Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Cancer (HCHTOG1903)

Esophageal Squamous Cell Carcinoma Clinical Trial

— HCHTOG1903  

Official title:

Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized, Controlled Clinical Trial (HCHTOG1903)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04138212
• Other study ID #: 2019082223
• Status: Recruiting
• Phase: Phase 3
• Start date: October 22, 2019
• Est. completion date: December 21, 2028

Study information

• Verified date: August 2022
• Source: Henan Cancer Hospital
• Contact: Haibo Sun
• Phone: +8615188301091
• Email: sunny-haipo[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multimodal treatment combining surgery with chemotherapy and/or radiotherapy is necessary to improve the chances of survival in patients with locally advanced thoracic esophageal cancer. However, there is no consensus about the neoadjuvant treatment for resectable locally advanced esophageal squamous cell carcinoma. The aim of current randomized controlled clinical trail is to investigate the impact of neoadjuvant chemotherapy plus surgery and neoadjuvant chemoradiation therapy plus surgery on overall survival for patients with resectable locally advanced esophageal squamous cell carcinoma. The investigators plan to enroll 456 patients with locally advanced esophageal squamous cell carcinoma in 3 years. Eligible patients will be randomized into neoadjuvant chemotherapy group (paclitaxel 175mg/m2 plus cisplatin 75mg/m2, q21d, 2 cycles) or neoadjuvant chemoradiation group (41.4Gy, 1.8Gy*23d plus paclitaxel 50mg/m2 plus carboplatin AUC=2, q1w, 5 cycles). The primary endpoint is 5 year overall survival and the secondary endpoints include 5 year disease-free survival, adverse events, pathologic complete response, postoperative complications, quality of life. The biomarkers predicting the sensitivity of neoadjuvant therapy will be explored.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 456
• Est. completion date: December 21, 2028
• Est. primary completion date: December 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• cT2-T4aN+M0 or cT3-4aN0M0 (8th TNM staging system) thoracic esophageal squamous cell carcinoma
• No metastatic cervical lymph node
• No anti-cancer treatment
• No contraindication for esophagectomy
• No contraindication for chemotherapy or chemoradiation therapy
• PS score 0-1
• Written consent is obtained

Exclusion Criteria:

• Previous cancer treatment history
• Concurrent cancer disease in other site
• Tumor length =8cm
• Tumor width =5cm
• Need continuous steroid treatment
• Cardiac infarction in 6 months
• Psychotic patient
• Can not achieve R0 resection
• Gastric tube can not be used for reconstruction after esophagectomy
• Pregnant woman

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Paclitaxel, Cisplatin
Paclitaxel 175mg/m2 plus Cisplatin 75mg/m2, q21d, 2 cycles

Radiation:
• neoadjuvant chemoradiation therapy
Paclitaxel 50mg/m2 plus Carboplatin AUC=2, q1w, 5 cycles; 41.4Gy, 1.8Gy/d*23

Locations

Country	Name	City	State
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (20)

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Shiraishi O, Yamasaki M, Makino T, Motoori M, Miyata H, Shinkai M, Kimura Y, Hirao M, Fujitani K, Tamura S, Kobayashi K, Yano M, Doki Y, Yasuda T. Feasibility of Preoperative Chemotherapy with Docetaxel, Cisplatin, and 5-Fluorouracil versus Adriamycin, Cisplatin, and 5-Fluorouracil for Resectable Advanced Esophageal Cancer. Oncology. 2017;92(2):101-108. doi: 10.1159/000452765. Epub 2016 Dec 2. — View Citation

Sjoquist KM, Burmeister BH, Smithers BM, Zalcberg JR, Simes RJ, Barbour A, Gebski V; Australasian Gastro-Intestinal Trials Group. Survival after neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal carcinoma: an updated meta-analysis. Lancet Oncol. 2011 Jul;12(7):681-92. doi: 10.1016/S1470-2045(11)70142-5. Epub 2011 Jun 16. — View Citation

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Tang H, Tan L, Shen Y, Wang H, Lin M, Feng M, Xu S, Guo W, Qian C, Liu T, Zeng Z, Hou Y, Yu Z, Jiang H, Li Z, Chen C, Lian C, Du M, Li H, Xie D, Yin J, Zhao N, Wang Q. CMISG1701: a multicenter prospective randomized phase III clinical trial comparing neoadjuvant chemoradiotherapy to neoadjuvant chemotherapy followed by minimally invasive esophagectomy in patients with locally advanced resectable esophageal squamous cell carcinoma (cT(3-4a)N(0-1)M(0)) (NCT03001596). BMC Cancer. 2017 Jun 28;17(1):450. doi: 10.1186/s12885-017-3446-7. — View Citation

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Yamasaki M, Yasuda T, Yano M, Hirao M, Kobayashi K, Fujitani K, Tamura S, Kimura Y, Miyata H, Motoori M, Shiraishi O, Makino T, Satoh T, Mori M, Doki Y. Multicenter randomized phase II study of cisplatin and fluorouracil plus docetaxel (DCF) compared with cisplatin and fluorouracil plus Adriamycin (ACF) as preoperative chemotherapy for resectable esophageal squamous cell carcinoma (OGSG1003). Ann Oncol. 2017 Jan 1;28(1):116-120. doi: 10.1093/annonc/mdw439. — View Citation

Yang H, Liu H, Chen Y, Zhu C, Fang W, Yu Z, Mao W, Xiang J, Han Y, Chen Z, Yang H, Wang J, Pang Q, Zheng X, Yang H, Li T, Lordick F, D'Journo XB, Cerfolio RJ, Korst RJ, Novoa NM, Swanson SJ, Brunelli A, Ismail M, Fernando HC, Zhang X, Li Q, Wang G, Chen B, Mao T, Kong M, Guo X, Lin T, Liu M, Fu J; AME Thoracic Surgery Collaborative Group. Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial. J Clin Oncol. 2018 Sep 20;36(27):2796-2803. doi: 10.1200/JCO.2018.79.1483. Epub 2018 Aug 8. — View Citation

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* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		5 year
Secondary	disease-free survival		5 year
Secondary	pathological complete response		3 months
Secondary	adverse events		3 months
Secondary	postoperative complications		3 months