Gastric Cancer, Gastrointestinal Neoplasms
Conditions
Keywords
Combined Modality, Gastric Cancer, Radiation Therapy, S-1
Brief summary
The purpose of this study is to determine maximum tolerated dose (MTD), dose limiting toxicities (DLT) and recommend a proper dose for our phase II study of S-1 when combined with radiation therapy for locally advanced or recurrent gastric cancer.
Detailed description
This is a Phase I trial of S-1 given in treatment days with an oral dose from 30mg/m2/d to 80mg/m2/d, concurrently with radiation in patients with locally advanced or locally recurrent gastric cancer. Patients will be treated with external beam radiation therapy in a standard manner. S-1 will be administered for 6 dose levels,30/40/50/60/70/80mg/m2/d. Patients will be assessed for acute toxicities according to Common Toxicity Criteria for Adverse Effects (CTCAE)3.0.
Interventions
DRUGS-1
S-1,30mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically proven locally advanced gastric adenocarcinoma in patients undergoing R0, R1, R2 resection, or with unresectable or locoregional recurrent disease * Any prior chemotherapy is allowed in this protocol. * No distant metastasis in liver,lung,,bone,central nervous system(CNS),no peritoneal transplantation * No prior abdominal or pelvic radiotherapy. * Karnofsky performance status(KPS)≥ 70,predictive life span no less than 6 months * Patients must have normal organ and marrow function as defined below: * Leukocytes greater than or equal to 3,000 G/L * Platelets: greater than or equal to 100,000/mm3 * Hemoglobin:greater than or equal to 10g/L * Total bilirubin: within normal institutional limits * AST/ALT: less than or equal to 1.5 times the upper limit * Creatinine within normal upper limits * Informed consent * Without any serious complications,such as hypertension,coronary artery disease,psychiatric history.
Exclusion criteria
* Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer * With any distant metastasis in liver,lung,,bone,CNS,or peritoneal transplantation * History of allergic reactions attributed to similar chemical or biologic complex to S-1 * Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness * History of myocardial infarction within the past 6 months or history of ventricular arrhythmia * History of prior radiation to the abdomen * Pregnant or lactating females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To define dose limited toxicities(DLT) of S-1, peroral BID, in treatment days concurrently with radiation therapy (RT) in locally advanced or recurrent gastric cancer. | up to 9 weeks | Dose limited toxicities defined as below: leucopenia ≥4 neutropenia ≥ 4, anemia ≥ 3, thrombocytopenia ≥ 3, alanine aminotransferase/aspartate aminotransferase (AST) ≥ 3, alkaline phosphatase (ALT) ≥ 3, total bilirubin ≥ 3,blood urea nitrogen (BUN)/Cr ≥ 2,non-granular cell decreased fever ≥ 2, nausea/vomiting ≥ 2, fatigue ≥ 3, weight loss ≥ 3, diarrhea ≥ 3, abdominal pain ≥ 3, dysphagia ≥ 3, hand-foot syndrome ≥ 2, neurotoxicity ≥ 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To define maximum tolerated dose(MTD) of S-1, peroral BID, in treatment days concurrently with radiation therapy | up to 9 weeks | If 1 of 3 patients treated within a S-1 dose level experiences DLTs, 3 more patients will be treated at the same level. If a second patient experiences DLTs, then escalation will be stopped and the MTD is defined as the level below DLT dose level. |
Countries
China
Outcome results
None listed