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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

July 31, 2010
March 4, 2012
February 2010
December 2011   (final data collection date for primary outcome measure)
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.
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 ]
Complete list of historical versions of study NCT01175447 on ClinicalTrials.gov Archive Site
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 ]
Objective response rate [ Time Frame: dependent upon results ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
S-1 and Radiotherapy in Elderly Patients With Esophageal Cancer
A Phase I Study of S-1 With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Esophageal Cancer
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
70 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01175447
ZhejiangCH07
Yes
JYongling, Zhejiang Cancer Hospital
Zhejiang Cancer Hospital
Not Provided
Study Chair: Xianghui Du, MD Zhejiang Cancer Hospital
Zhejiang Cancer Hospital
March 2012

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