NCT00738790

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2003

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

April 15, 2010

Status Verified

April 1, 2010

Enrollment Period

7 years

First QC Date

August 19, 2008

Last Update Submit

April 14, 2010

Conditions

Rectal Cancer

Keywords

rectal cancerpreoperative radiotherapy and local excision

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The rate of local control, overall survival and disease-free survival and toxicity.

    5 years

Study Arms (2)

1

EXPERIMENTAL

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

Radiation: Short course of radiotherapy

2

ACTIVE COMPARATOR

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

Radiation: Radiochemotherapy

Interventions

Short course of radiotherapyRADIATION

5 x 5 Gy plus boost 4 Gy

Also known as: short radiation
1
RadiochemotherapyRADIATION

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)

Also known as: chemoradiation
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Poorly differentiated pathology (G3)
  • Patients unfit for chemotherapy
  • No agreement for randomisation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M. Sklodowska-Curie Memorial Cancer Centre

Warsaw, 02-781, Poland

RECRUITING

Related Publications (2)

  • 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.

    PMID: 17766096BACKGROUND

  • 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.

    PMID: 19297050BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyRadiotherapy

Study Officials

  • Krzysztof Bujko, Prof.

    Roentgena 5, 02-781 Warsaw, Poland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wojciech Michalski, M. S.

CONTACT

+48226433909W.Michalski@coi.waw.pl

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 20, 2008

Study Start

November 1, 2003

Primary Completion

November 1, 2010

Study Completion

November 1, 2013

Last Updated

April 15, 2010

Record last verified: 2010-04

Locations

PL(1)