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NCT02984410: Best Of

Study Assessing The "Best of" Radiotherapy vs the "Best of" Surgery in Patients With Oropharyngeal Carcinoma

Active, enrolled NA Last updated 14 August 2025
What this trial tests

NA trial testing Intensity-Modulated Radiation Therapy (IMRT) in Oropharyngeal Cancer in 112 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
27 November 2017
Primary endpoint
30 June 2025
30 June 2029

Quick facts

Lead sponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment112
Start date27 November 2017
Primary completion30 June 2025
Estimated completion30 June 2029
Sites32 locations across France, Italy, Belgium, United Kingdom, Germany, Poland, Switzerland, Spain

Drugs / interventions tested

Conditions studied

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC — full company profile →

Who can join

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

Sponsor's own description

Oropharyngeal Squamous Cell Carcinoma (OPSCC) arises in the soft palate, tonsils, base of tongue, pharyngeal wall, and the vallecula. Most of the patients with early stage OPSCC are usually cured. Treatment of early stage OPSCC can be successfully achieved with primary surgery including neck dissection, as indicated, or with definitive radiotherapy. The current standard treatment for OPSCC is therefore based on either surgery and/or radiotherapy, both associated with comparable, high tumor control rates but with different side effects profiles and technical constraints. In order to decrease the potential morbidity of surgery, transoral approaches have been developed within the last decades, including transoral robotic surgery (TORS), transoral laser microsurgery (TLM) or conventional transoral techniques. On the other hand, patients with head and neck cancer treated with IMRT experienced significant improvements in cause specific survival (CSS) compared with patients treated with non-IMRT techniques thus suggesting that IMRT may be beneficial in terms of patient's outcomes and toxicity profile. It is as yet unclear however, which one of the new techniques is superior to the other in terms of function preservation. Given that the functional outcome of most importance is swallowing function, the preservation of swallowing is thus of major importance. The main objective of the study is to assess and compare the patient-reported swallowing function over the first year after randomization to either IMRT or TOS among patients with early stage OPSCC, SGSCC, and HPSCC.

Publications & conference data

8 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. Current Role of Surgery in the Management of Oropharyngeal Cancer.
    Golusiński W, Golusińska-Kardach E. · · 2019 · cited 50× · PMID 31179239 · DOI 10.3389/fonc.2019.00388
  3. Deintensification of Adjuvant Treatment After Transoral Surgery in Patients With Human Papillomavirus-Positive Oropharyngeal Cancer: The Conception of the PATHOS Study and Its Development.
    Hargreaves S, Beasley M, Hurt C, Jones TM, et al · · 2019 · cited 37× · PMID 31632901 · DOI 10.3389/fonc.2019.00936
  4. 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
  5. Prospective <i>in silico</i> study of the feasibility and dosimetric advantages of MRI-guided dose adaptation for human papillomavirus positive oropharyngeal cancer patients compared with standard IMRT.
    Mohamed ASR, Bahig H, Aristophanous M, Blanchard P, et al · · 2018 · cited 27× · PMID 30014042 · DOI 10.1016/j.ctro.2018.04.005
  6. Recent advances in the understanding and management of oropharyngeal cancer.
    Hay A, Nixon IJ. · · 2018 · cited 19× · PMID 30228861 · DOI 10.12688/f1000research.14416.1
  7. Functional Organ Preservation Surgery in Head and Neck Cancer: Transoral Robotic Surgery and Beyond.
    Golusiński W. · · 2019 · cited 18× · PMID 31058091 · DOI 10.3389/fonc.2019.00293
  8. Treatment preferences in human papillomavirus-associated oropharyngeal cancer.
    Windon MJ, D'Souza G, Fakhry C. · · 2018 · cited 18× · PMID 30265132 · DOI 10.2217/fon-2018-0063

Verify or expand the search:

Other trials of Intensity-Modulated Radiation Therapy (IMRT)

Trials testing the same drug.

Other recruiting trials for Oropharyngeal Cancer

Currently open trials in the same condition.

Other European Organisation for Research and Treatment of Cancer - EORTC trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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