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Chemoradiotherapy for Advanced Esophageal Cancer
Conditions
Esophageal Cancer
Conditions: official terms
Esophageal Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Carboplatin and Taxol (paclitaxel)
Type: Drug
Name: External Beam Radiation
Type: Radiation
Overall Status
Not yet recruiting
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, 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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 dysphagia scores of ≥ 1 i.e. able to eat only some solids (Mellow Dysphagia Scale).
4. Performance status ECOG ≤ 2.
5. Patients able to begin treatment within 2 weeks of enrollment.
6. Patient is at least 18 years old.
7. Adequate hematological and renal function to undergo chemotherapy.
8. Patients capable of childbearing are using adequate contraception.
9. Written and informed consent of patient.
Exclusion Criteria:
1. Previous Radiotherapy delivered to the chest.
2. Synchronous active malignancies.
3. Pregnant or lactating patients.
4. Patients unfit for any treatment component, including absolute contraindications for radiotherapy such as known DNA repair defects or Connective Tissue Disease.
5. Tracheo-esophageal fistula.
6. Stents in situ.
7. Previous chemotherapy for esophageal cancer
8. Unable to complete surveys in English without aid of interpreter.
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 dysphagia scores of ≥ 1 i.e. able to eat only some solids (Mellow Dysphagia Scale).
4. Performance status ECOG ≤ 2.
5. Patients able to begin treatment within 2 weeks of enrollment.
6. Patient is at least 18 years old.
7. Adequate hematological and renal function to undergo chemotherapy.
8. Patients capable of childbearing are using adequate contraception.
9. Written and informed consent of patient.
Exclusion Criteria:
1. Previous Radiotherapy delivered to the chest.
2. Synchronous active malignancies.
3. Pregnant or lactating patients.
4. Patients unfit for any treatment component, including absolute contraindications for radiotherapy such as known DNA repair defects or Connective Tissue Disease.
5. Tracheo-esophageal fistula.
6. Stents in situ.
7. Previous chemotherapy for esophageal cancer
8. Unable to complete surveys in English without aid of interpreter.
Location
Start Date
February 2015
Completion Date
December 2018
Sponsors
AHS Cancer Control Alberta
Source
AHS Cancer Control Alberta
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page