Trial · NCT03793361
Phase II Study of Regorafenib as Maintenance Therapy
NCT03793361, Phase 2, Completed, Centre Oscar Lambret
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Study of Regorafenib as Maintenance Therapy. Trials, record NCT03793361. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03793361
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Regorafenib as Maintenance Therapy
- NCT number
- NCT03793361
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 127 participants, actual
- Lead sponsor
- Centre Oscar Lambret
- Conditions
- Metastatic Soft Tissue Sarcoma
- Interventions
- Regorafenib, Placebo
- First posted
- 2019-01-04
- Last updated
- 2026-03-18
- Other registries' IDs
- eudract:2018-001574-22
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To assess the efficacy of regorafenib compared to placebo | from the date of randomization to the date of first observed disease progression (according to RECIST 1.1 criteria) or death from any cause, up to 12 months after the beginning of the treatment | Progression-Free Survival will be measured from the date of randomization until the date of radiological progression (according to RECIST 1.1 criteria) or death (if death occurs before progression). |
| Secondary | To assess the efficacy of regorafenib compared to placebo | from the date of randomization to the date of death from any cause | in terms of overall survival |
| Secondary | To assess the efficacy of regorafenib compared to placebo | from the date of randomization to the date of first observed disease progression (according to RECIST 1.1) or death from any cause, up to 12 months after the beginning of the treatment | Best response according to RECIST 1.1 evaluated by central radiological review: Complete Response, CR, or Partial Response, PR, achieved during the maintenance therapy. CR and PR will be counted as objective response to estimate the objective response rate (ORR) |
| Secondary | To assess the efficacy of regorafenib compared to placebo | from the date of randomization to the date of death from any cause, up to 12 months after the beginning of the treatment | Time to start subsequent line of anticancer therapy defined as the time interval from the date of randomization to the date of start subsequent line of anticancer therapy. Patient data will be censored at the date of last follow-up visit for patients alive at last follow-up visit without having started subsequent line of anticancer therapy. Death without having started subsequent line of anticancer therapy will be counted as a competing event. |
| Secondary | To assess the safety of regorafenib | Baseline, every 4 weeks, up to 12 months after the beginning of the treatment | Compared to placebo - Toxicity according to NCI-CTC AE V5.0 over the whole treatment duration plus 30 days, excluding AE unequivocally related to the disease under study or its progression. Adverse events of grade 3 or more (grade 3+) will be counted as severe adverse events |
| Secondary | To assess the relative benefit/risk ratio | up to 12 months | using the Q-TWiST approach - Quality-adjusted time without symptoms of disease or toxicity computed from survival times (overall survival and progression-free survival) and adverse events data (date of occurrence of grade 3+ adverse event classified as drug-related) |
| Other | assessment of the predictive value of SUMSCAN signature | up to 12 months | genomic signature established on initial diagnostic biopsies or resection specimen and identifying sarcoma patients benefitting from anti-angiogenetic agents |
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/NCT03793361
GET https://conductscience.org/api/trials/v1/NCT03793361/registered