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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | No Intervention | The cancer surgery is practice 8 weeks after neoadjuvant chemoradiotherapy | |
| Group 2 | Experimental | The cancer surgery will be performed in 12 weeks after neoadjuvant chemoradiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery after 12 weeks of delay after chemoradiotherapy. | Procedure | Surgery consists oncologic resection of the rectal cancer with total excision of the mesorectum after 12 weeks of delay after the end of chemoradiotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete pathologic response assessed by pathologist Dworak scale | 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response assessed using MRi | Rates of clinical response to chemoradiotherapy before surgery, comparison between the two groups | 8 weeks (2 months) |
| Pathological response assessed by pathologist using Dworak scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Audrius Dulskas, MD, PhD | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute | Vilnius | 08406 | Lithuania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42128940 | Derived | Sileika 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. doi: 10.1007/s00384-026-05144-4. Online ahead of print. | |
| 40736758 |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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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
| 6 months |
| Incidence of Treatment-Emergent Adverse Events as assessed by Clavien-Dindo scale | Rates of operative morbidity at 30 days, comparison between the two groups. Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside. Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusionsand total parenteral nutritionare also included. Grade III Requiring surgical, endoscopic or radiological intervention
| 30 days |
| Incidence of Mortality assessed by Clavien-Dindo scale | Rates of operative mortality at 30 days, comparison between the two groups. Grade V Death of a patient | 30 days |
| Total mesorectal excision (TME) quality assessed by TME completeness scale (by P.Quircke) | Quality of mesorectum resection assessed by TME completeness scale:
| 8-12 weeks |
| Distant recurrence assessed by CT scan | Distant recurrence rates, comparison between the two groups | 5 years |
| Local recurrence assessed by CT scan/MRI/endoscopy | Local recurrence rates, comparison between the two groups | 5 years |
| Oncological outcome - overall survival | Overall survival rates, comparison between the two groups | 5 years |
| Oncological outcome - disease-free survival | Disease-free survival rates, comparison between the two groups | 5 years |
| Radiotherapy skin toxicity assessed by EORTC scale | Radiotherapy related toxicity rates: skin reactions will be assessed using EORTC radiotherapy toxicity scale: Skin Grade 1 follicular, faint or dull erythema / epilation / dry desquamation / decreased sweating; Grade 2 tender or bright erythema, patchy moist desquamation / moderate edema; Grade 3 confluent, moist desquamation other than skin folds, pitting edema; Grade 4 - ulceration, hemorrhage, necrosis | 5 years |
| Radiotherapy toxicity assessed by EORTC scale | Radiotherapy related toxicity rates: gastrointestinal reactions will be assessed using EORTC radiotherapy toxicity scale: Grade 1 increased frequency or change in quality of bowel habits not requiring medication / rectal discomfort not requiring analgesics; Grade 2 diarrhea requiring parasympatholytic drugs (e.g. Lomotil) / mucous discharge not necessitating sanitary pads / rectal or abdominal pain requiring analgesics; Grade 3 diarrhea requiring parenteral support / severe mucous or blood discharge necessitating sanitary pads / abdominal distention (flat plate radiograph demonstrates distended bowel loops); Grade 4 acute or subacute obstruction, fistula or perforation; GI bleeding requiring transfusion; abdominal pain or tenesmus requiring tube decompression or bowel diversion | 5 years |
| Quality of Life assessed by Low anterior resection syndrome score | The Low anterior resection syndrome score (LARS) score consists of five items concerning the following: incontinence for flatus, incontinence for liquid stool, frequency of bowel movements, clustering of stools, and urgency. Each symptom of bowel dysfunction is weighed according to its impact on the quality of life. The calculated score ranges from 0 to 42, with a score of 0-20 representing no ARS, a score of 21-29 representing minor ARS, and a score of 30-42 representing major ARS. | 1 year |
| Immune response assessed | We have assessed the immune response before chemoradiotherapy and 8 weeks following the treatment. IL1B, IL6, IL8, IL10, IL2R, TNF alfa are assessed and will be correlated with the response to treatment. | 1 year |
| Urinary catheter removal timing | All the patients will have there urinary catheters removed on day 1. Some patients will get Urorec (adrenomimetic for prevention of urinary retention). The patients will be randomized 2:1 | 3 months |
| Derived |
| Didrikaite 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. |
| 40537941 | Derived | Gricius 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. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |