Chemoradiotherapy for Advanced Esophageal Cancer

NCT ID: NCT02297217

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-21
• Study Completion Date: 2028-04-30

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.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemotherapy with Concurrent Radiation

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

Group Type: EXPERIMENTAL

Carboplatin and Taxol (paclitaxel)

Intervention Type: DRUG

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

Intervention Type: 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.

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.

Intervention Type: DRUG

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.

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AHS Cancer Control Alberta

OTHER

Sponsor Role: lead

Responsible Party

Marc Kerba

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marc Kerba, MD

Role: PRINCIPAL_INVESTIGATOR

5872316617

Locations

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Marilyn David

Role: CONTACT

marilyn.david@cancercarealberta.ca

5872315492

Amy Abel

Role: CONTACT

amy.abel@albertahealthservices.ca

Facility Contacts

Marc Kerba, MD

Role: primary

marc.kerba@ahs.ca

403-521-3164

Amy Abel

Role: backup

Amy.Abel@ahs.ca

Other Identifiers

HREBA.CC-14-0122

Identifier Type: -

Identifier Source: org_study_id