Esophageal CancerNCT05177393
Treatment Outcomes of Esophageal Cancer
An observational study of Esophageal Cancer, run by University of California, San Francisco at 6 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Assessment of patient-reported outcomes (PROs)
- How many people
- 2,476 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 28 Feb 2019to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with esophageal cancer based on histological confirmation or presumptive clinical diagnosis who reside in Kenya, Tanzania, and Malawi.
Who may be able to join
- 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;
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 3 countries
Tanzania3 sites, 3 recruiting
- Recruiting
Muhimbili National Hospital
Dar es Salaam
Yona Ringo, MD, MMed
- Recruiting
Ocean Road Cancer Institute
Dar es Salaam
Alita Mrema, MD, MMed
- Recruiting
Kilimanjaro Christian Medical Centre
Moshi
Blandina Mmbaga, MD, MMed,PhD
Kenya2 sites, 2 recruiting
- Recruiting
Tenwek Hospital
Bomet
Michael Mwachiro, MBChB
- Recruiting
Moi Teaching and Referral Hospital
Eldoret
Fatma F Some, MBChB, MMed
Malawi1 site, 1 recruiting
- Recruiting
Kamuzu Central Hospital
Lilongwe
Gift Mulima, MBBS
About this study
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.
Read the 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.
- Conditions
- Esophageal Cancer
- Being tested
- Assessment of patient-reported outcomes (PROs)
- Keywords
- Treatment outcomes, Quality of life, Comparative effectiveness, Palliation
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of patient-reported outcomes (PROs)Other
Also called PROs
Questionnaires will be administered to participants
| Study group | Role | What they receive |
|---|---|---|
| Participants with Esophageal Cancer | Participants with esophageal cancer will be administered questionnaires, and medical charts will be accessed to collect study related data. Receives: Other: Assessment of patient-reported outcomes (PROs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start28 Feb 2019
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,476 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Westat, African Esophageal Cancer Consortium (AfrECC), Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Geoffrey Buckle, MD, MPH, Principal investigator, University of California, San FranciscoKatherine Van Loon, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177393
- Sponsor's protocol ID
- TOEC-AfrECC
- Other IDs
- 21455, 184510, 214520, 204510, 184515
- Status last verified
- Jul 2026
- First submitted
- 15 Dec 2021
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41232057Buckle 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.
PubMed 35045815
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcomes of Esophageal Cancer
- ClinicalTrials.gov ID
- NCT05177393
- Acronym / sponsor ID
- TOEC-AfrECC
- Conditions
- Esophageal Cancer
- Keywords
- Treatment outcomes, Quality of life, Comparative effectiveness, Palliation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,476 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Westat, African Esophageal Cancer Consortium (AfrECC), Celgene Corporation
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Esophageal Cancer | – | Other: Assessment of patient-reported outcomes (PROs)Participants with esophageal cancer will be administered questionnaires, and medical charts will be accessed to collect study related data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with esophageal cancer based on histological confirmation or presumptive clinical diagnosis who reside in Kenya, Tanzania, and Malawi.
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (1 listed)
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of patient-reported outcomes (PROs)Also: PROsQuestionnaires will be administered to participants | Other | Participants with Esophageal Cancer |
Primary outcome
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)
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Derived from this study: PubMed 41232057Mulima 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.
- Derived from this study: PubMed 35045815Buckle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Geoffrey Buckle, MD, MPH principal investigator
University of California, San Francisco
Katherine Van Loon, MD, MPH principal investigator
University of California, San Francisco
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by University of California, San Francisco at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Tanzania, Kenya, Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Geoffrey Buckle, MD, MPH ((415) 476-1528, geoffrey.buckle@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of esophageal cancer (EC) participants receiving treatment with varying treatment modalities at participating AfrECC sites (time frame: Up to 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05177393, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.