Chemoradiotherapy in Esophageal or Esophagogastric Junction Cancer

Chemotherapy Effect Clinical Trial

Official title:

Cohort Study of Definitive Chemoradiotherapy for Esophageal or Esophagogastric Junction Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04821778
• Other study ID #: NCC2722
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2002
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2022
• Source: Chinese Academy of Medical Sciences
• Contact: Xin Wang, MD
• Phone: +861013311583220
• Email: beryl_wx2000[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Definitive chemoradiotherapy is the standard of care in unresectable esophageal or esophagogastric cancer. A multidisciplinary approach, including chemotherapy and radiotherapy, is important for these patients. Morerover, molecular targeting agents does not show clear efficacy in EC up to now. Nowadays, the pace of development of cancer immunotherapies is accelerating. Clinical evidence of the efficacy of immune checkpoint inhibitors and adoptive immunotherapies herald the onset of a new era in cancer immunotherapy. There have also been recent developments to provide a promising frontier in extending the use of immunotherpay or targeting agents to radiotherapy. The purpose of this study was to explore the optimal treatment modalities including PD-1/PD-L1 antibody or targeted drug for patients with unresectable esophageal or esophagogastric junction cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years;

• Esophageal or Esophagogastric cancer;

• Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as I-IVa(AJCC 8th);

• Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences;

• ECOG PS score: 0~1;

• Estimated survival time =3 months;

• Normal organ and marrow function as defined below:Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 4,000 G/L; Neutrophil: greater than or equal to 2,000 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml/min; AST/ALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit;

• Informed consent;

Exclusion Criteria:

• With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc;

• Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer;

• Existing active infection such as active tuberculosis and hepatitis;

• History of myocardial infarction within the past 6 months or history of ventricular arrhythmia;

• Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness History of allergic reactions attributed to paclitaxel, albumin or cisplatin;

• Participation in other clinical trials currently or within 4 weeks of selection;

• Pregnant or lactating females;

• Absence of medical records.

Related Conditions & MeSH terms

• Chemoradiation
• Chemotherapy Effect
• Esophageal Neoplasms
• Esophagogastric Junction Cancer
• Esophagus Cancer
• Immunotherapy
• Targeted Therapy

Intervention

Radiation:
• Radiotherapy
50-66Gy/1.8-2.2Gy/25-30f

Drug:
• Platinum based chemotherapy
q1-3W according to physician's preference
• Paclitaxel based chemotherapy
q1-3W according to physician's preference
• Immunotherapy
Anti-PD-1/PD-L1 Antibody
• 5-FU Analog based chemotherapy
W1-5 qW or d1-14, q3W according to physician's preference
• Nimotuzumab
200-400mg, d1,qW

Locations

Country	Name	City	State
China	Department 4th of Radiation Oncology, Anyang Cancer Hospital	Anyang	Henan
China	Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)	Beijing
China	Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University	Changsha
China	Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University	Nanjing
China	Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Analysis of correlation between radiomics signature extracted by LASSO and the number of participants with treatment-related adverse events as assessed by CTCAE v4.0.		1 year, 2 year, 3 year, 5 year
Other	Radiomics analysis	Analysis of correlation between radiomics signature extracted by LASSO and the rate of participants who achieve pathological complete response (pCR) and the overall survival based on MRI and CT simulation.	1 year, 2 year, 3 year, 5 year
Primary	Overall survival		1year
Primary	Overall survival		2 year
Primary	Overall survival		3 year
Primary	Overall survival		5 year
Secondary	Progression free survival		1 year, 2 year, 3 year, 5 year
Secondary	Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy		3 months
Secondary	Pathological response rate	Pathological response were classified into three grades.Grade I signifies that there is little shrinkage in the tumor; only mild regression in the tumor cells is observed under themicroscope. Grade II shows gross reduction in size of the tumor and marked regression in the cancer cells microscopically, yet viable nests of cancer tissue are still visible. Grade III implies complete or almost total resolution of the tumor on exploration, and disappearance of the tumor tissue microscopically; only remnants of degenerated cancer cells can be seen (so-called ghost cancer cells).	3 months
Secondary	R0 resection rate		3 months
Secondary	Locoregional recurrence free survival		1 year, 2 year, 3 year, 5 year
Secondary	Distant metastasis free survival		1 year, 2 year, 3 year, 5 year