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

AZ Sint-Jan AV (Other)
Overall Status
Recruiting ID

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Anticipated Enrollment :
    94 participants
    Observational Model:
    Time Perspective:
    Official Title:
    Determination of the Value of Geriatric Screening to Predict Postoperative Morbidity in an Older Head and Neck Cancer Population (GEROP)
    Actual Study Start Date :
    Jan 25, 2017
    Anticipated Primary Completion Date :
    Feb 28, 2024
    Anticipated Study Completion Date :
    Feb 28, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Primary (P) - group

    Patients with a primary diagnosis Patients treated with curative intent (stage I-IVb)

    Relapse (R) - group

    Patients with a recurrent (loco)regional tumour Patients treated with curative intent (stage I-IVb)

    Outcome Measures

    Primary Outcome Measures

    1. 30-day postoperative comorbidity [30 days postoperative]

    Secondary Outcome Measures

    1. vulnerability percentage of patients undergoing HNCA surgery, based on geriatric consult [at time of surgery]

    2. percentage of patients not considered eligible for HNCA surgery, based on geriatric consult and/or MOC consult [prior to surgery, at time of multidisciplinary oncology consult]

    3. percentage of patients with major postoperative complications (grade >=3), Graded According to NCI CTCAE Version 4.0 [30 days postoperative]

    4. quality of life, as measured with EORTC questionnaire [30 days, 6 months and 12 months postoperative]

    Eligibility Criteria


    Ages Eligible for Study:
    70 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
      • Patients aged 70 years or older at time of enrolment
    • Both female and male patients

    • Patients that are Dutch or French-speaking

    • Patients with a histologically confirmed malignant tumour in the head and neck region, in specific oral cavity, larynx, and pharynx ('head and neck cancer', defined according to the NCCN guidelines)

    • Patients undergoing surgery for a solid head and neck cancer tumour under general anaesthesia. Preoperative data from patients considered ineligible for surgery, will also be registered for scientific purposes

    • Patients undergoing surgery and follow-up care at the division of maxillofacial surgery or Department of Otorhinolaryngology, Head and Neck Surgery

    Exclusion Criteria:
      • Patients not eligible according to the abovementioned criteria
    • Patients with a spinocellular carcinoma of the skin

    • Patients with distant metastases (stage IVc)

    • Patients with another non-cured cancer, except for a squamous or basal cell carcinoma of the skin

    • Patients arriving at the emergency department for urgent surgical intervention

    • Patients diagnosed with severe dementia, according to the DSM IV or MMSE ≤18, or diagnosed psychiatric problems impeding proper preoperative assessment

    Contacts and Locations


    Site City State Country Postal Code
    1 AZ Sint-Jan Brugge-Oostende AV Bruges Belgium

    Sponsors and Collaborators

    • AZ Sint-Jan AV


    • Principal Investigator: Johan Abeloos, MD, AZ Sint-Jan Brugge-Oostende AV

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Johan Abeloos, head of department of maxillofacial surgery, principal investigator, AZ Sint-Jan AV Identifier:
    Other Study ID Numbers:
    • B049201629484
    First Posted:
    Feb 15, 2017
    Last Update Posted:
    Feb 24, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Keywords provided by Johan Abeloos, head of department of maxillofacial surgery, principal investigator, AZ Sint-Jan AV
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 24, 2022