Preoperative Radiotherapy and Local Excision in Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00738790
• Other study ID #: PGBRJG0108
• Secondary ID: KBN0655/P05/2005
• Status: Recruiting
• Phase: Phase 3
• First received: August 19, 2008
• Last updated: April 14, 2010
• Start date: November 2003
• Est. completion date: November 2013

Study information

• Verified date: April 2010
• Source: Polish Colorectal Cancer Study Group
• Contact: Wojciech Michalski, M. S.
• Phone: +48226433909
• Email: W.Michalski[@]coi.waw.pl
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: November 2013
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Radiation:
• Short course of radiotherapy
5 x 5 Gy plus boost 4 Gy
• Radiochemotherapy
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)

Locations

Country	Name	City	State
Poland	M. Sklodowska-Curie Memorial Cancer Centre	Warsaw

Sponsors (4)

Lead Sponsor	Collaborator
Polish Colorectal Cancer Study Group	Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology, Medical University of Lublin, Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

References & Publications (2)

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. — View 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. Epub 2007 Sep 4. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of patients with downstaging after radiotherapy to pathological complete response or ypT1 disease with negative margins.		Surrogate endpoint available immediatly after surgery.	No
Secondary	The rate of local control, overall survival and disease-free survival and toxicity.		5 years	Yes