Preoperative Chemoradiotherapy and Transanal Endoscopic Microsurgery Versus Ttransanal Endoscopic Microsurgery in T1 N0, M0 Rectal Cancer (TAUTEM-T1 Study)

Launched by CORPORACION PARC TAULI · Jun 7, 2024

Keywords

ClinConnect Summary

The TAUTEM-T1 study is a clinical trial that aims to improve treatment for patients with early-stage rectal cancer (specifically, stage T1, N0, M0). The trial will compare two approaches: one group of patients will receive a combination of chemotherapy and radiation (called chemoradiotherapy) before undergoing a specific type of surgery known as transanal endoscopic microsurgery (TEM), while the other group will have the surgery alone. The goal is to see if adding chemoradiotherapy can reduce the chances of the cancer coming back and improve overall survival, while also minimizing complications from surgery.

To participate in this study, patients must have rectal adenocarcinoma tumors that are small (up to 4 cm) and located within 10 cm of the anal opening. They should not have any signs of advanced cancer or other serious health issues. Throughout the trial, researchers will monitor patients for any side effects from the treatment, as well as their quality of life after surgery. Importantly, this study is not yet recruiting participants, so individuals interested in joining will need to wait until the trial begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Indication by multidisciplinary committee of indication for local excision, according to ESMO and NCCN criteria.
• • Rectal adenocarcinomas in the biopsy, located at a distance from the anal margin less than or equal to 10 cm measured by rigid rectoscopy at the time of ER.
• • Preoperative staging by ER and pelvic MRI of T1,N0. In case of disparity, higher staging will be considered the definitive diagnosis. If it is greater than T1, it will be excluded.
• • Tumors equal to or less than 4 cm in maximum diameter measured by MRI.
• • ASA index equal to or less than III.
• • Absence of distant metastases by abdominal CT and chest X-ray (if inconclusive, Thoracic CT)
• Exclusion Criteria:
• • Preoperative staging by EER or pelvic MRI higher than T1 or N0.
• • Presence of distant metastases. Synchrony with other colorectal adenocarcinomas.
• • Undifferentiated rectal adenocarcinomas or with the presence of poor prognostic factors in the preoperative biopsy (undifferentiated, venous, lymphatic or perineural infiltration, budding) .
• • Patients with intolerance to preoperative chemotherapy or radiotherapy.
• • Do not sign informed consent.