Rectal CancerPhase 2NCT01157806
Palliative Radiochemotherapy Against Palliative Surgery in Stage IV Rectal Cancer With Unresectable Metastases
A Phase 2 study testing short course of palliative radiotherapy in people with Rectal Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial summary
Short course palliative radiotherapy (5x5Gy)to the pelvis in patients with symptomatic rectal tumours and with unresectable metastases may prevent palliative surgery with a good palliative outcome.The consolidating chemotherapy of XELOX may increase the efficacy of irradiation. 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 palliative radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2010to Jun 2012
- Phase
- Phase 2
- 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
- Histologically confirmed primary carcinoma of the rectum (Lower border of tumour ≤ 10 cm from anal verge)
- Occurrence of subjective clinical symptoms of the primary tumor
- Non-resectable synchronous distant metastases. The decision of non-resectable metastases will be made at multidisciplinary clinical meetings.
Who cannot join
- Obstruction of the gastrointestinal tract
- Previously constructed stoma
- prior radiotherapy of the pelvis
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: Palliative Radiotherapy Followed by Chemotherapy Against Palliative Surgery in Patients With Rectal Cancer With Unresectable Synchronous Distant Metastases
Short course palliative radiotherapy (5x5Gy)to the pelvis in patients with symptomatic rectal tumours and with unresectable metastases may prevent palliative surgery with a good palliative outcome.The consolidating chemotherapy of XELOX may increase the efficacy of irradiation.
Read the detailed description
Patients with symptomatic rectal cancer and unresectable metastases receive 25 Gy in 5 fractions of 5 Gy over 5 days to the pelvis and XELOX consolidating chemotherapy after one week. Investigators arbitrarily assumed that palliative radiotherapy to the pelvis can replace the immediate surgery if at least 30% of patients would avoid delayed surgery until the end of their lives, or for at least 18 months in the case of long-term survival.
- Conditions
- Rectal Cancer
- Being tested
- short course of palliative radiotherapy
- Keywords
- rectal cancer, unresectable synchronous metastases, pelvic radiochemotherapy
- 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 palliative radiotherapyRadiation
5x5 Gy + XELOX 7 days after radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| radiochemotherapy instead of surgery | Experimental | Not described Receives: Radiation: short course of palliative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients not requiring palliative surgery during the follow-up
Measured: every three months
Secondary outcomes (4)
The rate of early toxicity of radiotherapy according to the NCI CTCAE (version 3.0)
Assess prospectively by filling forms.
Measured: 3 months
Palliative effect of radiotherapy
Assessment of radiochemotherpy effectivenes by patients using questionaire.
Measured: every three months
Time from palliative radiotherapy to delayed palliative surgery
Measured: 18 months
Determination of prognostic factors indicating the need for immediate palliative surgery.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2010 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Investigators
- Krzysztof Bujko, Prof., Principal investigator, M. Sklodowska-Curie Memorial Cancer Centre Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157806
- Sponsor's protocol ID
- 0109
- Status last verified
- Feb 2011
- First submitted
- 6 Jul 2010
- Last updated
- 16 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tyc-Szczepaniak D, Wyrwicz L, Kepka L, Michalski W, Olszyna-Serementa M, Palucki J, Pietrzak L, Rutkowski A, Bujko K. Palliative radiotherapy and chemotherapy instead of surgery in symptomatic rectal cancer with synchronous unresectable metastases: a phase II study. Ann Oncol. 2013 Nov;24(11):2829-34. doi: 10.1093/annonc/mdt363. Epub 2013 Sep 6.
PubMed 24013512
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Radiotherapy Followed by Chemotherapy Against Palliative Surgery in Patients With Rectal Cancer With Unresectable Synchronous Distant Metastases
- ClinicalTrials.gov ID
- NCT01157806
- Acronym / sponsor ID
- 0109
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, unresectable synchronous metastases, pelvic radiochemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 7 Jul 2010 (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.
Short course palliative radiotherapy (5x5Gy)to the pelvis in patients with symptomatic rectal tumours and with unresectable metastases may prevent palliative surgery with a good palliative outcome.The consolidating chemotherapy of XELOX may increase the efficacy of irradiation.
Detailed description
Patients with symptomatic rectal cancer and unresectable metastases receive 25 Gy in 5 fractions of 5 Gy over 5 days to the pelvis and XELOX consolidating chemotherapy after one week. Investigators arbitrarily assumed that palliative radiotherapy to the pelvis can replace the immediate surgery if at least 30% of patients would avoid delayed surgery until the end of their lives, or for at least 18 months in the case of long-term survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| radiochemotherapy instead of surgery | Experimental | Radiation: short course of palliative radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed primary carcinoma of the rectum (Lower border of tumour ≤ 10 cm from anal verge)
- Occurrence of subjective clinical symptoms of the primary tumor
- Non-resectable synchronous distant metastases. The decision of non-resectable metastases will be made at multidisciplinary clinical meetings.
Key exclusion criteria (3 listed)
- Obstruction of the gastrointestinal tract
- Previously constructed stoma
- prior radiotherapy of the pelvis
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 palliative radiotherapy5x5 Gy + XELOX 7 days after radiotherapy | Radiation | radiochemotherapy instead of surgery |
Primary outcome
percentage of patients not requiring palliative surgery during the follow-up
Time frame: every three months
4 secondary outcomes
The rate of early toxicity of radiotherapy according to the NCI CTCAE (version 3.0)
Time frame: 3 months
Palliative effect of radiotherapy
Time frame: every three months
Time from palliative radiotherapy to delayed palliative surgery
Time frame: 18 months
Determination of prognostic factors indicating the need for immediate palliative surgery.
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2011.
- Derived from this study: PubMed 24013512Tyc-Szczepaniak D, Wyrwicz L, Kepka L, Michalski W, Olszyna-Serementa M, Palucki J, Pietrzak L, Rutkowski A, Bujko K. Palliative radiotherapy and chemotherapy instead of surgery in symptomatic rectal cancer with synchronous unresectable metastases: a phase II study. Ann Oncol. 2013 Nov;24(11):2829-34. doi: 10.1093/annonc/mdt363. Epub 2013 Sep 6.
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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
M. Sklodowska-Curie Memorial Cancer Centre 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 2 study testing short course of palliative radiotherapy in people with Rectal Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology 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 3 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 16 Feb 2011. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
percentage of patients not requiring palliative surgery during the follow-up (time frame: every three months). 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 NCT01157806, which also lists 1 linked publication.
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 16 Feb 2011.