Actively Recruiting
Total Neoadjuvant Therapy and Organ Preservation Versus Surgery for Rectal Cancer A Randomized Phase 2/3 Study Evaluating Watch-and-Wait Strategy
Led by National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos · Updated on 2026-05-11
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
Lead Sponsor
V
Vilnius University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether a watch-and-wait approach can help about half of rectal cancer patients preserve their rectum after achieving a complete or near-complete clinical response to total neoadjuvant therapy (TNT). The study compares complications, quality of life, and survival rates between patients who follow watch-and-wait after TNT and those who undergo surgery first. The trial also aims to find markers that predict treatment response and factors affecting survival after chemoradiotherapy (CRT) or TNT. The study has two parts. In the first, participants with specific stages of rectal cancer are randomized to receive either TNT—which includes CRT followed by consolidation chemotherapy—or initial surgery. Those in the TNT group are assessed 4 to 5 weeks after chemotherapy to see if they have a complete or near-complete response; if so, they are monitored without surgery. Those without a response have surgery. The second part collects data from participants who have received CRT or TNT as part of routine care or who did not join the first part. Participants will undergo regular assessments including digital exams, MRI scans, rectoscopy, and biopsies to monitor response and side effects. The study measures complications, toxicity, mortality, quality of life, fatigue, and rectal preservation rates over up to three years, as well as survival outcomes for up to five years. Follow-up includes monitoring for tumor regrowth and long-term side effects, with the total participation duration varying by individual treatment paths.
CONDITIONS
Brief Title
Total Neoadjuvant Therapy and Organ Preservation Versus Surgery for Rectal Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 18 years of age
- Signed informed consent to participate
- ECOG performance status between 0 and 2
- Pathologically confirmed rectal adenocarcinoma
- Tumor located up to 10 cm from the anus for Part One and up to 12 cm for Part Two
- MRI of pelvis and CT of thorax and abdomen confirming diagnosis
- Specific clinical staging: cT1N1, T2-T3 N0-1, M0, with negative mesorectal fascia (MRF-) and extramural vascular invasion (EMVI-) for Part One
- Normal bone marrow function with specified blood counts
- Normal renal and liver function within defined limits
- Participants who refused Part One or do not meet its criteria but have received or are planned to receive CRT or TNT for Part Two
You will not qualify if you...
- Prior surgery or chemotherapy before study entry
- Ineligibility for pelvic MRI
- History of other malignancy within 5 years, except certain skin or cervical cancers
- ECOG status of 3 or higher
- Presence of distant metastases or Stage IV cancer
- Uncontrolled therapeutic or psychiatric conditions
- Infectious diseases requiring antibiotic treatment
- New cancer diagnosed within 2 years after CRT
- Refusal or inability to sign informed consent for participation in Part Two
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 to 6 weeks of chemoradiotherapy plus 12 weeks of consolidation chemotherapy for experimental group; initial surgery and possible adjuvant therapy duration varies for control group
Participants in the experimental group receive total neoadjuvant therapy (TNT), which includes chemoradiotherapy with capecitabine or 5-FU during radiation therapy for 5 to 6 weeks, followed by consolidation chemotherapy lasting 12 weeks. Response to TNT is assessed 4 to 5 weeks after the last chemotherapy cycle through digital examination, pelvic MRI, rectoscopy, and biopsy. Participants with complete or near-complete response are followed without further treatment unless surgery is needed. Participants in the control group undergo surgery first, followed by adjuvant therapy if indicated according to standard clinical practice.
Weekly visits during chemoradiotherapy; visits every 2 to 3 weeks during consolidation chemotherapy; surgery visit and approximately 6 post-operative visits if applicable
Duration - Up to 5 years after treatment
Participants are actively followed to monitor treatment response, quality of life, and long-term outcomes including survival and disease recurrence for up to 3 to 5 years after treatment.
Periodic visits depending on clinical status and assigned group
Trial Site Locations
Total: 1 location
1
Nacional Cancer Institute
Vilnius, Lithuania, 08660
Actively Recruiting
Research Team
E
Ernestas Šileika, MD
A
Audrius Dulskas, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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