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Recruiting NCT05177393

Treatment Outcomes of Esophageal Cancer

Observational Esophageal Cancer

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Assessment of patient-reported outcomes (PROs).
Who it may be relevant to
Registry conditions: Esophageal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Kenya, Malawi, Tanzania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This study will be a carried out through a prospective observational cohort design in conjunction with researchers in the African Esophageal Cancer Consortium (AfrECC). The purpose of this research is to prospectively evaluate outcomes related to existing treatment strategies for esophageal cancer (EC) at participating sites within AfrECC.

Detailed description

SPECIFIC AIMS:

Aim 1: To describe the types of treatments administered for all patients diagnosed with EC at participating AfrECC sites, including chemotherapeutic regimens, radiation therapy, chemo-radiotherapy, esophageal stenting, esophagectomy, and basic supportive care.

Aim 2: To evaluate the effect of different EC treatment modalities on patient reported outcomes during and after completion of treatment.

Aim 3: To measure the effect of different treatment modalities on overall survival.

Interventions

  • Other Assessment of patient-reported outcomes (PROs)
    Questionnaires will be administered to participants

Primary outcome measures

  • Proportion of esophageal cancer (EC) participants receiving treatment with varying treatment modalities at participating AfrECC sites [Time frame: Up to 4 years]
  • Change in scores of the Modified Rosenblatt Index over time [Time frame: Up to 4 years]
  • Median Overall Survival [Time frame: Up to 4 years]

Eligibility criteria

Inclusion criteria

  • Participants with histopathologically confirmed or presumptive clinical diagnosis of EC. For patients who do not have histopathologically confirmed disease, presumptive clinical diagnosis may be based upon barium swallow or endoscopy without biopsy.
  • Age 18 years of age or older;

Exclusion criteria

  • Unable to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Tanzania · 3 centers
  • Muhimbili National Hospital — Dar es Salaam
  • Ocean Road Cancer Institute — Dar es Salaam
  • Kilimanjaro Christian Medical Centre — Moshi
Kenya · 2 centers
  • Tenwek Hospital — Bomet
  • Moi Teaching and Referral Hospital — Eldoret
Malawi · 1 center
  • Kamuzu Central Hospital — Lilongwe

Publications

  • Mulima G, Mody GN, Kaimila B, Salima A, Williams B, Paciorek A, Zhang L, Charles A, Westmoreland KD, Van Loon K, Buckle GC. Treatment Outcomes of Esophageal Cancer in Malawi: An Analysis of Overall Survival and Patient-Reported Outcomes. JCO Glob Oncol. 2025 Nov;11:e2500221. doi: 10.1200/GO-25-00221. Epub 2025 Nov 13. PMID 41232057
  • Buckle GC, Mrema A, Mwachiro M, Ringo Y, Selekwa M, Mulima G, Some FF, Mmbaga BT, Mody GN, Zhang L, Paciorek A, Akoko L, Ayuo P, Burgert S, Bukusi E, Charles A, Chepkemoi W, Chesumbai G, Kaimila B, Kenseko A, Kibwana KS, Koech D, Macharia C, Moirana EN, Mushi BP, Mremi A, Mwaiselage J, Mwanga A, Ndumbalo J, Nvakunga G, Ngoma M, Oduor M, Oloo M, Opakas J, Parker R, Seno S, Salima A, Servent F, Wand PMID 35045815

Identifiers

NCT: NCT05177393 · TOEC-AfrECC · 21455 · 184510 · 214520 · 204510 · 184515

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗