Trial · NCT03627728
Study Maintenance Regorafenib vs Placebo, no Progression Patients After I Line Chemotherapy Metastatic Gastric Cancer
NCT03627728, Phase 2, Completed, Gruppo Oncologico Italiano di Ricerca Clinica
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Maintenance Regorafenib vs Placebo, no Progression Patients After I Line Chemotherapy Metastatic Gastric Cancer. Trials, record NCT03627728. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03627728
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Maintenance Regorafenib vs Placebo, no Progression Patients After I Line Chemotherapy Metastatic Gastric Cancer
- NCT number
- NCT03627728
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 67 participants, actual
- Lead sponsor
- Gruppo Oncologico Italiano di Ricerca Clinica
- Conditions
- Gastric Cancer
- Interventions
- Regorafenib, placebo
- First posted
- 2018-08-13
- Last updated
- 2025-03-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PFS1 | 36 months | Progression free survival will be calculated for all patients from the date of randomization until the date PD or death is first reported. |
| Secondary | OS | 36 months | time from date of randomization to the date of Death from any cause |
| Secondary | PFS2 | 36 months | PFS 2 will be calculated from the start of second line therapy to PD or death |
| Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability | 36 months | The overall incidences of AEs will be summarized. Patients who experienced the same event on more than one occasion are counted only once in the calculation of the event frequency, at the highest intensity ever observed. |
| Secondary | Response Rate | 36 months | in patients who are randomized at enrollment to treatment with regorafenib vs placebo, |
| Secondary | quality of life To compare the patient treatment-related symptoms | up to 8 months | To compare the patient treatment-related symptoms as measured by the European Organization for research and treatment of cancer EORTC QLQ-C30, (days 1, week , 8, 16, 24, 32) , for patients in each treatment arm. |
| Secondary | biomarker evaluation | 36 months | To correlate the genetic mutational profile of the tumors with the RR and the OS of the patients |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03627728
GET https://conductscience.org/api/trials/v1/NCT03627728/registered