Treatment Outcomes of Esophageal Cancer

University of California, San Francisco2,476 enrolled

Overview

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.

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

2,476

Conditions

Esophageal Cancer

Interventions

Assessment of patient-reported outcomes (PROs)OTHER

Questionnaires will be administered to participants

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Tenwek Hospital

Bomet, Kenya

RECRUITING

Moi Teaching and Referral Hospital

Eldoret, Kenya

RECRUITING

Kamuzu Central Hospital

Lilongwe, Malawi

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 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.

Time frame: 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.

Time frame: Up to 4 years

Central Contacts

Geoffrey Buckle, MD, MPH

CONTACT

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

Data from ClinicalTrials.gov

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