Recruiting
Phase 2

Chemoradiotherapy

Sponsor:

AHS Cancer Control Alberta

Code:

NCT02297217

Conditions

Esophageal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Carboplatin and Taxol (paclitaxel)

External Beam Radiation

Study Details

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 life in patients with unresectable esophageal cancer.

Conditions

Esophageal Cancer

Study ID

NCT02297217

Start date

Nov 21, 2019

Status verified date

Oct, 2025

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Biopsy proven carcinoma of the esophagus.
2. Not a candidate for radical/curative treatment due to the advanced nature of the disease, presence of metastases, or intercurrent illness.
3. Symptomatic patients with Mellow Dysphagia Scores of ≥ 1 i.e. able to eat only some solids.
4. ECOG Performance status ≤ 2.
5. Patients able to begin treatment within 14 days of signing the informed consent form.
6. Patient is at least 18 years old.
7. Hematological function as defined by the following laboratory parameters:

  • Hemoglobin > 100g/L
  • Platelet count > 100x10E9/L
  • Absolute neutrophil count > 1.5x10E9/L
8. 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
9. Patients capable of childbearing are using adequate contraception.
10. Written and informed consent of patient.

Exclusion Criteria:

1. Previous radiotherapy delivered to the chest.
2. Synchronous active malignancies.
3. 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.
4. Patients unfit for any treatment component, including absolute contraindications for radiotherapy or Connective Tissue Disease.
5. Tracheo-esophageal fistula.
6. Esophageal stents in situ.
7. Previous chemotherapy for esophageal cancer
8. Unable to complete surveys in English without aid of interpreter.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Chemotherapy with Concurrent Radiation

Carboplatin and paclitaxel will be administered intravenously on Days 1 and 8 while radiation therapy is administered

Interventions

Carboplatin and Taxol (paclitaxel)

Patients will receive carboplatin (AUC 2) and paclitaxel (50 mg/m2) intravenously on Days 1 and 8. Patients are seen for 2 weekly Treatment Visits during concurrent chemo-radiation then every 28 days until the End of Study Visit, approximately 6 months after Treatment Visit 1. Preparation and administration of chemotherapy will be according to local site standard of care.

External Beam Radiation

Patients will receive external beam radiation therapy of 30Gy/10 fractions over two weeks (or reduced to 25 Gy/10 fractions if acute toxicity parameters are met during the run-in) and receive carboplatin (AUC 2) and paclitaxel (50 mg/m2) intravenously on Days 1 and 8. Treatment will be planned, prescribed and delivered using standard 3D radiotherapy planning techniques to encompass the primary tumor and surrounding clinical target volume. Patients are seen for 2 weekly Treatment Visits during concurrent chemo-radiation then every 28 days until the End of Study Visit, approximately 6 months after Treatment Visit 1.

Primary outcome measure

  • Proportion of patients who achieve relief of dysphagia [ Time Frame: up to day 85 ]

Central Contacts and Locations

Locations

Tom Baker Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 4N2

Contacts

More Information

Sponsor

AHS Cancer Control Alberta

Last update posted

Dec 16, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AHS Cancer Control Alberta on 2025-12-16.