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NCT Number: NCT01308190

Preoperative Chemoradiotherapy and Transanal Endoscopic Microsurgery Versus Total Mesorectal Excision in T2-T3s N0, M0 Rectal Cancer

The standard treatment of rectal adenocarcinoma is total mesorectal excision (TME). The technique involves a low anterior rectal or colo-anal resection, very often associated with a protective stoma or abdominal-perineal resection with permanent colostomy. Transanal endoscopic microsurgery (TEM) allows access to tumors up to 20 cm from the anal margin, with minimal postoperative morbidity and mortality. Recent studies of T1 rectal adenocarcinomas consider TEM to be the technique of choice. However the treatment of T2 rectal cancers remains controversial. Chemotherapy and radiotherapy (CT/RT) has achieved a concomitant reduction in local recurrence and an increase in survival.

Hypothesis: Patients with rectal adenocarcinoma less than 10 cm from the anal margin and up to 4 cm in size, staged after endorectal ultrasound and MRI as T2 or superficial T3 N0-M0-N0-M0, who underwent surgery after preoperative local chemoradiotherapy (TEM), achieve effective results in terms of local recurrence similar to radical surgery (TME).

OBJECTIVES:

Primary: To compare the results of local recurrence at 2 years in patients treated with preoperative chemoradiotherapy and TEM and in patients treated with conventional radical surgery (TME).

Secondary: To analyse the 3-year survival results in patients treated with CT/RT.

Methodology: Multicenter clinical trial in a calculated sample of 173 patients.

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Key information

Conditions

Rectal Cancer 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

Primary location

Corporació Parc Taulí

Sabadell, Barcelona, 08208, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Rectal adenocarcinomas located 10 cm or less from the inferior anal verge measured using a rigid rectoscope at the time of the EUS.
  • Preoperative staging by EUS and pelvic MRI of T2 or T3 superficial, N0. In case of disparity, the higher staging is considered as the definitive diagnosis.
  • Tumours equal to or less than 4 cm of diameter maximum measured using colonoscopy, EUS or MRI. We use the highest score on both scores.
  • ASA score III or less.
  • Absence of distance metastasis as shown on abdominal CT.

Exclusion criteria

  • Preoperative staging by EUS or pelvic MRI of T1, deep T3, T4 or N1.
  • Presence of distance metastasis.
  • Synchrony with other colorectal adenocarcinomas.
  • Undifferentiated rectal adenocarcinomas or with presence of poor prognosis factors in preoperative biopsy.
  • Patients with intolerance of preoperative chemotherapy or radiotherapy.
  • Refusal to sign informed consent to enter the study.

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

Procedure

6-8 weeks after Chemoradiotherapy

Total mesorectal excision

Procedure

Standard surgical treatment of T2 , T3s, N0, M0 rectal cancer. Early after diagnosis

Primary outcomes

  1. Local recurrence

    Time frame: 2 years

    To analyse the results for local recurrence after 2 years in patients treated with preoperative chemoradiotherapy and TEO, with patients treated with conventional radical surgery (TME).

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Collaborators

  • Fundación Olga Torres

Registry information

Official study title

Prospective Randomized Clinical Trial for no Inferiority With Preoperative Chemoradiotherapy and Transanal Endoscopic Microsurgery (TEM) Versus Total Mesorectal Excision in T2-T3s N0, M0 Rectal Cancer

Important dates

Study start
2010
Primary completion
2017
Study completion
2021
First posted
Mar 4, 2011
Registry last updated
Nov 23, 2021

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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