Preoperative Radiotherapy and Local Excision in Rectal Cancer

Phase 3

• Conditions: Rectal Cancer
• Interventions: Radiation: Short course of radiotherapy; Radiation: Radiochemotherapy

• Registration Number: NCT00738790
• Lead Sponsor: Polish Colorectal Cancer Study Group

Brief Summary

According to the current opinion, local excision in rectal cancer should be limited to selected T1N0 tumours. The investigators addressed the question whether preoperative radio(chemo)therapy can expand the use of this procedure for more advanced cancers. The rationale of preoperative radiotherapy is eradication of mesorectal subclinical disease. Besides, there is a correlation between radiosensitivity of rectal cancers and low cancer aggressiveness. For this reason, conversion to abdominal surgery is needed in patients with radioresistant tumour. The investigators aim to compare the short-course radiotherapy schedule with the chemoradiation in order to determine an optimal scheme. The study hypothesis is that the chemoradiation assures 25% more patients who do not require conversion to an open surgery. In addition, the aim is to asses safety and efficiency of preoperative radiotherapy and local excision for radiosensitive rectal cancer.

Detailed Description

Local excision must involve all tissue invaded on pretreatment examination. For this reason, 4-5 tatoos of mucosa at the tumour border should be performed before the onset of treatment. Next, the long-course radiochemotherapy or short-course radiotherapy is randomly allocated. After 6 weeks interval, the full thickness local excision should be carried out with 1 cm margin. Patients with good pathological response (complete response or downstaging to ypT1 disease)are followed up. Conversion to open surgery is offered to patients with poor pathological response (ypT2-3 or positive margin). Close follow-up is carried out in order to detect an early local recurrence either in a bowel wall or in mesorectal lymph nodes. Rescue surgery is offered in patients with local recurrence.

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2008-08-19
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-20
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-14
• Last Update Posted: 2010-04-15
• Primary Completion: 2010-11
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Biopsy proven good or moderately differentiated adenocarcinoma of rectum
• Extraperitoneal tumour (< 3-4 cm; unfavourable cT1 or cT2-3; N0)
• No evidence of distant metastases on chest X-ray and abdominal CT or sonography
• Signed by patient written informed consent

Exclusion Criteria

• Poorly differentiated pathology (G3)
• Patients unfit for chemotherapy
• No agreement for randomisation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Short course of radiotherapy	Preoperative radiotherapy with five fractions of 5 Gy during one week and boost 4 Gy after 1 week interval, total dose 29 Gy; after 6 weeks full-thickness local excision
2	Radiochemotherapy	Radiochemotherapy with 28 fractions of 1,8 Gy plus boost 5,4 Gy in 3 fractions + simultaneous bolus 5-Fluorouracil and leucovorin; after 6 weeks full-thickness local excision

Primary Outcome Measures

Name	Time	Method
The rate of patients with downstaging after radiotherapy to pathological complete response or ypT1 disease with negative margins.	Surrogate endpoint available immediatly after surgery.

Secondary Outcome Measures

Name	Time	Method
The rate of local control, overall survival and disease-free survival and toxicity.	5 years

Trial Locations

Locations (1)

M. Sklodowska-Curie Memorial Cancer Centre; 🇵🇱 Warsaw, Poland