Local Excision in Downstaged Rectal Cancer (GRECCAR 2)

University Hospital of Bordeaux

Status and phase: Completed; Phase 3

Conditions: Rectal Neoplasms

Treatments: Procedure: local rectal excision; Procedure: total mesorectal excision

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00427375

2005-025

CHUBX 2006/03

Details and patient eligibility

About

Patients with T2T3 low rectal cancer (size =< 4 cm) received neoadjuvant treatment (50Gy in 5 weeks with concomitant chemotherapy. Good responders (residual tumour =< 2 cm) are randomised in local vs rectal excision, 6-8 weeks after treatment. The composite end point evaluates the rate of patients with death, recurrence, major morbidity or severe after effects at two years.

Full description

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.

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

1

Experimental group

Description:

New surgical option in good responders after neoadjuvant treatment for low rectal cancer

Treatment:

Procedure: local rectal excision

2

Active Comparator group

Description:

Standard surgery

Treatment:

Procedure: total mesorectal excision