Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT03171558
Eligibility Criteria:
Inclusion Criteria:
* Willing to provide informed consent, attend follow-up visits and complete questionnaires
* Have an Eastern Cooperation Oncology Group (ECOG) performance status of 0-2
* Patients with carcinoma of thyroid, larynx, hypopharynx, or cervical esophagus requiring surgery as a primary treatment modality or after chemoradiation treatment failure
* Laryngectomy and circumferential pharyngectomy as recommended by the head and neck tumor board
Exclusion Criteria:
* Serious medical co morbidities or other contraindications to surgery
* Metastatic disease
* Pregnant or lactating women
* Patients whose clinical circumstances are such that one surgical intervention would be recommended over the other: The cancer extends into the the thorax as seen on pre-operative CT scan. In these patients, the GPU reconstruction is preferred.
* Patients who have liver cirrhosis or multiple previous surgeries on the stomach would not be candidates for the GPU and thus will be excluded from the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03171558
Study Brief:
Protocol Section:
NCT03171558