Clinical trial NCT05460403: Adjuvant Radiotherapy for Patients With Esophageal Squamous Cell Carcinoma After R0 Resection
Official title: Adjuvant Radiotherapy for Patients With Esophageal Squamous Cell Carcinoma After R0 Resection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Cancer
Keywords: esophageal cancer
postoperative radiotherapy
adjuvant radiotherapy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Fujian Cancer Hospital
First posted: 2022-07-15
Enrollment: 3591
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with esophageal squamous cell carcinoma after R0 resection were enrolled from January 1993 and December 2012.

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.

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

Primary outcomes:
measure: Overall survival (OS)
timeFrame: up to 5 years
Secondary outcomes:
measure: Disease-free survival (DFS)
timeFrame: up to 5 years
measure: Local-regional recurrence-free survival (LRFS)
timeFrame: up to 5 years
measure: Distant metastasis (DM)
timeFrame: up to 5 years
Other outcomes:
measure: Adverse events
timeFrame: up to 5 years
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Science
state: Chaoyang
Study officials:
affiliation: Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Science
name: Zefen Xiao, MD
role: PRINCIPAL_INVESTIGATOR
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