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NCT04095468
Organ-preserving Management in Patients With Complete or Near-complete Tumour Response After Preoperative Radio(Chemo)Therapy for Rectal Cancer
trial testing Preoperative Radio(Chemo)Therapy in Rectal Neoplasms in 215 participants. Status unknown.
1 January 2021
Quick facts
| Lead sponsor | Maria Sklodowska-Curie National Research Institute of Oncology |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 215 |
| Start date | 18 September 2017 |
| Primary completion | 1 January 2021 |
| Estimated completion | 1 January 2026 |
| Sites | 7 locations across Poland |
Drugs / interventions tested
- Preoperative Radio(Chemo)Therapy
Conditions studied
- Rectal Neoplasms — all drugs for Rectal Neoplasms →
- Rectal Cancer — all drugs for Rectal Cancer →
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Who can join
18 and older, any sex, with Rectal Neoplasms or Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Watch-and-wait strategy in rectal cancer is gaining momentum. There is a large variability in reporting the proportion of patients achieving clinical complete response (cCR) after routinely delivered preoperative radio(chemo)therapy, likely because of patients' selection. This proportion in population-based level is poorly defined. In addition, predictive factors for cCR are also poorly defined. It is known that cCR response is observed often in small tumours. However, cCR proportion in large cancers has not been sufficiently evaluated. For example, even though pathological complete response (pCR) does occur in large fixed cancer, it is unknown whether cCR does also occur because persistent fibrous stroma may mimic residual cancer in all of such cases. This is a prospective observational population-based cohort study on low rectal cancer to answer the question of how often clinical or near-clinical tumour response occur after routinely delivered preoperative radiotherapy in relation to the pre-treatment tumour characteristics. The additional question was how often pCR occur in relation to the pre-treatment tumour characteristics in the patients managed by total mesorectal excision because of persistent tumour after radiotherapy. The additional aim was the implementation of watch-and-wait strategy or full-thickness local excision (as an option instead of total mesorectal excision in the patients with sustained near-cCR) within a frame of a prospective study. In the patients managed by organ preservation, the secondary outcome measures were: i) local regrowth rate, ii) effectiveness of salvage surgery, iii) disease-free survival at 3 years and overall survival at 5 years, iv) anorectal function.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04095468
- Europe PMC full search
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Related trials
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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 NCT04095468 (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 Maria Sklodowska-Curie National Research Institute of Oncology
- Last refreshed: 19 September 2019
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/NCT04095468.
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