Gastric CancerPhase 2NCT01836120
A Study of Raltitrexed Plus Docetaxel Versus Docetaxel as Second-line Chemotherapy in Subjects With Gastric Cancer
A Phase 2 study testing Raltitrexed plus Docetaxel and Docetaxel in people with Gastric Cancer, run by Hebei Tumor Hospital at 1 site in China.
Trial summary
A study of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with Gastric Cancer.The purpose of this study is to compare the activity of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with gastric carcinoma by estimating progression free survival… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Raltitrexed plus Docetaxel and Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Jun 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
- Signed informed consent form
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;
- Histologically or cytologically confirmed gastric cancer;
- The first-line chemotherapy failure (required containing 5-fluorouracil)
- At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
- Life expectancy of at least 3 months;
Who cannot join
- Received any prior treatment including Raltitrexed;
- Active or uncontrolled infection;
- Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
A study of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with Gastric Cancer.The purpose of this study is to compare the activity of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with gastric carcinoma by estimating progression free survival (PFS) in each treatment arm.
- Conditions
- Gastric Cancer
- Being tested
- Raltitrexed plus Docetaxel, Docetaxel
- Keywords
- second-line chemotherapy, Raltitrexed
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raltitrexed plus DocetaxelDrug
Raltitrexed plus Docetaxel (Raltitrexed 3mg/m2 d
1; Docetaxel 75mg/m2 d1, every 3 weeks, 4-6 cycles)
DocetaxelDrug
Docetaxel (Docetaxel 75mg/m2 d1, every 3weeks,4-6 cycles)
| Study group | Role | What they receive |
|---|---|---|
| Raltitrexed plus Docetaxel | Experimental | Not described Receives: Drug: Raltitrexed plus Docetaxel |
| Docetaxel | Active comparator | Not described Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: 1 years
Secondary outcomes (2)
Objective Response Rate (ORR)
Measured: 1 year
Overall Survival (OS)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836120
- Sponsor's protocol ID
- HBTH103
- Status last verified
- Apr 2013
- First submitted
- 17 Apr 2013
- Last updated
- 19 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Raltitrexed Plus Docetaxel Versus Docetaxel as Second-line Chemotherapy in Subjects With Gastric Cancer
- ClinicalTrials.gov ID
- NCT01836120
- Acronym / sponsor ID
- HBTH103
- Conditions
- Gastric Cancer
- Keywords
- second-line chemotherapy, Raltitrexed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hebei Tumor HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 19 Apr 2013 (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.
A study of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with Gastric Cancer.The purpose of this study is to compare the activity of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with gastric carcinoma by estimating progression free survival (PFS) in each treatment arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raltitrexed plus Docetaxel | Experimental | Drug: Raltitrexed plus Docetaxel |
| Docetaxel | Active comparator | Drug: Docetaxel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent form
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;
- Histologically or cytologically confirmed gastric cancer;
- The first-line chemotherapy failure (required containing 5-fluorouracil)
- At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
Key exclusion criteria (4 listed)
- Received any prior treatment including Raltitrexed;
- Active or uncontrolled infection;
- Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
- Pregnant or lactating women.
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 |
|---|---|---|
| Raltitrexed plus DocetaxelRaltitrexed plus Docetaxel (Raltitrexed 3mg/m2 d 1; Docetaxel 75mg/m2 d1, every 3 weeks, 4-6 cycles) | Drug | Raltitrexed plus Docetaxel |
| DocetaxelDocetaxel (Docetaxel 75mg/m2 d1, every 3weeks,4-6 cycles) | Drug | Docetaxel |
Primary outcome
Progression-free survival (PFS)
Time frame: 1 years
2 secondary outcomes
Objective Response Rate (ORR)
Time frame: 1 year
Overall Survival (OS)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2013.
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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 Raltitrexed plus Docetaxel and Docetaxel in people with Gastric Cancer, run by Hebei Tumor 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 6 inclusion and 4 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 19 Apr 2013. 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?
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?
Progression-free survival (PFS) (time frame: 1 years). 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 19 Apr 2013.