Carboplatin and paclitaxel with short-course radiotherapy for advanced esophageal cancer

A Phase 2 Study of Palliative Chemo-Radiotherapy With Carbo-Taxol in Non-Curative Cancer of the Esophagus

This treatment tries adding carboplatin and paclitaxel to a two-week palliative course of external beam radiation to help people with unresectable esophageal cancer swallow better and improve quality of life.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AHS Cancer Control Alberta (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Calgary, Alberta)
• Trial ID: NCT02297217 on ClinicalTrials.gov

What this trial studies

This phase 2 trial enrolls adults with biopsy-proven esophageal carcinoma who are not candidates for curative treatment and who have symptomatic dysphagia. Participants receive carboplatin (AUC 2) and paclitaxel (50 mg/m2) intravenously on days 1 and 8 concurrent with external beam radiotherapy delivering 30 Gy in 10 fractions over two weeks. The primary outcome is relief of dysphagia, with secondary outcomes including treatment toxicity, patient-reported quality of life, and metabolomic analyses. All treatment is delivered at Tom Baker Cancer Centre with follow-up for symptomatic and safety outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults with biopsy-proven, unresectable esophageal cancer who have symptomatic dysphagia (Mellow score ≥1), ECOG performance status ≤2, and adequate blood counts, liver, and renal function.

Not a fit: Patients who are eligible for curative treatment, have poor performance status (ECOG >2), significant organ dysfunction, or contraindications to chemo-radiotherapy are unlikely to receive benefit from this regimen.

Why it matters

Potential benefit: If successful, this approach could provide faster and better relief of swallowing difficulties and improve quality of life with a short outpatient treatment course.

How similar studies have performed: Carboplatin plus paclitaxel with radiotherapy has demonstrated benefit in neoadjuvant and some palliative contexts, but this particular short two-week palliative schedule has limited prior trial data.

Eligibility criteria

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.

Where this trial is running

Calgary, Alberta

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

Study contacts

• Principal investigator: Marc Kerba, MD — 5872316617
• Study coordinator: Marilyn David

Conditions: Esophageal Cancer