马上注册，阅读更多内容，享用更多功能！
您需要 登录 才可以下载或查看，没有账号？立即注册 
×
ITACA研究
ERCC1/TS预测顺铂/培美曲塞疗效
Phase III Multicenter Randomized Trial Comparing Adjuvant Pharmacogenomic-Driven Chemotherapy versus Standard Adjuvant Chemotherapy in Completely Resected Stage II-IIIA Non-Small Cell Lung Cancer
Protocol ID / Trial Identifier EudraCT #: 2008-001764-36 ITACA TrialTroveID-146909
Start Date 2008-1
Trial Objectives
Objectives
To compare adjuvant pharmacogenomic-driven chemotherapy, based on thymidilate
synthase (TS) and excision-repair cross-complementing -1 (ERCC1) gene expression
versus standard adjuvant chemotherapy in completely resected stage II-IIIA non-small
cell lung cancer To assess expression of ERCC1 and TS by qRT-PCR on paraffin-
embedded tumor specimens in a central laboratory. To evaluate the efficacy of
individualized chemotherapy in patients with non-small cell lung cancer operated
radically.
Primary Endpoint/Outcome measures/objectives
Primary end point is overall survival
Other Endpoint/Outcome measures/objectives
Secondary end points include recurrence-free survival, therapeutic compliance, toxicity
profile and comparative evaluation of ERCC1 and TS mRNA versus protein.
Patient Population
Population
ASCO 2011: Patients with resected stage II-IIIA non-small cell lung cancer
Inclusion Criteria
Patient diagnosed with non-small cell lung cancer, radically resected, never subjected
to chemotherapy, good organ function. ECOG performance status 0 or 1 Accepted
types of resection: lobectomy,bilobectomy,sleeve lobectomy,pnemonectomy Complete
mediastinal lymph node resection or sampling. Surgical margins of resection negative
for tumor Patients not have received any systemic chemotherapy or radiation therapy
prior to resection of lung cancer and an interval of 45 to 60 days must have been
elapsed between surgery and the start of adjuvant therapy.
Exclusion Criteria
Non-radical surgical resection, the diagnosis of small cell lung cancer, previous
malignancy. Patients must not have any prior malignancy except for adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from
which the patient has been disease-free for at least 5 years prior to enrollment,
peripheral neuropathy ?common toxicity criteria Grade 1. In addition, patients must not
have had recent (within 30 days of study treatment) or concurrent yellow fever
vaccination, a serious cardiac condition, such as myocardial infarction within 6 months,
angina, or heart disease, as defined by the New York Heart Association Class III or IV.
Patients must be able to interrupt concurrent treatment with aspirin or other non-
steroidal anti-inflammatory agents, other than an aspirin dose ≤ 1.3 grams per day, for a
5-day period (8-day period for longacting agents, such as piroxicam) and must be
willing and able to take folic acid, vitamin B12 supplementation or corticosteroids.
Patients must have no history of severe hypersensitivity reactions to products
containing cremophor.
Gender: Both Age: 18 Years to 65 Years
Target Accrual 700 (350 patients in Italy)
Study Design
This is a multicenter, randomized study
Study Keyword
N/A
Treatment Plan
Randomization is stratified by stage and smoking status.
The final statistical analysis will group together all control arms and all tailored
chemotherapies groups.
Within 45 days post-surgery, patients in each genetic profile are randomized to receive
either a standard chemotherapy selected by the investigator (cisplatin/vinorelbine,
cisplatin/docetaxel or cisplatin/gemcitabine) or an experimental treatment (tailored
arms) selected as follows: 1) high ERCC1 and high TS 4 cycles of single agent
paclitaxel 2) high ERCC1 and low TS 4 cycles of single agent pemetrexed 3) low
ERCC1 and high TS 4 cycles of cisplatin/gemcitabine 4) low ERCC1 and low TS) 4
cycles of cisplatin/pemetrexed. All chemotherapy regimens are administered for a total
of 4 cycles on a 3-weekly basis.
|
顺铂, ITACA, ERCC1, 培美曲塞, 顺铂, ITACA, ERCC1, 培美曲塞, 顺铂, ITACA, ERCC1, 培美曲塞
|
