Preoperative Radiotherapy and Local Excision in Rectal Cancer

NCT ID: NCT00738790

Last Updated: 2010-04-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2013-11-30

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Preoperative radiotherapy with five fractions of 5 Gy during one week and boost 4 Gy after 1 week interval, total dose 29 Gy; after 6 weeks full-thickness local excision

Group Type: EXPERIMENTAL

Short course of radiotherapy

Intervention Type: RADIATION

5 x 5 Gy plus boost 4 Gy

2

Radiochemotherapy with 28 fractions of 1,8 Gy plus boost 5,4 Gy in 3 fractions

+ simultaneous bolus 5-Fluorouracil and leucovorin; after 6 weeks full-thickness local excision

Group Type: ACTIVE_COMPARATOR

Radiochemotherapy

Intervention Type: RADIATION

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)

Interventions

Short course of radiotherapy

5 x 5 Gy plus boost 4 Gy

Intervention Type: RADIATION

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)

Intervention Type: RADIATION

Other Intervention Names

short radiation; chemoradiation

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

Sponsor Role: collaborator

Poznan University of Medical Sciences

OTHER

Sponsor Role: collaborator

Medical University of Lublin

OTHER

Sponsor Role: collaborator

Polish Colorectal Cancer Study Group

NETWORK

Sponsor Role: lead

Responsible Party

Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology in Warsaw

Principal Investigators

Krzysztof Bujko, Prof.

Role: PRINCIPAL_INVESTIGATOR

Roentgena 5, 02-781 Warsaw, Poland

Locations

M. Sklodowska-Curie Memorial Cancer Centre

Warsaw, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Wojciech Michalski, M. S.

Role: CONTACT

W.Michalski@coi.waw.pl

+48226433909

Facility Contacts

Krzysztof Bujko, Prof.

Role: primary

bujko@coi.waw.pl

+48226439287

References

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.

Reference Type: BACKGROUND

PMID: 17766096 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19297050 (View on PubMed)

Other Identifiers

KBN0655/P05/2005/28

Identifier Type: -

Identifier Source: secondary_id

PGBRJG0108

Identifier Type: -

Identifier Source: org_study_id