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NCT Number: NCT06450574

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

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).

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Key information

Conditions

Rectal Cancer Stage I Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Capecitabine (Xeloda)

Drug

Capecitabine 825 mg/m2 every 12 hours orally on days of radiotherapy

50.4 Gy

Radiation

Radiotherapy was administered in daily fractions of 1.8 Gy 5 days a week according to standard schema. The total dose is 45 Gy plus a boost of 5.4 Gy to the tumor area

Transanal Endoscopic Microsurgery (TEM)

Procedure

10 weeks after Chemoradiotherapy

Other names: Transanal Endoscopic Operation (TEO), Transanal Minimal Invasive Surgery (TAMIS)

Transanal Endoscopic Microsurgery

Procedure

Standard surgical treatment of T1, N0, M0 rectal cancer. Early after diagnosis

Other names: Transanal Endoscopic Operation (TEO), Transanal Minimal Invasive Surgery (TAMIS)

Primary outcomes

  1. Rectal preservation in T1,N0,M0 rectal cancer

    Time frame: 2 years

    Number of patients where local surgery has been maintained after applying the protocol exit criteria.minimum follow-up of 2 years in both groups.

  2. Total mesorectal excision in T1,N0,M0 rectal cancer

    Time frame: 2 years

    Number of patients with Total mesorectal Excision (TME) after applying the protocol exit criteria.minimum follow-up of 2 years in both groups.

Secondary outcomes

  1. Analysis of tolerance and side effects of preoperative chemoradiotherapy (CRT).

    Time frame: 30 days after preoperative CRT

    NCI Common Terminology Criteria for Adverse Events v3.0 after chemoradiotherapy, is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term.

  2. Postoperative morbidity and mortality in both groups.

    Time frame: 30 days after surgery

    Postoperative (30 days post-surgery): nosocomial, surgical, and non-surgical postoperative complications; complications according to the Dindo-Clavien classification and the CCI (Comprehensive Complication Index); hospital stay.

  3. The clinical and pathological response of patients undergoing CRT.

    Time frame: 30 days after surgery

    The presence of a correct histological response after chemoradiotherapy is determined by the pathology study of the tumor excised after TEM, in order to establish TRG1 in Bouzourene's classification

  4. Quality of life one year after surgery.

    Time frame: One year after surgery

    Law anterior resection syndrom (LARS), Wexner incontinence scale, EORTC QLQ-C30, EORTC QLQ-CR29, and Karnofsky quality of life questionnaires. Before treatment and One year after surgery en both groups

  5. Local recurrence in both groups

    Time frame: At two years

    Local recurrence defined as the presence of adenocarcinoma in the biopsy on the residual scar, anastomosis, or the defect area of the excised tumor.

  6. 3-year survival results in both groups,

    Time frame: Three years

    3-year survival results in both groups, reflected in overall survival, disease-free survival (DFS), distant recurrence (DR), and rectal cancer survival.

Study contacts

Contact information is provided by the study sponsor or research team.

Xavier Serra-Aracil, MD

CONTACT

[email protected]

+34937231010

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

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)

Acronym: TAUTEM-T1

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 10, 2024
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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