Non-small Cell Lung CancerPhase 2NCT01459185
A Feasibility Study of Oral Adjuvant Chemotherapy With S-1
A Phase 2 study testing S-1 in people with Non-small Cell Lung Cancer, run by Tomoshi Tsuchiya at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- S-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2005to Mar 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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))
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Division of Surgical Oncology, Nagasaki University Graduate School of BIomedical Sciences
Nagasaki, Nagasaki, 852-8501
About this study
Official title: A Feasibility Study of Adjuvant Chemotherapy With Oral Fluoropyrimidine S-1 for Non-small Cell Lung Cancer
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.
Read the detailed description
Chemotherapy comprised eight courses (4-week administration, 2-week withdrawal) of S-1 (FT, gineracil, oteracil potassium; Taiho Pharmaceutical, Tokyo, Japan) at 80-120 mg/body/day according to body surface area (BSA): BSA <1.25 m2, 80 mg/day; BSA >1.25 m2 but <1.5 m2, 100 mg/day; and BSA >1.5 m2, 120 mg/day. S-1 was administered orally, twice daily after meals, starting within 4 weeks after surgery.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- S-1
- Keywords
- Non-small cell lung cancer, Adjuvant chemotherapy, oral fluoropyrimidine, S-1, Feasibility study, Surgery
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1Drug
Also called Oral fluoropyrimidine S-1
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)
| Study group | Role | What they receive |
|---|---|---|
| S-1 | Experimental | Single arm of the patients who received complete resection of pathological stage IB, II, or IIIA Non-small cell lung cancer Receives: Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rate
Measured: One year
Secondary outcomes (1)
Incidence and grade of adverse reactions
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startJun 2005
- Primary completionMay 2008
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomoshi Tsuchiya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tomoshi Tsuchiya, Nagasaki University
- Investigators
- Takeshi Nagayasu, MD. PhD., Study chair, Division of Surgical Oncology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459185
- Sponsor's protocol ID
- R000007795
- Status last verified
- Sep 2014
- First submitted
- 21 Oct 2011
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Adjuvant Chemotherapy With Oral Fluoropyrimidine S-1 for Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01459185
- Acronym / sponsor ID
- R000007795
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer, Adjuvant chemotherapy, oral fluoropyrimidine, S-1, Feasibility study, Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Tomoshi TsuchiyaUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- May 2008 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 25 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chemotherapy comprised eight courses (4-week administration, 2-week withdrawal) of S-1 (FT, gineracil, oteracil potassium; Taiho Pharmaceutical, Tokyo, Japan) at 80-120 mg/body/day according to body surface area (BSA): BSA <1.25 m2, 80 mg/day; BSA >1.25 m2 but <1.5 m2, 100 mg/day; and BSA >1.5 m2, 120 mg/day. S-1 was administered orally, twice daily after meals, starting within 4 weeks after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S-1 | Experimental | Drug: S-1Single arm of the patients who received complete resection of pathological stage IB, II, or IIIA Non-small cell lung cancer |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- History of drug hypersensitivity.
- Contraindication of oral S-1 administration (refer appended paper).
- Serious surgical or non-surgical complications
- Active secondary cancer.
- Watery diarrhea.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-1Also: Oral fluoropyrimidine S-1Chemotherapy 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) | Drug | S-1 |
Primary outcome
Completion rate
Time frame: One year
1 secondary outcome
Incidence and grade of adverse reactions
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takeshi Nagayasu, MD. PhD. study chair
Division of Surgical Oncology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-1 in people with Non-small Cell Lung Cancer, run by Tomoshi Tsuchiya at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion rate (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.