| August 19, 2008 |
| August 19, 2008 |
| November 2003 |
| The rate of patients with downstaging after radiotherapy to pathological complete response or ypT1 disease with negative margins. [ Time Frame: Surrogate endpoint available immediatly after surgery. ] [ Designated as safety issue: No ] |
| Same as current |
| No Changes Posted |
| The rate of local control, overall survival and disease-free survival and toxicity. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| Preoperative Radiotherapy and Local Excision in Rectal Cancer |
| The Randomised Study of Preoperative Radiotherapy and Local Excision for Radiosensitive Rectal Cancer |
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. |
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. |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Rectal Cancer |
- Radiation: Short course of radiotherapy
- Radiation: Radiochemotherapy
|
|
|
| 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. Epub 2007 Sep 4. Review. |
| |
| Recruiting |
| 102 |
| November 2013 |
| November 2010 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years and older |
| No |
|
|
| Poland |
|
| |
| NCT00738790 |
| Prof. Marek P. Nowacki, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology in Warsaw |
| KBN0655/P05/2005/28 |
| Polish Colorectal Cancer Study Group |
- Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology in Warsaw
- Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology in Cracow
- Poznan University of Medical Sciences
- Medical University of Lublin
|
| Principal Investigator: |
Krzysztof Bujko, Prof. |
Roentgena 5, 02-781 Warsaw, Poland |
|
|
| Polish Colorectal Cancer Study Group |
| August 2008 |
