Rectal CancerPhase 3NCT00738790
Preoperative Radiotherapy and Local Excision in Rectal Cancer
A Phase 3 study testing Short course of radiotherapy and Radiochemotherapy in people with Rectal Cancer, run by Polish Colorectal Cancer Study Group at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Short course of radiotherapy and Radiochemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2003to Nov 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Poorly differentiated pathology (G3)
- Patients unfit for chemotherapy
- No agreement for randomisation
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
M. Sklodowska-Curie Memorial Cancer Centre
Warsaw, 02-781
Krzysztof Bujko, Prof., +48226439287, bujko@coi.waw.pl
Krzysztof Bujko, Prof.
About this study
Official title: 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.
Read the 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
- Being tested
- Short course of radiotherapy, Radiochemotherapy
- Keywords
- rectal cancer, preoperative radiotherapy and local excision
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short course of radiotherapyRadiation
Also called short radiation
5 x 5 Gy plus boost 4 Gy
RadiochemotherapyRadiation
Also called chemoradiation
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Radiation: Radiochemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of patients with downstaging after radiotherapy to pathological complete response or ypT1 disease with negative margins.
Measured: Surrogate endpoint available immediatly after surgery.
Secondary outcomes (1)
The rate of local control, overall survival and disease-free survival and toxicity.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startNov 2003
- Primary completionNov 2010 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polish Colorectal Cancer Study Group
- Sponsor type
- Research network
- Collaborators
- Maria Sklodowska-Curie National Research Institute of Oncology, Poznan University of Medical Sciences, Medical University of Lublin
- Investigators
- Krzysztof Bujko, Prof., Principal investigator, Roentgena 5, 02-781 Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738790
- Sponsor's protocol ID
- PGBRJG0108
- Other IDs
- KBN0655/P05/2005/28
- Status last verified
- Apr 2010
- First submitted
- 19 Aug 2008
- Last updated
- 15 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17766096Bujko 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.
PubMed 19297050
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomised Study of Preoperative Radiotherapy and Local Excision for Radiosensitive Rectal Cancer
- ClinicalTrials.gov ID
- NCT00738790
- Acronym / sponsor ID
- PGBRJG0108
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, preoperative radiotherapy and local excision
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Polish Colorectal Cancer Study GroupResearch network
- Collaborators
- Maria Sklodowska-Curie National Research Institute of Oncology, Poznan University of Medical Sciences, Medical University of Lublin
- Study start
- Nov 2003
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 20 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Radiation: Short course of radiotherapyPreoperative 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 |
| 2 | Active comparator | Radiation: RadiochemotherapyRadiochemotherapy 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Poorly differentiated pathology (G3)
- Patients unfit for chemotherapy
- No agreement for randomisation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short course of radiotherapyAlso: short radiation5 x 5 Gy plus boost 4 Gy | Radiation | 1 |
| RadiochemotherapyAlso: chemoradiation28 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) | Radiation | 2 |
Primary outcome
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.
1 secondary outcome
The rate of local control, overall survival and disease-free survival and toxicity.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2010.
- Background: PubMed 17766096Bujko 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.
- Background: PubMed 19297050Bujko 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krzysztof Bujko, Prof. principal investigator
Roentgena 5, 02-781 Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Short course of radiotherapy and Radiochemotherapy in people with Rectal Cancer, run by Polish Colorectal Cancer Study Group at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wojciech Michalski, M. S. (+48226433909, W.Michalski@coi.waw.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00738790, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2010.