NCT03053310: GEROP

Value of Geriatric Screening to Predict Postoperative Morbidity for Head and Neck Cancer

Active, enrolled Last updated 9 August 2024

What this trial tests

trial in Head and Neck in 94 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

25 January 2017

Primary endpoint
28 February 2024

28 February 2025

Quick facts

Lead sponsor	AZ Sint-Jan AV
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	94
Start date	25 January 2017
Primary completion	28 February 2024
Estimated completion	28 February 2025
Sites	1 location across Belgium

Conditions studied

• Head and Neck — all drugs for Head and Neck →

Sponsor

AZ Sint-Jan AV — full company profile →

Who can join

70 and older, any sex, with Head and Neck. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background Approximately half of head and neck cancer patients are 65 years or older at diagnosis. Treatment decisions in this older HNCA population are challenging, because of the lack of evidence-based guidelines. Surgery is often the treatment of choice in a HNCA setting where curative treatment is intended. Though chronological age per se has not been reported as a contraindication for surgery, data are limited and often the result of retrospective studies. Measurement of functional age, through a comprehensive geriatric assessment, has been suggested by several international cancer organizations to be a better prognostic indicator. At the divisions of maxillofacial surgery and otorhinolaryngology, a geriatric assessment is part of routine preoperative staging for patients of 70 years old or older.

Objectives The investigators aim to determine the value of G8 to predict 30-day postoperative comorbidity in an older HNCA population undergoing elective curative surgery. Moreover, they aim to examine the vulnerability profile of patients undergoing elective head and neck surgery for an oncology diagnosis.

Study design All patients of 70 years and older, presenting at the divisions of maxillofacial surgery and otorhinolaryngology for curative surgery of a solid head and neck tumour undergo a geriatric consult as part of routine preoperative staging. The presence of postoperative morbidity and mortality within the first 30 days after surgery will be collected as a primary endpoint.

At 30±10 days postoperative, all patients will be re-evaluated with the G8 and the CGA. Patient' quality of life will also be re-examined within 30 days postoperative and again at 6 and 12 months postoperative.

Conclusion There is still no consensus whether older HNCA patients should receive a different treatment compared to younger patients. Data related to the vulnerability profile of older patients requiring HN surgery, and the predictive value of geriatric screening for postoperative morbidity could enable better patient selection in the future.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Prognostic Factors Predict Oncological Outcome in Older Patients With Head and Neck Cancer Undergoing Chemoradiation Treatment.
   Stromberger C, Yedikat B, Coordes A, Tinhofer I, et al · · 2020 · cited 9× · PMID 33708616 · DOI 10.3389/fonc.2020.566318