Preoperative Radiotherapy and Local Excision in Rectal Cancer

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00738790

Enrollment

102

Registered

2008-08-20

Start date

2003-11-30

Completion date

2013-11-30

Last updated

2010-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

rectal cancer, preoperative radiotherapy and local excision

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.

Interventions

RADIATIONShort course of radiotherapy

5 x 5 Gy plus boost 4 Gy

RADIATIONRadiochemotherapy

28 x 1,8Gy plus boost 3 x 1,8 Gy with three 2-days cycles of chemotherapy during weeks 1, 3 and 5 of irradiation (the each cycle consisted of leukovorin 20 mg/m2 per day and 10-20 minutes later of 5-fluorouracil 400 mg/m2 per day, both administrated as rapid intravenous infusion)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Poland

Contacts

Primary ContactWojciech Michalski, M. S.

W.Michalski@coi.waw.pl+48226433909

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026