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Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy

Phase 3
18 Years
Open (Enrolling)
Rectal Neoplasms

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Trial Information

Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy

Rectal excision is the standard surgical treatment of rectal cancer. The risk of mortality
and major short and long term morbidity induced by rectal excision justifies new treatments.
Local excision is a conservative alternative approach associated with low mortality and
morbidity. The purpose of this prospective randomised multicenter study is to compare local
vs rectal excision in good responders after radiochemotherapy for low rectal cancer.

Patients with T2T3 low rectal cancer, less than 8 cm from the anal verge, size =< 4 cm,
received neoadjuvant treatment, included radiotherapy between 45-55Gy in 5 weeks with
concomitant chemotherapy consist of at least, one fluoropyrimidine.

Good clinical responders (residual tumour =< 2 cm) are randomised in local vs rectal
excision, 6-8 weeks after treatment. In case of not confirmed pathological response
following local excision, complementary rectal excision is required.

Bad responders (residual tumour > 2cm) are treated by primary rectal excision. Follow-up
includes digital rectal examination, CT-scan and endorectal ultrasound (if local excision)
every 4 months for 2 years, then every 6 months for 3 years.

Inclusion Criteria:

- T2T3 low adenocarcinoma of the rectum

- Tumour size =< 4cm

- Less than 8 cm from the anal verge

- No metastatic disease

- Patient is at least 18 years of age

- ECOG performance status score =< 2

- Patient and doctor have signed informed consent

- inclusion criteria : Residual clinical tumour size =< 2cm after radiochemotherapy

Exclusion Criteria:

- T1, T4 tumour or anal sphincter invasion

- Metastatic disease (M1)

- Contra indication for radiotherapy and/or fluoropyrimidine use in chemotherapy

- History of cancer

- Symptomatic cardiac or coronary insufficiency

- Severe renal insufficiency

- Peripheral neuropathy

- Patient included in a trial

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Compare the proportion of patients presenting at least 1 component of the composite outcome (4 components: death, recurrence, major morbidity and severe after effects) at 2 years after

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU Bordeaux


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CHUBX 2006/03



Start Date:

March 2007

Completion Date:

December 2017

Related Keywords:

  • Rectal Neoplasms
  • Rectal cancer surgery
  • Neoadjuvant radiochemotherapy
  • Randomized clinical trial
  • Multicenter study
  • Neoplasms
  • Rectal Neoplasms