NCT06450574Not yet recruitingPhase 3
Preoperative Chemoradiotherapy and Transanal Endoscopic Microsurgery Versus Ttransanal Endoscopic Microsurgery in T1 N0, M0 Rectal Cancer (TAUTEM-T1 Study)
Prospective, Controlled and Randomized Phase III Multicentric Study of the Treatment of T1,N0,M0 Rectal Cancer. Neoadjuvant Therapy and Transanal Endoscopic Surgery vs. Transanal Endoscopic Surgery (TAUTEM-T1 Study)
Source: ClinicalTrials.gov · Last updated 10 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Introduction: The standard treatment for rectal adenocarcinoma is total mesorectal excision (TME), a technique involving resection of the rectum, with or without a temporary or permanent stoma. TME is associated with high morbidity and genitourinary alterations. On the other hand, transanal endoscopic surgery (TEM) allows access to tumors up to 20 cm from the anal margin, with much lower postoperative morbidity and without the need for ostomy. For T1, N0, M0 rectal adenocarcinomas without poor prognostic factors, TEM is the technique of choice. However, recent studies have described local recurrences of up to 20%. Our group, TAUTEM, has just completed a phase III clinical trial in T2-T3ab, N0, M0 rectal cancer, comparing preoperative chemoradiotherapy (CRT) and TEM versus TME, with very positive results in terms of postoperative morbidity, quality of life, and a local recurrence rate of 7.4%, not inferior to TME. These results encourage our TAUTEM group to launch a similar project at the T1, N0, M0 stage, comparing standard TEM treatment versus QRT and TEM, aiming to improve rectal preservation outcomes and enhance results regarding local recurrence, distant recurrence, and oncologic survival. Method: Prospective, controlled, randomized phase III multicenter clinical trial. Patients with rectal adenocarcinoma within 10 cm of the anal margin and up to 4 cm in size, staged as T1, N0, M0, will be included. These patients will be randomized into two groups: TEM after CRT and TEM alone. Postoperative morbidity and mortality, CRT side effects, and quality of life will be recorded. The minimum follow-up will evaluate rectal preservation and local recurrence and survival at two and three years. The sample size calculation for the study will be 106 patients. Conclusions: The aim of the study is to improve oncological outcomes in stage T1, N0, M0 rectal cancer through preoperative chemoradiotherapy associated with local surgery (TEM).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 106 (estimated)
- First submitted
- 19 May 2024
- Start date
- Oct 2024
- Primary completion date
- Oct 2026
- Lead sponsor
- Corporacion Parc Tauli
- Diseases
- Colorectal cancer
- NCT number
- NCT06450574
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 106
- From Oct 2024 to the primary completion date, Oct 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with intolerance to preoperative chemotherapy or radiotherapy.
Other
- 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) .
- Do not sign informed consent.
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.