S-1 and Radiotherapy for Elderly Esophageal Cancer Patients

Esophageal Cancer Clinical Trial

Official title:

A Phase Ⅱ Study of S-1 With Concurrent Radiotherapy in Elderly Esophageal Cancer Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02716688
• Other study ID #: ZhejiangPPH02
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2016
• Est. completion date: December 2020

Study information

• Verified date: September 2023
• Source: Zhejiang Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Radiotherapy
• S-1

Intervention

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.

Locations

Country	Name	City	State
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	response rate	Response rate will be done after 4 weeks following the last radiotherapy session.	week 4
Secondary	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
Secondary	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).	year 0 - year 1
Secondary	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