Adjuvant Radiotherapy for Patients With Esophageal Squamous Cell Carcinoma After R0 Resection

NCT ID: NCT05460403

Last Updated: 2022-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 3591 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-23
• Study Completion Date: 2023-08-31

Brief Summary

This retrospective study is exploring the treatment effect and toxicity of adjuvant radiotherapy in patients diagnosed with esophageal squamous cell carcinoma after R0 resection.

Detailed Description

Surgery is one of the most important curative approaches for esophageal cancer. In real-world clinical practice, over 50% of the patients receiving surgical resection as primary management. For patients treated with surgical resection without adjuvant therapy, the probability of local-regional recurrence ranged from 23.0% to 56.5%, accounting for 55.6%-84.5% of the disease recurrence. Once encountering disease recurrence, the subsequent prognosis could be dismal. The median survival time after postoperative disease recurrence ranged from 3 to 8 months. Postoperative radiotherapy (PORT) was one of the potential topical treatment approaches prolonging local-regional recurrence time or moreover, attaining superior disease-free survival (DFS) or overall survival (OS) in selected patients. It is essential to identify patients potentially benefit from PORT. Besides, there were few studies evaluating the impact of postoperative radiation dose to survival outcomes in patients receiving PORT. Whether the PORT-related local-regional recurrence free survival (LRFS) enhancement could convert to OS or DFS improvement is still vague. The current study aimed at evaluating the value of PORT in patients diagnosed with esophageal squamous cell carcinoma after R0 resection.

Conditions

Esophageal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Surgery alone

patients without adjuvant radiotherapy after R0 resection.

No interventions assigned to this group

Adjuvant Radiotherapy

patients treated with adjuvant radiotherapy after R0 resection.

Adjuvant Radiotherapy

Intervention Type: RADIATION

Patients undergo radiotherapy once daily 5 days a week for an average of 5.5 weeks within 12 weeks after surgery in the absence of disease progression or unacceptable toxicity.

Interventions

Adjuvant Radiotherapy

Patients undergo radiotherapy once daily 5 days a week for an average of 5.5 weeks within 12 weeks after surgery in the absence of disease progression or unacceptable toxicity.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• KPS≥70
• Pathologically diagnosis of esophageal cancer
• Complete resection (R0 resection)

Exclusion Criteria

• Diagnosed with other malignancy within 5 years before surgery
• Encountered recurrence or port-site implantation receiving palliative-intended radiotherapy
• Diagnosed with adenosquamous carcinoma or basal cell-like carcinoma
• Treated with PORT with uncertain radiation dose
• Treated with PORT with radiation dose > 60Gy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Zefen Xiao

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zefen Xiao, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Science

Locations

Cancer Institute and Hospital, Chinese Academy of Medical Science

Beijing, Chaoyang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zefen Xiao, MD

Role: CONTACT

xiaozefen@sina.com

8610-87787643

Weiming Han, MD

Role: CONTACT

weiming_han@163.com

86-13661373730

Facility Contacts

Zefen Xiao, MD

Role: primary

xiaozefen@sina.com

8610-87787463

Weiming Han, MD

Role: backup

weiming_han@163.com

86-13661373730

References

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Reference Type: BACKGROUND

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Related Links

http://www.cicams.ac.cn

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Other Identifiers

K201427

Identifier Type: -

Identifier Source: org_study_id