S-1 and Radiotherapy in Elderly Patients With Esophageal Cancer

NCT ID: NCT01175447

Last Updated: 2012-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-12-31

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.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemoradiotherapy with S-1

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

Group Type: EXPERIMENTAL

S-1

Intervention Type: DRUG

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

Interventions

S-1

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

JYongling

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xianghui Du, MD

Role: STUDY_CHAIR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Countries

China

References

Ji Y, Qiu G, Sheng L, Sun X, Zheng Y, Chen M, Du X. A phase I dose escalation study of S-1 with concurrent radiotherapy in elderly patients with esophageal cancer. J Thorac Dis. 2016 Mar;8(3):451-8. doi: 10.21037/jtd.2016.02.70.

Reference Type: DERIVED

PMID: 27076940 (View on PubMed)

Other Identifiers

ZhejiangCH07

Identifier Type: -

Identifier Source: org_study_id