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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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.

China1 site

Chinese Academy of Medical Sciences
Beijing, 10000

Other trials in China

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

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.

Conditions: Gastric Cancer, 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 groups in NCT03083613
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.

May 20151 Dec 2018

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Gastric Cancer trials

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
Conditions: Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
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.

Detailed description

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

Related trials for Gastric Cancer

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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?

On the ClinicalTrials.gov record for NCT03083613.

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.