Gastric CancerNCT02179463
Compare Different Response Evaluations to Neoadjuvant Chemotherapy for Gastric Cancer
An observational study of Gastric Cancer, run by Peking University at 1 site in China.
Trial summary
RATIONALE: Neoadjuvant chemotherapy has been proved effective for locally advanced gastric cancer, yet the best pattern of response evaluation remain unknown. PURPOSE: Compare different pattern of response evaluation for Gastric Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Dec 2017
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Locally advanced Gastric Cancer(cT2-4NanyM0)，estimated to do neoadjuvant chemotherapy
Who may be able to join
- sign written informed consent form
- age ≥ 18 years
- pathologically confirmed gastric or GEJ adenocarcinoma
- disease at clinical stage of locally advanced gastric cancer by CT/EUS(cT2+NanyM0)
- No prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy
- Adequate organ function as defined below:
Show all 11Show fewer
- Hematologic ANC ≥ 1.5109/l Hemoglobin ≥ 9 g/dl Platelets ≥ 100109/l Hepatic Albumin ≥ 30g/l Serum bilirubin ≤ 1.5×ULN AST and ALT ≤ 2.5×ULN ALP ≤ 2.5×ULN TBIL ≤ 1.5×ULN Renal Serum Creatinine < 1.5 ULN
- KPS ≥ 70
- Adequate lung and heart function
- Negative serum or urine pregnant test within 7 days prior to randomization for child-bearing age women
- Sexually active males or females willing to practice contraception during the study until 30 days after end of study.
Who cannot join
- Refuse to provide blood/tissue sample；
- With distant metastasis diagnosed by CT/EUS；
- Sexually active males or females refuse to practice contraception during the study until 30 days after end of study.
- History of organ transplantation（including autologous bone marrow transplantation and Peripheral stem cell transplantation）；
- Prior long term steroid therapy (excluding short term steroid treatment which is completed prior to > 2 weeks of study enrollment)；
- Patients with central nervous system(CNS) disorder or peripheral nervous system disorder or psychiatric disease；
Show all 11Show fewer
- Concurrent severe infection；
- Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety (including current active hepatic, biliary, renal, respiratory disease, uncontrolled diabetes hypertension et al)；
- History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible；
- Known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and hypertension, or congestive heart failure, or cardiac infarction within 6 months prior to study enrollment, or cardiac insufficiency；
- Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Unicersity Cancer Hospital
Beijing, Beijing Municipality, 100142
Jiafu Ji, MD, 0086-10-88196391, jiafuj@hotmail.com
About this study
Official title: A Multicenter Clinical Registry to Compare Different Patterns of Response Evaluation to Neoadjuvant Chemotherapy for Gastric Cancer
RATIONALE: Neoadjuvant chemotherapy has been proved effective for locally advanced gastric cancer, yet the best pattern of response evaluation remain unknown.
PURPOSE: Compare different pattern of response evaluation for Gastric Cancer.
Read the detailed description
OBJECTIVES: I. Find the best pattern for response evaluation for gastric cancer. II. Assess the factor associated with this pattern.
OUTLINE: Neoadjuvant chemotherapy.
PROJECTED ACCRUAL: Up to 150 patients will be accrued over approximately 2 years.
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, Neoadjuvant chemotherapy, Response Evaluation
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Chemotherapy | undergo neoadjuvant chemotherapy before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Response
Measured: 7days
Secondary outcomes (1)
downstage proportion
compared pathological stage with initial clinical stage, define T downstage or N downstage as downstage
Measured: 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiafu Ji, Peking University
- Investigators
- Jiafu Ji, MD, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179463
- Sponsor's protocol ID
- KW-NeoCT-Evaluation-2014
- Other IDs
- D141100000414004
- Status last verified
- Dec 2014
- First submitted
- 21 Jun 2014
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Registry to Compare Different Patterns of Response Evaluation to Neoadjuvant Chemotherapy for Gastric Cancer
- ClinicalTrials.gov ID
- NCT02179463
- Acronym / sponsor ID
- KW-NeoCT-Evaluation-2014
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, Neoadjuvant chemotherapy, Response Evaluation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 1 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Neoadjuvant chemotherapy has been proved effective for locally advanced gastric cancer, yet the best pattern of response evaluation remain unknown.
PURPOSE: Compare different pattern of response evaluation for Gastric Cancer.
Detailed description
OBJECTIVES: I. Find the best pattern for response evaluation for gastric cancer. II. Assess the factor associated with this pattern.
OUTLINE: Neoadjuvant chemotherapy.
PROJECTED ACCRUAL: Up to 150 patients will be accrued over approximately 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Chemotherapy | – | –undergo neoadjuvant chemotherapy before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Locally advanced Gastric Cancer(cT2-4NanyM0)，estimated to do neoadjuvant chemotherapy
Key inclusion criteria (11 listed)
- sign written informed consent form
- age ≥ 18 years
- pathologically confirmed gastric or GEJ adenocarcinoma
- disease at clinical stage of locally advanced gastric cancer by CT/EUS(cT2+NanyM0)
- No prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy
Key exclusion criteria (11 listed)
- Refuse to provide blood/tissue sample；
- With distant metastasis diagnosed by CT/EUS；
- Sexually active males or females refuse to practice contraception during the study until 30 days after end of study.
- History of organ transplantation（including autologous bone marrow transplantation and Peripheral stem cell transplantation）；
- Prior long term steroid therapy (excluding short term steroid treatment which is completed prior to > 2 weeks of study enrollment)；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pathological Response
Time frame: 7days
1 secondary outcome
downstage proportion
Time frame: 7days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiafu Ji, MD principal investigator
Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiafu Ji, MD (86-10-88196050, jiafuj@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Response (time frame: 7days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2014.