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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05460403
• Other study ID #: K201427
• Status: Recruiting
• Start date: April 23, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: July 2022
• Source: Chinese Academy of Medical Sciences
• Contact: Zefen Xiao, MD
• Phone: 8610-87787643
• Email: xiaozefen[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3591
• Est. completion date: August 31, 2023
• Est. primary completion date: July 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Cancer
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma

Intervention

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.

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Science	Beijing	Chaoyang

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences	Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

Blom RL, Lagarde SM, van Oudenaarde K, Klinkenbijl JH, Hulshof MC, van Laarhoven HW, Bergman JJ, Busch OR, van Berge Henegouwen MI. Survival after recurrent esophageal carcinoma has not improved over the past 18 years. Ann Surg Oncol. 2013 Aug;20(8):2693-8. doi: 10.1245/s10434-013-2936-3. Epub 2013 Apr 3. — View Citation

Deng W, Yang J, Ni W, Li C, Chang X, Han W, Zhou Z, Chen D, Feng Q, Liang J, Lv J, Wang X, Wang X, Deng L, Wang W, Bi N, Zhang T, Li Y, Gao S, Xue Q, Mao Y, Sun K, Liu X, Fang D, Wang D, Li J, Zhao J, Shao K, Li Z, Chen X, Han L, Wang L, He J, Xiao Z. Postoperative Radiotherapy in Pathological T2-3N0M0 Thoracic Esophageal Squamous Cell Carcinoma: Interim Report of a Prospective, Phase III, Randomized Controlled Study. Oncologist. 2020 Apr;25(4):e701-e708. doi: 10.1634/theoncologist.2019-0276. Epub 2020 Feb 21. — View Citation

Hsu PK, Chen HS, Huang CS, Liu CC, Hsieh CC, Hsu HS, Wu YC, Wu SC. Patterns of recurrence after oesophagectomy and postoperative chemoradiotherapy versus surgery alone for oesophageal squamous cell carcinoma. Br J Surg. 2017 Jan;104(1):90-97. doi: 10.1002/bjs.10334. Epub 2016 Nov 15. — View Citation

Ni W, Yu S, Xiao Z, Zhou Z, Chen D, Feng Q, Liang J, Lv J, Gao S, Mao Y, Xue Q, Sun K, Liu X, Fang D, Li J, Wang D, Zhao J, Gao Y. Postoperative Adjuvant Therapy Versus Surgery Alone for Stage IIB-III Esophageal Squamous Cell Carcinoma: A Phase III Randomized Controlled Trial. Oncologist. 2021 Dec;26(12):e2151-e2160. doi: 10.1002/onco.13914. Epub 2021 Aug 19. — View Citation

Parry K, Visser E, van Rossum PS, Mohammad NH, Ruurda JP, van Hillegersberg R. Prognosis and Treatment After Diagnosis of Recurrent Esophageal Carcinoma Following Esophagectomy with Curative Intent. Ann Surg Oncol. 2015 Dec;22 Suppl 3:S1292-300. doi: 10.1245/s10434-015-4840-5. Epub 2015 Sep 3. — View Citation

Rice TW, Chen LQ, Hofstetter WL, Smithers BM, Rusch VW, Wijnhoven BP, Chen KL, Davies AR, D'Journo XB, Kesler KA, Luketich JD, Ferguson MK, Räsänen JV, van Hillegersberg R, Fang W, Durand L, Cecconello I, Allum WH, Cerfolio RJ, Pera M, Griffin SM, Burger R, Liu JF, Allen MS, Law S, Watson TJ, Darling GE, Scott WJ, Duranceau A, Denlinger CE, Schipper PH, Lerut TE, Orringer MB, Ishwaran H, Apperson-Hansen C, DiPaola LM, Semple ME, Blackstone EH. Worldwide Esophageal Cancer Collaboration: pathologic staging data. Dis Esophagus. 2016 Oct;29(7):724-733. doi: 10.1111/dote.12520. — View Citation

Rice TW, Ishwaran H, Hofstetter WL, Kelsen DP, Apperson-Hansen C, Blackstone EH; Worldwide Esophageal Cancer Collaboration Investigators. Recommendations for pathologic staging (pTNM) of cancer of the esophagus and esophagogastric junction for the 8th edition AJCC/UICC staging manuals. Dis Esophagus. 2016 Nov;29(8):897-905. doi: 10.1111/dote.12533. — View Citation

Xiao ZF, Yang ZY, Liang J, Miao YJ, Wang M, Yin WB, Gu XZ, Zhang DC, Zhang RG, Wang LJ. Value of radiotherapy after radical surgery for esophageal carcinoma: a report of 495 patients. Ann Thorac Surg. 2003 Feb;75(2):331-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	From the date of surgery to the date of death or last follow-up	up to 5 years
Primary	Overall survival (OS)	From the date of surgery to the date of death or the most recent follow-up.	up to 5 years
Secondary	Disease-free survival (DFS)	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.	up to 5 years
Secondary	Local-regional recurrence-free survival (LRFS)	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.	up to 5 years
Secondary	Distant metastasis (DM)	From the date of surgery to the date of metastasis in distant lymph nodes, distant organs or the most recent follow-up.	up to 5 years

External Links

•   It is a national center for cancer research and treatment. It is one of the clinical trial bases approved by the Food and Drug Administration of State (SFDA)