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S-1 and Radiotherapy for Elderly Esophageal Cancer Patients

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ClinicalTrials.gov Identifier: NCT02716688
Recruitment Status : Recruiting
First Posted : March 23, 2016
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Shiliang Lv, Zhejiang Provincial People's Hospital

Brief Summary:
To investigate the efficacy and toxicity of S-1 with concurrent radiotherapy in older patients with esophageal cancer.

Condition or disease Intervention/treatment Phase
Esophageal Cancer S-1 Radiotherapy Drug: S-1 Radiation: radiotherapy Phase 2

Detailed Description:
Older patients with esophageal cancer have been correlated with poor prognosis because of having little chance to receive aggressive local therapy, including concurrent chemoradiotherapy. In this phase II trial, the efficacy and toxicity of S-1 with concurrent radiotherapy will be investigated in this setting.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ⅱ Study of S-1 With Concurrent Radiotherapy in Elderly Esophageal Cancer Patients
Study Start Date : January 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Radiotherapy and S-1 arm
Radiotherapy will be delivered with a daily fraction of 1.8 Gy to a total dose of 50.4 Gy. Preplanned concurrent S-1 (70mg/m²/day) will be administered on Day 1 for 14 days, every 3 weeks. After dCRT, maintenance S-1 will be given up to two cycles.
Drug: S-1
S-1 will be administered orally twice daily for 14 days at a dose of 70 mg/m2/day with concurrent radiotherapy for 2 cycles. Patients who showed a response greater than that of stable disease underwent additional S-1 until disease progression, serious adverse events, or patient refusal up to four cycles.

Radiation: radiotherapy
Radiotherapy wiil be delivered with a daily fraction of 1.8 Gy to a total dose of 50.4 Gy.
Other Name: Irradiation




Primary Outcome Measures :
  1. response rate [ Time Frame: week 4 ]
    Response rate will be done after 4 weeks following the last radiotherapy session.


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: year 0 - year 2 ]
    Progression-free survival (PFS) will be calculated from the date of CCRT initiation to the date of documented failure (local recurrence or metastasis occurrence) or the date of the last follow-up for those remaining.

  2. Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0) [ Time Frame: year 0 - year 1 ]
    Acute and late toxicities will be assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0).

  3. Overall survival [ Time Frame: year 0 - year 2 ]
    Overall survival (OS) wiil be determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.


Other Outcome Measures:
  1. Dysphagia score [ Time Frame: month 0 - month 6 ]
    Dysphagia score was measured according to the following scale: 0, able to consume a normal diet; 1, able to swallow certain solid foods; 2, able to swallow only semisolid foods; 3, able to swallow liquids only; and 4, unable to swallow anything.



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Cytologically or histologically confirmed esophageal carcinoma;
  2. ECOG performance status: 0-1;
  3. No treatments prior to enrollment;
  4. At least one measurable lesion on CT, MRI or esophageal barium exam;
  5. Normal functions of heart, lung, liver, kidney and bone marrow;
  6. Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL;
  7. Informed consent signed.

Exclusion Criteria:

  1. Prior treatments of chemotherapy or irradiation;
  2. Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;
  3. Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;
  4. Participating in other clinical trials;
  5. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities;
  6. The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.

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): NCT02716688


Contacts
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Contact: Shiliang Lv, Dr +8657787666666 547475708@qq.com
Contact: Tao Song, MD +8657187666666 taosong01@hotmail.com

Locations
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China, Zhejiang
Zhejiang Provincial People's Hospital Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Yongshi Jia, MD    +8657187666666    jyssrmyy@163.com   
Sponsors and Collaborators
Zhejiang Provincial People's Hospital
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Responsible Party: Shiliang Lv, MD, Zhejiang Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT02716688    
Other Study ID Numbers: ZhejiangPPH02
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Keywords provided by Shiliang Lv, Zhejiang Provincial People's Hospital:
Esophageal cancer
Radiotherapy
elder
S-1
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases