Gastric CancerPhase 2NCT03392103
Adjuvant IMRT With Concommitant Raltitrexed Chemotherapy for Locally Advanced Gastric Cancer After D0/D1 Radical Resection
A Phase 2 study testing Raltitrexed and postoperative radiotherapy in people with Gastric Cancer, run by Zhongnan Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether raltitrexed concurrent with IMRT is safe, tolerable and effective in the treatment for patients with local-advanced gastric cancer after D0/D1 radical resection. 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?
- Raltitrexed and postoperative radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Dec 2019
- 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
- Informed consent signed.;
- Age: 18-70 years old, sex is not restricted;
- Pathologically diagnosed as gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; did not receive neoadjuvant chemotherapy or radiotherapy before surgery;received the 2-3 cycles of chemotherapy of FOLFOX regimens or 1-2 cycles of XeLOX or SOX regimens after operation;
- Received D0 or D1 operation, no tumor residual (R0);
- Postoperative pathological stage of pT3N0, pT4N0 or any T, N1-2, without distant metastatic disease;
- ECOG 0-2;
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- Normal blood analysis: WBC≥3.5 X 109/L, GRAN≥2.0 X 109/L = 2, Hb≥90g/L, PLT≥100 X 109/L;
- Liver function: ALT or AST is less than or equal to 2.5 times of the normal high value (ULN); bilirubin is less than 1.5*ULN, serum APK is less than 2.5 * ULN;
- Renal function: serum creatinine is less than 1.5 * ULN, and creatinine clearance rate is more than 60ml/min;
- No previous chemotherapy or radiation therapy history;
- No organ transplant history;
- Urine pregnancy test results are negative for women of childbearing age in the first 7 days and not in lactation before treatment;
- Men and women of childbearing age agreed to adopt reliable methods of contraception for 30 days before , during and after the course of the study
Who cannot join
- Received D2 radical operation;
- Tumor residual (R1/R2);
- There was found evidence of distant metastasis (M1) or suspicious metastasis after examination;
- Other cancer history, except skin basal cell carcinoma or cervix in-situ carcinoma;
- Previously received chemotherapy or other systemic anticancer therapy, including cytotoxic drugs, targeted drugs; or had received abdominal radiotherapy;
- Anticipate other clinical trials in four weeks before enrollment.
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- Severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes, severe cardiac arrhythmia, etc.
- Drug abuse history or alcohol addiction;
- Active infection existed.
- with severe malnutrition or severe anemia;
- Human immunodeficiency virus (HIV) infection;
- Pregnancy (confirmed by serum or urine beta -HCG test) or during lactation;
- Can not tolerate this study or may be allergic to the drug used in this study;
- Persons who have no or restricted capacity for civil conduct; or have mental illness, whom the researchers believe can not fully understand the possible complications of this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hopital of Wuhan University
Wuhan, Hubei, 430071
Fuxiang Zhou, M.D., +86（0）2767813155, fuxiang.zhou@whu.edu.cn
Jing Dai, M.D., +86（0）2767813155, daijing1116@163.com
About this study
The purpose of this study is to determine whether raltitrexed concurrent with IMRT is safe, tolerable and effective in the treatment for patients with local-advanced gastric cancer after D0/D1 radical resection.
- Conditions
- Gastric Cancer
- Being tested
- Raltitrexed, postoperative radiotherapy
- Keywords
- Raltitrexed, IMRT
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltitrexedDrug
Also called Raltitrexed Injectable Solution
concurrent chemotherapy
postoperative radiotherapyRadiation
Also called adjuvant radiotherapy
concurrent postoperative radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| postoperative CRT | Experimental | postoperative CRT: Treatment including postoperative radiotherapy (IMRT) with concurrent chemotherapy of Raltitrexed. Radiotherapy will be delivered to a planning target volume with a dose of 45-50.4Gy (1.8-2.0Gy daily) using with Intensity-Modulated Radiotherapy technique. During the radiation treatment, concurrent chemotherapy will be delivered (Raltitrexed, intravenous infusion, 3 mg/m2, on w1 and w4). Receives: Drug: Raltitrexed; Radiation: postoperative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of patients occured Grade 3 or higher adverse events
Measured: From the first day of the concurrent chemoradiotherapy (CRT) to the 180th day after CRT.
Secondary outcomes (6)
2-year local-regionally recurrence rate
The probability of locally and/or regionally recurrence at 2 year after CRT on imaging or pathological examination.
Measured: 2 year
3-year local-regionally recurrence rate
The probability of locally and/or regionally recurrence at 3 year after CRT on imaging or pathological examination.
Measured: 3 year
2-year disease-free survival probability
The probability of staying free from recurrence at 2 year after CRT on imaging or pathological examination.
Measured: 2 year
3-year disease-free survival probability
The probability of staying free from recurrence at 3 year after CRT on imaging or pathological examination.
Measured: 3 year
2-year overall survival probability
The probability of staying alive at 2 year after CRT.
Measured: 2 year
3-year overall survival probability
The probability of staying alive at 3 year after CRT.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study startJan 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (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.
- 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Fuxiang, Zhongnan Hospital
- Investigators
- Fuxiang Zhou, M.D., Study chair, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392103
- Sponsor's protocol ID
- HCCSC G03
- Status last verified
- Dec 2017
- First submitted
- 19 Dec 2017
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant IMRT With Concommitant Raltitrexed Chemotherapy for Locally Advanced Gastric Cancer After D0/D1 Radical Resection
- ClinicalTrials.gov ID
- NCT03392103
- Acronym / sponsor ID
- HCCSC G03
- Conditions
- Gastric Cancer
- Keywords
- Raltitrexed, IMRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 Jan 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.
The purpose of this study is to determine whether raltitrexed concurrent with IMRT is safe, tolerable and effective in the treatment for patients with local-advanced gastric cancer after D0/D1 radical resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| postoperative CRT | Experimental | Drug: Raltitrexed, Radiation: postoperative radiotherapypostoperative CRT: Treatment including postoperative radiotherapy (IMRT) with concurrent chemotherapy of Raltitrexed. Radiotherapy will be delivered to a planning target volume with a dose of 45-50.4Gy (1.8-2.0Gy daily) using with Intensity-Modulated Radiotherapy technique. During the radiation treatment, concurrent chemotherapy will be delivered (Raltitrexed, intravenous infusion, 3 mg/m2, on w1 and w4). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Informed consent signed.;
- Age: 18-70 years old, sex is not restricted;
- Pathologically diagnosed as gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; did not receive neoadjuvant chemotherapy or radiotherapy before surgery;received the 2-3 cycles of chemotherapy of FOLFOX regimens or 1-2 cycles of XeLOX or SOX regimens after operation;
- Received D0 or D1 operation, no tumor residual (R0);
- Postoperative pathological stage of pT3N0, pT4N0 or any T, N1-2, without distant metastatic disease;
Key exclusion criteria (14 listed)
- Received D2 radical operation;
- Tumor residual (R1/R2);
- There was found evidence of distant metastasis (M1) or suspicious metastasis after examination;
- Other cancer history, except skin basal cell carcinoma or cervix in-situ carcinoma;
- Previously received chemotherapy or other systemic anticancer therapy, including cytotoxic drugs, targeted drugs; or had received abdominal radiotherapy;
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 |
|---|---|---|
| RaltitrexedAlso: Raltitrexed Injectable Solutionconcurrent chemotherapy | Drug | postoperative CRT |
| postoperative radiotherapyAlso: adjuvant radiotherapyconcurrent postoperative radiation therapy | Radiation | postoperative CRT |
Primary outcome
The ratio of patients occured Grade 3 or higher adverse events
Time frame: From the first day of the concurrent chemoradiotherapy (CRT) to the 180th day after CRT.
6 secondary outcomes
2-year local-regionally recurrence rate
Time frame: 2 year
3-year local-regionally recurrence rate
Time frame: 3 year
2-year disease-free survival probability
Time frame: 2 year
3-year disease-free survival probability
Time frame: 3 year
2-year overall survival probability
Time frame: 2 year
3-year overall survival probability
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Fuxiang Zhou, M.D. study chair
Zhongnan Hospital
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 Raltitrexed and postoperative radiotherapy in people with Gastric Cancer, run by Zhongnan Hospital 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 13 inclusion and 14 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 5 Jan 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 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 Dai, M.D. (+86（0）2767813155, daijing1116@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ratio of patients occured Grade 3 or higher adverse events (time frame: From the first day of the concurrent chemoradiotherapy (CRT) to the 180th day after CRT.). 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 5 Jan 2018.