Treatment outcomes of esophageal cancer in Eastern Africa: protocol of a multi-center, prospective, observational, open cohort study
Authors: Buckle Geoffrey C. , Mrema Alita , Mwachiro Michael , Ringo Yona , Selekwa Msiba , Mulima Gift , Some Fatma F. , Mmbaga Blandina T. , Mody Gita N. , Zhang Li , Paciorek Alan , Akoko Larry , Ayuo Paul , Burgert Stephen , Bukusi Elizabeth , Charles Anthony , Chepkemoi Winnie , Chesumbai Gladys , Kaimila Bongani , Kenseko Aida , Kibwana Kitembo Salum , Koech David , Macharia Caren , Moirana Ezekiel N. , Mushi Beatrice Paul , Mremi Alex , Mwaiselage Julius , Mwanga Ally , Ndumbalo Jerry , Nvakunga Gissela , Ngoma Mamsau , Oduor Margaret , Oloo Mark , Opakas Jesse , Parker Robert , Seno Saruni , Salima Ande , Servent Furaha , Wandera Andrew , Westmoreland Kate D. , White Russell E. , Williams Brittney , Mmbaga Elia J. , Van Loon Katherine ,   of the African Esophageal Cancer Consortium (AfrECC)
Published: January 2022

Abstract
Background
Esophageal squamous cell carcinoma (ESCC) is a major cause of cancer morbidity and mortality in Eastern Africa. The majority of patients with ESCC in Eastern Africa present with advanced disease at the time of diagnosis. Several palliative interventions for ESCC are currently in use within the region, including chemotherapy, radiation therapy with and without chemotherapy, and esophageal stenting with self-expandable metallic stents; however, the comparative effectiveness of these interventions in a low resource setting has yet to be examined.

Methods
This prospective, observational, multi-center, open cohort study aims to describe the therapeutic landscape of ESCC in Eastern Africa and investigate the outcomes of different treatment strategies within the region. The 4.5-year study will recruit at a total of six sites in Kenya, Malawi and Tanzania (Ocean Road Cancer Institute and Muhimbili National Hospital in Dar es Salaam, Tanzania; Kilimanjaro Christian Medical Center in Moshi, Tanzania; Tenwek Hospital in Bomet, Kenya; Moi Teaching and Referral Hospital in Eldoret, Kenya; and Kamuzu Central Hospital in Lilongwe, Malawi). Treatment outcomes that will be evaluated include overall survival, quality of life (QOL) and safety. All patients (≥18 years old) who present to participating sites with a histopathologically-confirmed or presumptive clinical diagnosis of ESCC based on endoscopy or barium swallow will be recruited to participate. Key clinical and treatment-related data including standardized QOL metrics will be collected at study enrollment, 1 month following treatment, 3 months following treatment, and thereafter at 3-month intervals until death. Vital status and QOL data will be collected through mobile phone outreach.

Discussion
This study will be the first study to prospectively compare ESCC treatment strategies in Eastern Africa, and the first to investigate QOL benefits associated with different treatments in sub-Saharan Africa. Findings from this study will help define optimal management strategies for ESCC in Eastern Africa and other resource-limited settings and will serve as a benchmark for future research.

Trial registration
This study was retrospectively registered with the ClinicalTrials.gov database on December 15, 2021, NCT05177393.