---
title: Functional Outcome After Treatment for Oropharyngeal Squamous Cell Carcinoma
nct_id: NCT03418909
overall_status: UNKNOWN
sponsor: Rigshospitalet, Denmark
study_type: OBSERVATIONAL
primary_condition: Oropharynx Cancer
countries: Denmark
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03418909.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03418909"
ct_last_update_post_date: 2023-03-30
last_seen_at: "2026-05-12T07:24:21.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Functional Outcome After Treatment for Oropharyngeal Squamous Cell Carcinoma

**Official Title:** Functional Outcome After Transoral Robotic Surgery (TORS) vs Oncological Treatment for Oropharyngeal Squamous Cell Carcinoma

**NCT ID:** [NCT03418909](https://clinicaltrials.gov/study/NCT03418909)

## Key Facts

- **Status:** UNKNOWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 44
- **Lead Sponsor:** Rigshospitalet, Denmark
- **Conditions:** Oropharynx Cancer, Pain, Swallowing Disorder, Quality of Life, Saliva Altered, Human Papilloma Virus
- **Start Date:** 2017-04-01
- **Completion Date:** 2024-06-30
- **CT.gov Last Update:** 2023-03-30

## Brief Summary

To investigate the treatment related effects of transoral robotic surgery (TORS) or oncological treatment of oropharyngeal squamous cell carcinoma with a 1-year follow up.

## Detailed Description

Patients are enrolled prospectively at the department of Otorhinolaryngology, Head and Neck Surgery \& Audiology at Copenhagen University Hospital, Rigshospitalet.

All eligible patients with histologically verified squamous cell carcinoma of the oropharynx regardless of treatment option (as long as the intent is curative) can be included.

Outcome measures are assessed at baseline and repeated 3 and 12 months after treatment.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

TORS group:

1. WHO performance status 0-2
2. Squamous cell carcinoma of the oropharynx
3. TNM: T1-2, N0-1 (without of evidence of extra capsular extent), M0.
4. No previous head and neck cancer
5. Absence of factors that inhibit the patient from participate in all or parts of the study e.g. geographical, mental, cognitive or other.
6. Signed written consent.
7. Cancer eligible for surgery in the absence of significant trismus.

Oncological group:

1. WHO performance status 0-2
2. Squamous cell carcinoma of the oropharynx
3. Qualified for curative intended oncological treatment
4. Signed written consent

Exclusion Criteria:

TORS group:

1. Serious co-morbidity
2. Distant metastasis
3. Previous radiotherapy to the head and neck region.
4. Concurrent treatment eller investigations for another cancer, except carcinoma in situ.

Oncological group:

1. Previous radiotherapy to the head and neck region.
2. Concurrent treatment eller investigations for another cancer, except carcinoma in situ.
3. Presence of factors that inhibit the patient from participate in all or parts of the study e.g. geographical, mental, cognitive or other.
4. Presence of facors that inhibit the patient from completing the treatment.
5. Previous head and neck cancer
6. Distant metastasis
```

## Arms

- **Oropharyngeal carcinoma (excluding M+ stage)** — Eligible patients with histologically verified early stage squamous cell carcinoma of the oropharynx.

Patients will be treated in accordance with current hospital protocols with transoral robotic surgery (T1-2, N1, M0) or radio(chemo)therapy (any T-stage, any N-stage, M0).

## Interventions

- **Primary Trans Oral Robotic Surgery (TORS)** (PROCEDURE) — In the absence of severe mobidity patients with early stage disease (T1-2, N1, M0) were offered TORS, as an alternative to the standard of care (radiotherapy).
- **Radio(chemo)therapy** (RADIATION) — As the standard of care radiotherapy was offered to all of the patients. Patients that qualified for both TORS and radiotherapy were free to choose between the two.

## Primary Outcomes

- **Altered salivatory function** _(time frame: 3 and 12 months follow up)_ — Measured as change in flow rate or composition compared to baseline measurements performed prior to treatment.

## Secondary Outcomes

- **Changes in swallowing function (MBSS)** _(time frame: 3 and 12 months as well as 3 years after treatment)_
- **Changes in swallowing function (FEES)** _(time frame: 3 and 12 months as well as 3 years after treatment)_
- **Change to quality of life scores (MDADI)** _(time frame: 3 and 12 months as well as 3 years after treatment)_
- **Change to quality of life scores (EORTC QLQ-C30)** _(time frame: 3 and 12 months as well as 3 years after treatment)_
- **Change to quality of life scores (EORTC QLQ-H&N35)** _(time frame: 3 and 12 months as well as 3 years after treatment)_
- **Treatment related pain** _(time frame: For as long as the patient needs analgesics or up to three months)_

## Locations (1)

- Rigshospitalet, Copenhagen, Denmark

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.rigshospitalet|copenhagen||denmark` — added _(2026-05-12)_

---

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