Clinical trial NCT06481449: Definitive Radiotherapy for Cervical and Upper Thoracic Esophageal Cancer (ChC&UES): A Multi-center Real World Study
Official title: Definitive Radiotherapy for Cervical and Upper Thoracic Esophageal Cancer (ChC&UES): A Multi-center Real World Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Neoplasm
Lead sponsor: Hebei Medical University Fourth Hospital
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University Cancer Institute and Hospital
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Fujian Cancer Hospital
name: Fudan University
name: Shandong Cancer Hospital and Institute
First posted: 2024-07-01
Enrollment: 2600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is a real-world study. All esophageal cancer patients over 18 years old who received radical radiotherapy in cervical and upper thoracic segment eligible for inclusion were retrospectively collected. This study is a reflection of real-world, no restriction on treatment was made.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival time (OS)
timeFrame: 2000.1.1-2024.6.20
measure: progression-free survival (PFS)
timeFrame: 2000.1.1-2024.6.20
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: 2000.1.1-2024.6.20
Other outcomes:
measure: Side effect
timeFrame: 2000.1.1-2024.6.20
Locations:
city: Shijiazhuang
country: China
facility: Because this study is a response to real-world patient treatment and outcomes
state: Hebei
Study officials:
affiliation: Hebei Medical University Fourth Hospital
name: Wenbin Shen
role: PRINCIPAL_INVESTIGATOR
References: