Stomach NeoplasmsPhase 2NCT02301481
A Randomized Phase II Trial of Neoadjuvant Chemotherapy Compared With Chemoradiotherapy in Gastric Adenocarcinoma
A Phase 2 study testing SIB-IMRT, S-1 and Surgery in people with Stomach Neoplasms and Neoadjuvant Therapy, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This prospective, randomized phase II study is designed to evaluate weather neoadjuvant chemoradiotherapy is superior to neoadjuvant chemotherapy with both followed by surgery and postoperative chemotherapy for locally advanced gastric adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stomach Neoplasms, Neoadjuvant Therapy, Chemoradiotherapy
- What is being tested?
- SIB-IMRT, S-1 and Surgery
- 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
- 71 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Dec 2017
- 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 cT3-4N0M0 or anyTN+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
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, 100021
About this study
Official title: A Prospective, Randomized Phase II Trial of Neoadjuvant Chemotherapy Compared With Concomitant Boost Intensity-Modulated Radiotherapy With S-1 in Locally Advanced Gastric Adenocarcinoma
This prospective, randomized phase II study is designed to evaluate weather neoadjuvant chemoradiotherapy is superior to neoadjuvant chemotherapy with both followed by surgery and postoperative chemotherapy for locally advanced gastric adenocarcinoma.
- Being tested
- SIB-IMRT, S-1, Surgery, SOX
- 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
45.1Gy and 40.04Gy in 22 fractions using intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) to primary tumor
S-1Drug
Also called TS-1
40mg/m2, orally twice daily every weekday concurrently with radiotherapy treatment
SurgeryProcedure or surgery
Surgery, preferred D2 lymphadenectomy
SOXDrug
Also called TS-1; Oxaliplatin for injection
SOX (S-1: 40~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle)
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Chemoradiotherapy (NCRT) | Experimental | NCRT arm receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (45.1Gy and 40.04Gy in 22 fractions) concurrently with oral S-1(40mg/m2, orally twice daily every weekday) followed by surgery and four to six cycles of SOX at the same dosage with NCT arm. Receives: Radiation: SIB-IMRT; Drug: S-1; Procedure: Surgery; Drug: SOX |
| Neoadjuvant Chemotherapy (NCT) | Active comparator | NCT arm consists of neoadjuvant three cycles of SOX(S-1: 40~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle followed by radical surgery and another postoperative three cycles of SOX. Receives: Procedure: Surgery; Drug: SOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
The surgical procedure was total or subtotal gastrectomy with recommended D2 lymphadenectomy 4-6 weeks after neoadjuvant therapy.
Measured: 2-3 months
Secondary outcomes (7)
Pathological response 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 themicroscope. 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: 2-3 months
Tumor down-staging
Down-staging was considered as any stage reduction between clinical and pathologic stage.
Measured: 2-3 months
Postoperative complications
During hospital stay and within the first 30 days after completion of surgery.
Measured: 2-3 months
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
Distant metastasis free survival
Measured: 3 years
Locoregional recurrence free survival
Measured: 3 years
Overall survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Jin, M.D., Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301481
- Sponsor's protocol ID
- NCC2015ST-09
- Status last verified
- Oct 2019
- First submitted
- 23 Nov 2014
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang X, Zhao DB, Yang L, Chi Y, Zhao H, Jiang LM, Jiang J, Tang Y, Li N, Liu WY, Dou LZ, Zou SM, Xue LY, Ren JS, Tian YT, Che X, Guo CG, Bai XF, Sun YM, Wang SL, Song YW, Liu YP, Fang H, Li YX, Jin J. Preoperative Concurrent Chemoradiotherapy Versus Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer: Phase II Randomized Study. Front Oncol. 2022 Apr 29;12:870741. doi: 10.3389/fonc.2022.870741. eCollection 2022.
PubMed 35574368
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Phase II Trial of Neoadjuvant Chemotherapy Compared With Concomitant Boost Intensity-Modulated Radiotherapy With S-1 in Locally Advanced Gastric Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02301481
- Acronym / sponsor ID
- NCC2015ST-09
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 26 Nov 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.
This prospective, randomized phase II study is designed to evaluate weather neoadjuvant chemoradiotherapy is superior to neoadjuvant chemotherapy with both followed by surgery and postoperative chemotherapy for locally advanced gastric adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Chemoradiotherapy (NCRT) | Experimental | Radiation: SIB-IMRT, Drug: S-1, Procedure: Surgery, Drug: SOXNCRT arm receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (45.1Gy and 40.04Gy in 22 fractions) concurrently with oral S-1(40mg/m2, orally twice daily every weekday) followed by surgery and four to six cycles of SOX at the same dosage with NCT arm. |
| Neoadjuvant Chemotherapy (NCT) | Active comparator | Procedure: Surgery, Drug: SOXNCT arm consists of neoadjuvant three cycles of SOX(S-1: 40~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle followed by radical surgery and another postoperative three cycles of SOX. |
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 cT3-4N0M0 or anyTN+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-IMRT45.1Gy and 40.04Gy in 22 fractions using intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) to primary tumor | Radiation | Neoadjuvant Chemoradiotherapy (NCRT) |
| S-1Also: TS-140mg/m2, orally twice daily every weekday concurrently with radiotherapy treatment | Drug | Neoadjuvant Chemoradiotherapy (NCRT) |
| SurgerySurgery, preferred D2 lymphadenectomy | Procedure or surgery | Neoadjuvant Chemoradiotherapy (NCRT), Neoadjuvant Chemotherapy (NCT) |
| SOXAlso: TS-1; Oxaliplatin for injectionSOX (S-1: 40~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle) | Drug | Neoadjuvant Chemoradiotherapy (NCRT), Neoadjuvant Chemotherapy (NCT) |
Primary outcome
R0 resection rate
Time frame: 2-3 months
The surgical procedure was total or subtotal gastrectomy with recommended D2 lymphadenectomy 4-6 weeks after neoadjuvant therapy.
7 secondary outcomes
Pathological response rate
Time frame: 2-3 months
Tumor down-staging
Time frame: 2-3 months
Postoperative complications
Time frame: 2-3 months
Acute chemotherapy/Chemoradiotherapy toxicities
Time frame: 6-8 months
Distant metastasis free survival
Time frame: 3 years
Locoregional recurrence free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Derived from this study: PubMed 35574368Wang X, Zhao DB, Yang L, Chi Y, Zhao H, Jiang LM, Jiang J, Tang Y, Li N, Liu WY, Dou LZ, Zou SM, Xue LY, Ren JS, Tian YT, Che X, Guo CG, Bai XF, Sun YM, Wang SL, Song YW, Liu YP, Fang H, Li YX, Jin J. Preoperative Concurrent Chemoradiotherapy Versus Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer: Phase II Randomized Study. Front Oncol. 2022 Apr 29;12:870741. doi: 10.3389/fonc.2022.870741. eCollection 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Surgery in people with Stomach Neoplasms and Neoadjuvant Therapy, run by Chinese Academy of Medical Sciences 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: finished, as of the sponsor's last update on 16 Oct 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: 2-3 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 NCT02301481, which also lists 1 linked publication.
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 16 Oct 2019.