S-1 and Radiotherapy in Elderly Patients With Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01175447
• Other study ID #: ZhejiangCH07
• Status: Completed
• Phase: Phase 1
• First received: July 31, 2010
• Last updated: March 4, 2012
• Start date: February 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Elderly patients with esophageal cancer will receive thoracic radiation therapy 54Gy over 30 fractions, and concurrent with s-1 on days 1-14 and 29-42 at the following dosages: 60, 70, and 80 mg/m(2)/day.

Description:

Purpose:evaluated the dose-limiting toxicity and recommended dose of S-1 for a future phase II study when administered concurrently with thoracic radiation in elderly patients (>70 years old) with esophageal Cancer.

Methods:S-1 was administered on days 1-14 and 29-42 at the following dosages: 60, 70, and 80mg/m(2)/day. Thoracic radiation therapy was administered in 1.8Gy fractions five times weekly to a total dose of 54 Gy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years to 85 Years

Eligibility

Inclusion Criteria:

• Histologically documented diagnosis of esophageal Cancer

• Disease must be encompassed in a radiotherapy field.Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible

• age:70-85 years

• Written informed consent.

• Performance status of 0 to 2

• Neutrophil count >1.5 x 10 to the 9th power/L and platelets > 100 x 10 to the 9th power/L.

• Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement

• Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN)

Exclusion Criteria:

• Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi.

• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).

• Prior systemic chemotherapy or radiation therapy for esophageal cancer

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• S-1
S-1 was administered on days 1-14 and 29-42 at the following dosages: 60, 70, and 80mg/m(2)/day

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD) of s-1 in combination with thoracic radiotherapy in elderly patients (> 70 years old) with esophageal Cancer	the MTD will be defined as the maximum dose level at which no more than one subject out of six experiences a dose-limiting toxicity (DLT) during treatment.	3 months per patient	Yes
Secondary	Objective response rate (e.g. complete response [CR], partial response [PR], stable disease [SD], or progressive disease [PD]).		dependent upon results	No