Trial · NCT07472868
Neoadjuvant FOLFOXIRI and Chemoradiotherapy Versus Neoadjuvant CAPOX/FOLFOX and Chemoradiotherapy Followed by Surgery or a Watch-and-Wait Approach in High Risk Locally Advanced Rectal Cancer
NCT07472868, Phase 3, Recruiting, J. W. A. Burger
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Neoadjuvant FOLFOXIRI and Chemoradiotherapy Versus Neoadjuvant CAPOX/FOLFOX and Chemoradiotherapy Followed by Surgery or a Watch-and-Wait Approach in High Risk Locally Advanced Rectal Cancer. Trials, record NCT07472868. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07472868
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant FOLFOXIRI and Chemoradiotherapy Versus Neoadjuvant CAPOX/FOLFOX and Chemoradiotherapy Followed by Surgery or a Watch-and-Wait Approach in High Risk Locally Advanced Rectal Cancer
- NCT number
- NCT07472868
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 394 participants, estimated
- Lead sponsor
- J. W. A. Burger
- Conditions
- Locally Advanced Rectal Carcinoma
- Interventions
- FOLFOXIRI, CAPOX, FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin), Chemoradiotherapy, Total mesorectal excision (+/- IORT), Watch-and-wait approach
- First posted
- 2026-03-16
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete response | pCR: date of surgery sustained cCR: from date of surgery or date of entering a watch-and-wait approach, up until 1 year later. | To evaluate if neoadjuvant FOLFOXIRI leads to higher pCR rates/sustained cCR rates (≥ 1 year) compared to neoadjuvant CAPOX/FOLFOX in patients with high risk LARC. |
| Secondary | Regrowth free survival | 3 and 5 years post-treatment. | To compare long term oncological outcomes at 3- and 5 years between neoadjuvant FOLFOXIRI and neoadjuvant CAPOX/FOLFOX, including regrowth free survival. |
| Secondary | Local recurrence free survival at 3 and 5 years | 3 and 5 years post-treatment | To compare long term oncological outcomes at 3- and 5 years between neoadjuvant FOLFOXIRI and neoadjuvant CAPOX/FOLFOX, including local recurrence free survival. |
| Secondary | Distant metastasis free survival | 3 and 5 years post-treatment. | To compare long term oncological outcomes at 3- and 5 years between neoadjuvant FOLFOXIRI and neoadjuvant CAPOX/FOLFOX, including distant metastasis free survival. |
| Secondary | Progression free survival | 3 and 5 years post-treatment. | To compare long term oncological outcomes at 3- and 5 years between neoadjuvant FOLFOXIRI and neoadjuvant CAPOX/FOLFOX, including progression free survival. |
| Secondary | Disease free survival (DFS) | 3 and 5 years post-treatment | To compare long term oncological outcomes at 3- and 5 years between neoadjuvant FOLFOXIRI and neoadjuvant CAPOX/FOLFOX, including disease free survival. |
| Secondary | Overall survival | 3 and 5 years post-treatment | To compare long term oncological outcomes at 3- and 5 years between neoadjuvant FOLFOXIRI and neoadjuvant CAPOX/FOLFOX, including overall survival. |
| Secondary | Successful organ preservation | 1 and 3 years post-treatment | Organ preservation, defined as no bowel resection or stoma placement at 1 and 3 years follow-up. |
| Secondary | Radiological response | At baseline, after induction chemotherapy (= approximately 12-14 weeks after enrollment), and after chemoradiotherapy (= approximately 20-28 weeks after enrollment). | To compare radiological response between neoadjuvant FOLFOXIRI and neoadjuvant CAPOX/FOLFOX. |
| Secondary | Pathological response | Date of surgery. | To compare pathological response between neoadjuvant FOLFOXIRI and neoadjuvant CAPOX/FOLFOX. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42151882 | 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.
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/NCT07472868
GET https://conductscience.org/api/trials/v1/NCT07472868/registered