Rectal CancerST812NCT03607370
Timing for Rectal Surgery After Chemoradiotherapy
A study testing Surgery after 12 weeks of delay after chemoradiotherapy. in people with Rectal Cancer, run by National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos at 1 site in Lithuania.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Surgery after 12 weeks of delay after chemoradiotherapy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Jul 2017to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Curative total mesorectal excision intended
- Written informed consent
- Patients undergoing preoperative radiotherapy should not be excluded
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Timing for Rectal Surgery After ChST
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
- Rectal Cancer
- Being tested
- Surgery after 12 weeks of delay after chemoradiotherapy.
- Keywords
- Rectal cancer, Chemoradiotherapy, Surgery
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery after 12 weeks of delay after chemoradiotherapy.Procedure or surgery
Surgery consists oncologic resection of the rectal cancer with total excision of the mesorectum after 12 weeks of delay after the end of chemoradiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Surgery after 12 weeks of delay after chemoradiotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (14)
Clinical response assessed using MRi
Rates of clinical response to chemoradiotherapy before surgery, comparison between the two groups
Measured: 8 weeks (2 months)
Pathological response assessed by pathologist using 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
Measured: 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
- IIIa Intervention not under general anesthesia
- IIIb Intervention under general anesthesia Grade IV Life-threatening complication (including CNS complications)* requiring IC/ICU-management
- IVa single organ dysfunction (including dialysis)
- IVb multiorgan dysfunction
Measured: 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
Measured: 30 days
Total mesorectal excision (TME) quality assessed by TME completeness scale (by P.Quircke)
Quality of mesorectum resection assessed by TME completeness scale:
- Mesorectal resection (MRR)/good/complete: intact mesorectum and smooth mesorectal surface with only minor irregularities; no defects deeper than 5 mm; no coning of the specimen towards the distal margin; and smooth macro-circular resection margin (CRM) on slicing.
- Intramesorectal resection (IMR)/intermediate/nearly complete: intermediate bulk of the mesorectum with an irregular surface; a defect deeper than 5 mm, and no visible muscularis propria other than inserted levator; intermediate coning; intermediate irregularity of macro-CRM on slicing.
- Muscularis propria resection (MPR)/poor/incomplete: small bulk of the mesorectum with a very irregular surface; defect down to the muscularis propria; severe coning; severe irregularity of macro-CRM on slicing.
Measured: 8-12 weeks
Distant recurrence assessed by CT scan
Distant recurrence rates, comparison between the two groups
Measured: 5 years
Local recurrence assessed by CT scan/MRI/endoscopy
Local recurrence rates, comparison between the two groups
Measured: 5 years
Oncological outcome - overall survival
Overall survival rates, comparison between the two groups
Measured: 5 years
Oncological outcome - disease-free survival
Disease-free survival rates, comparison between the two groups
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start1 Jul 2017
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Audrius Dulskas, National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
- Investigators
- Audrius Dulskas, MD, PhD, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607370
- Sponsor's protocol ID
- ST812
- Acronym
- ST812
- Status last verified
- Nov 2023
- First submitted
- 20 Jun 2018
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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;41(1):113. doi: 10.1007/s00384-026-05144-4.
PubMed 42128940Didrikaite 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.
PubMed 40736758Gricius 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.
PubMed 40537941
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing for Rectal Surgery After ChST
- ClinicalTrials.gov ID
- NCT03607370
- Acronym / sponsor ID
- ST812 / ST812
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, Chemoradiotherapy, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (actual)
- Lead sponsor
- National Cancer Center Affiliate of Vilnius University Hospital Santaros KlinikosUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –The cancer surgery is practice 8 weeks after neoadjuvant chemoradiotherapy |
| Group 2 | Experimental | Procedure: Surgery after 12 weeks of delay after chemoradiotherapy.The cancer surgery will be performed in 12 weeks after neoadjuvant chemoradiotherapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery after 12 weeks of delay after chemoradiotherapy.Surgery consists oncologic resection of the rectal cancer with total excision of the mesorectum after 12 weeks of delay after the end of chemoradiotherapy. | Procedure or surgery | Group 2 |
Primary outcome
Complete pathologic response assessed by pathologist Dworak scale
Time frame: 6 months
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
14 secondary outcomes
Clinical response assessed using MRi
Time frame: 8 weeks (2 months)
Pathological response assessed by pathologist using Dworak scale
Time frame: 6 months
Incidence of Treatment-Emergent Adverse Events as assessed by Clavien-Dindo scale
Time frame: 30 days
Incidence of Mortality assessed by Clavien-Dindo scale
Time frame: 30 days
Total mesorectal excision (TME) quality assessed by TME completeness scale (by P.Quircke)
Time frame: 8-12 weeks
Distant recurrence assessed by CT scan
Time frame: 5 years
Local recurrence assessed by CT scan/MRI/endoscopy
Time frame: 5 years
Oncological outcome - overall survival
Time frame: 5 years
Oncological outcome - disease-free survival
Time frame: 5 years
Radiotherapy skin toxicity assessed by EORTC scale
Time frame: 5 years
Radiotherapy toxicity assessed by EORTC scale
Time frame: 5 years
Quality of Life assessed by Low anterior resection syndrome score
Time frame: 1 year
Immune response assessed
Time frame: 1 year
Urinary catheter removal timing
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Derived from this study: PubMed 42128940Sileika 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.
- Derived from this study: PubMed 40736758Didrikaite 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.
- Derived from this study: PubMed 40537941Gricius 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.
Related trials for Rectal Cancer
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
RecruitingPhase 1
Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal Cancer
Phase 1, SAR445877
Recruiting
Addressing Disparities in Colorectal Cancer Screening in Black and Underserved Phoenix Communities
Colorectal Carcinoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruiting
Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Testing Across TeXas
Colorectal Cancer (CRC) Screening
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audrius Dulskas, MD, PhD principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery after 12 weeks of delay after chemoradiotherapy. in people with Rectal Cancer, run by National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete pathologic response assessed by pathologist Dworak scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03607370, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.