Treatment Outcomes of Esophageal Cancer

NCT05177393 | Recruiting

• 7 other identifiers: TOEC-AfrECC214551845102145202045101845153P30CA082103-21SA
• Study Type: observational
• Target: 2,476
• Locations: 3 countries
• Sites: 6

Brief Summary

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.

Conditions

Esophageal Cancer

Keywords

Treatment outcomes; Quality of life; Comparative effectiveness; Palliation

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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)

Interventions

Assessment of patient-reported outcomes (PROs) OTHER

Questionnaires will be administered to participants

Also known as: PROs

Participants with Esophageal Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• Unable to provide informed consent

Sponsors & Collaborators

• University of California, San Francisco: lead
• Westat: collaborator
• African Esophageal Cancer Consortium (AfrECC): collaborator
• National Cancer Institute (NCI): collaborator
• Celgene Corporation: collaborator

Study Sites (6)

Tenwek Hospital

Bomet, Kenya

RECRUITING

Moi Teaching and Referral Hospital

Eldoret, Kenya

RECRUITING

Kamuzu Central Hospital

Lilongwe, Malawi

RECRUITING

Muhimbili National Hospital

Dar es Salaam, Tanzania

RECRUITING

Ocean Road Cancer Institute

Dar es Salaam, Tanzania

RECRUITING

Kilimanjaro Christian Medical Centre

Moshi, Tanzania

RECRUITING

Related Publications (2)

• 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 DERIVED

• 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.

  PMID: 35045815 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Geoffrey Buckle, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Katherine Van Loon, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geoffrey Buckle, MD, MPH

CONTACT

(415) 476-1528; geoffrey.buckle@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 4, 2022
• Study Start: February 28, 2019
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TA (3); MA (1); KE (2)