Chemoradiotherapy in Unresectable Esophageal Cancer

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Cancer; Unresectable Malignant Neoplasm; Chemoradiotherapy; Albumin-bound Paxlitaxel
• Intervention / Treatment: Radiation: Radiotherapy; Drug: Albumin-Bound Paclitaxel; Drug: Cisplatin

• Study Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100021
    • Recruiting
    • 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)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Albumin-Bound Paclitaxel and Cisplatin based chemoradiotherapy; Chemoradiotherapy arm receives intensity-modulated radiation therapy, volume modulated arc therapy or tomotherapy concurrently with albumin-bound paclitaxel and cisplatin (weekly intravenous infusion in 5-6 weeks).	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.; Drug: Cisplatin; 25mg/m2 weekly,by intravenous infusion in 5-6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Objective response rate	Objective Response Rate are evaluated by RECIST 1.1	5.5 week
Disease Free Survival		1 year, 2 year
Progression Free Survival		1 year, 2 year
Overall Survival		1 year, 2 year
Radiomics analysis	Radiomics analysis for tumor response and survival prediction with pre- and post-chemoradiotherapy based on MRI and CT simulation	5.5 week
ctDNA analysis	ctDNA analysis to monitor therapeutic efficacy including tumor response and survival outcome	4 week, 2 month, 1 year, 2 year

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms; Esophageal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Cisplatin; Albumin-Bound Paclitaxel
• Other Study ID Numbers: 19/325-2109

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No