Clinical trial NCT01291407: A Phase I Study of S-1 in Combination With Radiotherapy in Locally Advanced or Recurrent Gastric Cancer
Official title: A Phase I Study of S-1 in Combination With Radiotherapy in Locally Advanced or Recurrent Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastrointestinal Neoplasms
Gastric Cancer
Keywords: Combined Modality
Gastric Cancer
Radiation Therapy
S-1
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2011-02-08
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: up to 9 weeks
Secondary outcomes:
measure: To define maximum tolerated dose(MTD) of S-1, peroral BID, in treatment days concurrently with radiation therapy
timeFrame: up to 9 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Study officials:
affiliation: Department of Radiation Oncology,Cancer Hospital and Institute,CAMS
name: Jing Jin, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Radiation Oncology,Cancer Hospital and Institute, CAMS
name: Yexiong Li, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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