RecruitingNot ApplicableNCT05370144

A Study Involving Neoadjuvant Chemoradiotherapy with Hypofractionated Radiotherapy in Patients with Esophageal and Gastroesophageal Junction Adenocarcinoma

Phase II Study of Neoadjuvant Chemoradiotherapy with Hypofractionated Radiotherapy in Patients with Esophageal and Gastroesophageal Junction Adenocarcinoma


Sponsor

AHS Cancer Control Alberta

Enrollment

42 participants

Start Date

Feb 8, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

An open-label, single-centre, non-randomized, Phase II trial in patients with esophageal adenocarcinoma. This study aims to show that delivering hypofractionated neoadjuvant concurrent chemoradiotherapy is is equally effective as conventionally fractionated neoadjuvant concurrent chemoradiotherapy.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a modified radiation approach (hypofractionated radiotherapy — delivering fewer but slightly higher doses of radiation) combined with chemotherapy before surgery for people with esophageal or gastroesophageal junction cancer. Researchers want to see if this schedule is as effective as standard treatment but with fewer visits. **You may be eligible if...** - You are 18–80 years old - You have been diagnosed with adenocarcinoma of the esophagus or the junction between the esophagus and stomach - Your cancer is resectable (can be surgically removed) and has not spread to other organs - Your tumor is not too large (under 8 cm long, under 5 cm wide) - You can begin radiation within 30 days of consenting - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have had previous chemotherapy or radiation for this cancer - You have serious heart problems (heart failure, recent heart attack, severe arrhythmia) - You are pregnant or breastfeeding - You have had a major weight loss (more than 20% in 3 months) - You have an esophageal stent in place - You have severe nerve damage (neuropathy above WHO grade 1) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHypofractionated radiotherapy

Hypofractionated radiation 23 Gy in 5 fractions with a simultaneous integrated boost of 26 Gy in 5 fractions to the gross tumor volume (GTV) given concurrently over 1 week during week 3 of chemotherapy.


Locations(1)

Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

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NCT05370144


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