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Chemoradiotherapy for Advanced Esophageal Cancer (PaRCUS)

Primary Purpose

Esophageal Cancer

Status

Recruiting

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Carboplatin and Taxol (paclitaxel)

External Beam Radiation

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Biopsy proven carcinoma of the esophagus.
Not a candidate for radical/curative treatment due to the advanced nature of the disease, presence of metastases, or intercurrent illness.
Symptomatic patients with Mellow Dysphagia Scores of ≥ 1 i.e. able to eat only some solids.
ECOG Performance status ≤ 2.
Patients able to begin treatment within 14 days of signing the informed consent form.
Patient is at least 18 years old.
Hematological function as defined by the following laboratory parameters:
- Hemoglobin > 100g/L
- Platelet count > 100x10E9/L
- Absolute neutrophil count > 1.5x10E9/L
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
Patients capable of childbearing are using adequate contraception.
Written and informed consent of patient.

Exclusion Criteria:

Previous radiotherapy delivered to the chest.
Synchronous active malignancies.
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.
Patients unfit for any treatment component, including absolute contraindications for radiotherapy or Connective Tissue Disease.
Tracheo-esophageal fistula.
Esophageal stents in situ.
Previous chemotherapy for esophageal cancer
Unable to complete surveys in English without aid of interpreter.

Sites / Locations

Tom Baker Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemotherapy with Concurrent Radiation

Arm Description

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

Outcomes

Primary Outcome Measures

Proportion of patients who achieve relief of dysphagia

Will be measured as the proportion of patients who achieve relief of dysphagia, defined as improvement of at least one point on the Mellow Dysphagia Score, measured at Day 57 after the start of radiotherapy, and maintained for at least 28 calendar days (until the Day 85 visit).

Secondary Outcome Measures

Dysphagia progression free survival

Will be measured from screening to the time of first progression of dysphagia. Progression of dysphagia will be defined as follows: A drop of at least 1 point on the 5 point Mellow Dysphagia Score, Stricture requiring intervention, or Death, Other secondary objectives as follows: Time to achieving any response in dysphagia after treatment as measured by an improvement of at least 1 point on the 5 point Mellow Dysphagia Score. Number of patients receiving secondary treatment (radiation, chemotherapy or stenting), Utility assessments pre to post treatment and at 3 and 6 months, Quality of life differences post treatment and at 3 and 6 months. Measures of biological/serological correlates of response, Acute and late toxicity.

Full Information

NCT ID

NCT02297217

First Posted

November 19, 2014

Last Updated

March 23, 2022

Sponsor

AHS Cancer Control Alberta

1. Study Identification

Unique Protocol Identification Number

NCT02297217

Brief Title

Chemoradiotherapy for Advanced Esophageal Cancer

Acronym

PaRCUS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 21, 2019 (Actual)

Primary Completion Date

April 30, 2024 (Anticipated)

Study Completion Date

April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

AHS Cancer Control Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chemotherapy with Concurrent Radiation

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Carboplatin and Taxol (paclitaxel)

Intervention 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.

Intervention Type

Radiation

Intervention Name(s)

External Beam Radiation

Intervention 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.

Primary Outcome Measure Information:

Title

Proportion of patients who achieve relief of dysphagia

Description

Time Frame

up to day 85

Secondary Outcome Measure Information:

Title

Dysphagia progression free survival

Description

Time Frame

6 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Biopsy proven carcinoma of the esophagus. Not a candidate for radical/curative treatment due to the advanced nature of the disease, presence of metastases, or intercurrent illness. Symptomatic patients with Mellow Dysphagia Scores of ≥ 1 i.e. able to eat only some solids. ECOG Performance status ≤ 2. Patients able to begin treatment within 14 days of signing the informed consent form. Patient is at least 18 years old. Hematological function as defined by the following laboratory parameters: Hemoglobin > 100g/L Platelet count > 100x10E9/L Absolute neutrophil count > 1.5x10E9/L 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 Patients capable of childbearing are using adequate contraception. Written and informed consent of patient. Exclusion Criteria: Previous radiotherapy delivered to the chest. Synchronous active malignancies. 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. Patients unfit for any treatment component, including absolute contraindications for radiotherapy or Connective Tissue Disease. Tracheo-esophageal fistula. Esophageal stents in situ. Previous chemotherapy for esophageal cancer Unable to complete surveys in English without aid of interpreter.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marc Kerba, MD

Phone

403 521 3164

marc.kerba@albertahealthservices.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Amy Abel

Phone

403-476-2506

amy.abel@albertahealthservices.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marc Kerba, MD

Organizational Affiliation

403 521 3164

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tom Baker Cancer Centre

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marc Kerba, MD

Phone

403-521-3164

marc.kerba@ahs.ca

First Name & Middle Initial & Last Name & Degree

Amy Abel

Amy.Abel@ahs.ca

12. IPD Sharing Statement

Learn more about this trial

Chemoradiotherapy for Advanced Esophageal Cancer

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