Comparing total neoadjuvant therapy with surgery for rectal cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: ernestas.sileika@nvc.santa.lt
• Phone: +37060950402

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.