Rectal CancerPhase 2/3NCT06758830
Total Neoadjuvant Therapy and Organ Preservation Versus Surgery for Rectal Cancer.
A Phase 2/3 study testing Radiation Therapy, Chemoradiotherapy and Consolidation Chemotherapy in people with Rectal Cancer and Total Neoadjuvant Treatment, run by National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos at 1 site in Lithuania.
Trial summary
This study hypothesizes that approximately 50% of rectal cancer patients can preserve their rectum using a watch-and-wait strategy if they achieve a complete or near-complete clinical response to total neoadjuvant therapy (TNT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Total Neoadjuvant Treatment, Neoadjuvant Therapy
- What is being tested?
- Radiation Therapy, Chemoradiotherapy and Consolidation Chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteLithuania
- Study dates
- 6 Jan 2025to 27 Dec 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age.
- Participants who agreed to participate in the study signed an informed consent form.
- The Eastern Cooperative Oncology Group (ECOG) score ranges from 0 to 2.
- Pathologically confirmed rectal adenocarcinoma.
- Tumor up to 10 cm from the anus.
- Magnetic resonance imaging (MRI) of the pelvis and computed tomography (CT) of the thorax and abdomen were performed to confirm the diagnosis.
Show all 18Show fewer
- cT1N1, T2-T3 N0 - 1, M0, MRF -, EMVI -.
- Normal bone marrow function: blood leucocytes > 3.5 × 10⁹/l, neutrophils > 1.5 × 10⁹/l, platelets > 100 × 10⁹/l.
- Normal renal function: creatinine within 1,5 × normal.
- Normal liver function: blood bilirubin levels within 1,5 times normal, AST, ALT levels within 2,5 times the upper limit.
- Over 18 years of age.
- Participants who agreed to participate in the study signed an informed consent form.
- ECOG score between 0 and 2.
- Pathological confirmed rectal adenocarcinoma.
- Stage I to III rectal cancer confirmed.
- The tumor is localized up to 12 cm from the anus.
- Participants who refused to participate in the first part of the study or did not meet the inclusion criteria for the first part.
- Participants have received preoperative CRT or TNT or are in the planning stages of neoadjuvant treatment.
Who cannot join
- Prior ST or Ch.
- Participants who are not eligible for pelvic MRI.
- Participants who have had a malignancy in the last 5 years, except for treatment for basal cell or squamous cell skin cancer or in situ cervical cancer.
- ECOG status ≥ 3.
- Distant metastases detected.
- Participants with uncontrolled therapeutic or psychiatric conditions.
Show all 11Show fewer
- Infectious diseases requiring antibiotic treatment.
- Part Two
- New cancer two years after CRT.
- Stage IV cancer before treatment.
- Participants refusing to participate in the study or unable to sign the informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lithuania1 site, 1 recruiting
- Recruiting
Nacional Cancer Institute
Vilnius, 08660
Ernestas Šileika, MD, +37060950402, ernestas.sileika@nvc.santa.lt
Audrius Dulskas, PhD, +37067520094, audrius.dulskas@gmail.com
About this study
Official title: Total Neoadjuvant Therapy for Rectal Cancer - a New Standard of Care?
This study hypothesizes that approximately 50% of rectal cancer patients can preserve their rectum using a watch-and-wait strategy if they achieve a complete or near-complete clinical response to total neoadjuvant therapy (TNT). The objective is to determine whether the complications, quality of life, and survival rates of rectal cancer patients who have achieved a complete or near-complete clinical response to TNT, followed by a watch-and-wait approach, are comparable to those of patients who undergo surgery first. Additionally, the study aims to identify potential prognostic and predictive markers for rectal cancer and examine survival rates and factors influencing responses to chemoradiotherapy (CRT) or TNT.
The study is divided into two parts:
Read more
Part One: Participants with cT1N1, T2-T3 N0-1 rectal cancer, MRF-, and EMVI-, with surgery as one of the possible first-line treatment options, will be randomized into two groups. The experimental group will consist of participants receiving TNT, including CRT and consolidation chemotherapy (Ch). If these participants achieve a complete or near-complete clinical response, they will be observed using a watch-and-wait strategy, which is a non-operative approach. The control group will consist of participants who undergo surgical treatment initially.
Part Two: All participants with rectal cancer who have received CRT or TNT will be included. Additionally, participants diagnosed with rectal cancer who are scheduled for CRT or TNT but declined to participate in Part One or do not meet the inclusion criteria will also be included.
- Conditions
- Rectal Cancer, Total Neoadjuvant Treatment, Neoadjuvant Therapy, Radiotherapy, Chemotherapy, Organ Preservation
- Being tested
- Radiation Therapy, Chemoradiotherapy, Consolidation Chemotherapy, Surgery, Part two
- Keywords
- Rectal cancer, Total Neoadjuvant Treatment, Neoadjuvant therapy, Radiotherapy, Chemotherapy, Chemoradiotherapy, Organ Preservation, Radiotherapy Side Effect, Chemotherapy side effects, Quality of Lifte, Fatigue, Postoperative complications, Low Anterior Resection Syndrome
- Medical subject headings
- Rectal Neoplasms, Radiation Injuries, Low Anterior Resection Syndrome, Fatigue, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
Radiation therapy (RT) is administered at a dose of 2 Gy per day for a total dose of 50 Gy delivered to the pelvis. This is done throughout 5 to 6 weeks.
ChemoradiotherapyDrug
Capecitabine: 825 mg/m² twice daily, prescribed 1-5 days per week, for 5 weeks during RT.
Or Bolus 5-FU regimen: 5-fluorouracil (5-FU) 400 mg/m2/day intravenously, administered on days 1-4 and 33-35. Calcium folinate (folinic acid) 20 mg/m2/day intravenously on days 1-4 and 33-35.
Consolidation ChemotherapyDrug
XELOX: Oxaliplatin 130 mg/m² (day 1) + capecitabine 1000 mg/m² (days 1-14), every 3 weeks for 4 cycles.
Or FOLFOX: Oxaliplatin - 85 mg/m2 intravenously (2-hour infusion), drip for 1 day. Calcium folinate (folinic acid) - 400 mg/m2/d. intravenously (2-hour infusion), started on day 1. F(5-fluorouracil) - 400 mg/m2/d. intravenously (bolus), started on day 1. Repeat every 2 weeks for 6 times.
SurgeryProcedure or surgery
Transabdominal Resection: Abdominoperineal resection, low anterior resection, or coloanal anastomosis using total mesorectal excision.
Part twoOther
Standard treatment protocols and follow-up procedures are implemented in clinical practice.
Adjuvant treatmentOther
If indicated, adjuvant therapy will be administered as usual in clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Part one. The first group: an experimental group - TNT, organ preservation. | Experimental | Participants in the experimental group will be treated with TNT - CRT plus consolidating Ch. Consolidation Ch lasts 12 weeks. The response to TNT will be assessed 4 to 5 weeks after the last cycle of Ch. Response assessment will be performed through digital examination, pelvic MRI, rectoscopy, and biopsy. Participants will be actively followed up and not treated after a complete or near-complete response. In case of non-response, participants will undergo surgery. If the participant is diagnosed with a near-complete clinical response and wishes to avoid surgery, the response is reassessed after 8 weeks. If there is no response, i.e., near-complete clinical response persists, the participant is offered surgery.
Participants in the experimental group do not receive adjuvant treatment after TNT and surgery. Receives: Radiation: Radiation Therapy; Drug: Chemoradiotherapy; Drug: Consolidation Chemotherapy; Procedure: Surgery |
| Part one. Second Group: a control Group - surgery | Active comparator | In the control group, treatment will start with surgery. Following surgical treatment, adjuvant therapy may be provided for control group participants according to standard clinical practice if indicated. |
| Part two of the study | Other | In the second part of the study, investigators will prospectively collect and analyze the personal medical records of participants who have already received treatment with CRT or TNT. No new diagnostic or therapeutic approaches will be implemented; routine clinical practices for long-term follow-up will continue. For participants who have not received specific treatment and do not meet the inclusion criteria for the first part of the study, as well as those who declined to participate in that part, investigators will follow the routine clinical practices for investigation, treatment, and follow-up as long as they meet the inclusion criteria for the second part of the study. Receives: Other: Part two |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Assessed based on the Clavien Dindo classification.
Measured: From the start of treatment until 3 months after surgery.
TNT toxicity
Local and systemic toxicity and (or) side effects will be recorded according to the general terminology criteria for adverse events version 5.0 (CTCAE v5.0).
Measured: From the start of treatment until 3 months after TNT.
Mortality rate
Mortality after TNT or surgery.
Measured: From the start of treatment until 3 months after treatment.
Quality of life
Quality of life Will be assessed using scoring manual of European Organisation For Research And Treatment Of Cancer of CR29 (Colorectal).
Measured: From the start of treatment until 3 years after treatment.
Low anterior resection syndrome rate.
Assessed based on the LARS questionnaire
Measured: From the start of treatment until 3 years after treatment.
Fatigue
Fatigue will be assessed using scoring manual of the functional assessment of chronic illness therapy - fatigue (FACIT-F) questionnaire.
Measured: From the start of treatment until 3 years after treatment
Complete clinical response rate
Criteria for Complete Clinical Response
DRE:
- Smooth, flat scar
- No nodularity
Endoscopy:
- Pale smooth scar with or without telangiectasia
- No ulceration, nodularity, or mucosal irregularities
- No stricture
MRT:
- Fibrotic, linear scar with low signal intensity on T2-weighted images
- No diffusion restriction
- No suspicious lymph nodes All of the criteria must be satisfied to define a complete clinical response.
Measured: 12 - 14 weeks after TNT
Near-complete clinical response rate
Near Complete Response
DRE:
- Smooth induration or superficial minor mucosal irregularity
Endoscopic:
- Appearance with irregular small mucosal nodules, superficial ulceration, or mild persistent erythema MRI
- Downstaging with or without residual fibrosis, small area of residual signal, and complete or partial regression of lymph nodes
- Diffusion-weighted MRI with a small area of residual high signal intensity
Measured: 12 - 14 weeks after TNT
Secondary outcomes (7)
Rectal preservation rate
Percentage of participants achieving complete or near-complete clinical response and rectal preservation using a "watch and wait" approach.
Measured: 3 years after TNT
Local regrowth rate
Percentage of participants with tumor regrowth after watch-and-wait when a complete or near-complete clinical response was achieved after TNT
Measured: 3 years after TNT
Overall survival
The time between enrolment and death from any cause.
Measured: 3 - 5 years.
Disease-free survival
The time between enrolment and the first documented disease progression, i.e. local recurrence or metastasis, or death from any cause.
Measured: 3 - 5 years.
Local recurrence-free survival
Local recurrence rates in participants who underwent surgery.
Measured: 3 - 5 years.
Distant metastasis-free survival
Incidence of distant metastases
Measured: 3 - 5 years.
Stoma free survival
Stoma-free survival is defined as the period after treatment during which the patient does not develop a stoma.
Measured: 3 - 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start6 Jan 2025
- Primary completion27 Dec 2029 (estimated)
- Study completion27 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- \*\*Part One:\*\* A prospective randomized study. Participants will be randomly divided into two groups: an experimental group and a control group. \*\*Part Two:\*\* A prospective cohort study. In the second part of the study, there is no planned allocation of groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
- Sponsor type
- University, hospital or other
- Collaborators
- Vilnius University, Tomas Poskus, Faculty of Medicine, Vilnius University, Vilnius University Hospital Santaros Klinikos, Research Council of Lithuania
- Responsible party
- Sponsor
- Investigators
- Tomas Poškus, PhD, Study chair, Translational Health Research Institute, Faculty of Medicine, Vilnius University Ciurlionio str. 21, LT-03101 VilniusAudrius Dulskas, PhD, Principal investigator, General and Abdominal Surgery and Oncology Department, National Cancer Institute, Vilnius, Lithuania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758830
- Sponsor's protocol ID
- STart
- Status last verified
- May 2026
- First submitted
- 19 Dec 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Neoadjuvant Therapy for Rectal Cancer - a New Standard of Care?
- ClinicalTrials.gov ID
- NCT06758830
- Acronym / sponsor ID
- STart
- Conditions
- Rectal Cancer, Total Neoadjuvant Treatment, Neoadjuvant Therapy, Radiotherapy, Chemotherapy, Organ Preservation
- Keywords
- Rectal cancer, Total Neoadjuvant Treatment, Neoadjuvant therapy, Radiotherapy, Chemotherapy, Chemoradiotherapy, Organ Preservation, Radiotherapy Side Effect
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Cancer Center Affiliate of Vilnius University Hospital Santaros KlinikosUniversity, hospital or other
- Collaborators
- Vilnius University, Tomas Poskus, Faculty of Medicine, Vilnius University, Vilnius University Hospital Santaros Klinikos, Research Council of Lithuania
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 27 Dec 2029 (estimated)
- Study completion
- 27 Dec 2029 (estimated)
- First posted
- 6 Jan 2025 (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.
This study hypothesizes that approximately 50% of rectal cancer patients can preserve their rectum using a watch-and-wait strategy if they achieve a complete or near-complete clinical response to total neoadjuvant therapy (TNT). The objective is to determine whether the complications, quality of life, and survival rates of rectal cancer patients who have achieved a complete or near-complete clinical response to TNT, followed by a watch-and-wait approach, are comparable to those of patients who undergo surgery first. Additionally, the study aims to identify potential prognostic and predictive markers for rectal cancer and examine survival rates and factors influencing responses to chemoradiotherapy (CRT) or TNT.
The study is divided into two parts:
Part One: Participants with cT1N1, T2-T3 N0-1 rectal cancer, MRF-, and EMVI-, with surgery as one of the possible first-line treatment options, will be randomized into two groups. The experimental group will consist of participants receiving TNT, including CRT and consolidation chemotherapy (Ch). If these participants achieve a complete or near-complete clinical response, they will be observed using a watch-and-wait strategy, which is a non-operative approach. The control group will consist of participants who undergo surgical treatment initially.
Part Two: All participants with rectal cancer who have received CRT or TNT will be included. Additionally, participants diagnosed with rectal cancer who are scheduled for CRT or TNT but declined to participate in Part One or do not meet the inclusion criteria will also be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Part One: A prospective randomized study. Participants will be randomly divided into two groups: an experimental group and a control group. Part Two: A prospective cohort study. In the second part of the study, there is no planned allocation of groups.
| Arm | Type | Receives |
|---|---|---|
| Part one. The first group: an experimental group - TNT, organ preservation. | Experimental | Radiation: Radiation Therapy, Drug: Chemoradiotherapy, Drug: Consolidation Chemotherapy, Procedure: SurgeryParticipants in the experimental group will be treated with TNT - CRT plus consolidating Ch. Consolidation Ch lasts 12 weeks. The response to TNT will be assessed 4 to 5 weeks after the last cycle of Ch. Response assessment will be performed through digital examination, pelvic MRI, rectoscopy, and biopsy. Participants will be actively followed up and not treated after a complete or near-complete response. In case of non-response, participants will undergo surgery. If the participant is diagnosed with a near-complete clinical response and wishes to avoid surgery, the response is reassessed after 8 weeks. If there is no response, i.e., near-complete clinical response persists, the participant is offered surgery. Participants in the experimental group do not receive adjuvant treatment after TNT and surgery. |
| Part one. Second Group: a control Group - surgery | Active comparator | –In the control group, treatment will start with surgery. Following surgical treatment, adjuvant therapy may be provided for control group participants according to standard clinical practice if indicated. |
| Part two of the study | Other | Other: Part twoIn the second part of the study, investigators will prospectively collect and analyze the personal medical records of participants who have already received treatment with CRT or TNT. No new diagnostic or therapeutic approaches will be implemented; routine clinical practices for long-term follow-up will continue. For participants who have not received specific treatment and do not meet the inclusion criteria for the first part of the study, as well as those who declined to participate in that part, investigators will follow the routine clinical practices for investigation, treatment, and follow-up as long as they meet the inclusion criteria for the second part of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Over 18 years of age.
- Participants who agreed to participate in the study signed an informed consent form.
- The Eastern Cooperative Oncology Group (ECOG) score ranges from 0 to 2.
- Pathologically confirmed rectal adenocarcinoma.
- Tumor up to 10 cm from the anus.
Key exclusion criteria (11 listed)
- Prior ST or Ch.
- Participants who are not eligible for pelvic MRI.
- Participants who have had a malignancy in the last 5 years, except for treatment for basal cell or squamous cell skin cancer or in situ cervical cancer.
- ECOG status ≥ 3.
- Distant metastases detected.
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 |
|---|---|---|
| Radiation TherapyRadiation therapy (RT) is administered at a dose of 2 Gy per day for a total dose of 50 Gy delivered to the pelvis. This is done throughout 5 to 6 weeks. | Radiation | Part one. The first group: an experimental group - TNT, organ preservation. |
| ChemoradiotherapyCapecitabine: 825 mg/m² twice daily, prescribed 1-5 days per week, for 5 weeks during RT. Or Bolus 5-FU regimen: 5-fluorouracil (5-FU) 400 mg/m2/day intravenously, administered on days 1-4 and 33-35. Calcium folinate (folinic acid) 20 mg/m2/day intravenously on days 1-4 and 33-35. | Drug | Part one. The first group: an experimental group - TNT, organ preservation. |
| Consolidation ChemotherapyXELOX: Oxaliplatin 130 mg/m² (day 1) + capecitabine 1000 mg/m² (days 1-14), every 3 weeks for 4 cycles. Or FOLFOX: Oxaliplatin - 85 mg/m2 intravenously (2-hour infusion), drip for 1 day. Calcium folinate (folinic acid) - 400 mg/m2/d. intravenously (2-hour infusion), started on day 1. F(5-fluorouracil) - 400 mg/m2/d. intravenously (bolus), started on day 1. Repeat every 2 weeks for 6 times. | Drug | Part one. The first group: an experimental group - TNT, organ preservation. |
| SurgeryTransabdominal Resection: Abdominoperineal resection, low anterior resection, or coloanal anastomosis using total mesorectal excision. | Procedure or surgery | Part one. The first group: an experimental group - TNT, organ preservation. |
| Part twoStandard treatment protocols and follow-up procedures are implemented in clinical practice. | Other | Part two of the study |
| Adjuvant treatmentIf indicated, adjuvant therapy will be administered as usual in clinical practice. | Other | – |
Primary outcome
Postoperative complications
Time frame: From the start of treatment until 3 months after surgery.
Assessed based on the Clavien Dindo classification.
TNT toxicity
Time frame: From the start of treatment until 3 months after TNT.
Local and systemic toxicity and (or) side effects will be recorded according to the general terminology criteria for adverse events version 5.0 (CTCAE v5.0).
Mortality rate
Time frame: From the start of treatment until 3 months after treatment.
Mortality after TNT or surgery.
Quality of life
Time frame: From the start of treatment until 3 years after treatment.
Quality of life Will be assessed using scoring manual of European Organisation For Research And Treatment Of Cancer of CR29 (Colorectal).
Low anterior resection syndrome rate.
Time frame: From the start of treatment until 3 years after treatment.
Assessed based on the LARS questionnaire
Fatigue
Time frame: From the start of treatment until 3 years after treatment
Fatigue will be assessed using scoring manual of the functional assessment of chronic illness therapy - fatigue (FACIT-F) questionnaire.
Complete clinical response rate
Time frame: 12 - 14 weeks after TNT
Criteria for Complete Clinical Response DRE: * Smooth, flat scar * No nodularity Endoscopy: * Pale smooth scar with or without telangiectasia * No ulceration, nodularity, or mucosal irregularities * No stricture MRT: * Fibrotic, linear scar with low signal intensity on T2-weighted images * No diffusion restriction * No suspicious lymph nodes All of the criteria must be satisfied to define a complete clinical response.
Near-complete clinical response rate
Time frame: 12 - 14 weeks after TNT
Near Complete Response DRE: - Smooth induration or superficial minor mucosal irregularity Endoscopic: * Appearance with irregular small mucosal nodules, superficial ulceration, or mild persistent erythema MRI * Downstaging with or without residual fibrosis, small area of residual signal, and complete or partial regression of lymph nodes * Diffusion-weighted MRI with a small area of residual high signal intensity
7 secondary outcomes
Rectal preservation rate
Time frame: 3 years after TNT
Local regrowth rate
Time frame: 3 years after TNT
Overall survival
Time frame: 3 - 5 years.
Disease-free survival
Time frame: 3 - 5 years.
Local recurrence-free survival
Time frame: 3 - 5 years.
Distant metastasis-free survival
Time frame: 3 - 5 years.
Stoma free survival
Time frame: 3 - 5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Tomas Poškus, PhD study chair
Translational Health Research Institute, Faculty of Medicine, Vilnius University Ciurlionio str. 21, LT-03101 Vilnius
Audrius Dulskas, PhD principal investigator
General and Abdominal Surgery and Oncology Department, National Cancer Institute, Vilnius, Lithuania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Radiation Therapy, Chemoradiotherapy and Consolidation Chemotherapy in people with Rectal Cancer and Total Neoadjuvant Treatment, 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 18 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 11 May 2026. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ernestas Šileika, MD (+37060950402, ernestas.sileika@nvc.santa.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: From the start of treatment until 3 months after surgery.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2026.