Chemoradiotherapy for Advanced Esophageal Cancer

Recruiting now · Phase 2

Conditions studied: Esophageal Cancer

In brief

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 life in patients with unresectable esophageal cancer.

Key facts

Study ID

NCT02297217

Run by

AHS Cancer Control Alberta

People needed

50

Starts

2019-11-21

Expected to finish

2028-04-30

Last updated by the study team

2025-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Tom Baker Cancer Centre — Calgary, Alberta, Canada (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.