Clinical trial · Interventional
Total Neoadjuvant Therapy in Rectal Cancer Treatment
NCT04747951CI-TRIAL-00050063unknownPhase 4ClinicalTrials.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)
This is a randomized, controlled, parallel study to determine the efficiency and safety of total neoadjuvant therapy in rectal cancer 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 Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant chemotherapy | Drug | Adjuvant Chemotherapy | ALIAS |
| Concurrent Chemoradiotherapy | Combination Product | — | UNRESOLVED |
| consolidation chemotherapy | Drug | — | UNRESOLVED |
| TME | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- total neoadjuvant therapy
- description
- Total neoadjuvant therapy consisted chemoradiotherapy with capecitabine and nine weeks of consolidation chemotherapy with XELOX prior to surgery and adjuvant therapy if necessary.
- interventionNames
- Combination Product: Concurrent Chemoradiotherapy
- Procedure: TME
- Drug: consolidation chemotherapy
- Drug: adjuvant chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- standard therapy
- description
- Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)
- interventionNames
- Combination Product: Concurrent Chemoradiotherapy
- Procedure: TME
- Drug: adjuvant chemotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have signed an approved informed consent form for the stud; * Histologically confirmed rectal adenocarcinoma low (cT2-4N0-2M0) or mid rectum (сТ2-T4N1-2M0); Exclusion Criteria: * rectal cancer recurrence; * Primary-multiple tumours of other localizations; * pelvis radiotherapy in anamnesis; * pregnancy, breastfeeding; * distant metastasis; * ECOG score 3-4
References
Publications (3)
- BACKGROUNDMartin ST, Heneghan HM, Winter DC. Systematic review and meta-analysis of outcomes following pathological complete response to neoadjuvant chemoradiotherapy for rectal cancer. Br J Surg. 2012 Jul;99(7):918-28. doi: 10.1002/bjs.8702. Epub 2012 Feb 23. PMID 22362002
- BACKGROUNDZorcolo L, Rosman AS, Restivo A, Pisano M, Nigri GR, Fancellu A, Melis M. Complete pathologic response after combined modality treatment for rectal cancer and long-term survival: a meta-analysis. Ann Surg Oncol. 2012 Sep;19(9):2822-32. doi: 10.1245/s10434-011-2209-y. Epub 2012 Mar 21. PMID 22434243
- BACKGROUNDRodel C, Martus P, Papadoupolos T, Fuzesi L, Klimpfinger M, Fietkau R, Liersch T, Hohenberger W, Raab R, Sauer R, Wittekind C. Prognostic significance of tumor regression after preoperative chemoradiotherapy for rectal cancer. J Clin Oncol. 2005 Dec 1;23(34):8688-96. doi: 10.1200/JCO.2005.02.1329. Epub 2005 Oct 24. PMID 16246976