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Compares treatment options for Rectal Cancer
Official title Total Neoadjuvant Therapy and Organ Preservation Versus Surgery for Rectal Cancer.
ClinicalTrials.gov ID: NCT06758830
What this study is testing
What is Chemoradiotherapy?
Chemoradiotherapy is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for rectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Part One
- 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.
You likely can't join if
- 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...
- ECOG status ≥ 3.
- Distant metastases detected.
- Participants with uncontrolled therapeutic or psychiatric conditions.
See the full eligibility criteria
- Part One
- 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.
- 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.
- 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.
- Infectious diseases requiring antibiotic treatment. Part Two Inclusion Criteria:
- 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. Exclusion Criteria:
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Vilnius, Lithuania
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vilnius, Lithuania. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.