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

Head and Neck Clinical Trial

— GEROP  

Official title:

Determination of the Value of Geriatric Screening to Predict Postoperative Morbidity in an Older Head and Neck Cancer Population (GEROP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03053310
• Other study ID #: B049201629484
• Status: Recruiting
• Start date: January 25, 2017
• Est. completion date: February 28, 2025

Study information

• Verified date: February 2022
• Source: AZ Sint-Jan AV
• Contact: Araceli Diez-Fraile, Phd
• Phone: 0032(0)50459660
• Email: araceli.diez-fraile[@]azsintjan.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck
• Head and Neck Neoplasms

Locations

Country	Name	City	State
Belgium	AZ Sint-Jan Brugge-Oostende AV	Bruges

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day postoperative comorbidity		30 days postoperative
Secondary	vulnerability percentage of patients undergoing HNCA surgery, based on geriatric consult		at time of surgery
Secondary	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
Secondary	percentage of patients with major postoperative complications (grade >=3), Graded According to NCI CTCAE Version 4.0		30 days postoperative
Secondary	quality of life, as measured with EORTC questionnaire		30 days, 6 months and 12 months postoperative