Trial · NCT07381764
ROMANCE: "Irinotecan Plus Cetuximab Rechallenge Versus Trifluridine/Tipiracil Plus Bevacizumab in Molecularly Selected Metastatic Colorectal Cancer"
NCT07381764, Phase 2, Recruiting, Gruppo Oncologico Italia Meridionale
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. ROMANCE: "Irinotecan Plus Cetuximab Rechallenge Versus Trifluridine/Tipiracil Plus Bevacizumab in Molecularly Selected Metastatic Colorectal Cancer". Trials, record NCT07381764. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07381764
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ROMANCE: "Irinotecan Plus Cetuximab Rechallenge Versus Trifluridine/Tipiracil Plus Bevacizumab in Molecularly Selected Metastatic Colorectal Cancer"
- NCT number
- NCT07381764
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 150 participants, estimated
- Lead sponsor
- Gruppo Oncologico Italia Meridionale
- Conditions
- Metastatic Colorectal Cancer (CRC)
- Interventions
- Erbitux (Cetuximab), Bevacizumab, Irinotecan, Trifluridine/tipiracil
- First posted
- 2026-02-02
- Last updated
- 2026-09-11
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | From Week 8 through disease progression or end of treatment, up to approximately 24 months. | Objective Response Rate (ORR) is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria. Tumor assessments are based on radiological imaging reviewed centrally by an independent blinded radiology reviewe |
| Secondary | Progressio-Free Survival (PFS) | From date of randomization until the date of first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first, assessed up to 36 months. | Progression-Free Survival (PFS) is defined as the time from randomization to documented disease progression according to RECIST version 1.1 criteria or death from any cause, whichever occurs first. |
| Secondary | Overall Survival (OS) | From date of enrollment until death from any cause, assessed up to 36 months. | Overall Survival (OS) is defined as the time from enrollment to death from any cause. |
| Secondary | Incidence of Adverse Events and Serious Adverse Events | From first dose of study treatment until 30 days after the last dose of study treatment. | Safety will be assessed by the incidence and severity of adverse events (AEs) and serious adverse events (SAEs), as well as by changes in clinical laboratory parameters, vital signs, physical examinations, electrocardiogram (ECG) findings, and ECOG performance status. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
| Secondary | Treatment Exposure as a Measure of Tolerability | Through study completion, an average of approximately 24 months | Tolerability will be assessed by the frequency of treatment discontinuations, dose reductions, and dose delays due to adverse events during study treatment. |
| Secondary | The impact of treatment with irinotecan plus cetuximab and trifluridine/tipiracil plus bevacizumab on quality of life | From baseline through study completion, an average of approximately 12 months | The impact of treatment with irinotecan plus cetuximab and trifluridine/tipiracil plus bevacizumab on quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). |
| Other | Progression-Free Survival (PFS) of the Subsequent Line of Treatment | From initiation of subsequent line of treatment until documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first, assessed up to approximately 36 months. | Progression-Free Survival (PFS) following the subsequent line of treatment is defined as the time from initiation of the first subsequent anticancer therapy to the first documented disease progression according to RECIST v1.1 or death from any cause, whichever occurs first. |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42907240 | DERIVED |
Source PubMed
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT07381764
GET https://conductscience.org/api/trials/v1/NCT07381764/registered