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Treatment Outcomes of Esophageal Cancer

Treatment Outcomes of Esophageal Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05177393
Enrollment
2476
Registered
2022-01-04
Start date
2019-02-28
Completion date
2027-06-30
Last updated
2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

Treatment outcomes, Quality of life, Comparative effectiveness, Palliation

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.

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

OTHERAssessment of patient-reported outcomes (PROs)

Questionnaires will be administered to participants

Sponsors

University of California, San Francisco
Lead SponsorOTHER
Westat
CollaboratorOTHER
African Esophageal Cancer Consortium (AfrECC)
CollaboratorUNKNOWN
Celgene Corporation
CollaboratorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of esophageal cancer (EC) participants receiving treatment with varying treatment modalities at participating AfrECC sitesUp to 4 yearsDescriptive 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 timeUp to 4 yearsThe 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 SurvivalUp to 4 yearsSurvival 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.

Countries

Kenya, Malawi, Tanzania

Contacts

CONTACTGeoffrey Buckle, MD, MPH
geoffrey.buckle@ucsf.edu(415) 476-1528
PRINCIPAL_INVESTIGATORGeoffrey Buckle, MD, MPH

University of California, San Francisco

PRINCIPAL_INVESTIGATORKatherine Van Loon, MD, MPH

University of California, San Francisco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026