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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
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
 Drug: S-1
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of S-1 With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Zhejiang Cancer Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: February 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemoradiotherapy with S-1
radiation 54Gy over 30 fractions,and concurrent with s-1 on days 1-14 and 29-42
 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

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.

  Eligibility

Ages Eligible for Study:   70 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175447

Locations
China, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
Study Chair: Xianghui Du, MD Zhejiang Cancer Hospital
  More Information

No publications provided

Responsible Party: JYongling, MD, Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT01175447     History of Changes
Other Study ID Numbers: ZhejiangCH07
Study First Received: July 31, 2010
Last Updated: March 4, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Zhejiang Cancer Hospital:
S-1
radiation
esophageal Cancer

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013