A Phase I Study of S-1 in Combination With Radiotherapy in Locally Advanced or Recurrent Gastric Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wang Xin, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01291407
First received: February 7, 2011
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Neoplasms
Gastric Cancer
Drug: S-1
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of S-1 in Combination With Radiotherapy in Locally Advanced or Recurrent Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • 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. [ Time Frame: up to 9 weeks ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • To define maximum tolerated dose(MTD) of S-1, peroral BID, in treatment days concurrently with radiation therapy [ Time Frame: up to 9 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 27
Study Start Date: November 2010
Study Completion Date: September 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S-1,peroral BID,capsule Drug: S-1
S-1,30mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
Other Name: an oral fluorinated pyrimidine combination
Drug: S-1
S-1,40mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
Other Name: an oral fluorinated pyrimidine combination
Drug: S-1
S-1,50mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner
Other Name: an oral fluorinated pyrimidine combination
Drug: S-1
S-1,60mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
Other Name: an oral fluorinated pyrimidine combination
Drug: S-1
S-1,70mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
Other Name: an oral fluorinated pyrimidine combination
Drug: S-1
S-1,80mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
Other Name: an oral fluorinated pyrimidine combination

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291407

Locations
China
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, China, 100021
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Jing Jin, MD,PhD Department of Radiation Oncology,Cancer Hospital and Institute,CAMS
Principal Investigator: Yexiong Li, MD,PhD Department of Radiation Oncology,Cancer Hospital and Institute, CAMS
  More Information

Publications:

Responsible Party: Wang Xin, Dr., Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01291407     History of Changes
Other Study ID Numbers: CH-GI-012
Study First Received: February 7, 2011
Last Updated: September 17, 2013
Health Authority: China: Ethics Committee

Keywords provided by Chinese Academy of Medical Sciences:
Combined Modality
Gastric Cancer
Radiation Therapy
S-1

Additional relevant MeSH terms:
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Stomach Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on April 15, 2014