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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2027-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Rectal Cancer Stage I

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Capecitabine (Xeloda)

Intervention Type DRUG

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

50.4 Gy

Intervention Type 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)

Intervention Type PROCEDURE

10 weeks after Chemoradiotherapy

ransanal endoscopic microsurgery (TEM)

Transanal endoscopic microsurgery (TEM)

Group Type ACTIVE_COMPARATOR

Transanal Endoscopic Microsurgery

Intervention Type PROCEDURE

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

Interventions

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Capecitabine (Xeloda)

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

Intervention Type DRUG

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

Intervention Type RADIATION

Transanal Endoscopic Microsurgery (TEM)

10 weeks after Chemoradiotherapy

Intervention Type PROCEDURE

Transanal Endoscopic Microsurgery

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

Intervention Type PROCEDURE

Other Intervention Names

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Transanal Endoscopic Operation (TEO) Transanal Minimal Invasive Surgery (TAMIS) Transanal Endoscopic Operation (TEO) Transanal Minimal Invasive Surgery (TAMIS)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No