Primary Rectal CancerPhase 3NCT00597311
Preoperative Chemoradiation Versus Short Term Radiation Alone With Delayed Surgery for Stage II and III Resectable Rectal Cancer
A Phase 3 study testing radiotherapy in people with Primary Rectal Cancer, run by Kaunas University of Medicine at 1 site in Lithuania.
Trial summary
Trial compares two preoperative stage II and III rectal cancer treatment strategies: short term radiotherapy 5x5 Gy and delayed surgery after 6 weeks versus conventional chemoradiotherapy 50 Gy + 5Fu/Lv and surgery also after 6 weeks. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Rectal Cancer
- What is being tested?
- radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteLithuania
- Study dates
- Jan 2007to Jan 2012
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed stage II and III rectal cancer less than 15 cm from anal verge
- less than 80 years old
- no other cancer during 5 years period
- compensate cardiovascular, pulmonary, hepatic and renal functions.
Who cannot join
- stage I or IV rectal cancer
- other cancer in 5 years period
- radiotherapy or chemotherapy in anamnesis
- not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc.
- pregnancy or baby feeding
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
KMUH, surgery department
Kaunas, LT3000
Tadas Latkauskas, +370 676 08901, tadas.latkauskas@kmuk.lt
About this study
Trial compares two preoperative stage II and III rectal cancer treatment strategies: short term radiotherapy 5x5 Gy and delayed surgery after 6 weeks versus conventional chemoradiotherapy 50 Gy + 5Fu/Lv and surgery also after 6 weeks.
- Conditions
- Primary Rectal Cancer
- Being tested
- radiotherapy
- Keywords
- rectal cancer, radiotherapy, 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.
radiotherapyRadiation
- Short term radiotherapy 5x5 Gy during 5 days
- Chemoradiotherapy 50 Gy + 5Fu/Lv
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | preoperative short term radiation group 5x5 Gy and surgery after 6 weeks Receives: Radiation: radiotherapy |
| 2 | Experimental | preoperative chemoradiotherapy group 50Gy + 5FU/Lv and surgery after 6 weeks. Receives: Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 years overall and disease free survival
Measured: 5 years
recurrence rate
Measured: 5 years
Secondary outcomes (4)
pathological "complete response" and downstaging rates
Measured: 5 years
Impact on sphincter sparing operation rates
Measured: 5 years
morbidity and mortality rates
Measured: 5 years
Impact on quality of surgical resection
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 posted18 Jan 2008 (estimated)
- Study startJan 2007
- Primary completionJan 2012 (estimated)
- Study completionJan 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 Primary 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaunas University of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Dainius Pavalkis, professor, Principal investigator, Kaunas Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597311
- Sponsor's protocol ID
- BE-2-48
- Other IDs
- 137/2006
- Status last verified
- Jan 2008
- First submitted
- 9 Jan 2008
- Last updated
- 18 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Latkauskas T, Pauzas H, Kairevice L, Petrauskas A, Saladzinskas Z, Janciauskiene R, Gudaityte J, Lizdenis P, Svagzdys S, Tamelis A, Pavalkis D. Preoperative conventional chemoradiotherapy versus short-course radiotherapy with delayed surgery for rectal cancer: results of a randomized controlled trial. BMC Cancer. 2016 Dec 1;16(1):927. doi: 10.1186/s12885-016-2959-9.
PubMed 27903247
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Chemoradiation Versus Short Term Radiation Alone With Delayed Surgery for Stage II and III Resectable Rectal Cancer
- ClinicalTrials.gov ID
- NCT00597311
- Acronym / sponsor ID
- BE-2-48
- Conditions
- Primary Rectal Cancer
- Keywords
- rectal cancer, radiotherapy, radiochemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kaunas University of MedicineUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 18 Jan 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.
Trial compares two preoperative stage II and III rectal cancer treatment strategies: short term radiotherapy 5x5 Gy and delayed surgery after 6 weeks versus conventional chemoradiotherapy 50 Gy + 5Fu/Lv and surgery also after 6 weeks.
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: radiotherapypreoperative short term radiation group 5x5 Gy and surgery after 6 weeks |
| 2 | Experimental | Radiation: radiotherapypreoperative chemoradiotherapy group 50Gy + 5FU/Lv and surgery after 6 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- histologically confirmed stage II and III rectal cancer less than 15 cm from anal verge
- less than 80 years old
- no other cancer during 5 years period
- compensate cardiovascular, pulmonary, hepatic and renal functions.
Key exclusion criteria (5 listed)
- stage I or IV rectal cancer
- other cancer in 5 years period
- radiotherapy or chemotherapy in anamnesis
- not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc.
- pregnancy or baby feeding
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 |
|---|---|---|
| radiotherapy1. Short term radiotherapy 5x5 Gy during 5 days 2. Chemoradiotherapy 50 Gy + 5Fu/Lv | Radiation | 1, 2 |
Primary outcome
5 years overall and disease free survival
Time frame: 5 years
recurrence rate
Time frame: 5 years
4 secondary outcomes
pathological "complete response" and downstaging rates
Time frame: 5 years
Impact on sphincter sparing operation rates
Time frame: 5 years
morbidity and mortality rates
Time frame: 5 years
Impact on quality of surgical resection
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 18 Jan 2008.
- Derived from this study: PubMed 27903247Latkauskas T, Pauzas H, Kairevice L, Petrauskas A, Saladzinskas Z, Janciauskiene R, Gudaityte J, Lizdenis P, Svagzdys S, Tamelis A, Pavalkis D. Preoperative conventional chemoradiotherapy versus short-course radiotherapy with delayed surgery for rectal cancer: results of a randomized controlled trial. BMC Cancer. 2016 Dec 1;16(1):927. doi: 10.1186/s12885-016-2959-9.
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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.
Dainius Pavalkis, professor principal investigator
Kaunas Medical University
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 radiotherapy in people with Primary Rectal Cancer, run by Kaunas University of Medicine at 1 site in Lithuania.
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 5 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 18 Jan 2008. 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 Lithuania. 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 Tadas Latkauskas (+370 676 08901, tadas.latkauskas@kmuk.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 years overall and disease free survival (time frame: 5 years). The study lists 2 primary outcomes in all. 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 NCT00597311, 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 18 Jan 2008.