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

This study is currently recruiting participants.
Verified November 2009 by Corporacion Parc Tauli
Sponsor:
Collaborator:
Fundación Olga Torres
Information provided by (Responsible Party):
Xavier Serra-Aracil, Corporacion Parc Tauli
ClinicalTrials.gov Identifier:
NCT01308190
First received: March 3, 2011
Last updated: November 21, 2011
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Rectal Cancer
Drug: Capecitabine (Xeloda)
Radiation: 50.4 Gy
Procedure: Transanal Endoscopic Microsurgery
Procedure: Total Mesorectal Excision
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Corporacion Parc Tauli:

Primary Outcome Measures:
  • Local recurrence [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 173
Study Start Date: August 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chemoradiotherapy+TEM
Preoperative chemotherapy: capecitabine 825 mg/m2 every 12 hours orally, plus Radiotherapy (50.4 Gy). After 6-8 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
6-8 weeks after Chemoradiotherapy
Total Mesorectal Excision
Standard surgical treatment of T2 , T3s, N0, M0 rectal cancer
Procedure: Total Mesorectal Excision
Standard surgical treatment of T2 , T3s, N0, M0 rectal cancer. Early after diagnosis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Rectal adenocarcinomas located 10 cm or less from the inferior anal verge measured using a rigid rectoscope at the time of the EUS.
  2. 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.
  3. 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.
  4. ASA score III or less.
  5. Absence of distance metastasis as shown on abdominal CT.

Exclusion Criteria:

  1. Preoperative staging by EUS or pelvic MRI of T1, deep T3, T4 or N1.
  2. Presence of distance metastasis.
  3. Synchrony with other colorectal adenocarcinomas.
  4. Undifferentiated rectal adenocarcinomas or with presence of poor prognosis factors in preoperative biopsy.
  5. Patients with intolerance of preoperative chemotherapy or radiotherapy.
  6. Refusal to sign informed consent to enter the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308190

Contacts
Contact: Xavier Serra-Aracil, MD +34937231010 ext 20009 jserraa@tauli.cat

Locations
Spain
Corporació Parc Taulí Recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Xavier Serra-Aracil, MD    +34937231010 ext 2009    jserraa@tauli.cat   
Principal Investigator: Xavier Serra-Aracil, MD         
Sub-Investigator: Jordi Bombardo-Juncà, MD         
Sub-Investigator: Carles Pericay Pijaume, MD         
Sponsors and Collaborators
Corporacion Parc Tauli
Fundación Olga Torres
  More Information

Publications:
Responsible Party: Xavier Serra-Aracil, Medical Doctor, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT01308190     History of Changes
Other Study ID Numbers: TAU-TEM-2009-01
Study First Received: March 3, 2011
Last Updated: November 21, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Corporacion Parc Tauli:
Preoperative chemoradiotherapy
Transanal endoscopic microsurgery
Rectal Cancer
T2-T3s-N0

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014