Clinical trial · Observational
Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) for the Treatment of Low-Risk Oropharynx Squamous Cell
Observational Parallel Cohort Study of Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) for the Treatment of Low-Risk Oropharynx Squamous Cell Carcinoma
NCT02663583CI-TRIAL-00038781unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this laboratory research study is to learn about symptoms and activity levels of patients with OPSCC that receive IMPT or TORS.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Mouth | Oral Cavity Carcinoma | ALIAS | 0.90 |
| Oropharynx Squamous Cell Carcinoma | Oropharynx Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Activity Bands | Behavioral | — | UNRESOLVED |
| Dysphagia Inventory Questionnaire | Behavioral | — | UNRESOLVED |
| Symptom Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Intensity-Modulated Proton Therapy or( IMPT) Group
- description
- Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, every week during IMPT, at 3 months, and at 6 months. Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, every week during IMPT, at 3 months, and at 6 months. Activity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits.
- interventionNames
- Behavioral: Symptom Questionnaires
- Behavioral: Dysphagia Inventory Questionnaire
- Behavioral: Activity Bands
- label
- TransOral Robotic Surgery (TORS) Group
- description
- Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, after TORS, at 3 months, and at 6 months. Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, after TORS, at 3 months, and at 6 months. Activity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits.
- interventionNames
- Behavioral: Symptom Questionnaires
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years 2. Histologically documented or suspected, previously untreated OPSCC (Clinical Stage I-Va; Tx,0-2, N0-2b) eligible for standard of care single-modality treatment with either IMPT or TORS. Patients with suspected OPSCC must have a diagnosis confirmed prior to treatment per the current clinical standard of care 3. Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2 Exclusion Criteria: N/A
References
Publications (0)
Data not yet available
No reference posted for this study.