NCT02297217RecruitingPhase 2
Chemoradiotherapy for Advanced Esophageal Cancer
A Phase 2 Study of Palliative Chemo-Radiotherapy With Carbo-Taxol in Non-Curative Cancer of the Esophagus
Source: ClinicalTrials.gov · Last updated 16 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 19 Nov 2014
- Start date
- 21 Nov 2019
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- AHS Cancer Control Alberta
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT02297217
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 21 Nov 2019 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radiotherapy delivered to the chest.
- Previous chemotherapy for esophageal cancer
Other illness
- Synchronous active malignancies.
- Patients unfit for any treatment component, including absolute contraindications for radiotherapy or Connective Tissue Disease.
- Tracheo-esophageal fistula.
Lab values
- 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.
Other
- Esophageal stents in situ.
- Unable to complete surveys in English without aid of interpreter.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tom Baker Cancer Centre Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.