Treatment Outcomes of Esophageal Cancer

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: Esophageal Cancer
• Intervention / Treatment: Other: Assessment of patient-reported outcomes (PROs)

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

• Study Contact: Name: Geoffrey Buckle, MD, MPH; Phone Number: (415) 476-1528; Email: geoffrey.buckle@ucsf.edu

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

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

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	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	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	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

• Sponsor: University of California, San Francisco
• Collaborators: National Cancer Institute (NCI); 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

General Publications

• 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, Wandera A, Westmoreland KD, White RE, Williams B, Mmbaga EJ, Van Loon K; of the African Esophageal Cancer Consortium (AfrECC). Treatment outcomes of esophageal cancer in Eastern Africa: protocol of a multi-center, prospective, observational, open cohort study. BMC Cancer. 2022 Jan 19;22(1):82. doi: 10.1186/s12885-021-09124-5.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2019
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

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): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Quality of life; Comparative effectiveness; Treatment outcomes; Palliation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: TOEC-AfrECC; 21455 (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); 3P30CA082103-21SA (U.S. NIH Grant/Contract)

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