S-1 and Radiotherapy in Elderly Patients With Esophageal Cancer

NCT01175447 | Completed Phase 1 DMC

• 1 other identifier: ZhejiangCH07
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Keywords

S-1; radiation; esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Objective response rate (e.g. complete response [CR], partial response [PR], stable disease [SD], or progressive disease [PD]).

  dependent upon results

Study Arms (1)

Chemoradiotherapy with S-1

EXPERIMENTAL

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

Drug: S-1

Interventions

S-1 DRUG

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

Chemoradiotherapy with S-1

Eligibility Criteria

• Age: 70 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (1)

• 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.

  PMID: 27076940 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Xianghui Du, MD

  Zhejiang Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 31, 2010
• First Posted: August 4, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 6, 2012

Record last verified: 2012-03

Locations

CN (1)