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
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer S-1 Radiotherapy||Drug: S-1 Radiation: radiotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
Radiotherapy wiil be delivered with a daily fraction of 1.8 Gy to a total dose of 50.4 Gy.
Other Name: Irradiation
- response rate [ Time Frame: week 4 ]Response rate will be done after 4 weeks following the last radiotherapy session.
- 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.
- 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).
- 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.
- 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.
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
|Contact: Shiliang Lv, Dremail@example.com|
|Contact: Tao Song, MDfirstname.lastname@example.org|
|Zhejiang Provincial People's Hospital||Recruiting|
|Hangzhou, Zhejiang, China, 310000|
|Contact: Yongshi Jia, MD +8657187666666 email@example.com|