A Feasibility Study of Oral Adjuvant Chemotherapy With S-1

NCT01459185 | Completed Phase 2

• 1 other identifier: R000007795
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators confirm the feasibility of 1-year administration of oral fluoropyrimidine S-1 as an adjuvant chemotherapy for the patient who received complete resection of non-small cell lung cancer. The investigators presume they can achieve high completion rate with low toxicity.

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancer; Adjuvant chemotherapy; oral fluoropyrimidine; S-1; Feasibility study; Surgery

Outcome Measures

Primary Outcomes (1)

• Completion rate

  One year

Secondary Outcomes (1)

• Incidence and grade of adverse reactions

  One year

Study Arms (1)

S-1

EXPERIMENTAL

Single arm of the patients who received complete resection of pathological stage IB, II, or IIIA Non-small cell lung cancer

Drug: S-1

Interventions

S-1 DRUG

Chemotherapy comprised eight courses (4-week administration, 2-week withdrawal; total 1 year) of S-1 at 80-120 mg/body/day according to body surface area (BSA)

Also known as: Oral fluoropyrimidine S-1

S-1

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NSCLC with histological proof.
• Pathological stage IB, II, or IIIA NSCLC (fifth edition of UICC/AJCC 1997) after complete resection.
• No prior treatment except for surgery.
• Sufficient oral intake.
• Performance status (PS) 0 or 1.
• Patients also had to have adequate organ function (3500 \<leukocytes \< 12,000/mm3; thrombocytes, \>100,000/mm3; total bilirubin,\<1.5 mg/dl; AST and ALT, less than twice the normal limits at each institution; BUN, \<25 mg/dl; creatinine, less than the normal limits at each institution; and creatinine clearance (Ccr))

You may not qualify if:

• History of drug hypersensitivity.
• Contraindication of oral S-1 administration (refer appended paper).
• Serious surgical or non-surgical complications
• Active secondary cancer.
• Watery diarrhea.
• Pregnant or lactating women.
• Male who has intention to make pregnant
• Patient to whom primary doctor judged inadequate to register.

Sponsors & Collaborators

• Tomoshi Tsuchiya: lead

Study Sites (1)

Division of Surgical Oncology, Nagasaki University Graduate School of BIomedical Sciences

Nagasaki, Nagasaki, 852-8501, Japan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Takeshi Nagayasu, MD. PhD.

  Division of Surgical Oncology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Assistant Professor

Study Record Dates

• First Submitted: October 21, 2011
• First Posted: October 25, 2011
• Study Start: June 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: March 1, 2012
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

JP (1)