Gastric CancerPhase 1/2NCT03427684
Study of Hypo-fractionated Neoadjuvant Radiotherapy for Locally Advanced Gastric Cancer
A Phase 1/2 study testing Hypo-fractionated radiotherapy and S1 in people with Gastric Cancer and Chemoradiation, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Gastric cancer is one of the most common malignant tumors in China, and the incidence and mortality rate are second in malignant tumors. The treatment of gastric cancer need integrated multidisciplinary treatment, and surgery is the only possible curative method for gastric cancer at present. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Chemoradiation
- What is being tested?
- Hypo-fractionated radiotherapy and S1
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2016to 31 Dec 2020
- Phase
- Phase 1/2
- 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
- Clinical stage T3-4N+M0
- Gastric cancer or Siewert II/III esophagogastric junction carcinoma;
- Pathologically confirmed adenocarcinoma;
- 18-75 years old, male or female;
- Karnofsky score >= 70;
- White blood cell count >= 4 x 109 / L; platelet count >= 100 x109/L; serum creatinine =< 1 x upper limit of normal, total bilirubin =< 1 x upper limit of normal, alanine aminotransferase and aspartate aminotransferase =< 2.5 x upper limit of normal, alkaline phosphatase =< 5 x upper limit of normal.
Who cannot join
- Any chemotherapy or radiotherapy history before enrollment
- Siewert I EGJ cancer
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese academy of medical sciences
Beijing, Beijing Municipality, 100021
Ning Li, MD, 8610-87787625, lee_ak@163.com
About this study
Official title: Phase I Study of Hypo-fractionated Neoadjuvant Radiotherapy for Locally Advanced Gastric Cancer
Gastric cancer is one of the most common malignant tumors in China, and the incidence and mortality rate are second in malignant tumors. The treatment of gastric cancer need integrated multidisciplinary treatment, and surgery is the only possible curative method for gastric cancer at present. Previous studies have reported that neoadjuvant chemoradiotherapy can downstage primary tumor to increase radical resection rate in order to improve the long-term prognosis of advanced gastric cancer. However, there is no study on the application of hypo-radiotherapy to neoadjuvant radiotherapy in gastric cancer. The aim of this study was to observe the maximum tolerated dose (MTD) and dose limited toxicity (DLT) of hypo-fractionated radiotherapy for locally advanced gastric cancer.
Read the detailed description
After enrolled in this study, the patient was first treated with radiotherapy, concurrent with oral S-1 80mg/m2/day, on radiotherapy days. 3 weeks after the end of radiotherapy, patients treated with neoadjuvant chemotherapy with oxaliplatin and S-1. Oxaliplatin is given on dose of 130mg/m2 iv on day 1; S-1 on 40-60mg po BID on day 1-14, oral. Imaging evaluation was performed 3 weeks after neoadjuvant treatment. The radical operation and surgical procedure were determined on MDT discussion. Non-operable patients continue with 3 cycles of chemotherapy, and the chemotherapy regimen can be changed. A 3 cycle of SOX adjuvant chemotherapy was performed after surgery.
- Conditions
- Gastric Cancer, Chemoradiation
- Being tested
- Hypo-fractionated radiotherapy, S1
- Keywords
- Gastric cancer, Chemo-radiotherapy, Phase I study, Hypo-fractionated radiotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypo-fractionated radiotherapyRadiation
Hypo-fractionated radiotherapy with fraction >2Gy .
S1Drug
S-1 80mg/m2/day, orally intake on radiotherapy days.
| Study group | Role | What they receive |
|---|---|---|
| Hypo-fractionated radiotherapy | Experimental | Hypo-fractionated neoadjuvant radiotherapy concurrent with S1 chemotherapy for local advanced gastric cancer Receives: Radiation: Hypo-fractionated radiotherapy; Drug: S1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose AND Dose limited toxicity
To assess maximum tolerated dose and dose limited toxicity of hypo-fractionated neoadjuvant radiotherapy
Measured: From date of enrollment until one month after chemo-radiotherapy
Secondary outcomes (2)
Response rate
To evaluate the pathological response rate of gastric cancer after hypo-fractionated neoadjuvant radiotherapy
Measured: From date of enrollment until surgery, assessed up to 2 months
2-year disease-free survival
To evaluate the 2-year disease-free survival of gastric cancer after hypo-fractionated neoadjuvant radiotherapy
Measured: From date of enrollment until the date of first documented progression or date of relapse, whichever came first, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start1 May 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2020 (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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI Ning, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427684
- Sponsor's protocol ID
- CAMS-GIRO-G005
- Status last verified
- Feb 2018
- First submitted
- 28 Jan 2018
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Publications
Li 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 35219300Li N, Wang X, Tang Y, Zhao D, Chi Y, Yang L, Jiang L, Jiang J, Liu W, Tang Y, Fang H, Liu Y, Song Y, Wang S, Jin J, Li Y. A prospective phase I study of hypo-fractionated neoadjuvant radiotherapy for locally advanced gastric cancer. BMC Cancer. 2018 Aug 8;18(1):803. doi: 10.1186/s12885-018-4707-9.
PubMed 30089457
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Hypo-fractionated Neoadjuvant Radiotherapy for Locally Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT03427684
- Acronym / sponsor ID
- CAMS-GIRO-G005
- Conditions
- Gastric Cancer, Chemoradiation
- Keywords
- Gastric cancer, Chemo-radiotherapy, Phase I study, Hypo-fractionated radiotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 9 Feb 2018 (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.
Gastric cancer is one of the most common malignant tumors in China, and the incidence and mortality rate are second in malignant tumors. The treatment of gastric cancer need integrated multidisciplinary treatment, and surgery is the only possible curative method for gastric cancer at present. Previous studies have reported that neoadjuvant chemoradiotherapy can downstage primary tumor to increase radical resection rate in order to improve the long-term prognosis of advanced gastric cancer. However, there is no study on the application of hypo-radiotherapy to neoadjuvant radiotherapy in gastric cancer. The aim of this study was to observe the maximum tolerated dose (MTD) and dose limited toxicity (DLT) of hypo-fractionated radiotherapy for locally advanced gastric cancer.
Detailed description
After enrolled in this study, the patient was first treated with radiotherapy, concurrent with oral S-1 80mg/m2/day, on radiotherapy days. 3 weeks after the end of radiotherapy, patients treated with neoadjuvant chemotherapy with oxaliplatin and S-1. Oxaliplatin is given on dose of 130mg/m2 iv on day 1; S-1 on 40-60mg po BID on day 1-14, oral. Imaging evaluation was performed 3 weeks after neoadjuvant treatment. The radical operation and surgical procedure were determined on MDT discussion. Non-operable patients continue with 3 cycles of chemotherapy, and the chemotherapy regimen can be changed. A 3 cycle of SOX adjuvant chemotherapy was performed after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypo-fractionated radiotherapy | Experimental | Radiation: Hypo-fractionated radiotherapy, Drug: S1Hypo-fractionated neoadjuvant radiotherapy concurrent with S1 chemotherapy for local advanced gastric cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical stage T3-4N+M0
- Gastric cancer or Siewert II/III esophagogastric junction carcinoma;
- Pathologically confirmed adenocarcinoma;
- 18-75 years old, male or female;
- Karnofsky score >= 70;
Key exclusion criteria (2 listed)
- Any chemotherapy or radiotherapy history before enrollment
- Siewert I EGJ cancer
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 |
|---|---|---|
| Hypo-fractionated radiotherapyHypo-fractionated radiotherapy with fraction >2Gy . | Radiation | Hypo-fractionated radiotherapy |
| S1S-1 80mg/m2/day, orally intake on radiotherapy days. | Drug | Hypo-fractionated radiotherapy |
Primary outcome
Maximum tolerated dose AND Dose limited toxicity
Time frame: From date of enrollment until one month after chemo-radiotherapy
To assess maximum tolerated dose and dose limited toxicity of hypo-fractionated neoadjuvant radiotherapy
2 secondary outcomes
Response rate
Time frame: From date of enrollment until surgery, assessed up to 2 months
2-year disease-free survival
Time frame: From date of enrollment until the date of first documented progression or date of relapse, whichever came first, assessed up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
- 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.
- Derived from this study: PubMed 30089457Li N, Wang X, Tang Y, Zhao D, Chi Y, Yang L, Jiang L, Jiang J, Liu W, Tang Y, Fang H, Liu Y, Song Y, Wang S, Jin J, Li Y. A prospective phase I study of hypo-fractionated neoadjuvant radiotherapy for locally advanced gastric cancer. BMC Cancer. 2018 Aug 8;18(1):803. doi: 10.1186/s12885-018-4707-9.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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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 1/2 study testing Hypo-fractionated radiotherapy and S1 in people with Gastric Cancer and Chemoradiation, 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 2 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 Feb 2018. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 (8610-87787658, jinjing1025@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose AND Dose limited toxicity (time frame: From date of enrollment until one month after chemo-radiotherapy). 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 NCT03427684, 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 9 Feb 2018.