Definitive Chemo-Radiotherapy for Regionally Advanced Head and Neck Cancer With or Without Up-front Neck Dissection (UPFRONT-NECK)

  • STATUS
    Recruiting
  • End date
    Mar 7, 2030
  • participants needed
    65
  • sponsor
    University Hospital Inselspital, Berne
Updated on 7 June 2022
ct scan
cancer
measurable disease
carcinoma
squamous cell carcinoma
metastasis
chemoradiotherapy
neutrophil count
primary tumor
head and neck cancer
squamous cell carcinoma of head and neck
neck cancer
advanced head and neck carcinoma
neck dissection
advanced head and neck squamous cell carcinoma
advanced head and neck cancer

Summary

Treatment of regionally-advanced head and neck squamous cell carcinoma (HNSCC) requires a multidisciplinary approach with a combination of surgery, radiotherapy (RT) and chemotherapy. Due to these aggressive combined modalities, patients undergoing treatment and many survivors develop toxicities which impact quality of life (QoL) and sometimes lead to mortality.

Lymph node metastases of HNSCC are frequent and considered one of the most important prognostic factors, resulting in decreased survival by 50%. More than three decades, the optimal management strategy of node positive HNSCC was a key subject of debate. In summary, the current literature provides us two important findings: First, with the contemporary imaging and treatment modalities, there is no role of a planned neck dissection (ND) added to (chemo)radiotherapy ((C)RT) in terms of oncological outcome and survival. Second, with modern RT techniques, a tailored treatment followed after an up-front neck dissection (UFND) allows a significant reduction of treatment volumes and de-escalation of the dose to the neck, leading to reduction of treatment related toxicities.

In this study strategies with and without up-front neck dissection prior to chemo-radiotherapy will be compared.

Description

The main objective of this project is to test the hypothesis that the addition of UFND prior to (C)RT results in a significant reduction of treatment toxicities and improvement of QoL in regionally advanced (cN2-3) HNSCC through dose de-escalation and volume reduction of RT.

The primary endpoint of this trial is to evaluate the toxicity from the beginning of radiotherapy until 90 days after the end of the treatment. The incidence of acute and subacute toxicities higher than grade ≥3 (CTCAE v.4, except for Xerostomia, for which RTOG/EORTC scale will be used) will be compared between study arms. Secondary endpoints include the survival endpoints for both treatment modalities; i.e. loco-regional control, progression-free and overall survival. Assessment of QoL (EORTC QLQ-C30 + H&N43), late toxicity, surgical complications, cost-effectiveness and the need of feeding-tube will be a part of the final analysis of this trial.

Trial design: randomized multi-center open-label comparative one-staged phase III trial with a superiority design and the primary endpoint of highest grade radiation toxicity during and until 90 days after the completion of the treatment. Interventions in both arms of the trial are considered as standard treatments. No experimental diagnostic tools will be used during the trial. In addition to the randomized arms, two identical observational arms will be opened for the patients who are diagnosed before the activation of the randomized arms, and subsequently for those who refuse to be randomized. Their aim is to prospectively acquire high quality data for patients who refuse randomization. The observational and randomized cohorts will be analyzed separately for the pre-defined endpoints.

For the calculation of the sample size, grade ≥3 acute radiation toxicity in the CRT alone (Arm A) was assumed as 70% based on literature. For the primary endpoint, a follow-up period of 90 days after the last day of (C)RT is needed after the accrual of the last patient. However, 2 years of follow-up after (C)RT is needed for the secondary endpoints (exception: oncological outcome and survival will be calculated from the day of randomization in order to avoid immortal time bias). On this basis, sample size was calculated based on the Pearson chi-squared test and performed in Stata. Assuming a toxicity fraction of 70% for any grade 3 or higher toxicity in Arm A, a relative risk of 0.5 (35% in Arm B), a two-sided alpha of 0.05, a power of 80%, a drop-out rate of 5%, and an allocation ratio of 1 we calculated an overall sample size of 65. Expected accrual time is 3 years.

Details
Condition Head and Neck Neoplasms
Treatment Radiotherapy, up-front neck dissection, Chemotherapy (Cisplatin), Early Salvage Neck Dissection in case of less than cCR (Arm A only)
Clinical Study IdentifierNCT02918955
SponsorUniversity Hospital Inselspital, Berne
Last Modified on7 June 2022

Eligibility

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note