The total number of points for the 25 questions range from 0 to 100, with 0 indicating no handicap to 100 indicating total handicap.
- Mean change in patient-reported outcomes using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) [ Time Frame: 2 years ]The EORTC QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL, and six single items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. Most questions are scored 1 to 4, with exception to global health questions scored from 1 to 7. The raw scores are then standardized by a linear transformation, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
- Mean change in patient-reported outcomes using University of Michigan Xerostomia-Related Quality of Life Scale (XeQoLS) [ Time Frame: 2 years ]XeQOLS is a patient-reported, 15-item scale that measures four domains: physical functioning, pain/discomfort, personal/psychologic functioning, and social functioning. Patient responses to all four domains are averaged, and the total scores range from 0 to 4; an increased xerostomia burden is indicated by a higher score.
- Mean change in patient-reported outcomes using 5-level version of the EuroQol five dimensional instrument EQ-5D-5L [ Time Frame: 2 years ]The EQ-5D-5L descriptive system comprises of five dimensions: (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION), with each dimension having five response levels: no problems, slight problems, moderate problems, severe problems, unable to /extreme problems - severity level of each dimension are coded from 1 to 5, respectively. The visual analog scale (EQ VAS) attached to this questionnaire records the respondent's overall self-rated perception of current health status on a vertical visual analogue scale, where the endpoints are scored from 0 to 100, 100 being the 'The best health you can imagine' and 0 indicating 'The worst health you can imagine'
- Mean change in patient-reported outcomes using the MD Anderson Dysphagia Inventory (MDADI) [ Time Frame: 2 years ]The MDADI is a patient-reported, 20-item scale that quantifies four domains: an individual's global (G), physical (P), emotional (E), and functional (F) perceptions of their swallowing ability. Two summary scores can be obtained from the MDADI: 1) global and 2) composite. The global scale is a single question, scored individually, to assess the overall impact that swallowing abilities have on quality of life ("my swallowing impacts my day-to-day life"). The composite MDADI score summarizes overall performance on remaining 19-items of the MDADI, as a weighted average of the physical, emotional, and functional subscale questions. Summary and subscale MDADI scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning). Five possible responses to the items on the MDADI are: strongly agree, agree, no opinion, disagree, and strongly disagree, and scored on a scale of 1 to 5 respectively.
- Progression-free survival (PFS) in high-risk and intermediate risk patient subgroups [ Time Frame: 2 years ]The difference between the proportion of patients alive and without evidence of local, regional, or distant recurrence at 2 years from study enrollment, in high-risk and intermediate subgroups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04502407
|Contact: Amy Oppenheim||310-423-3713||Amy.Oppenheim@cshs.org|
|United States, California|
|Beverly Hills, California, United States, 90211|
|Contact: Kortnee Calkins email@example.com|
|Cedars-Sinai Medical Center (Beverly - Main Site)||Recruiting|
|Los Angeles, California, United States, 90048|
|Contact: Amy Oppenheim|
|Torrance Memorial Physician Network Cancer Care||Recruiting|
|Torrance, California, United States, 90505|
|Contact: Courtney Steeneken Courtney.Steeneken@tmphysicians.com|
|Principal Investigator:||Zachary S Zumsteg, MD||Cedars-Sinai Medical Center|