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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy and S-1 arm | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-1 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| response rate | Response rate will be done after 4 weeks following the last radiotherapy session. | week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | year 0 - year 2 |
| Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0) |
| Measure | Description | Time Frame |
|---|---|---|
| Dysphagia score | 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. | month 0 - month 6 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C079198 | S 1 (combination) |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
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|
| radiotherapy | Radiation | Radiotherapy wiil be delivered with a daily fraction of 1.8 Gy to a total dose of 50.4 Gy. |
|
|
Acute and late toxicities will be assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0). |
| 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. | year 0 - year 2 |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |