S-1 and Radiotherapy in Elderly Patients With Esophageal Cancer

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

JYongling, Zhejiang Cancer Hospital

ClinicalTrials.gov Identifier:

NCT01175447

First received: July 31, 2010

Last updated: March 4, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 31, 2010

Last Updated Date

March 4, 2012

Start Date ^ICMJE

February 2010

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Maximum tolerated dose (MTD) of s-1 in combination with thoracic radiotherapy in elderly patients (> 70 years old) with esophageal Cancer [ Time Frame: 3 months per patient ] [ Designated as safety issue: Yes ]

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.

Original Primary Outcome Measures ^ICMJE

Maximum tolerated dose (MTD) of s-1 in combination with thoracic radiotherapy in elderly patients (> 70 years old) with esophageal Cancer,and the phase II dose [ Time Frame: 3 months per patient ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT01175447 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Objective response rate (e.g. complete response [CR], partial response [PR], stable disease [SD], or progressive disease [PD]). [ Time Frame: dependent upon results ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Objective response rate [ Time Frame: dependent upon results ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

S-1 and Radiotherapy in Elderly Patients With Esophageal Cancer

Official Title ^ICMJE

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

Brief 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.

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Esophageal Cancer

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Chemoradiotherapy with S-1

radiation 54Gy over 30 fractions,and concurrent with s-1 on days 1-14 and 29-42

Intervention: Drug: S-1

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2011

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

70 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01175447

Other Study ID Numbers ^ICMJE

ZhejiangCH07

Has Data Monitoring Committee

Yes

Responsible Party

JYongling, Zhejiang Cancer Hospital

Study Sponsor ^ICMJE

Zhejiang Cancer Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Xianghui Du, MD

Zhejiang Cancer Hospital

Information Provided By

Zhejiang Cancer Hospital

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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