Esophageal Neoplasm
Conditions
Brief summary
Cervical and upper thoracic esophageal cancer (ESCA) presents treatment challenges due to limited clinical evidence. This multi-center study (ChC&UES) explores radical radio(chemo)therapy efficacy and safety
Detailed description
Cervical and upper thoracic esophageal cancer (ESCA) are relatively rare diseases, presenting treatment challenges due to limited clinical evidence. This multi-center study (ChC&UES) explores radical radiotherapy efficacy and safety, especially focusing on radiation dose. This study collected all eligible patients diagnosed with cervical and upper thoracic ESCA from 6 medical centers (Tianjin Cancer Hospital, Cancer Hospital of the Chinese Academy of Medical Sciences, Fujian Cancer Hospital, Fudan University Shanghai Cancer Center, Shandong Cancer Hospital and the Fourth Hospital of Hebei Medical University) in China. Patients were categoried into two group (low dose radiation group and high dose radiation group) based on radiation dose. Basic clinical information, including age, gender, ECOG score, pathological type, smoking and drinking history, initial visit date, radiotherapy dose, radiotherapy method, concurrent chemotherapy modality, immunotherapy, targeted drug usage, treatment efficacy assessment, toxicity and side effects and survival time was collected. Kaplan-Meier method was used to calculate OS, survival differences were assessed using the log-rank test. Univariate analysis was conducted via Cox regression modeling, with variables demonstrating P values \< 0.1 being included in multivariate analysis. A significance level of two-sided P \< 0.05 was considered statistically significant. The aim of this study was to compared the overall survival time between low dose radiation group and high dose radiation dose group and compared the underlying side effects.
Interventions
None listed
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Fujian Cancer Hospital
Fudan University
Shandong Cancer Hospital and Institute
Hebei Medical University Fourth Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 and older. 2. Confirmation of esophageal cancer through histopathology or cytology. 3. Primary tumor location within the cervical or upper thoracic segment, extending from the upper esophageal sphincter to the azygos vein. 4. Absence of distant metastasis. 5. Patients unable or unwilling to undergo surgical treatment for various reasons. 6. Receipt of radical radiotherapy as the first-line treatment, with or without chemotherapy, immunotherapy, or targeted therapy. 7. Undergoing conventional radiation therapy (1.8-2.0Gy per session, once per day). 8. Receiving 3DCRT or IMRT radiotherapy. 9. Availability of complete radiotherapy prescription dose information and follow-up records.
Exclusion criteria
1. Receipt of radiation dose below 50Gy. 2. History of other malignancies (except for cured cancer in situ and malignancies cured for over 5 years) or laryngeal invasion. 3. Diagnosis of double primary esophageal cancer. 4. Prior chest radiation therapy within the past 5 years. 5. Recurrent or metastatic esophageal cancer. 6. Receipt of 2D radiotherapy, large fractionation, or hyper-fractionation radiotherapy. 7. Patients with incomplete radiotherapy dose and follow-up data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival time (OS) | 2000.1.1-2024.6.20 | Compared the differences in overall survival (OS) between low dose radiation and high dose radiation group after definitive radiotherapy. OS is defined as time from start of enrollment to death from any cause. |
| progression-free survival (PFS) | 2000.1.1-2024.6.20 | Progression-free survival (PFS) is defined as the time from the start of enrollment until tumor progression or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 2000.1.1-2024.6.20 | The Objective Response Rate (ORR) is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). Measures the effectiveness of a cancer treatment by showing the percentage of patients whose tumors shrink significantly within a specified time. ORR includes: Complete Response (CR): All target tumors disappear, and no new tumors appear.Partial Response (PR): The size of target tumors decreases by at least 30%, and no new tumors appear. The proportion of patients who achieve CR+PR was ORR. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Side effect | 2000.1.1-2024.6.20 | The investigators employed the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, to assess treatment-related adverse effects during and after the course of treatmen |
Countries
China
Contacts
Primary ContactWenbin Shen
Outcome results
None listed