Trial · NCT07213570
STREAM-2: Second-line Treatment With REgorafenib in Advanced RAS-Mutant Colorectal Cancer
NCT07213570, Phase 2, Recruiting, National Cancer Institute, Naples
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. STREAM-2: Second-line Treatment With REgorafenib in Advanced RAS-Mutant Colorectal Cancer. Trials, record NCT07213570. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07213570
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- STREAM-2: Second-line Treatment With REgorafenib in Advanced RAS-Mutant Colorectal Cancer
- NCT number
- NCT07213570
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- National Cancer Institute, Naples
- Conditions
- Colorectal Cancer Metastatic
- Interventions
- standard second line treatment, at discretion of the investigator, Regorafenib (BAY73-4506)
- First posted
- 2025-10-09
- Last updated
- 2026-10-13
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival rate at 6 months in the two arms. | up to 6 months from randomization | Progression Free Survival rate at 6 months(PFS rate at 6-months) is defined as the rate of assessable patients alive and not progressed after 6 months from study initiation (i.e randomization) to the first documentation of objective disease progression by RECIST 1.1 criteria, or death due to any cause, whichever occurs first. |
| Secondary | Progression free survival (PFS) | up to 1 year last patients randomized | Progression free survival (PFS) calculated as the time from randomization until the date of death from any cause until the date of the first observation of disease progression or death due to any cause, whichever occurs first. |
| Secondary | Overall survival (OS) | up to 1 year last patients randomized | Overall survival (OS) calculated as the time from randomization until the date of death from any cause. |
| Secondary | Objective Tumor Response Rate (ORR) | up to 1 year last patients randomized | Objective Tumor Response Rate (ORR) assessed according to RECIST criteria 1.1, as the proportion of patients achieving complete or partial response relative to total enrolled patients. |
| Secondary | Disease Control Rate (DCR) | up to 1 year last patients randomized | Disease Control Rate (DCR) defined as the proportion of patients with complete/partial response and stable disease as their best response |
| Secondary | Progression free survival 2 (PFS2) | up to 1 year last patients randomized | Progression free survival 2 (PFS2) calculated as the time from registration to progression from subsequent line of treatment or death without progression, whichever occurred first. |
| Secondary | Overall Toxicity rate | up to 1 year last patients randomized | Overall Toxicity rate defined as adverse events graded according NCI CTCAE v 5.0. as the proportion of patients experiencing any grade AE accordingly to the NCI Common Terminology Criteria of Adverse Events (NCI CTC-AE) Version 5, relative to the total of patients receiving at least one cycle of treatment.AE will be listed individually by the patient and summarized overall (severity grades 1-4) and for grade ≥3 by treatment received. |
| Secondary | Quality of life (QoL) | questionnaires must be completed before any study procedure but within 2 weeks prior to randomization (baseline) and thereafter every 8 weeks from randomization until disease progression, treatment failure or death, assessed up to 18 months | Quality of life (QoL) investigated through the EORTC QOL-C30 questionnaires at baseline (prior to treatment start, once eligibility is confirmed) and every 8 weeks from randomization until disease progression, treatment failure or death. |
| Secondary | Quality of life (QoL) | questionnaires must be completed before any study procedure but within 2 weeks prior to randomization (baseline) and thereafter every 8 weeks from randomization until disease progression, treatment failure or death, assessed up to 18 months. | Quality of life (QoL) investigated through the EORTC QOL-CR29 questionnaires at baseline (prior to treatment start, once eligibility is confirmed) and every 8 weeks from randomization until disease progression, treatment failure or death. |
| Secondary | PRO-CTCAE | questionnaires must be completed before any study procedure but within 2 weeks prior to randomization (baseline) and thereafter every 8 weeks from randomization until disease progression, treatment failure or death, assessed up to 18 months. | PRO-CTCAE questionnaires will be administered at the same time points with items dedicated in particular to Hand-Foot Syndrome and Hand-Foot skin reactions, diarrhea and neuropathy, to better evaluate the effect of two different strategies of treatment on the health-related QoL. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
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/NCT07213570
GET https://conductscience.org/api/trials/v1/NCT07213570/registered