Gastric CancerPhase 2NCT04062058
A Phase II Study of Total Neoadjuvant Therapy for Locally Advanced Gastric Cancer
A Phase 2 study testing SIB-IMRT, S-1 and SOX in people with Gastric Cancer and Neoadjuvant Therapy, run by Jing Jin, M.D. at 1 site in China.
Trial summary
This prospective, single arm phase II study is designed to evaluate the rate of pathologic complete response of neoadjuvant chemoradiotherapy and neoadjuvant chemotherapy followed by surgery for locally advanced gastric adenocarcinoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Neoadjuvant Therapy
- What is being tested?
- SIB-IMRT, S-1 and SOX
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2019to 21 Sep 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically proven locally advanced gastric adenocarcinoma in patients staged as cT3-4N+M0
- 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
Who cannot join
- Any prior chemotherapy or other cancer treatment prior to this protocol
- 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 or Xeloda or Oxaliplatin
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, 100021
Ning Li, MD, +8613810381399, lee_ak@163.com
Jinming Shi, MD
About this study
This prospective, single arm phase II study is designed to evaluate the rate of pathologic complete response of neoadjuvant chemoradiotherapy and neoadjuvant chemotherapy followed by surgery for locally advanced gastric adenocarcinoma
- Conditions
- Gastric Cancer, Neoadjuvant Therapy
- Being tested
- SIB-IMRT, S-1, SOX, Surgery
- Keywords
- gastric cancer, neoadjuvant chemoradiotherapy, neoadjuvant chemotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIB-IMRTRadiation
45Gy in 25 fractions using intensity-modulated radiotherapy to the radiation target
S-1Drug
40-60mg/m2(according to patient's body surface area), orally twice daily every weekday concurrently with radiotherapy treatment
SOXDrug
SOX (S-1: 40~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle)
SurgeryProcedure or surgery
Surgery, preferred D2 lymphadenectomy
| Study group | Role | What they receive |
|---|---|---|
| Total Neoadjuvant Chemoradiotherapy | Experimental | Total neoadjuvant chemoradiotherapy arm receives intensity-modulated neoadjuvant chemoradiotherapy (45Gy in 25 fractions) concurrently with oral S-1(40-60mg/m2, orally twice daily every weekday) followed by six cycles of SOX neoadjuvant chemotherapy and surgery Receives: Radiation: SIB-IMRT; Drug: S-1; Drug: SOX; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR rate
Pathological response were classified into three grades.Grade I signifies that there is little shrinkage in the tumor; only mild regression in the tumor cells is observed under telemicroscope. Grade II shows gross reduction in size of the tumor and marked regression in the cancer cells microscopically, yet viable nests of cancer tissue are still visible. Grade III implies complete or almost total resolution of the tumor on exploration, and disappearance of the tumor tissue microscopically; only remnants of degenerated cancer cells can be seen (so-called ghost cancer cells).
Measured: 6-8 months
Secondary outcomes (4)
Acute chemotherapy/Chemoradiotherapy toxicities
chemotherapy toxicities are evaluated by NCI-CTC version 4.0 and radiotherapy toxicities are graded using the RTOG/EORTC Radiation Morbidity Scoring Schema.
Measured: 6-8 months
surgery complications
During hospital stay and within the first 30 days after completion of surgery.
Measured: 6-8 months
Tumor down-staging
Down-staging was considered as any stage reduction between clinical and pathologic stage.
Measured: 6-8 months
R0 resection rate
The surgical procedure was total or subtotal gastrectomy with recommended D2 lymphadenectomy 4-6 weeks after total neoadjuvant therapy.
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start20 Nov 2019
- Primary completion21 Sep 2022 (estimated)
- Study completion21 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- 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
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jing Jin, M.D.
- Collaborators
- Beijing Hope Run
- Responsible party
- Sponsor-investigator, Jing Jin, M.D., Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062058
- Sponsor's protocol ID
- LC2018L03
- Status last verified
- Jan 2022
- First submitted
- 18 Aug 2019
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shi JM, Li N, Jiang LM, Yang L, Wang SL, Song YW, Liu YP, Fang H, Lu NN, Qi SN, Chen B, Li YX, Zhao DB, Tang Y, Jin J. A prospective phase II clinical trial of total neoadjuvant therapy for locally advanced gastric cancer and gastroesophageal junction adenocarcinoma. Sci Rep. 2024 Mar 29;14(1):7522. doi: 10.1038/s41598-024-58177-6.
PubMed 38553594Shi J, Li N, Tang Y, Jiang L, Yang L, Wang S, Song Y, Liu Y, Fang H, Lu N, Qi S, Chen B, Li Z, Liu S, Wang J, Wang W, Zhu S, Yang J, Li Y, Zhao D, Jin J. Total neoadjuvant therapy for locally advanced gastric cancer and esophagogastric junction adenocarcinoma: study protocol for a prospective, multicenter, single-arm, phase II clinical trial. BMC Gastroenterol. 2022 Jul 28;22(1):359. doi: 10.1186/s12876-022-02440-5.
PubMed 35902798Li N, Xiang X, Zhao D, Wang X, Tang Y, Chi Y, Yang L, Jiang L, Jiang J, Shi J, Liu W, Fang H, Tang Y, Chen B, Lu N, Jing H, Qi S, Wang S, Liu Y, Song Y, Li Y, Zhang L, Jin J. Preoperative versus postoperative chemo-radiotherapy for locally advanced gastric cancer: a multicenter propensity score-matched analysis. BMC Cancer. 2022 Feb 26;22(1):212. doi: 10.1186/s12885-022-09297-7.
PubMed 35219300
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Total Neoadjuvant Therapy for Locally Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT04062058
- Acronym / sponsor ID
- LC2018L03
- Conditions
- Gastric Cancer, Neoadjuvant Therapy
- Keywords
- gastric cancer, neoadjuvant chemoradiotherapy, neoadjuvant chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Jing Jin, M.D.
- Collaborators
- Beijing Hope Run
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 21 Sep 2022 (estimated)
- Study completion
- 21 Sep 2023 (estimated)
- First posted
- 20 Aug 2019 (actual)
- 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.
This prospective, single arm phase II study is designed to evaluate the rate of pathologic complete response of neoadjuvant chemoradiotherapy and neoadjuvant chemotherapy followed by surgery for locally advanced gastric adenocarcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Neoadjuvant Chemoradiotherapy | Experimental | Radiation: SIB-IMRT, Drug: S-1, Drug: SOX, Procedure: SurgeryTotal neoadjuvant chemoradiotherapy arm receives intensity-modulated neoadjuvant chemoradiotherapy (45Gy in 25 fractions) concurrently with oral S-1(40-60mg/m2, orally twice daily every weekday) followed by six cycles of SOX neoadjuvant chemotherapy and surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically proven locally advanced gastric adenocarcinoma in patients staged as cT3-4N+M0
- 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
Key exclusion criteria (8 listed)
- Any prior chemotherapy or other cancer treatment prior to this protocol
- 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 or Xeloda or Oxaliplatin
- Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
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 |
|---|---|---|
| SIB-IMRT45Gy in 25 fractions using intensity-modulated radiotherapy to the radiation target | Radiation | Total Neoadjuvant Chemoradiotherapy |
| S-140-60mg/m2(according to patient's body surface area), orally twice daily every weekday concurrently with radiotherapy treatment | Drug | Total Neoadjuvant Chemoradiotherapy |
| SOXSOX (S-1: 40~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle) | Drug | Total Neoadjuvant Chemoradiotherapy |
| SurgerySurgery, preferred D2 lymphadenectomy | Procedure or surgery | Total Neoadjuvant Chemoradiotherapy |
Primary outcome
PCR rate
Time frame: 6-8 months
Pathological response were classified into three grades.Grade I signifies that there is little shrinkage in the tumor; only mild regression in the tumor cells is observed under telemicroscope. Grade II shows gross reduction in size of the tumor and marked regression in the cancer cells microscopically, yet viable nests of cancer tissue are still visible. Grade III implies complete or almost total resolution of the tumor on exploration, and disappearance of the tumor tissue microscopically; only remnants of degenerated cancer cells can be seen (so-called ghost cancer cells).
4 secondary outcomes
Acute chemotherapy/Chemoradiotherapy toxicities
Time frame: 6-8 months
surgery complications
Time frame: 6-8 months
Tumor down-staging
Time frame: 6-8 months
R0 resection rate
Time frame: 6-8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Derived from this study: PubMed 38553594Shi JM, Li N, Jiang LM, Yang L, Wang SL, Song YW, Liu YP, Fang H, Lu NN, Qi SN, Chen B, Li YX, Zhao DB, Tang Y, Jin J. A prospective phase II clinical trial of total neoadjuvant therapy for locally advanced gastric cancer and gastroesophageal junction adenocarcinoma. Sci Rep. 2024 Mar 29;14(1):7522. doi: 10.1038/s41598-024-58177-6.
- Derived from this study: PubMed 35902798Shi J, Li N, Tang Y, Jiang L, Yang L, Wang S, Song Y, Liu Y, Fang H, Lu N, Qi S, Chen B, Li Z, Liu S, Wang J, Wang W, Zhu S, Yang J, Li Y, Zhao D, Jin J. Total neoadjuvant therapy for locally advanced gastric cancer and esophagogastric junction adenocarcinoma: study protocol for a prospective, multicenter, single-arm, phase II clinical trial. BMC Gastroenterol. 2022 Jul 28;22(1):359. doi: 10.1186/s12876-022-02440-5.
- Derived from this study: PubMed 35219300Li N, Xiang X, Zhao D, Wang X, Tang Y, Chi Y, Yang L, Jiang L, Jiang J, Shi J, Liu W, Fang H, Tang Y, Chen B, Lu N, Jing H, Qi S, Wang S, Liu Y, Song Y, Li Y, Zhang L, Jin J. Preoperative versus postoperative chemo-radiotherapy for locally advanced gastric cancer: a multicenter propensity score-matched analysis. BMC Cancer. 2022 Feb 26;22(1):212. doi: 10.1186/s12885-022-09297-7.
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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.
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 SIB-IMRT, S-1 and SOX in people with Gastric Cancer and Neoadjuvant Therapy, run by Jing Jin, M.D. 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 6 inclusion and 8 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 24 Jan 2022. 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 Jing Jin, MD (+8613601365130, jingjin1025@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCR rate (time frame: 6-8 months). 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 NCT04062058, which also lists 3 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 24 Jan 2022.