A Pilot Study of Genomic Sequencing Guided Individualized Therapy in Gastrointestinal Cancers, GITIC Study
GITIC
1 other identifier
interventional
50
1 country
1
Brief Summary
Hypothesis: Different patients have different biomarkers, if doctors know about the biomarkers of patients; they may be able to prescribe a regimen that is better suited to the patient's specific needs. This is a pilot study. Here, we used whole exon sequencing and Integrated genomic network analysis to identify the biomarker or gene. We aimed to learn if the drug chosen based on biomarkers can help to control metastatic gastrointestinal cancer who had failed from all standard and available regimens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 11, 2013
CompletedFirst Posted
Study publicly available on registry
December 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedAugust 30, 2016
August 1, 2016
3.4 years
December 11, 2013
August 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
From the date of enrollment until the date of death from any cause.
1 year
Secondary Outcomes (1)
Response rate
1 year
Other Outcomes (1)
Disease control rate
1 year
Study Arms (6)
Erlotinib or Gefitinib
EXPERIMENTALErlotinib 150 mg tablet or Gefitinib 250 mg tablet by mouth every day
Everolimus
EXPERIMENTALEverolimus 10 mg orally once daily every day
Imatinib
EXPERIMENTALImatinib 400 mg tablet orally per day
Sorafenib or Sunitinib
EXPERIMENTALSorafenib 400 mg twice a day at least one hour before or two hours after eating or Sunitinib 50 mg orally once a day
Vandetanib
EXPERIMENTALVandetanib 300 mg orally once daily
Control
NO INTERVENTIONNo intervention was performed for patients without any gene alternation or without any available target agents
Interventions
Erlotinib 150mg talbet or Gefitinib 250 mg tablet per day for patients with EGFR gene alternation
Everolimus 10 mg orally once daily every day for patients with mTOR gene alternation
Imatinib 400 mg tablet orally per day for patietns with KIT, PDGFR, ABL gene alternation
Sorafenib 400 mg twice a day at least one hour before or two hours after eating or Sunitinib 50 mg orally once a day with or without food for patients with VEGFR, KIT, RAF gene alternation
Vandetanib 300 mg orally once daily for patients with RET gene fusion.
Eligibility Criteria
You may qualify if:
- Pathologic diagnosis of Gastrointestinal cancer
- The subject has a diagnosis metastatic gastrointestinal cancer, and failed from standard treatment, and no other regimen is available.
- The subject has measurable lesion of gastrointestinal cancer.
- The subject's The Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- The subject has adequate hematologic function as defined by an absolute neutrophil count (ANC) \>/= 1,500/mm3, platelet count \>/= 100,000/mm3, White Blood Count (WBC) \>/= 3,000/ mm3, and hemoglobin \>/= 9 g/dL.
- The subject has adequate hepatic function as defined by a total bilirubin level \</= 1.5 \* the upper limit of normal (ULN) (bilirubin \>/= 1.5 \* ULN with known Gilbert's disease is allowed), and alkaline phosphatase, aspartate aminotransferase/alanine aminotransferase (AST/ALT) \</= 2.5 \* the upper limit of normal or \</= 5.0 \* ULN if liver metastases are present.
- Serum creatinine clearance \>50ml/min, either by Cockcroft-Gault formula or 24-hour urine collection analysis
- The subject is \>/=18 years of age.
- The subject has signed informed consent.
- Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Childbearing potential will be defined as women who have had menses within the past 12 months, who have not had tubal ligation, hysterectomy or bilateral oophorectomy. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately.
You may not qualify if:
- pregnant or breast-feeding.
- Subjects will be excluded for other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study
- without enough tumor sample for analysis.
- Refuse to sign the informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gastrointestinal Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yanghong Deng, PhD
Sixth Affiliated Hospital, Sun Yat-sen University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 11, 2013
First Posted
December 17, 2013
Study Start
December 1, 2013
Primary Completion
May 1, 2017
Study Completion
December 1, 2017
Last Updated
August 30, 2016
Record last verified: 2016-08