Comparing total neoadjuvant therapy with surgery for rectal cancer treatment

Total Neoadjuvant Therapy for Rectal Cancer - a New Standard of Care?

This study is testing if rectal cancer patients who respond well to a new treatment can skip surgery and just be monitored to see how they do compared to those who have surgery right away.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Vilnius)
• Trial ID: NCT06758830 on ClinicalTrials.gov

What this trial studies

This study investigates whether rectal cancer patients who achieve a complete or near-complete clinical response to total neoadjuvant therapy (TNT) can preserve their rectum using a watch-and-wait strategy instead of undergoing immediate surgery. Participants will be randomized into two groups: one receiving TNT followed by observation and the other undergoing surgery first. The study aims to compare complications, quality of life, and survival rates between these two approaches, while also identifying prognostic markers and factors influencing treatment responses. The trial includes patients with specific staging criteria and evaluates the effectiveness of combined therapies including radiation and chemotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with pathologically confirmed rectal adenocarcinoma at specific stages and who meet the study's inclusion criteria.

Not a fit: Patients with prior surgeries or those who have had other malignancies in the last five years may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could allow many rectal cancer patients to avoid surgery and preserve their rectum, improving their quality of life.

How similar studies have performed: Other studies have shown promising results with similar neoadjuvant approaches, suggesting potential for success in this trial.

Eligibility criteria

Part One

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Vilnius

• Nacional Cancer Institute — Vilnius, Lithuania (Recruiting)

Study contacts

• Principal investigator: Audrius Dulskas, PhD — General and Abdominal Surgery and Oncology Department, National Cancer Institute, Vilnius, Lithuania
• Study coordinator: Ernestas Šileika, MD

Conditions Rectal Cancer; Total Neoadjuvant Treatment; Neoadjuvant Therapy; Radiotherapy; Chemotherapy; Organ Preservation; Radiotherapy Side Effect; Chemotherapy Side Effects