Chemoradiotherapy in Unresectable Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

A Phase I/II Study of Chemoradiotherapy Using Albumin-Bound Paclitaxel and Cisplatin in Unresectable Esophageal Squamous Cell Carcinomas Based on Nutritional Risk Screening Score (NRS2002)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04278287
• Other study ID #: 19/325-2109
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 1, 2019
• Est. completion date: September 2022

Study information

• Verified date: August 2021
• 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

This phase I/II clinical study is designed to evaluate the 1 year local tumor control rate of chemoradiotherapy using albumin-bound paclitaxel and cisplatin in unresectable esophageal squamous cell carcinomas based on Nutritional Risk Screening NRS2002.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18~75 years

• Pathologically or cytologically proven unresectable esophageal squamous cell carcinomas in patients staged as T3N1M0-1b and T4N0-1M0-1b(AJCC 6th TNM staging,M1b limited to clavicular or celiac lymph node metastasis)

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

• ECOG PS score: 0~1

• NRS2002 score <3

• 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

Related Conditions & MeSH terms

• Albumin-bound Paxlitaxel
• Chemoradiotherapy
• Esophageal Cancer
• Esophageal Neoplasms
• Neoplasms
• Unresectable Malignant Neoplasm

Intervention

Radiation:
• Radiotherapy
59.92Gy and 2.14Gy in 28 fractions to PGTV and 50.4Gy and 1.8Gy in 28 fractions 5 days every week in 5.5 weeks.

Drug:
• Albumin-Bound Paclitaxel
100mg/d weekly,repeatedly on the first day,by intravenous infusion in 5-6 weeks.
• Cisplatin
25mg/m2 weekly,by intravenous infusion in 5-6 weeks.

Locations

Country	Name	City	State
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

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
Primary	Local control rate	Control rate of primary esophageal cancer and metastatic lymph nodes within irradiation fields	1 year from the start of treatment to tumor recurrence
Secondary	Number of participants with acute toxicities	Acute toxicities are evaluated by NCI-CTC version 5.0	10 week, from the start of treatment to 1 month after chemoradiotherapy
Secondary	Objective response rate	Objective Response Rate are evaluated by RECIST 1.1	5.5 week
Secondary	Disease Free Survival		1 year, 2 year
Secondary	Progression Free Survival		1 year, 2 year
Secondary	Overall Survival		1 year, 2 year
Secondary	Radiomics analysis	Radiomics analysis for tumor response and survival prediction with pre- and post-chemoradiotherapy based on MRI and CT simulation	5.5 week
Secondary	ctDNA analysis	ctDNA analysis to monitor therapeutic efficacy including tumor response and survival outcome	4 week, 2 month, 1 year, 2 year