Actively Recruiting
A Study Involving Neoadjuvant Chemoradiotherapy with Hypofractionated Radiotherapy in Patients with Esophageal and Gastroesophageal Junction Adenocarcinoma
Led by AHS Cancer Control Alberta · Updated on 2024-11-18
42
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study Involving Neoadjuvant Chemoradiotherapy with Hypofractionated Radiotherapy in Patients with Esophageal and Gastroesophageal Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy-proven invasive adenocarcinoma of the esophagus or gastroesophageal junction (Siewert type I-II)
- Surgically resectable clinical stage T1N1-3 or T2-3N0-3 with no clinical evidence of metastasis (M0)
- Tumor size not exceeding 8 cm in length and 5 cm in width based on CT or endoscopy
- ECOG performance status of 2 or less
- Able to begin radiation treatment within 30 calendar days of signing informed consent
- Age between 18 and 80 years
- Adequate blood counts and organ function as defined by hemoglobin >100 g/L, platelets >100x10^9/L, neutrophils >1.5x10^9/L, total bilirubin ≤1.5 times institutional normal, creatinine ≤120 µmol/L, and FEV1 ≥1.5 L
- Patients who can use adequate contraception if capable of childbearing
- Provided written informed consent
You will not qualify if you...
- History of other malignancies except non-melanomatous skin cancer, cured carcinoma in situ of the cervix, or malignancies cured over 5 years ago
- Prior chemotherapy or radiotherapy
- Severe heart conditions including NYHA Class III/IV, recent heart attack within 6 months, significant ventricular arrhythmia, congestive heart failure, or advanced heart block
- Pre-existing motor or sensory neurotoxicity greater than WHO grade 1
- Active infection or serious medical conditions preventing planned treatment
- Dementia or altered mental status preventing informed consent
- Weight loss greater than 20% within 3 months before screening
- Presence of an esophageal stent
- Pregnant or lactating women; women of childbearing potential must have negative pregnancy test and use effective contraception
- Unfit for any treatment component, including contraindications to radiotherapy or connective tissue disease
- Unable to complete surveys in English without interpreter assistance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Actively Recruiting
Research Team
S
Sanjune Laurence Lee, MD
CONTACT
A
Amy Abel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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