NCT04124198: QoLATI

Quality of Life After Primary Transoral Robotic Surgery vs Intensity-modulated Radiotherapy for Patients With Early-stage Oropharyngeal Squamous Cell Carcinoma: A Randomized National Trial

Active, enrolled NA Last updated 23 December 2025

What this trial tests

NA trial testing Intensity-Modulated Radiation Therapy (IMRT) in Oropharynx Cancer in 138 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 March 2019

Primary endpoint
16 December 2025

1 December 2029

Quick facts

Lead sponsor	Christian von Buchwald
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	138
Start date	1 March 2019
Primary completion	16 December 2025
Estimated completion	1 December 2029
Sites	3 locations across Denmark

Drugs / interventions tested

• Intensity-Modulated Radiation Therapy (IMRT)
• Cisplatin (cisplatin) — full drug profile →
• Nimorazole.
• Transoral Robotic Surgery (TORS) with neck dissection

Conditions studied

• Oropharynx Cancer — all drugs for Oropharynx Cancer →
• Oropharynx Squamous Cell Carcinoma — all drugs for Oropharynx Squamous Cell Carcinoma →
• Carcinoma, Squamous Cell — all drugs for Carcinoma, Squamous Cell →
• Carcinoma — all drugs for Carcinoma →

Sponsor

Christian von Buchwald — full company profile →

Who can join

18 and older, any sex, with Oropharynx Cancer or Oropharynx Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Swallowing related quality of life by MDADI
  Time frame: evaluated at baseline, 3 and 12 months after treatment
  Difference in swallowing related quality of life measured by a composite MD Anderson Dysphagia Inventory (MDADI) score. The MDADI is a 20-item self-administered questionnaire that quantifies swallowing-related quality of life. Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). The composite MDADI score summarizes overall performance on r

Sponsor's own description

Oropharyngeal squamous cell carcinoma (OPSCC) is now the most frequently diagnosed head and neck cancer in Denmark which is mainly due to the increase of Human Papillomavirus (HPV). Patients with HPV-positive OPSCC have a significantly higher survival rate compared to HPV-negative OPSCC. The traditional primary treatment modality in Denmark is Intensity Modulated Radiation Therapy (IMRT), and in advanced stages in combination with chemotherapy. Since 2009, Transoral Robotic Surgery (TORS) has enabled surgeons to perform minimally invasive surgery as an alternative to standard radiotherapy treatment which is considered the primary treatment for OPSCC in many countries. There is a lack of randomised trials comparing long-term functional outcomes after TORS or IMRT. Current data are mostly derived from retrospective studies with selection bias. However, several small retrospective studies have shown promising results when comparing the two treatment modalities in favour of TORS with regards to treatment related swallowing function and quality of life (QoL) without compromising survival outcomes.

This study aims to evaluate the early and long-term functional outcomes following two treatment arms 1) TORS combined with neck dissection and 2) IMRT±concurrent chemotherapy with a special focus on swallowing-related QoL.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Consensuses, controversies, and future directions in treatment deintensification for human papillomavirus-associated oropharyngeal cancer.
   Kang JJ, Yu Y, Chen L, Zakeri K, et al · · 2023 · cited 52× · PMID 36305841 · DOI 10.3322/caac.21758
2. De-Escalation Strategies of (Chemo)Radiation for Head-and-Neck Squamous Cell Cancers-HPV and Beyond.
   Rühle A, Grosu AL, Nicolay NH. · · 2021 · cited 35× · PMID 34064321 · DOI 10.3390/cancers13092204
3. Human Papillomavirus and Squamous Cell Carcinoma of Unknown Primary in the Head and Neck Region: A Comprehensive Review on Clinical Implications.
   Larsen MHH, Channir HI, von Buchwald C. · · 2021 · cited 15× · PMID 34372502 · DOI 10.3390/v13071297
4. The Sinai Robotic Surgery Trial in HPV-related oropharyngeal squamous cell carcinoma (SIRS 2.0 trial) - study protocol for a phase II non-randomized non-inferiority trial.
   Chai RL, Ferrandino RM, Barron C, Donboli K, et al · · 2022 · cited 8× · PMID 36091121 · DOI 10.3389/fonc.2022.965578
5. Transoral Robotic Surgery and De-escalation of Cancer Treatment.
   Wahle B, Zevallos J. · · 2020 · cited 5× · PMID 32917423 · DOI 10.1016/j.otc.2020.07.009
6. Therapeutic Advances and Challenges for the Management of HPV-Associated Oropharyngeal Cancer.
   Muniz IAF, Araujo M, Bouassaly J, Farshadi F, et al · · 2024 · cited 4× · PMID 38612819 · DOI 10.3390/ijms25074009
7. Five-year survival outcomes in oropharyngeal squamous cell carcinoma following transoral laser microsurgery.
   Turner B, MacKay C, Taylor SM, Rigby MH. · · 2023 · cited 4× · PMID 36846422 · DOI 10.1002/lio2.994