Esophageal Cancer study: Carboplatin and Taxol vs External Beam Radiation
Official title Chemoradiotherapy for Advanced Esophageal Cancer
ClinicalTrials.gov ID: NCT02297217
What this study is testing
What is Carboplatin and Paclitaxel?
An investigational combination chemotherapy being studied as a potential treatment for unresectable esophageal cancer. It is designed to damage cancer cell DNA (carboplatin) and disrupt cell division (paclitaxel).
Also referred to as Carboplatin; Paclitaxel (Taxol).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if adding chemotherapy to palliative radiation improves relief of difficulty swallowing and overall quality of life.
- Who it's for
- People with esophageal cancer that cannot be removed by surgery.
- What's involved
- Participants will receive carboplatin and paclitaxel chemotherapy along with external beam radiation, plus follow‑up visits and assessments.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join 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.
- Patients unfit for any treatment component, including absolute contraindications for radiotherapy or Connective Tissue Disease.
- Tracheo-esophageal fistula.
- Esophageal stents in situ.
See the full eligibility criteria
- 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.
- Hemoglobin \> 100g/L
- Platelet count \> 100x10E9/L
- Absolute neutrophil count \> 1.5x10E9/L
- 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.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Calgary, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Calgary, Alberta, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.