Chemoradiotherapy for Advanced Esophageal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02297217|
Recruitment Status : Recruiting
First Posted : November 21, 2014
Last Update Posted : November 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Drug: Carboplatin and Taxol (paclitaxel) Radiation: External Beam Radiation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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, 2022|
|Estimated Study Completion Date :||April 30, 2023|
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.
- 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).
- 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
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02297217
|Contact: Marc Kerba, MD||403 521 firstname.lastname@example.org|
|Contact: Jennifer Spratlin, MDemail@example.com|
|Principal Investigator:||Marc Kerba, MD||403 521 3164|