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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05460403
Enrollment
3591
Registered
2022-07-15
Start date
2022-04-23
Completion date
2023-08-31
Last updated
2022-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

esophageal cancer, postoperative radiotherapy, adjuvant radiotherapy

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.

Interventions

RADIATIONAdjuvant 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.

Sponsors

Fujian Cancer Hospital
CollaboratorOTHER_GOV
Chinese Academy of Medical Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall survival (OS)up to 5 yearsFrom the date of surgery to the date of death or the most recent follow-up.

Secondary

MeasureTime frameDescription
Disease-free survival (DFS)up to 5 yearsFrom the date of surgery to the date of any evidence of disease recurrence (recurrence in the tumor bed, anastomotic orifice, or in the regional lymph nodes, or metastasis in distant lymph nodes or distant organs), death or the most recent follow-up.
Local-regional recurrence-free survival (LRFS)up to 5 yearsFrom the date of surgery to the date of recurrence in the tumor bed, anastomotic orifice, regional lymph nodes or the most recent follow-up.
Distant metastasis (DM)up to 5 yearsFrom the date of surgery to the date of metastasis in distant lymph nodes, distant organs or the most recent follow-up.

Other

MeasureTime frameDescription
Adverse eventsup to 5 yearsFrom the date of surgery to the date of death or last follow-up

Countries

China

Contacts

Primary ContactZefen Xiao, MD
xiaozefen@sina.com8610-87787643
Backup ContactWeiming Han, MD
weiming_han@163.com86-13661373730

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026