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The Randomised Study of Preoperative Radiotherapy and Local Excision for Radiosensitive Rectal Cancer

Phase 3
18 Years
Open (Enrolling)
Rectal Cancer

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Trial Information

The Randomised Study of Preoperative Radiotherapy and Local Excision for Radiosensitive Rectal Cancer

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

The rate of patients with downstaging after radiotherapy to pathological complete response or ypT1 disease with negative margins.

Outcome Time Frame:

Surrogate endpoint available immediatly after surgery.

Safety Issue:


Principal Investigator

Krzysztof Bujko, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roentgena 5, 02-781 Warsaw, Poland


Poland: Ministry of Science and Higher Education

Study ID:




Start Date:

November 2003

Completion Date:

November 2013

Related Keywords:

  • Rectal Cancer
  • rectal cancer
  • preoperative radiotherapy and local excision
  • Rectal Neoplasms