Definitive Radiotherapy for Cervical and Upper Thoracic Esophageal Cancer (ChC&UES): A Multi-center Real World Study

NCT06481449 | Recruiting DMC

• 1 other identifier: 2024KY155
• Study Type: observational
• Target: 2,600
• Locations: 1 country
• Sites: 1

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

Conditions

Esophageal Neoplasm

Outcome Measures

Primary Outcomes (2)

• Overall survival time (OS)

  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.

  2000.1.1-2024.6.20

• progression-free survival (PFS)

  Progression-free survival (PFS) is defined as the time from the start of enrollment until tumor progression or death from any cause.

  2000.1.1-2024.6.20

Secondary Outcomes (1)

• Objective response rate (ORR)

  2000.1.1-2024.6.20

Other Outcomes (1)

• Side effect

  2000.1.1-2024.6.20

Study Arms (2)

High dose radiotherapy (≥60Gy)

Patients who received 60 Gy or more than 60Gy radiation dose for radical radiation therapy for the primary tumor.

Low dose radiotherapy (50-<60Gy)

Patients who received 50-\<60Gy radiation dose for radical radiation therapy for the primary tumor.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age 18 and older.
• Confirmation of esophageal cancer through histopathology or cytology.
• Primary tumor location within the cervical or upper thoracic segment, extending from the upper esophageal sphincter to the azygos vein.
• Absence of distant metastasis.
• Patients unable or unwilling to undergo surgical treatment for various reasons.
• Receipt of radical radiotherapy as the first-line treatment, with or without chemotherapy, immunotherapy, or targeted therapy.
• Undergoing conventional radiation therapy (1.8-2.0Gy per session, once per day).
• Receiving 3DCRT or IMRT radiotherapy.
• Availability of complete radiotherapy prescription dose information and follow-up records.

You may not qualify if:

• Receipt of radiation dose below 50Gy.
• History of other malignancies (except for cured cancer in situ and malignancies cured for over 5 years) or laryngeal invasion.
• Diagnosis of double primary esophageal cancer.
• Prior chest radiation therapy within the past 5 years.
• Recurrent or metastatic esophageal cancer.
• Receipt of 2D radiotherapy, large fractionation, or hyper-fractionation radiotherapy.
• Patients with incomplete radiotherapy dose and follow-up data.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator
• Fujian Cancer Hospital: collaborator
• Fudan University: collaborator
• Shandong Cancer Hospital and Institute: collaborator

Study Sites (1)

Because this study is a response to real-world patient treatment and outcomes

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Wenbin Shen

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenbin Shen

CONTACT

+86 15831183879; wbshen2024@hebmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2024
• First Posted: July 1, 2024
• Study Start: January 1, 2000
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

CN (1)