S-1 IMRT Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma

Prospective, Randomized, Multicenter, Phase II Noninferiority Study of S-1 Concurrent Intensity-modulated Radiation Therapy (IMRT) Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma

Will meet the inclusion criteria of patients with esophageal squamous cell carcinoma, divided into 2 groups randomly:

Experimental group: radiotherapy combined with S-1 chemotherapy.

Control group: radiotherapy combined with S-1 chemotherapy and cisplatin.

Study Overview

• Status: Unknown
• Conditions: Esophageal Squamous Cell Carcinoma
• Intervention / Treatment: Other: S-1 concurrent radiotherapy; Other: S-1 plus Cisplatin concurrent radiotherapy

Detailed Description

Will meet the inclusion criteria of patients with unresectable esophageal squamous cell carcinoma, divided into 2 groups randomly:

Experimental group: radiotherapy combined with S-1 chemotherapy;

control group: radiotherapy combined with S-1 chemotherapy for first to 14 days and 29 ~ 42 days, plus cisplatin first 1~ 4 days and 29 ~ 33 days. Using IMRT radiotherapy.

Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1~ 14 days, or S-1 70 mg/m2 1~ 14 days, plus cisplatin 25mg/m2 1~ 4 days, 21 days for a cycle.

Primary Outcome Measure is complete remission rate.

Secondary Outcome Measures are overall survival (OS) and Progression-Free-Survival (PFS) and toxicity.

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Sichaung
    • Mianyang, Sichaung, China, 621000
      • Recruiting
      • Xiaobo du
      • Contact: Xaiobo Du, MD; Phone Number: +86 08162230478; Email: duxiaobo2005@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Histology or cytology confirmed esophageal squamous cell carcinoma.
2. There are measurable lesions in the RECIST standard.
3. American Joint Committee on Cancer/Union Internationale Contre le Cancer esophageal cancer staging (Sixth Edition) clinical stage II a~ IV B period.
4. Age younger than 75 years old.
5. Eastern Cooperative Oncology Group physical status score was 0 ~ 1.
6. No esophageal perforation and active esophageal bleeding, no obvious trachea, thoracic major vascular invasion.
7. Chest chemotherapy and radiotherapy, immunotherapy or biologic therapy have not been performed before.
8. Serum hemoglobin is<100g/L, platelet>100 * 109/L,Absolute neutrophil count>1.5 * 109/L.
9. Cr≤1.25 upper normal limit or CCr≥60 mL/min.
10. Serum bilirubin ≤1.5 times upper normal limit, Aspartate transaminase (SGOT) and Alanine aminotransferase (SGPT) ≤ 2.5 times upper normal limit,Alkaline phosphatase≤ 5 times upper normal limit.
11. A history of interstitial pneumonia and interstitial pneumonia.
12. FEV1>0.8 liters.
13. Patients or family members signed a formal informed consent.

Exclusion Criteria:

1. Prior to the start of the trial had received thoracic radiotherapy, chemotherapy or surgical resection of esophageal cancer.
2. Primary lesions were multifocal esophageal cancer patients, the lower bound of esophageal primary lesions was less than 3cm.
3. Patients with severe cardiovascular or pulmonary disease, interstitial pneumonia or a history of interstitial pneumonia.
4. Patients with distant metastases.
5. There were obvious esophageal ulcer, chest and back with moderate pain, and the symptoms of esophageal perforation.
6. Can't understand the test requirements, or patients may not comply with the requirements of the test.
7. There are other malignant lesion patients, but can cure skin cancer (non melanoma), cervical carcinoma in situ or malignant disease cured except for more than 5 years.
8. An allergic reaction known to have 3 or 4 levels of any treatment.
9. Had participated in other clinical trials in the past 30 days.
10. The researchers believe that some of the obvious diseases that should be excluded from this study are excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single drug; S-1 concurrent Radiotherapy	Other: S-1 concurrent radiotherapy; Radiotherapy 60~66 Gray/28~33 times (50.4~60 Gray /28~33 planning target volume times, 60~66 Gray/28~33 Gross tumor volume of primary tumor), synchronous chemotherapy S-1 70 mg/m2 5 to 1 per week, to the end of radiotherapy. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1, 70 mg/m2, 1~ 14 days, 21 days for a cycle.
Active Comparator: Double drug; S-1 plus cisplatin concurrent Radiotherapy	Other: S-1 plus Cisplatin concurrent radiotherapy; Radiotherapy 60~66 Gray/28~33 times (50.4~60 Gray /28~30 planning target volume times, Gross tumor volume of primary tumor60~66 Gray/28~33), synchronous chemotherapy S-1 70 mg/m2 1~ 14 days and 29 to 42 days, plus cisplatin 25mg/m2 1~ 4 days and 29 to 33 days. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1~ 14 days, plus cisplatin 25mg/m2 1~ 4 days, 21 days for a cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Remission Rate (CR)	Complete response rate of primary tumor which will be measured by endoscopy and computer tomography	Three months after radiotherapy finished

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	The time from treatment completion to patient death	Two years after adjuvant chemotherapy finished
Progression-Free-Survival (PFS)	The time from treatment completion to disease progression	Two years after adjuvant chemotherapy finished

Collaborators and Investigators

• Sponsor: Mianyang Central Hospital
• Investigators: Principal Investigator: Bo Du X, Doctor, Mianyang Central Hospital

Publications and helpful links

General Publications

• Zhao Z, Wen Y, Liao D, Miao J, Gui Y, Cai H, Chen Y, Wei M, Jia Q, Tian H, Sun M, Zhang Y, Feng G, Du X. Single-Agent Versus Double-Agent Chemotherapy in Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma: Prospective, Randomized, Multicenter Phase II Clinical Trial. Oncologist. 2020 Dec;25(12):e1900-e1908. doi: 10.1634/theoncologist.2020-0808. Epub 2020 Sep 28.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: September 20, 2016
• First Submitted That Met QC Criteria: September 22, 2016
• First Posted (Estimate): September 23, 2016

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 14, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Antineoplastic Agents; Cisplatin
• Other Study ID Numbers: XDu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES