---
title: Adaptive Radiotherapy in Head and Neck Tumor Patients
nct_id: NCT06216171
overall_status: RECRUITING
phase: NA
sponsor: University Hospital, Essen
study_type: INTERVENTIONAL
primary_condition: Head and Neck Neoplasms
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06216171.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06216171"
ct_last_update_post_date: 2024-09-27
last_seen_at: "2026-05-12T06:34:47.313Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Adaptive Radiotherapy in Head and Neck Tumor Patients

**Official Title:** Prospective Randomized Study on Adaptive Radiotherapy in Head and Neck Tumor Patients (Pro- Head and Neck -ART, ProHEART)

**NCT ID:** [NCT06216171](https://clinicaltrials.gov/study/NCT06216171)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** University Hospital, Essen
- **Conditions:** Head and Neck Neoplasms, Head and Neck Cancer, Adaptive Radiotherapy, Optimization
- **Start Date:** 2024-01-25
- **Completion Date:** 2028-01-30
- **CT.gov Last Update:** 2024-09-27

## Brief Summary

Most newly diagnosed oropharyngeal and hypopharyngeal cancers are treated with radiochemotherapy with curative intent. If the field-set UP margins are broad, the consequence may be that quality of life is impaired. The study group of Nutting et al. (2023) investigated this year whether dysphagia-optimized intensity-modulated radiotherapy can reduce the radiation dose to structures associated with dysphagia and aspiration and improve swallowing function compared to standard IMRT (Nutting C, Finneran L, Roe J, Petkar I, Rooney K, Hall E; DARS Triallist Group. Dysphagia-optimized intensity-modulated radiotherapy versus standard radiotherapy in patients with pharyngeal cancer - Authors' reply. Lancet Oncol. 2023 Oct;24(10):e398. doi: 10.1016/S1470-2045(23)00457-6. PMID: 37797636.) The study group concluded that the results suggest that dysphagia-optimized IMRT improves patient-reported swallowing function compared to standard IMRT. DO-IMRT should be considered the new standard of care for patients receiving radiotherapy for pharyngeal cancer, and ART could further improve outcomes.

## Detailed Description

Most newly diagnosed oropharyngeal and hypopharyngeal cancers are treated with radiochemotherapy with curative intent. If the field-set UP margins are broad, the consequence may be that quality of life is impaired. The study group of Nutting et al. (2023) investigated this year whether dysphagia-optimized intensity-modulated radiotherapy can reduce the radiation dose to structures associated with dysphagia and aspiration and improve swallowing function compared to standard IMRT (Nutting C, Finneran L, Roe J, Petkar I, Rooney K, Hall E; DARS Triallist Group. Dysphagia-optimized intensity-modulated radiotherapy versus standard radiotherapy in patients with pharyngeal cancer - Authors' reply. Lancet Oncol. 2023 Oct;24(10):e398. doi: 10.1016/S1470-2045(23)00457-6. PMID: 37797636.) The study group concluded that the results suggest that dysphagia-optimized IMRT improves patient-reported swallowing function compared to standard IMRT. DO-IMRT should be considered the new standard of care for patients receiving radiotherapy for pharyngeal cancer, and ART could further improve outcomes.

Thus, in this trial we analyze ART in head and neck cancer in a prospective randomized trial.

## Eligibility

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

```
Inclusion Criteria:

ECOG 0/1 No prior cancer treatment

Exclusion Criteria:

ECOG 2-4 Prior cancer treatment
```

## Arms

- **Adaptive Radiotherapy** (EXPERIMENTAL) — Adaptive Radiotherapy, online onboard adaptation of the dosis to actual anatomy of the day by a specialist of radiation oncology and a medical physicist
- **Standard conventional Treatment Arm, IGRT** (ACTIVE_COMPARATOR) — Standard treatment option, image guided radiotherapy without online adaptation

## Interventions

- **Adaptive Radiotherapy** (RADIATION) — Adaptive Radiotherapy
- **image guided radiotherapy without online adaptation** (RADIATION) — image guided radiotherapy without online adaptation

## Primary Outcomes

- **EORTC CTC AE Score** _(time frame: 2 months - 5 years)_ — quality of life, Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Published: November 27, 2017
- **Dysphagia score** _(time frame: 2 months - 5 years)_ — Dysphagia score

## Secondary Outcomes

- **Overall Survival** _(time frame: 2-5 years)_
- **Progression Free Survival** _(time frame: 2-5 years)_

## Locations (1)

- Maja Guberina, Essen, Germany — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — 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.maja guberina|essen||germany` — added _(2026-05-12)_

---

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