Total Neoadjuvant Therapy and Organ Preservation Versus Surgery for Rectal Cancer.

Launched by NATIONAL CANCER CENTER AFFILIATE OF VILNIUS UNIVERSITY HOSPITAL SANTAROS KLINIKOS · Dec 27, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new approach to treating rectal cancer, focusing on whether some patients can successfully avoid surgery by using a "watch-and-wait" strategy after receiving a combination of chemotherapy and radiation therapy known as total neoadjuvant therapy (TNT). The researchers believe that around 50% of patients who achieve a strong positive response to this treatment may not need surgery right away. Instead, they would be closely monitored to see if their cancer remains under control, comparing their overall health, quality of life, and survival rates with those who undergo surgery first.

To participate in this trial, individuals must be at least 18 years old and have been diagnosed with rectal adenocarcinoma that is not spreading to other parts of the body. They should have a certain type of tumor that meets specific size and location criteria. Participants will be randomly assigned to either receive the TNT treatment followed by observation or to have surgery right away. It's important for potential participants to understand that they will be contributing to important research that could change how rectal cancer is treated in the future.

Gender

ALL

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.