Chemoradiotherapy for Advanced Esophageal Cancer (PaRCUS)

• ClinicalTrials.gov Identifier: NCT02297217
• Recruitment Status: Recruiting
• First Posted: November 21, 2014
• Last Update Posted: April 4, 2022
• Sponsor: AHS Cancer Control Alberta
• Information provided by (Responsible Party): Marc Kerba, AHS Cancer Control Alberta

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.

Condition or disease	Intervention/treatment	Phase
Esophageal Cancer	Drug: Carboplatin and Taxol (paclitaxel); Radiation: External Beam Radiation	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Study of Palliative Chemo-Radiotherapy With Carbo-Taxol in Non-Curative Cancer of the Esophagus
• Actual Study Start Date: November 21, 2019
• Estimated Primary Completion Date: April 30, 2024
• Estimated Study Completion Date: April 30, 2025

Arms and Interventions

Arm

Intervention/treatment

Experimental: Chemotherapy with Concurrent Radiation; Carboplatin and paclitaxel will be administered intravenously on Days 1 and 8 while radiation therapy is administered

Drug: 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.; Radiation: 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.

Outcome Measures

Primary Outcome Measures :

1. Proportion of patients who achieve relief of dysphagia [ Time Frame: up to day 85 ]
   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 :

1. Dysphagia progression free survival [ Time Frame: 6 Months ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Marc Kerba, MD; 403 521 3164; marc.kerba@albertahealthservices.ca

Contact: Amy Abel; 403-476-2506; amy.abel@albertahealthservices.ca

Locations

Canada, Alberta

Tom Baker Cancer Centre; Recruiting

Calgary, Alberta, Canada, T2N 4N2

Contact: Marc Kerba, MD 403-521-3164 marc.kerba@ahs.ca

Contact: Amy Abel Amy.Abel@ahs.ca

Sponsors and Collaborators

AHS Cancer Control Alberta

Investigators

• Principal Investigator: Marc Kerba, MD; 403 521 3164

More Information

• Responsible Party: Marc Kerba, MD, AHS Cancer Control Alberta
• ClinicalTrials.gov Identifier: NCT02297217
• Other Study ID Numbers: HREBA.CC-14-0122
• First Posted: November 21, 2014
• Last Update Posted: April 4, 2022
• Last Verified: March 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Paclitaxel; Carboplatin; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action