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The incidence and mortality of esophageal cancer are at the forefront in China, among which the elderly patients account for a large proportion. Concurrent chemoradiotherapy is the standard treatment for inoperable locally advanced esophageal cancer. Most elderly patients with esophageal cancer cannot tolerate concurrent chemotherapy because of complications and other reasons. Immunotherapy has definite efficacy and low toxicity in advanced esophageal squamous cell carcinoma, and the results combined with radiotherapy have also been preliminarily reported. Therefore, it is necessary to further explore the efficacy and safety of radiotherapy combined with immunotherapy in elderly patients with esophageal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exprimental Arm | Experimental | IMRT plus Durvalumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | IMRT (Intensity Modulated RT) or 3D-CRT (three-dimensional conformal radiotherapy); 95% PGTV 59.92Gy/2.14Gy/28f; 95% GTVnd 59.92Gy/2.14Gy/28f; 95% PTV 50.40Gy/1.80Gy/28f; 5 days a week; 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | PFS was assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1. Progression-free survival defined as the time from enrollment to the first documented disease progression of local recurrence or distant metastasis or death due to any cause. | 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Overall survival defined as the time from enrollment to death due to any cause. | 1-, 2- and 3-year |
| Progression-free survival (PFS) | PFS was assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1. Progression-free survival defined as the time from enrollment to the first documented disease progression of local recurrence or distant metastasis or death due to any cause. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QOL): questionnaire EORTC QLQ-OES18 | Evaluate the quality of life via questionnaire EORTC QLQ-OES18, minimum value 18, maximum value 72, higher scores mean a better outcome. | up to 60 weeks |
Inclusion Criteria:
Age 70-85 years old, both men and women
Histologically confirmed esophageal squamous cell carcinoma located in thoracic segment, treatment naive
Stage cT2-4aNanyM0 (AJCC 8 TNM classification)
Unresectable, unable to tolerate or refuse surgery and concurrent chemoradiotherapy
ECOG PS 0-2
Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
No severe abnormalities of the Hematologic system, heart, lung, liver, kidney, and immunodeficiency
Adequate bone marrow and organ function as defined below (excluding the use of any blood components and cell growth factors within 7 days):
INR or PT or aPTT ≤ 1.5 x ULN
Life expectancy more than 6 months
Ability to understand and willingness to sign an IRB approved written informed consent document, and capable of proper therapeutic compliance, and accessible to correct follow-up
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | 100021 | China |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| C000613593 | durvalumab |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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RT + Durvalumab
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| Durvalumab | Drug | Durvalumab 1000 mg, intravenously (IV), on Day 1 of radiotherapy, every 3 weeks for up to 18 administrations. |
|
| 2- and 3-year |
| Objective Response Rate (ORR) | ORR was Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). | during the intervention up to 60 weeks |
| Disease Control Rate (DCR) | DCR was Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). | during the intervention up to 60 weeks |
| Number of participants with an adverse event | Evaluanted by CTCAE 5.0 | Up to 60 weeks |
| Quality of Life (QOL): questionnaire EORTC QLQ-C30 (version 3) | Evaluate the quality of life via questionnaire EORTC QLQ-C30 (version 3), minimum value 30, maximum value 126, higher scores mean a worse outcome. | up to 60 weeks |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |