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

June 7, 2024 updated by: Xavier Serra-Aracil, Corporacion Parc Tauli

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)

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chemoradiotherapy+TEM
Preoperative chemotherapy: capecitabine 825 mg/m2 every 12 hours orally, plus Radiotherapy (50.4 Gy). After 10 weeks, transanal endoscopic microsurgery (TEM) is done
Drug: Capecitabine (Xeloda)
Capecitabine 825 mg/m2 every 12 hours orally on days of radiotherapy
Radiation: 50.4 Gy
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
Procedure: Transanal Endoscopic Microsurgery (TEM)
10 weeks after Chemoradiotherapy
Other Names:
  • Transanal Endoscopic Operation (TEO)
  • Transanal Minimal Invasive Surgery (TAMIS)
Active Comparator: ransanal endoscopic microsurgery (TEM)
Transanal endoscopic microsurgery (TEM)
Procedure: Transanal Endoscopic Microsurgery
Standard surgical treatment of T1, N0, M0 rectal cancer. Early after diagnosis
Other Names:
  • Transanal Endoscopic Operation (TEO)
  • Transanal Minimal Invasive Surgery (TAMIS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days after preoperative CRT
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.
30 days after surgery
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
30 days after surgery
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
One year after surgery
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.
At two years
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.
Three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

May 19, 2024

First Submitted That Met QC Criteria

June 7, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

June 10, 2024

Last Update Submitted That Met QC Criteria

June 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAUTEM-T1_2024-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

SAP, Study Protocol, Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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