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

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

S-1 concurrent radiotherapy

S-1 plus Cisplatin concurrent radiotherapy

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Xiaobo duRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Single drug

Double drug

Arm Description

S-1 concurrent Radiotherapy

S-1 plus cisplatin concurrent Radiotherapy

Outcomes

Primary Outcome Measures

Complete Remission Rate (CR)

Complete response rate of primary tumor which will be measured by endoscopy and computer tomography

Secondary Outcome Measures

Overall Survival (OS)

The time from treatment completion to patient death

Progression-Free-Survival (PFS)

The time from treatment completion to disease progression

Full Information

NCT ID

NCT02913066

First Posted

September 20, 2016

Last Updated

June 14, 2017

Sponsor

Mianyang Central Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02913066

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

September 2016 (undefined)

Primary Completion Date

March 2019 (Anticipated)

Study Completion Date

March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mianyang Central Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Squamous Cell Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single drug

Arm Type

Experimental

Arm Description

S-1 concurrent Radiotherapy

Arm Title

Double drug

Arm Type

Active Comparator

Arm Description

S-1 plus cisplatin concurrent Radiotherapy

Intervention Type

Other

Intervention Name(s)

S-1 concurrent radiotherapy

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

S-1 plus Cisplatin concurrent radiotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Complete Remission Rate (CR)

Description

Complete response rate of primary tumor which will be measured by endoscopy and computer tomography

Time Frame

Three months after radiotherapy finished

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

The time from treatment completion to patient death

Time Frame

Two years after adjuvant chemotherapy finished

Title

Progression-Free-Survival (PFS)

Description

The time from treatment completion to disease progression

Time Frame

Two years after adjuvant chemotherapy finished

10. Eligibility

Sex

All

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bo Du X, Doctor

Phone

+8613550822229

duxiaobo2005@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xue W Y, Student

Phone

+8615181958867

532995900@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bo Du X, Doctor

Organizational Affiliation

Mianyang Central Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xiaobo du

City

Mianyang

State/Province

Sichaung

ZIP/Postal Code

621000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xaiobo Du, MD

Phone

+86 08162230478

duxiaobo2005@126.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

32864805

Citation

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.

Results Reference

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

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