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)
1 other identifier
interventional
105
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2019
Longer than P75 for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 18, 2020
CompletedFirst Posted
Study publicly available on registry
February 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedDecember 13, 2024
December 1, 2024
6.2 years
February 18, 2020
December 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Number of participants with acute toxicities
10 week, from the start of treatment to 1 month after chemoradiotherapy
Objective response rate
5.5 week
Disease Free Survival
1 year, 2 year
Progression Free Survival
1 year, 2 year
Overall Survival
1 year, 2 year
- +2 more secondary outcomes
Study Arms (1)
Albumin-Bound Paclitaxel and Cisplatin based chemoradiotherapy
EXPERIMENTALChemoradiotherapy 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).
Interventions
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.
100mg/d weekly,repeatedly on the first day,by intravenous infusion in 5-6 weeks.
25mg/m2 weekly,by intravenous infusion in 5-6 weeks.
Eligibility Criteria
You may qualify if:
- \~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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Department 4th of Radiation Oncology, Anyang Cancer Hospital
Anyang, Henan, 455001, China
Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Changsha, Hunan, 410031, China
Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210009, China
Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029, 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, 100021, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xin Wang, MD
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 18, 2020
First Posted
February 20, 2020
Study Start
October 1, 2019
Primary Completion
December 1, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
December 13, 2024
Record last verified: 2024-12