Treatment Outcomes of Esophageal Cancer

July 20, 2026 updated by: University of California, San Francisco
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

2476

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Kenya
      • Bomet, Kenya
        • Recruiting
        • Tenwek Hospital
        • Principal Investigator:
          • Michael Mwachiro, MBChB
      • Eldoret, Kenya
        • Recruiting
        • Moi Teaching and Referral Hospital
        • Principal Investigator:
          • Fatma F Some, MBChB, MMed
  • Malawi
      • Lilongwe, Malawi
        • Recruiting
        • Kamuzu Central Hospital
        • Principal Investigator:
          • Gift Mulima, MBBS
  • Tanzania
      • Dar es Salaam, Tanzania
        • Recruiting
        • Muhimbili National Hospital
        • Principal Investigator:
          • Yona Ringo, MD, MMed
      • Dar es Salaam, Tanzania
        • Recruiting
        • Ocean Road Cancer Institute
        • Principal Investigator:
          • Alita Mrema, MD, MMed
      • Moshi, Tanzania
        • Recruiting
        • Kilimanjaro Christian Medical Centre
        • Principal Investigator:
          • Blandina Mmbaga, MD, MMed,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants with esophageal cancer based on histological confirmation or presumptive clinical diagnosis who reside in Kenya, Tanzania, and Malawi.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with Esophageal Cancer
Participants with esophageal cancer will be administered questionnaires, and medical charts will be accessed to collect study related data.
Other: Assessment of patient-reported outcomes (PROs)
Questionnaires will be administered to participants
Other Names:
  • PROs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of esophageal cancer (EC) participants receiving treatment with varying treatment modalities at participating AfrECC sites
Time Frame: Up to 4 years
Descriptive statistics will be used to describe the proportion of EC patients receiving treatment with each modality at participating AfrECC sites. The investigators will assess the associations between demographic and clinicopathologic characteristic and treatment modalities employed (chemotherapy, radiotherapy, chemo-radiation, esophageal stenting, esophagectomy, supportive care alone, or a combination of these treatments)
Up to 4 years
Change in scores of the Modified Rosenblatt Index over time
Time Frame: Up to 4 years
The 6-item Modified Rosenblatt Index by Rosenblatt, et al. adapted for use within a resource-limited context evaluates EC related parameters scored on a Likert scale assessing presence and severity of symptoms: Odynophagia (0=no pain on swallowing to 3=severe pain); Dysphagia (0=normal, no dysphagia to 4=unable to swallow saliva); Regurgitation (0=never to 3=constant); Chest and/or Back Pain (0=no pain to 2=pain not relieved by non-narcotics or requiring opiate medication); World Health Organization (WHO) performance status/Overall Well-Being (0="A lot better" to 4="A lot worse"). Scores will be assessed at the following time points: Baseline, 1 month and 3 months after initiation of treatment, and every 3 months thereafter.
Up to 4 years
Median Overall Survival
Time Frame: Up to 4 years
Survival will be defined as the time elapsed from date of diagnosis (either confirmed or date of diagnostic modality leading to presumptive clinical diagnosis) to date of death. For participants who are not deceased, censorship will be performed on the date when the participant was last known to be alive.
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Celgene Corporation
Westat
African Esophageal Cancer Consortium (AfrECC)

Investigators

  • Principal Investigator: Geoffrey Buckle, MD, MPH, University of California, San Francisco
  • Principal Investigator: Katherine Van Loon, MD, MPH, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2019

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

December 15, 2021

First Submitted That Met QC Criteria

December 15, 2021

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOEC-AfrECC
  • 21455 (Other Identifier: University of California, San Francisco)
  • 184510 (Other Identifier: University of California, San Francisco)
  • 214520 (Other Identifier: University of California, San Francisco)
  • 204510 (Other Identifier: University of California, San Francisco)
  • 184515 (Other Identifier: University of California, San Francisco)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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