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

Esophageal Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02913066
• Other study ID #: XDu
• Status: Recruiting
• Phase: Phase 2
• First received: September 20, 2016
• Last updated: June 14, 2017
• Start date: September 2016
• Est. completion date: March 2019

Study information

• Verified date: June 2017
• Source: Mianyang Central Hospital
• Contact: Bo Du X, Doctor
• Phone: +8613550822229
• Email: duxiaobo2005[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Xiaobo du	Mianyang	Sichaung

Sponsors (1)

Lead Sponsor	Collaborator
Mianyang Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Survival (OS)	The time from treatment completion to patient death	Two years after adjuvant chemotherapy finished
Secondary	Progression-Free-Survival (PFS)	The time from treatment completion to disease progression	Two years after adjuvant chemotherapy finished