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

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ClinicalTrials.gov Identifier: NCT02913066
Recruitment Status : Unknown
Verified June 2017 by Xiaobo Du, Mianyang Central Hospital.
Recruitment status was:  Recruiting
First Posted : September 23, 2016
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
Xiaobo Du, Mianyang Central Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Other: S-1 concurrent radiotherapy Other: S-1 plus Cisplatin concurrent radiotherapy Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Complete Remission Rate (CR) [ Time Frame: Three months after radiotherapy finished ]
    Complete response rate of primary tumor which will be measured by endoscopy and computer tomography


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Two years after adjuvant chemotherapy finished ]
    The time from treatment completion to patient death

  2. Progression-Free-Survival (PFS) [ Time Frame: Two years after adjuvant chemotherapy finished ]
    The time from treatment completion to disease progression


Eligibility Criteria
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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913066


Contacts
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Contact: Bo Du X, Doctor +8613550822229 duxiaobo2005@126.com
Contact: Xue W Y, Student +8615181958867 532995900@qq.com

Locations
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China, Sichaung
Xiaobo du Recruiting
Mianyang, Sichaung, China, 621000
Contact: Xaiobo Du, MD    +86 08162230478    duxiaobo2005@126.com   
Sponsors and Collaborators
Mianyang Central Hospital
Investigators
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Principal Investigator: Bo Du X, Doctor Mianyang Central Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Xiaobo Du, Principal Investigator, Mianyang Central Hospital
ClinicalTrials.gov Identifier: NCT02913066    
Other Study ID Numbers: XDu
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal 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
Cisplatin
Antineoplastic Agents