Last reviewed · How we verify
NCT05495308
"Oncologic Results and Risk Factors for Recurrence in Patients With Locally Advanced Rectal Cancer and Pathologic Complete Response After Neoadjuvant Treatment. Results From an Observational Retrospective Multicenter Long-term Follow-up Study".
trial testing neoadjuvant treatment in Rectal Cancer, Adenocarcinoma in 4 participants. Completed in 1 May 2022.
1 March 2022
Quick facts
| Lead sponsor | Hospital San Carlos, Madrid |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 4 |
| Start date | 1 September 2021 |
| Primary completion | 1 March 2022 |
| Estimated completion | 1 May 2022 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- neoadjuvant treatment — full drug profile →
Conditions studied
- Rectal Cancer, Adenocarcinoma — all drugs for Rectal Cancer, Adenocarcinoma →
- Rectal Cancer Stage II — all drugs for Rectal Cancer Stage II →
- Rectal Cancer Stage III — all drugs for Rectal Cancer Stage III →
- Distant Metastasis — all drugs for Distant Metastasis →
Sponsor
Hospital San Carlos, Madrid
Who can join
Adults 18 to 100, any sex, with Rectal Cancer, Adenocarcinoma or Rectal Cancer Stage II. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Pathologic complete response (pCR) after multimodal treatment for locally advanced rectal cancer (LARC) patients is considered as the gold-standard of treatment success as it is associated to privileged oncologic outcome. Nevertheless, data from multicenter high-volume cohorts with long term follow-up are scarce. This is a multicenter observational study using prospectively collected data from the Spanish Rectal Cancer Project database. The main objective of the study is to update long-term oncologic follow-up of those patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR. Secondary objective is to analyze demographic, clinical, operative and treatment variables in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths. The results are reported in accordance with the STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) Statement for observational studies. All calculations are performed using Stata 13.1 (StataCorp, Texas, USA).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Conditional Survival in Patients with Locally Advanced Rectal Cancer and Pathologic Complete Response: Results from an Observational Retrospective Multicenter Long-Term Follow-Up Study.
Cerdán Santacruz C, Cano-Valderrama O, Fernández LM, Sanz-Ongil R, et al · · 2025 · PMID 40867336 · DOI 10.3390/cancers17162707
Verify or expand the search:
- PubMed search for NCT05495308
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Rectal Cancer, Adenocarcinoma
Currently open trials in the same condition.
- NCT07458529 — Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Rectal Cancer · Phase 2 · recruiting
- NCT07474103 — SCRT-NALIRIXELOX+Sintilimab as TNT for High-Risk LARC · NA · recruiting
- NCT07407465 — Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal · Phase 2 · recruiting
- NCT06793137 — Intestinal Microbiome Modulation With Antibiotics in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer · Phase 2 · recruiting
Other Hospital San Carlos, Madrid trials
Trials by the same sponsor.
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- NCT06113939 — Prevention of Infection of the Respiratory Tract Through Application of Non-Invasive Methods of Secretion Suctioning · NA · not yet recruiting
- NCT06156059 — Oral Bedtime Melatonin in Critically Ill Patients · Phase 4 · unknown
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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 NCT05495308 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital San Carlos, Madrid
- Last refreshed: 10 August 2022
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/NCT05495308.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing