Gastric CancerPhase 2NEWEARNCT02024217
Neoadjuvant Chemotherapy Plus Chemoradiation in Patients With Potentially Resectable Gastric Carcinoma
A Phase 2 study testing S1，oxaliplatin，radiation in people with Gastric Cancer, run by Fudan University at 1 site in China.
Trial summary
To investigate the feasibility, safety and tolerability of Preoperative Chemoradiation in Patients With Localized Gastric Cancer. Primary endpoint: R0 resection rate. Secondary endpoint: resection rate, pathological complete regression (pCR), effectiveness and safety of regime, disease free survival(DFS) and overall… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- S1，oxaliplatin，radiation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Aug 2015
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.18 ≤ age ≤ 70, Male or Female; 2.Minimum life expectancy of 6 months; 3.Patients with localized, histologically confirmed gastric or gastroesophageal adenocarcinoma; 4.Patients must have a performance status of < 2 Eastern Cooperative Oncology Group (ECOG); 5.No prior major surgery of the stomach or radiation therapy to the stomach or immunotherapy or chemotherapy; 6.CT or MRI, endorectal ultrasonography (EUS), laparoscopic exploration are required to stage; 7.Without other benign diseases such as lung, kidney, liver infections; 8.Without participating other clinical trials; 9.Patient must sign an informed consent prior to study entry; 10.Patients must have adequate bone marrow function (defined as peripheral absolute granulocyte count of >1,500/µL, and platelet count of > 100,000/µL), adequate liver function (bilirubin <= 1.5 mg/dl), and adequate renal function (creatinine <= 1.5 mg/dl). 11)Patients without cardiac disease , severe uncontrolled diabetes, hypertension, cerebrovascular disease, or infection.
Who cannot join
- Pregnant women are excluded from study entry due to the potential teratogenic effects of the study treatment;
- Female patients who planed to have a baby;
- Prior radiation therapy to the stomach, liver or kidney;
- Dysfunction of important organs such as liver, kidney or heart; 5.Abnormalities of mental status;
- 6.Active coronary artery disease; 7.Cardiac arrhythmia, and need to receive medication therapy; 8.Severe uncontrolled hypertension; 9.Active clinical serious infection; 10.The known human immunodeficiency virus (HIV) infection history; 11.The known central nervous system diseases, including brain metastatic tumors; 12.Patients have had clinical clear gastrointestinal bleeding in 6 months; 13.Drug abuse; 14.Swallowing difficulties for drugs; 15.Poor compliance; 16.Presence of concurrent or previous malignancies (except for cervical carcinoma in situ or basal cell carcinoma of the skin); 17.Presence of peritoneal metastasis, distant organs or lymph nodes metastasis; 18.Presence history of major surgery in the past three months; 19.Poor tolerability; 20.Prior history of medication; 21.allergy for chemotherapeutic drugs.
Trial locations and contacts
1 site in 1 country.
Xiaowen Liu, MD contact
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Guichao Li, MD, 11111230012@fudan.edu.cn
Xiaowen Liu, MD, liuxw1129@hotmail.com
About this study
Official title: Phase II Study of Neoadjuvant Chemotherapy Wtih S1+Oxaliplatin (SOX) Regimen Followed by Chemoradiation Concurrent With S-1 in Patients With Potentially Resectable Gastric Carcinoma
To investigate the feasibility, safety and tolerability of Preoperative Chemoradiation in Patients With Localized Gastric Cancer. Primary endpoint: R0 resection rate. Secondary endpoint: resection rate, pathological complete regression (pCR), effectiveness and safety of regime, disease free survival(DFS) and overall survival(OS).
Read the detailed description
The prognosis of gastric cancer is poor partially due to low R0 resection rate. Neoadjuvant chemoradiotherapy was reported to be effective in this setting by several phase II studies. The investigators aim to evaluate the efficacy and toxicity of neoadjuvant chemoradiotherapy in a prospective phase II study.
- Conditions
- Gastric Cancer
- Being tested
- S1，oxaliplatin，radiation
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S1，oxaliplatin，radiationRadiation
Also called S1(Tegafur，Gimeracil and Oteracil Potassium Capsules)
Radiation: 180 (cGy) /day, D1-5;S1: 50mg/m2,D1-5;
| Study group | Role | What they receive |
|---|---|---|
| chemoradiotherapy, S1, oxaliplatin | Experimental | chemoradiotherapy is given before surgical therapy,S1(Tegafur，Gimeracil and Oteracil Potassium Capsules) is given during radiation therapy and neoadjuvant chemotherapy, oxaliplatin is given during neoadjuvant chemotherapy. Receives: Radiation: S1，oxaliplatin，radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
6-8 weeks after Radiation therapy，we evaluate the lesion，if it is resectable，we will give surgical therapy，
Measured: 6-8 Weeks
Secondary outcomes (1)
safety and tolerability of the treatment regimen
after neoadjuvant chemotherapy and chemoradiotherapy，we evaluate the side effects , and record the side effects
Measured: up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startMar 2012
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Zhang, Fudan University
- Investigators
- Zhen Zhang, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024217
- Sponsor's protocol ID
- LAGCCS001
- Acronym
- NEWEAR
- Status last verified
- Dec 2013
- First submitted
- 5 Apr 2013
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Stahl M, Walz MK, Stuschke M, Lehmann N, Meyer HJ, Riera-Knorrenschild J, Langer P, Engenhart-Cabillic R, Bitzer M, Konigsrainer A, Budach W, Wilke H. Phase III comparison of preoperative chemotherapy compared with chemoradiotherapy in patients with locally advanced adenocarcinoma of the esophagogastric junction. J Clin Oncol. 2009 Feb 20;27(6):851-6. doi: 10.1200/JCO.2008.17.0506. Epub 2009 Jan 12.
PubMed 19139439Liu X, Li G, Long Z, Yin J, Zhu X, Sheng W, Huang D, Zhu H, Zhang Z, Cai H, Huang H, Zhao G, Zhou Y, Zhang Z, Wang Y. Phase II trial of preoperative chemoradiation plus perioperative SOX chemotherapy in patients with locally advanced gastric cancer. J Surg Oncol. 2018 Mar;117(4):692-698. doi: 10.1002/jso.24917. Epub 2017 Nov 30.
PubMed 29194623
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Neoadjuvant Chemotherapy Wtih S1+Oxaliplatin (SOX) Regimen Followed by Chemoradiation Concurrent With S-1 in Patients With Potentially Resectable Gastric Carcinoma
- ClinicalTrials.gov ID
- NCT02024217
- Acronym / sponsor ID
- NEWEAR / LAGCCS001
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 31 Dec 2013 (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.
To investigate the feasibility, safety and tolerability of Preoperative Chemoradiation in Patients With Localized Gastric Cancer. Primary endpoint: R0 resection rate. Secondary endpoint: resection rate, pathological complete regression (pCR), effectiveness and safety of regime, disease free survival(DFS) and overall survival(OS).
Detailed description
The prognosis of gastric cancer is poor partially due to low R0 resection rate. Neoadjuvant chemoradiotherapy was reported to be effective in this setting by several phase II studies. The investigators aim to evaluate the efficacy and toxicity of neoadjuvant chemoradiotherapy in a prospective phase II study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chemoradiotherapy, S1, oxaliplatin | Experimental | Radiation: S1，oxaliplatin，radiationchemoradiotherapy is given before surgical therapy,S1(Tegafur，Gimeracil and Oteracil Potassium Capsules) is given during radiation therapy and neoadjuvant chemotherapy, oxaliplatin is given during neoadjuvant chemotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.18 ≤ age ≤ 70, Male or Female; 2.Minimum life expectancy of 6 months; 3.Patients with localized, histologically confirmed gastric or gastroesophageal adenocarcinoma; 4.Patients must have a performance status of < 2 Eastern Cooperative Oncology Group (ECOG); 5.No prior major surgery of the stomach or radiation therapy to the stomach or immunotherapy or chemotherapy; 6.CT or MRI, endorectal ultrasonography (EUS), laparoscopic exploration are required to stage; 7.Without other benign diseases such as lung, kidney, liver infections; 8.Without participating other clinical trials; 9.Patient must sign an informed consent prior to study entry; 10.Patients must have adequate bone marrow function (defined as peripheral absolute granulocyte count of >1,500/µL, and platelet count of > 100,000/µL), adequate liver function (bilirubin <= 1.5 mg/dl), and adequate renal function (creatinine <= 1.5 mg/dl). 11)Patients without cardiac disease , severe uncontrolled diabetes, hypertension, cerebrovascular disease, or infection.
Key exclusion criteria (5 listed)
- Pregnant women are excluded from study entry due to the potential teratogenic effects of the study treatment;
- Female patients who planed to have a baby;
- Prior radiation therapy to the stomach, liver or kidney;
- Dysfunction of important organs such as liver, kidney or heart; 5.Abnormalities of mental status;
- 6.Active coronary artery disease; 7.Cardiac arrhythmia, and need to receive medication therapy; 8.Severe uncontrolled hypertension; 9.Active clinical serious infection; 10.The known human immunodeficiency virus (HIV) infection history; 11.The known central nervous system diseases, including brain metastatic tumors; 12.Patients have had clinical clear gastrointestinal bleeding in 6 months; 13.Drug abuse; 14.Swallowing difficulties for drugs; 15.Poor compliance; 16.Presence of concurrent or previous malignancies (except for cervical carcinoma in situ or basal cell carcinoma of the skin); 17.Presence of peritoneal metastasis, distant organs or lymph nodes metastasis; 18.Presence history of major surgery in the past three months; 19.Poor tolerability; 20.Prior history of medication; 21.allergy for chemotherapeutic drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S1，oxaliplatin，radiationAlso: S1(Tegafur，Gimeracil and Oteracil Potassium Capsules)Radiation: 180 (cGy) /day, D1-5;S1: 50mg/m2,D1-5; | Radiation | chemoradiotherapy, S1, oxaliplatin |
Primary outcome
R0 resection rate
Time frame: 6-8 Weeks
6-8 weeks after Radiation therapy，we evaluate the lesion，if it is resectable，we will give surgical therapy，
1 secondary outcome
safety and tolerability of the treatment regimen
Time frame: up to 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2013.
- Results publication: PubMed 19139439Stahl M, Walz MK, Stuschke M, Lehmann N, Meyer HJ, Riera-Knorrenschild J, Langer P, Engenhart-Cabillic R, Bitzer M, Konigsrainer A, Budach W, Wilke H. Phase III comparison of preoperative chemotherapy compared with chemoradiotherapy in patients with locally advanced adenocarcinoma of the esophagogastric junction. J Clin Oncol. 2009 Feb 20;27(6):851-6. doi: 10.1200/JCO.2008.17.0506. Epub 2009 Jan 12.
- Derived from this study: PubMed 29194623Liu X, Li G, Long Z, Yin J, Zhu X, Sheng W, Huang D, Zhu H, Zhang Z, Cai H, Huang H, Zhao G, Zhou Y, Zhang Z, Wang Y. Phase II trial of preoperative chemoradiation plus perioperative SOX chemotherapy in patients with locally advanced gastric cancer. J Surg Oncol. 2018 Mar;117(4):692-698. doi: 10.1002/jso.24917. Epub 2017 Nov 30.
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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.
Xiaowen Liu, MD contact
Zhen Zhang, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S1，oxaliplatin，radiation in people with Gastric Cancer, run by Fudan 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 1 inclusion and 5 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 31 Dec 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Guichao Li, MD (862164175590 ext. 1606, 11111230012@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: 6-8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02024217, which also lists 2 linked publications.
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 31 Dec 2013.