East Asian S-1 Trial(EAST) - Lung Cancer(LC).

JRCT ID: jRCT1080221121

Registered date:08/06/2010

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Locally advanced or metastatic NSCLC (clinical stage IIIB or IV) for which curative radiotherapy is not indicated.
• Date of first enrollment: 01/07/2010
• Target sample size: 1200
• Countries of recruitment: Japan,Asia except Japan
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : S-1(tegafur + gimeracil + oteracil potassium)
INN of investigational material : TS-1: tegafur, gimeracil, oteracil potassium
Therapeutic category code : 422 Antimetabolic agents
Dosage and Administration for Investigational material : S-1 will be administered orally twice daily after morning and evening meals at a dose of 40-60 mg (80-120 mg/day), depending on the body surface area on days 1 to 28. The treatment will be followed by a 14-day recovery period.

control material(s)
Generic name etc : Docetaxel
INN of investigational material : docetaxel
Therapeutic category code : 424 Antineoplastic preparations extracted from plants
Dosage and Administration for Investigational material : Indicated dose of Docetaxel (75 mg/m2 for outside of Japan , 60mg/m2 for Japan) by intravenous infusion over the course of 1 hour on day 1 in a 3-week cycle.

Outcome(s)

Primary Outcome

efficacy
Overall Survival (OS)

Secondary Outcome

safety
efficacy
1)Progression-free survival (PFS)
2)Time to treatment failure (TTF)
3)Response rate (RR)
4)Quality of life (QOL)
5)Time to deterioration of disease-related symptoms (TDS)
6)Incidence and severity of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Histologically or cytologically proven NSCLC.
2)Locally advanced or metastatic NSCLC (Clinical Stage IIIB/IV, according to TNM classification ver.7) for which curative radiotherapy is not indicated.
3)Age of 20 years or older at entry.
4)ECOG performance status 2 or less.
5)Measurable or non-measurable lesions ( A lesion confirmed with objective evidence such as CT, MRI images, or X-ray taken within 21 days before randomizatzation, regardless of its measurability). Patients with only pleural effusion can not be registered.
6)Progression or recurrence after the last treatment is confirmed by radiological image. Previous treatments should include at least one platinum-based regimen. The number of previous regimens must be 3 or less for whom EGFR-TKI (gefitinib/erlotinib) was administered, or 2 or less for whom EGFR-TKI was not administered for metastatic disease.
Adjuvant chemotherapy is counted as one regimen if the disease recurred within a year after the completion of postoperative adjuvant chemotherapy, or within a year after surgery in patients given preoperative adjuvant chemotherapy.
7)Ability to take drugs orally.
8)Adequate major organ functions within 7 days before randomization, as defined
below:
Neutrophil count >= 2,000/mm3
Platelet count >= 100,000/mm3
Hemoglobin >= 9.0 g/dL
AST =< 2.5 x ULN
ALT =< 2.5 x ULN
Total bilirubin =< 1.5 x ULN
PaO2 >= 60 Torr or SpO2 >= 94%
CCr measured or estimated by the Cockcroft-Gault formula >= 60 ml/min.
9)Written informed consent

Exclude criteria

1)Previous treatment with docetaxel or fluoropyrimidine.
Patient who experienced recurrence more than one year after completion of postoperative adjuvant chemotherapy with tegafur-uracil capsules/granules (UFT) will be eligible.
2)Chemotherapy within 4 weeks and/or EGFR-TKI within 2 weeks before the initial administration of the study drug.
3)Curative radiotherapy within 6 weeks before the initial administration of the study drug. Palliative local radiation within 2 weeks before the initial administration of the study drug.
4)Major surgery within 4 weeks and/or surgical incision within 2 weeks before the initial administration of the study drug.
5)Symptomatic brain metastasis(Patients with known asymptomatic brain metastasis is allowed for registration if they are clinically stable and no treatment is required).
6)Pleural, peritoneal, or pericardial effusion requiring treatment.
7)Active infection requiring administration of systemic treatment with antibiotics, e.g., body temperature rose higher than 38 degree centigrade.
8)Patients with Grede 2 or higher diarrhea.
9)Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis (except documented radiation pneumonitis) or pulmonary fibrosis, poorly-controlled diabetes, cardiac failure, renal failure, liver failure, active gastrointestinal ulceration, myocardial infarction within 6 months, and Grade3 or higher angina.
10)Patients with autoimmune disease requiring treatment with an immunosuppressive agent such as azathiopurine, chlorambucil, cyclophosphamide, ciclosporin, methotrexate, and steroids.
11)Active double cancer (synchronous cancer, or metachronous cancer with less than 5 years of disease-free interval), except in situ cervical cancer cured by local treatment, gastric or colon cancer curatively resectable with endoscopy, and resectable non-melanoma skin cancer.
12)Confirmed or possible pregnancy, lactation, willingness to become pregnant (for women), or willingness to have a child (for men).
13)Psychiatric disorder or symptom that makes participation of the patient difficult.
14)Continuous systemic administration of a steroid (oral or intravenous).
15)History of severe hypersensitivity reaction to polysorbate 80, or to tegafur-uracil capsules/granules (UFT).
16)Current use of flucytosine.
17)Participation in other registration trial within one month before randomization in this trial.
18)Caucasian
19)Physician concludes that the patient's participation in this trial is inappropriate.

Related Information

• Primary Sponsor: Taiho Pharmaceutical Co., Ltd.
• Secondary Sponsor: -
• Source(s) of Monetary Support: Taiho Pharmaceutical Co.,Ltd.
• Secondary ID(s): JapicCTI-101155