Treatment Outcomes of Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

Treatment Outcomes of Esophageal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05177393
• Other study ID #: TOEC-AfrECC
• Secondary ID: 2145518451021452
• Status: Recruiting
• Start date: February 28, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: University of California, San Francisco
• Contact: Geoffrey Buckle, MD, MPH
• Phone: (415) 476-1528
• Email: geoffrey.buckle[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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 participating sites within AfrECC.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2476
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Other:
• Assessment of patient-reported outcomes (PROs)
Questionnaires will be administered to participants

Locations

Country	Name	City	State
Kenya	Tenwek Hospital	Bomet
Kenya	Moi Teaching and Referral Hospital	Eldoret
Malawi	Kamuzu Central Hospital	Lilongwe
Tanzania	Muhimbili National Hospital	Dar es Salaam
Tanzania	Ocean Road Cancer Institute	Dar es Salaam
Tanzania	Kilimanjaro Christian Medical Centre	Moshi

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Francisco	African Esophageal Cancer Consortium (AfrECC), Celgene Corporation, National Cancer Institute (NCI), Westat

Countries where clinical trial is conducted

Kenya,  Malawi,  Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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