Clinical trial NCT03053310: Value of Geriatric Screening to Predict Postoperative Morbidity for Head and Neck Cancer
Official title: Determination of the Value of Geriatric Screening to Predict Postoperative Morbidity in an Older Head and Neck Cancer Population (GEROP)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Head and Neck
Keywords: surgery
curative intent
geriatric assessment
30-day postoperative morbidity
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 94
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive patients, aged 70 years or older, with a primary diagnosis (P-group) or (loco)regional recurrence (R-group) of a solid head and neck tumour, requiring elective surgery under general anaesthesia with curative intent.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 30-day postoperative comorbidity
timeFrame: 30 days postoperative
Secondary outcomes:
measure: vulnerability percentage of patients undergoing HNCA surgery, based on geriatric consult
timeFrame: at time of surgery
measure: percentage of patients not considered eligible for HNCA surgery, based on geriatric consult and/or MOC consult
timeFrame: prior to surgery, at time of multidisciplinary oncology consult
measure: percentage of patients with major postoperative complications (grade >=3), Graded According to NCI CTCAE Version 4.0
timeFrame: 30 days postoperative
measure: quality of life, as measured with EORTC questionnaire
timeFrame: 30 days, 6 months and 12 months postoperative
Other outcomes:
Locations:
city: Bruges
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende AV
Study officials:
affiliation: AZ Sint-Lucas Brugge
name: Johan Abeloos, MD
role: PRINCIPAL_INVESTIGATOR
References: