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

NCT02913066 | Unknown Phase 2 DMC

• 1 other identifier: XDu
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall Survival (OS)

  Two years after adjuvant chemotherapy finished

• Progression-Free-Survival (PFS)

  Two years after adjuvant chemotherapy finished

Study Arms (2)

Single drug

EXPERIMENTAL

S-1 concurrent Radiotherapy

Other: S-1 concurrent radiotherapy

Double drug

ACTIVE COMPARATOR

S-1 plus cisplatin concurrent Radiotherapy

Other: S-1 plus Cisplatin concurrent radiotherapy

Interventions

S-1 concurrent radiotherapy OTHER

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.

Single drug

S-1 plus Cisplatin concurrent radiotherapy OTHER

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.

Double drug

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Prior to the start of the trial had received thoracic radiotherapy, chemotherapy or surgical resection of esophageal cancer.
• Primary lesions were multifocal esophageal cancer patients, the lower bound of esophageal primary lesions was less than 3cm.
• Patients with severe cardiovascular or pulmonary disease, interstitial pneumonia or a history of interstitial pneumonia.
• Patients with distant metastases.
• There were obvious esophageal ulcer, chest and back with moderate pain, and the symptoms of esophageal perforation.
• Can't understand the test requirements, or patients may not comply with the requirements of the test.
• 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.
• An allergic reaction known to have 3 or 4 levels of any treatment.
• Had participated in other clinical trials in the past 30 days.
• The researchers believe that some of the obvious diseases that should be excluded from this study are excluded.

Sponsors & Collaborators

• Mianyang Central Hospital: lead

Study Sites (1)

Xiaobo du

Mianyang, Sichaung, 621000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 32864805 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Bo Du X, Doctor

  Mianyang Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Du X, Doctor

CONTACT

+8613550822229; duxiaobo2005@126.com

Xue W Y, Student

CONTACT

+8615181958867; 532995900@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 23, 2016
• Study Start: September 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: June 16, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)