Clinical trial · Interventional
Timing for Rectal Surgery After Chemoradiotherapy
Timing for Rectal Surgery After ChST
NCT03607370CI-TRIAL-00071164ST812unknownN/AClinicalTrials.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)
The aim of this study is to determine whether greater rectal cancer downstaging and regression occurs when surgery is delayed to 12 weeks after completion of radiotherapy/chemotherapy compared to 8 weeks. Hypothesis: Greater down-staging and tumor regression is observed when surgery is delayed to 12 weeks after completion of chemoradiotherapy compared to 8 weeks.
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 |
|---|---|---|---|
| Surgery after 12 weeks of delay after chemoradiotherapy. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Group 1
- description
- The cancer surgery is practice 8 weeks after neoadjuvant chemoradiotherapy
- type
- EXPERIMENTAL
- label
- Group 2
- description
- The cancer surgery will be performed in 12 weeks after neoadjuvant chemoradiotherapy
- interventionNames
- Procedure: Surgery after 12 weeks of delay after chemoradiotherapy.
Primary outcomes (1)
- measure
- Complete pathologic response assessed by pathologist Dworak scale
- timeFrame
- 6 months
- description
- Dworak scale assesses the response: 0. No regression; 1. Predominantly tumor with significant fibrosis and/or vasculopathy; 2. Predominantly fibrosis with scattered tumor cells (slightly recognizable histologically); 3. Only scattered tumor cells in the space of fibrosis with/without acellular mucin; 4. No vital tumor cells detectable
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Over 18 years old * Eastern Cooperative Oncology Group (ECOG) 0-1, * American Society of Anesthesiologists' (ASA) score I-III * Histological confirmation of adenocarcinoma of rectum * T3 or T4 N0, T any N positive cancer on MRI, without metastasis on CT scan * Undergoing preoperative radiotherapy/ chemotherapy * Curative total mesorectal excision intended * Written informed consent * Patients undergoing preoperative radiotherapy should not be excluded Exclusion Criteria: * Patients with distant metastasis * T1 or T2, N0 cancer on MRI * Rectal cancer 12 cm above the dentate line * Contraindications to MRI * Patients previously treated of pelvic organ cancer * Medical or psychiatric conditions that compromise the patients ability to give informed consent
References
Publications (3)
- DERIVEDSileika E, Cerkauskaite D, Bausys A, Bernotaite V, Stulpinas R, Mickys U, Zilevice L, Suziedelis K, Aleinikov A, Smolskas E, Urbonas V, Dulskas A. Effect of prolonged interval between neoadjuvant chemoradiotherapy and surgery on pathological and oncological outcomes in locally advanced rectal cancer: a randomized controlled trial. Int J Colorectal Dis. 2026 May 13;41(1):113. doi: 10.1007/s00384-026-05144-4. PMID 42128940
- DERIVEDDidrikaite G, Klimovskij M, Civilka I, Buckus B, Aukstikalnis T, Sileika E, Dulskas A. Quality of life following ileostomy takedown: single-centre, retrospective clinical trial-does closure time matter? Tech Coloproctol. 2025 Jul 30;29(1):154. doi: 10.1007/s10151-025-03196-2. PMID 40736758
- DERIVEDGricius Z, Kuliavas J, Stratilatovas E, Buckus B, Dulskas A. Early urinary catheter removal in patients undergoing rectal cancer surgery: a randomized controlled trial on silodosin versus no pharmacological treatment on urinary function in the early postoperative period. Ann Coloproctol. 2025 Jun;41(3):239-245. doi: 10.3393/ac.2024.00703.0100. Epub 2025 Jun 20. PMID 40537941