Status:
RECRUITING
Chemoradiotherapy for Advanced Esophageal Cancer
Lead Sponsor:
AHS Cancer Control Alberta
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study aims to show that the addition of carboplatin and paclitaxel chemotherapy to a palliative course of external beam radiation treatment improves both dysphagia relief and patient quality of l...
Detailed Description
Patients with carcinoma of the esophagus not suitable for definitive radical treatment who have symptomatic dysphagia requiring locoregional palliation, and who have no contra-indications to chemo-rad...
Eligibility Criteria
Inclusion
- Biopsy proven carcinoma of the esophagus.
- Not a candidate for radical/curative treatment due to the advanced nature of the disease, presence of metastases, or intercurrent illness.
- Symptomatic patients with Mellow Dysphagia Scores of ≥ 1 i.e. able to eat only some solids.
- ECOG Performance status ≤ 2.
- Patients able to begin treatment within 14 days of signing the informed consent form.
- Patient is at least 18 years old.
- Hematological function as defined by the following laboratory parameters:
- Hemoglobin \> 100g/L
- Platelet count \> 100x10E9/L
- Absolute neutrophil count \> 1.5x10E9/L
- Renal function to undergo chemotherapy as defined by the following laboratory parameters:
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x the upper limit of institutional normal (≤ 5 if liver metastases)
- Total bilirubin ≤ 1.5x the upper limit of institutional normal
- Calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault formula
- Patients capable of childbearing are using adequate contraception.
- Written and informed consent of patient.
Exclusion
- Previous radiotherapy delivered to the chest.
- Synchronous active malignancies.
- Pregnant or lactating patients: women of child bearing potential must have a negative serum pregnancy test within 7 days of Treatment Visit 1. Women or men of child bearing potential must use effective contraception (defined by the use of two birth control methods, which can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy). Subjects must start using birth control from the time they have signed the Informed Consent Form prior to start of therapy until 120 days post completion of study therapy or study discontinuation, which must be documented in the eCRF.
- Patients unfit for any treatment component, including absolute contraindications for radiotherapy or Connective Tissue Disease.
- Tracheo-esophageal fistula.
- Esophageal stents in situ.
- Previous chemotherapy for esophageal cancer
- Unable to complete surveys in English without aid of interpreter.
Key Trial Info
Start Date :
November 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02297217
Start Date
November 21 2019
End Date
April 30 2028
Last Update
December 16 2025
Active Locations (1)
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1
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2