Clinical trial NCT02297217: Chemoradiotherapy for Advanced Esophageal Cancer
Official title: A Phase 2 Study of Palliative Chemo-Radiotherapy With Carbo-Taxol in Non-Curative Cancer of the Esophagus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Cancer
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Patients with carcinoma of the esophagus not suitable for definitive radical treatment who have symptomatic dysphagia requiring locoregional palliation, and who have no contra-indications to chemo-radiotherapy will be offered Carboplatin (AUC 2) and paclitaxel (50 mg/m2) intravenously on days 1 and 8 concurrent with external beam radiation therapy of 30Gy/10 fractions over two weeks where the primary goal is relief of dysphagia and other outcomes include toxicity, quality of life and metabolomics.

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.

Primary outcomes:
measure: Proportion of patients who achieve relief of dysphagia
timeFrame: up to day 85
Secondary outcomes:
measure: Dysphagia progression free survival
timeFrame: 6 Months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
Study officials:
affiliation: 403 521 3164
name: Marc Kerba, MD
role: PRINCIPAL_INVESTIGATOR
References: