Gastric CancerPhase 2NCT03083613
Raltitrexed and Paclitaxel for Gastric or Gastroesophageal Junction Adenocarcinoma
A Phase 2 study testing Raltitrexed and Paclitaxel in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a single-arm clinical trial.The purpose of this study is to evaluate the efficacy and safety of Raltitrexed and Paclitaxel as second-line chemotherapy for patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma .The primary endpoint of this study is objective response… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Raltitrexed and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- May 2015to 1 Dec 2018
- 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 confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma;
- Patients failed first-line chemotherapy containing fluoropyrimidines and platinums;
- ECOG (Eastern Cooperative Oncology Group)performance status 0-1;
- At least 1 measurable lesion should be present（RECIST1.1）
- Available Organ function: Neutrophils>2g/L, Hemoglobin>9g/L, Blood platelet >100g/L; Alanine aminotransferase(ALT） and Aspartate aminotransferase(AST)<1.5 ULN(upper limit of normal); Total bilirubin(TBIL)<1.0 ULN; Cr <1.0ULN
- Signed informed consent.
- Life expectancy ≥3 months;
Who cannot join
- Previous treatment with Raltitrexed or Paclitaxel;
- Known history of allergic reaction to Raltitrexed or Paclitaxel;
- Known brain metastases;
- Pregnant or breast feeding women;
- Severe diarrhea,intestinal obstruction;
- other co-existing malignancies or malignancies diagnosed within the last 5 years(except cured cutaneum carcinoma or carcinoma in situs of cervix);
- Previous myocardial infarction, unstable angina, stroke ,or uncontrollable Arrhythmia;
- Kown HIV infecton.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of Raltitrexed and Paclitaxel as Second-line Chemotherapy for Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
This is a single-arm clinical trial.The purpose of this study is to evaluate the efficacy and safety of Raltitrexed and Paclitaxel as second-line chemotherapy for patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma .The primary endpoint of this study is objective response rate.The secondary endpoint of this study is safety,progression-free survival and overall survival.
Read the detailed description
Raltitrexed is an antifolate thymidylate synthase inhibitor that has shown efficacy and good safety profile in the treatment of colorectal cancer. To our knowledge, there has been no study published with the Raltitrexed and Paclitaxel regimen as second-line chemotherapy for patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.The aim of our study was to evaluate the efficacy, safety and survival of this regimen in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
- Being tested
- Raltitrexed, Paclitaxel
- Keywords
- Raltitrexed, Paclitaxel, chemotherapy, Gastric cancer, Gastroesophageal Junction Adenocarcinoma
- 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 RTX
Raltitrexed:3mg/m2,iv,d1, Every 3 weeks
PaclitaxelDrug
Paclitaxel:80mg/m2,iv,d1,d8, Every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Raltitrexed and Paclitaxel | Experimental | All patients receive the combination therapy of Raltitrexed and Paclitaxel for a maximum of 6 cycles
Raltitrexed:3mg/m2,d1 Paclitaxel:80mg/m2,d1,d8,
Eery 3 weeks Receives: Drug: Raltitrexed; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Measured: 18-26 months
Secondary outcomes (2)
Overall Survival
From date of randomization until date of death
Measured: 18-26 months
Progression-free survival
From date of randomization until date of first documented PD, date of death
Measured: 18-26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study startMay 2015
- Primary completion1 Sep 2017
- Study completion1 Dec 2018
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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aiping Zhou, Chinese Academy of Medical Sciences
- Investigators
- Ai Ping Zhou, Doctor of medcine, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083613
- Sponsor's protocol ID
- CH-G1-070
- Status last verified
- Jan 2021
- First submitted
- 14 Mar 2017
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Raltitrexed and Paclitaxel as Second-line Chemotherapy for Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03083613
- Acronym / sponsor ID
- CH-G1-070
- Keywords
- Raltitrexed, Paclitaxel, chemotherapy, Gastric cancer, Gastroesophageal Junction Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 20 Mar 2017 (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 is a single-arm clinical trial.The purpose of this study is to evaluate the efficacy and safety of Raltitrexed and Paclitaxel as second-line chemotherapy for patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma .The primary endpoint of this study is objective response rate.The secondary endpoint of this study is safety,progression-free survival and overall survival.
Detailed description
Raltitrexed is an antifolate thymidylate synthase inhibitor that has shown efficacy and good safety profile in the treatment of colorectal cancer. To our knowledge, there has been no study published with the Raltitrexed and Paclitaxel regimen as second-line chemotherapy for patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.The aim of our study was to evaluate the efficacy, safety and survival of this regimen in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Raltitrexed and Paclitaxel | Experimental | Drug: Raltitrexed, Drug: PaclitaxelAll patients receive the combination therapy of Raltitrexed and Paclitaxel for a maximum of 6 cycles Raltitrexed:3mg/m2,d1 Paclitaxel:80mg/m2,d1,d8, Eery 3 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma;
- Patients failed first-line chemotherapy containing fluoropyrimidines and platinums;
- ECOG (Eastern Cooperative Oncology Group)performance status 0-1;
- At least 1 measurable lesion should be present（RECIST1.1）
- Available Organ function: Neutrophils>2g/L, Hemoglobin>9g/L, Blood platelet >100g/L; Alanine aminotransferase(ALT） and Aspartate aminotransferase(AST)<1.5 ULN(upper limit of normal); Total bilirubin(TBIL)<1.0 ULN; Cr <1.0ULN
Key exclusion criteria (8 listed)
- Previous treatment with Raltitrexed or Paclitaxel;
- Known history of allergic reaction to Raltitrexed or Paclitaxel;
- Known brain metastases;
- Pregnant or breast feeding women;
- Severe diarrhea,intestinal obstruction;
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: RTXRaltitrexed:3mg/m2,iv,d1, Every 3 weeks | Drug | Raltitrexed and Paclitaxel |
| PaclitaxelPaclitaxel:80mg/m2,iv,d1,d8, Every 3 weeks | Drug | Raltitrexed and Paclitaxel |
Primary outcome
Objective Response Rate
Time frame: 18-26 months
2 secondary outcomes
Overall Survival
Time frame: 18-26 months
Progression-free survival
Time frame: 18-26 months
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 1 Feb 2021.
- 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.
Ai Ping Zhou, Doctor of medcine principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 Paclitaxel in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, 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 7 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 1 Feb 2021. 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?
Objective Response Rate (time frame: 18-26 months). 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 1 Feb 2021.