To investigate the efficacy and toxicity of S-1 with concurrent radiotherapy in older patients with esophageal cancer.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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.
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
response rate
Response rate will be done after 4 weeks following the last radiotherapy session.
Time frame: week 4
Progression-free survival
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.
Time frame: year 0 - year 2
Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0)
Acute and late toxicities will be assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0).
Time frame: year 0 - year 1
Overall survival
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.
Time frame: year 0 - year 2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.