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NCT05358704
Preoperative ChemoRadiation And FOLFOXIRI for Rectal Cancer (CRAFTER) for Rectal Cancer
Phase 2 trial testing combination of drugs (chemoradiation (capecitabine and radiation) + FOLFOXIRI (Oxaliplatin, leucovorin, irinotecan, and fluorouracil) in Cancer of Rectum in 38 participants. Suspended.
30 December 2027
Quick facts
| Lead sponsor | Rutgers, The State University of New Jersey |
|---|---|
| Phase | Phase 2 |
| Status | Suspended |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 38 |
| Start date | 13 May 2022 |
| Primary completion | 30 December 2027 |
| Estimated completion | 30 January 2028 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- combination of drugs (chemoradiation (capecitabine and radiation) + FOLFOXIRI (Oxaliplatin, leucovorin, irinotecan, and fluorouracil)
Conditions studied
- Cancer of Rectum — all drugs for Cancer of Rectum →
Sponsor
Rutgers, The State University of New Jersey
Who can join
18 and older, any sex, with Cancer of Rectum. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the safety and preliminary efficacy of Preoperative ChemoRadiation and FOLFOXIRI and to Escalate Complete Response for Rectal Cancer patients.Go through laboratory and medical tests to verify eligibility to enter the study, receive the experimental combination of drugs (chemoradiation (capecitabine and radiation) + FOLFOXIRI (Oxaliplatin, leucovorin, irinotecan, and fluorouracil) prior to surgery and undergo laboratory tests and study procedures on specified days during the study period, complete end of study evaluations and tests, and participate in post-study follow up every three months for three to four years. The time in the study will take approximately four to six hours during pre-study, study and end of study visits.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05358704
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Rutgers, The State University of New Jersey trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05358704 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rutgers, The State University of New Jersey
- Last refreshed: 4 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05358704.
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