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Trial Title:
Chemoradiotherapy for Advanced Esophageal Cancer
NCT ID:
NCT02297217
Condition:
Esophageal Cancer
Conditions: Official terms:
Esophageal Neoplasms
Paclitaxel
Carboplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Carboplatin and Taxol (paclitaxel)
Description:
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.
Arm group label:
Chemotherapy with Concurrent Radiation
Intervention type:
Radiation
Intervention name:
External Beam Radiation
Description:
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.
Arm group label:
Chemotherapy with Concurrent Radiation
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tom Baker Cancer Centre
Address:
City:
Calgary
Zip:
T2N 4N2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Marc Kerba, MD
Phone:
403-521-3164
Email:
marc.kerba@ahs.ca
Contact backup:
Last name:
Amy Abel
Email:
Amy.Abel@ahs.ca
Start date:
November 21, 2019
Completion date:
April 30, 2025
Lead sponsor:
Agency:
AHS Cancer Control Alberta
Agency class:
Other
Source:
AHS Cancer Control Alberta
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02297217