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NCT Number: NCT05177393

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tenwek Hospital, Bomet, Kenya

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment of patient-reported outcomes (PROs)

Other

Questionnaires will be administered to participants

Other names: PROs

Primary outcomes

  1. 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)

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Geoffrey Buckle, MD, MPH

CONTACT

[email protected]

(415) 476-1528

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • African Esophageal Cancer Consortium (AfrECC)
  • Celgene Corporation
  • Westat

Registry information

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Jan 4, 2022
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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