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Moderately Hypofractionated Conformal Radiation Combined With S-1 for Esophageal Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT03660449
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Hui Liu, Sun Yat-sen University

Study Description
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Brief Summary:
This Phase II randomized study is to determine the efficacy and toxicities of moderately hypofractionated conformal radiation combined With S-1 for esophageal squamous cell carcinoma.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Combination Product: Moderately hypofractionated conformal radiation combined With S-1 Phase 2

Detailed Description:

This Phase II randomized study is to determine the efficacy and toxicities of moderately hypofractionated conformal radiation combined With S-1 for esophageal squamous cell carcinoma.

All patients will receive two cycles of S-1 (40mg/㎡, BID, po) on D1-14, D22-35, combined with thoracic radiotherapy of 60 Gy/24 fractions for GTV and 40 Gy/16 fractions for CTV. The primary end point is progression-free survival, which is the time that passes from the first day of radiotherapy to the date on which disease progresses. Progression-free survival will be calculated and compared using the Kaplan-Meier method.Toxicities will be graded according to CTCAE v. 4.0.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Phase Ⅱ Study of S-1 Plus Moderately Hypofractionated Conformal Radiation for Esophageal Squamous Cell Carcinoma
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experiment
All patients will receive two cycles of S-1 (40mg/㎡, BID, po) on D1-14, D22-35, combined with thoracic radiotherapy of 60 Gy/24 fractions for GTV and 40 Gy/16 fractions for CTV.
 Combination Product: Moderately hypofractionated conformal radiation combined With S-1
All patients will receive two cycles of S-1 (40mg/㎡, BID, po) on D1-14, D22-35, combined with thoracic radiotherapy of 60 Gy/24 fractions for GTV and 40 Gy/16 fractions for CTV.


Outcome Measures
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Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 3 years ]
  2. rate of grade 3-4 radiation esophagitis [ Time Frame: 1 year ]
  3. rate of grade 3-4 radiation pneumonitis [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed esophageal squamous cell carcinoma
  • Inoperable stage II-IVa (UICC 2002; sixth edition), confirmed by contrast enhanced computed tomography,endoscopic ultrasonography, barium esophagram, emission computed tomography and/or positron emission tomography/computed tomography.
  • Eastern Cooperative Oncology Group (ECOG) performance status 1-2
  • Estimated life expectancy of at least 12 weeks
  • Charlson comorbidity index.4
  • Adequate bone marrow function: white blood cells grade 0 or 1,absolute neutrophils grade 0 or 1, platelets grade 0, haemoglobin grade 0 or 1
  • Adequate renal function: creatinine grade 0 or 1
  • Adequate liver function: serum bilirubin grade 0 or 1, alanine aminotransferase and aspartate aminotransferase <2 times of the upper normal limit
  • Weight loss.15% during 6 months prior to diagnosis
  • Forced expiratory volume second.1L

Exclusion Criteria:

  • Prior history of malignancy, except for nonmelanoma skin carcinoma or cervical carcinoma in situ
  • Previous anti-tumor therapy, including surgery, chemotherapy or radiotherapy
  • Contraindication for chemotherapy or radiotherapy
  • Malignant pleural or pericardial effusion
  • Women in pregnancy or lactation period
  • Women who has the probability of pregnancy without contraception
  • Weight loss≥15% during 3 months prior to diagnosis
  • In other clinical trials within 30 days
  • Addicted in drugs or alcohol, AIDS patients
  • Uncontrollable seizure or psychotic patients without self-control ability
  • Severe allergy or idiosyncrasy
  • Not suitable for this study judged by researchers
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): NCT03660449


Contacts
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Contact: Bo Qiu, Ph.D +86-020-87343031 qiubo@sysucc.org.cn
Contact: Hui Liu, Ph.D +86-020-87343031 liuhui@sysucc.org.cn

Locations
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China, Guangdong
Hui Liu Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Hui Liu, professor    +86-020-87343031    liuhui@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Hui Liu, Ph.D Sun Yat-sen University
More Information
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Publications:

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Responsible Party: Hui Liu, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03660449    
Other Study ID Numbers: GASTO-1045
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hui Liu, Sun Yat-sen University:
Esophageal Squamous Cell Carcinoma
Hypofractionated Conformal Radiation
S-1
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