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

Sponsor

Chinese Academy of Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT05460403

Collaborator

Fujian Cancer Hospital (Other)

3,591

Enrollment

Location

16.3

Anticipated Duration (Months)

220.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Radiation: Adjuvant Radiotherapy

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

3591 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Apr 23, 2022

Anticipated Primary Completion Date :

Jul 2, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Surgery alone patients without adjuvant radiotherapy after R0 resection.
Adjuvant Radiotherapy patients treated with adjuvant radiotherapy after R0 resection.	Radiation: 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.

Arm

Intervention/Treatment

Surgery alone

patients without adjuvant radiotherapy after R0 resection.

Adjuvant Radiotherapy

patients treated with adjuvant radiotherapy after R0 resection.

Radiation: 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.

Outcome Measures

Primary Outcome Measures

Overall survival (OS) [up to 5 years]
From the date of surgery to the date of death or the most recent follow-up.

Secondary Outcome Measures

Disease-free survival (DFS) [up to 5 years]
From 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 years]
From 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 years]
From the date of surgery to the date of metastasis in distant lymph nodes, distant organs or the most recent follow-up.

Other Outcome Measures

Adverse events [up to 5 years]
From the date of surgery to the date of death or last follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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