Esophageal Cancer, Radiotherapy, S-1
Conditions
Keywords
Esophageal cancer, Radiotherapy, elder, S-1
Brief summary
To investigate the efficacy and toxicity of S-1 with concurrent radiotherapy in older patients with esophageal cancer.
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.
Interventions
DRUGS-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.
RADIATIONradiotherapy
Radiotherapy wiil be delivered with a daily fraction of 1.8 Gy to a total dose of 50.4 Gy.
Sponsors
Zhejiang Provincial People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| response rate | week 4 | Response rate will be done after 4 weeks following the last radiotherapy session. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 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) | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Dysphagia score | 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. |
Countries
China
Outcome results
None listed