Clinical trial · Observational
Predictive Factors of Disease-free Survival After Complete Pathological Response to Neoadjuvant Radiotherapy in Rectal Adenocarcinoma
NCT03601689CI-TRIAL-00033983completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Many data suggest that patients with low rectal adenocarcinoma who achieved ypT0N0 status have improved survival and disease-free survival (DFS) compared to all other stages however only few data are available regarding the specific prognosis factors of this subgroup. This retrospective multicentric study aimed to predict the prognosis of patients with complete pathological response after neoadjuvant treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rectal resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Local recurrence rate
- timeFrame
- From date of surgery until the date of first documented local progression assessed up to 100 months
- description
- A postoperative local recurrence was defined by biopsy-proven or radiographic evidence of local recurrent disease.
- measure
- Distant recurrence rate
- timeFrame
- From date of surgery until the date of first documented distant progression assessed up to 100 months
- description
- A postoperative distant recurrence was defined by biopsy-proven or radiographic evidence of distant recurrent disease.
Secondary outcomes (1)
- measure
- Predictive factors of disease free survival
- timeFrame
- From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * patients with a histologically proven low rectal adenocarcinoma, * no previous or synchronous colorectal disease, * UICC stage I-III patients who underwent neoadjuvant chemoradiotherapy or chemotherapy, * followed by total mesorectal excision (TME), and * a complete pathological response defined as ypT0N0 Exclusion Criteria: \- all patients with metastatic tumors or missing data
References
Publications (1)
- DERIVEDSouadka A, Majbar MA, Benkabbou A, Serji B, Souiki T, Bouchentouf SM, Abid M, El Khannousi B, El Harroudi T, El Malki HO, Raiss M, Ifrine L, Mazaz K, Zentar A, Mohsine R, Souadka A, Belkouchi A, Ahallat M, Hrora A; Moroccan Society of Surgery. Predictive factors of disease-free survival after complete pathological response to neoadjuvant radiotherapy for rectal adenocarcinoma: retrospective case series. BMC Cancer. 2019 Oct 28;19(1):1008. doi: 10.1186/s12885-019-6239-3. PMID 31660903