Clinical trial NCT00738790: Preoperative Radiotherapy and Local Excision in Rectal Cancer
Official title: The Randomised Study of Preoperative Radiotherapy and Local Excision for Radiosensitive Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Rectal Cancer
Keywords: rectal cancer
preoperative radiotherapy and local excision
Lead sponsor: Polish Colorectal Cancer Study Group
Sponsor class: NETWORK
Collaborators: name: Maria Sklodowska-Curie National Research Institute of Oncology
name: Poznan University of Medical Sciences
name: Medical University of Lublin
First posted: 2008-08-20
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The rate of patients with downstaging after radiotherapy to pathological complete response or ypT1 disease with negative margins.
timeFrame: Surrogate endpoint available immediatly after surgery.
Secondary outcomes:
measure: The rate of local control, overall survival and disease-free survival and toxicity.
timeFrame: 5 years
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: M. Sklodowska-Curie Memorial Cancer Centre
Study officials:
affiliation: Roentgena 5, 02-781 Warsaw, Poland
name: Krzysztof Bujko, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bujko K, Sopylo R, Kepka L. Local excision after radio(chemo)therapy for rectal cancer: is it safe? Clin Oncol (R Coll Radiol). 2007 Nov;19(9):693-700. doi: 10.1016/j.clon.2007.07.014. Epub 2007 Sep 4.
citation: Bujko K, Richter P, Kolodziejczyk M, Nowacki MP, Kulig J, Popiela T, Gach T, Oledzki J, Sopylo R, Meissner W, Wierzbicki R, Polkowski W, Kowalska T, Stryczynska G, Paprota K; Polish Colorectal Study Group. Preoperative radiotherapy and local excision of rectal cancer with immediate radical re-operation for poor responders. Radiother Oncol. 2009 Aug;92(2):195-201. doi: 10.1016/j.radonc.2009.02.013. Epub 2009 Mar 16.