Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)
NCT ID: NCT04519905
Last Updated: 2021-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
320 participants
INTERVENTIONAL
2020-01-06
2027-12-31
Brief Summary
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Detailed Description
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Three hundred and twenty elderly patients with ESCC would be recruited. There are two stratification factors including 80 years old and lymph node metastasis. The patients in the chemoradiotherapy group were treated with paclitaxel (45mg/m2) and carboplatin (AUC=2) one cycle per week for five cycles.The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival. The life quality questionnaire included QlQ-C30 and OES-18.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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chemoradiotherapy
50.4Gy/28Fx; Paclitaxel plus carboplatin
Paclitaxel plus carboplatin
Paclitaxel （45mg/m2) plus carboplatin (AUC=2); five cycles; qw
radiotherapy
Different radiotherapy dose in different groups.
radiotherapy
61.2Gy/34Fx
radiotherapy
Different radiotherapy dose in different groups.
Interventions
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Paclitaxel plus carboplatin
Paclitaxel （45mg/m2) plus carboplatin (AUC=2); five cycles; qw
radiotherapy
Different radiotherapy dose in different groups.
Eligibility Criteria
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Inclusion Criteria
* The 76 years old for the minimum age a potential participant must meet to be eligible for the clinical study.
* Esophageal squamous cell carcinoma confirmed by pathology
* No radiotherapy, chemotherapy or other treatments prior to enrollment
* Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a, TxN1M0-1a, TxNxM1a, TxNxM1b (M1b only for supraclavicular lymph node metastasis) (AJCC 6th)
* Use of an effective contraceptive for adults to prevent pregnancy
* No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function
* No immunodeficiency
* ECOG 0-1.
* Life expectancy of more than 3 months.
Exclusion Criteria
* Esophageal perforation, or hematemesis
* History of radiotherapy or chemotherapy for esophageal cancer
* History of surgery within 28 days before Day 1
* History of prior malignancies (other than skin basal cell carcinoma or cervical carcinoma in situ with a disease-free survival of at least 3 years)
* Participation in other interventional clinical trials within 30 days
* Pregnant or breast-feeding women or fertile patients
* Drug addiction,
* alcoholism or AIDS
* Uncontrolled seizures or psychiatric disorders
76 Years
ALL
No
Sponsors
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Huadong Hospital
OTHER
Jiangsu Cancer Institute & Hospital
OTHER
Gansu Cancer Hospital
OTHER
The First Affiliated Hospital of Xiamen University
OTHER
Fujian Cancer Hospital
OTHER_GOV
Taihe Hospital
OTHER
Wuxi No. 4 People's Hospital
OTHER
Ningbo No.2 Hospital
OTHER
Fudan University
OTHER
Responsible Party
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Principal Investigators
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Kuaile Zhao, doctor
Role: STUDY_CHAIR
Fudan University
Xiangpeng Zheng, doctor
Role: PRINCIPAL_INVESTIGATOR
Huadong Hospital
Locations
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Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Huadong Hospital
Shanghai, Shanghai Municipality, China
Fudan Universtiy Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jinjun C Ye, M.D.
Role: primary
Xiangpeng Zheng, M.D.
Role: primary
Xiangpeng Zheng
Role: backup
Kuaile Zhao, MD
Role: primary
Other Identifiers
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ESO-Shanghai15
Identifier Type: -
Identifier Source: org_study_id