Gastric Cancer Stage IVNCT06666582
Real-world Data of Paclitaxel and Ramucirumab Compared to Other Treatment Regimens in Advanced Gastric Cancer
An observational study of Gastric Cancer Stage IV and Second-line Treatment, run by Hellenic Cooperative Oncology Group at 1 site in Greece.
Trial summary
Our aim was to evaluate whether second-line treatment with paclitaxel and ramucirumab was associated with improved clinical outcomes compared to other available therapies. This study involved real-world data collection, focusing on the safety and efficacy of therapeutic combinations, administered to patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer Stage IV, Second-line Treatment, Ramucirumab Paclitaxel
- What is being tested?
- Paclitaxel and ramucirumab
- How many people
- 185 participants
- Where
- 1 siteGreece
- Study dates
- 1 Mar 2015to 15 Jan 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study included patients with unresectable or metastatic, locally advanced adenocarcinoma of the stomach, gastroesophageal junction, or distal esophagus who had been treated at Departments of Medical Oncology affiliated with the Hellenic Cooperative Oncology Group (HeCOG). All patients had received second-line treatment for advanced disease based on international/national guidelines. All regimens, combinations of drugs as well as monotherapy, were accepted. Patients were included in the analysis if they have received at least two months of second-line treatment. Patient clinicopathological characteristics and outcome data were retrospectively recorded from patient medical records. Toxicity data were retrospectively recorded from the clinicians' documentations of patient-reported symptoms and laboratory results during scheduled clinical visits or patient hospitalizations.
Who may be able to join
- Patients with unresectable or metastatic, locally advanced adenocarcinoma of the stomach, gastroesophageal junction, or distal esophagus
- Treated at Departments of Medical Oncology affiliated with the Hellenic Cooperative Oncology Group (HeCOG)
- Second-line treatment for advanced disease
- Treatment for at least two months of second-line treatment.
Who cannot join
- Lack of informed consent in case the patient was alive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-world Efficacy and Toxicity Data of the Combination of Paclitaxel and Ramucirumab Compared to Other Treatment Regimens in Patients With Advanced Gastric Cancer
Our aim was to evaluate whether second-line treatment with paclitaxel and ramucirumab was associated with improved clinical outcomes compared to other available therapies. This study involved real-world data collection, focusing on the safety and efficacy of therapeutic combinations, administered to patients with pretreated advanced gastric cancer in the Oncology Departments affiliated with the Hellenic Cooperative Oncology Group (HeCOG).
- Being tested
- Paclitaxel and ramucirumab
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel and ramucirumabDrug
Second-line treatment with paclitaxel/ramucirumab vs other regimens
| Study group | Role | What they receive |
|---|---|---|
| Patients who received paclitaxel - ramucirumab as second-line treatment | Patients with unresectable or metastatic, locally advanced adenocarcinoma of the stomach, gastroesophageal junction, or distal esophagus who had been treated at Departments of Medical Oncology affiliated with the Hellenic Cooperative Oncology Group (HeCOG). All patients had received second-line treatment for advanced disease with paclitaxel and ramucirumab, for at least two months. Receives: Drug: Paclitaxel and ramucirumab | |
| Patients who received other regimens as second-line treatment | patients with unresectable or metastatic, locally advanced adenocarcinoma of the stomach, gastroesophageal junction, or distal esophagus who had been treated at Departments of Medical Oncology affiliated with the Hellenic Cooperative Oncology Group (HeCOG). All patients had received second-line treatment for advanced disease based on international/national guidelines, except from paclitaxel and ramucirumab. All other regimens, combinations of drugs as well as monotherapy, were accepted. Patients were included in the analysis if they have received at least two months of second-line treatment. Receives: Drug: Paclitaxel and ramucirumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The primary endpoint of interest was the assessment of progression-free survival (PFS1), defined as the time interval from the initiation of second-line treatment to the date of discontinuation (due to any reason), first documented progression, death from any cause or last contact, whichever occurred first.
Measured: From the initiation of second-line treatment to the date of discontinuation (due to any reason), first documented progression, death from any cause or last contact, through study completion, up to 2 years
Secondary outcomes (1)
Overall survival
overall survival (OS), defined as the time interval from the date of disease progression to the date of death from any cause or last contact.
Measured: From the date of disease progression to the date of death from any cause or last contact, through study completion, up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start1 Mar 2015
- Primary completion30 Mar 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer Stage IVStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666582
- Sponsor's protocol ID
- RE721
- Status last verified
- Oct 2024
- First submitted
- 9 Apr 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Could share anonymized clinical data upon request, after approval by our institutions
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Efficacy and Toxicity Data of the Combination of Paclitaxel and Ramucirumab Compared to Other Treatment Regimens in Patients With Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT06666582
- Acronym / sponsor ID
- RE721
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Hellenic Cooperative Oncology GroupUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 30 Oct 2024 (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.
Our aim was to evaluate whether second-line treatment with paclitaxel and ramucirumab was associated with improved clinical outcomes compared to other available therapies. This study involved real-world data collection, focusing on the safety and efficacy of therapeutic combinations, administered to patients with pretreated advanced gastric cancer in the Oncology Departments affiliated with the Hellenic Cooperative Oncology Group (HeCOG).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who received paclitaxel - ramucirumab as second-line treatment | – | Drug: Paclitaxel and ramucirumabPatients with unresectable or metastatic, locally advanced adenocarcinoma of the stomach, gastroesophageal junction, or distal esophagus who had been treated at Departments of Medical Oncology affiliated with the Hellenic Cooperative Oncology Group (HeCOG). All patients had received second-line treatment for advanced disease with paclitaxel and ramucirumab, for at least two months. |
| Patients who received other regimens as second-line treatment | – | Drug: Paclitaxel and ramucirumabpatients with unresectable or metastatic, locally advanced adenocarcinoma of the stomach, gastroesophageal junction, or distal esophagus who had been treated at Departments of Medical Oncology affiliated with the Hellenic Cooperative Oncology Group (HeCOG). All patients had received second-line treatment for advanced disease based on international/national guidelines, except from paclitaxel and ramucirumab. All other regimens, combinations of drugs as well as monotherapy, were accepted. Patients were included in the analysis if they have received at least two months of second-line treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included patients with unresectable or metastatic, locally advanced adenocarcinoma of the stomach, gastroesophageal junction, or distal esophagus who had been treated at Departments of Medical Oncology affiliated with the Hellenic Cooperative Oncology Group (HeCOG). All patients had received second-line treatment for advanced disease based on international/national guidelines. All regimens, combinations of drugs as well as monotherapy, were accepted. Patients were included in the analysis if they have received at least two months of second-line treatment. Patient clinicopathological characteristics and outcome data were retrospectively recorded from patient medical records. Toxicity data were retrospectively recorded from the clinicians' documentations of patient-reported symptoms and laboratory results during scheduled clinical visits or patient hospitalizations.
Key inclusion criteria (4 listed)
- Patients with unresectable or metastatic, locally advanced adenocarcinoma of the stomach, gastroesophageal junction, or distal esophagus
- Treated at Departments of Medical Oncology affiliated with the Hellenic Cooperative Oncology Group (HeCOG)
- Second-line treatment for advanced disease
- Treatment for at least two months of second-line treatment.
Key exclusion criteria (1 listed)
- Lack of informed consent in case the patient was alive
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 |
|---|---|---|
| Paclitaxel and ramucirumabSecond-line treatment with paclitaxel/ramucirumab vs other regimens | Drug | Patients who received other regimens as second-line treatment, Patients who received paclitaxel - ramucirumab as second-line treatment |
Primary outcome
Progression-free survival
Time frame: From the initiation of second-line treatment to the date of discontinuation (due to any reason), first documented progression, death from any cause or last contact, through study completion, up to 2 years
The primary endpoint of interest was the assessment of progression-free survival (PFS1), defined as the time interval from the initiation of second-line treatment to the date of discontinuation (due to any reason), first documented progression, death from any cause or last contact, whichever occurred first.
1 secondary outcome
Overall survival
Time frame: From the date of disease progression to the date of death from any cause or last contact, through study completion, up to 2 years.
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 30 Oct 2024.
- Individual participant dataSharing planned: Undecided. Could share anonymized clinical data upon request, after approval by our institutions
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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?
An observational study of Gastric Cancer Stage IV and Second-line Treatment, run by Hellenic Cooperative Oncology Group at 1 site in Greece.
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 4 inclusion and 1 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 30 Oct 2024. 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 Greece. 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.
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?
Progression-free survival (time frame: From the initiation of second-line treatment to the date of discontinuation (due to any reason), first documented progression, death from any cause or last contact, through study completion, up to 2 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 30 Oct 2024.