Clinical trial · Observational
Total Neoadjuvant Therapy Versus Standard Therapy of Locally Advanced Rectal Cancer With High Risk Factors for Failure
NCT04679597CI-TRIAL-00081711completedClinicalTrials.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)
In a retrospective study, the investigators will compare patients with locally advanced rectal cancer with high risk factors for failure who were treated with standard therapy or with total neoadjuvant therapy.
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 Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- total neoadjuvant therapy
- description
- Total neoadjuvant therapy consisted of 12 weeks of induction chemotherapy with CAPOX or FOLFOX, chemoradiotherapy with capecitabine and six to eight weeks of consolidation chemotherapy with CAPOX or FOLFOX prior to surgery.
- interventionNames
- Drug: Capecitabine
- label
- standard therapy
- description
- Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)
- interventionNames
- Drug: Capecitabine
Primary outcomes (1)
- measure
- pathological complete response
- timeFrame
- during surgery
- description
- pathological complete response is defined as the absence of tumor cells in the surgical resection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * histologically proven locally advanced rectal cancer and * the presence of one of the factors: T4, N2, positive mesorectal fascia, presence of extramural vascular invasion or presence of lateral lymph node. Exclusion Criteria: * distant metastases, * concomitant malignancy, * inflammatory bowel disease, or * malabsorption syndrome.
References
Publications (0)
Data not yet available
No reference posted for this study.