Rectal CancerNCT01444495
Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer
A study testing Preoperative radiotherapy and Surgery in people with Rectal Cancer, run by Jagiellonian University at 1 site in Poland.
Trial summary
The purpose of this study is to establish the influence of time-interval between preoperative hyperfractionated radiotherapy (5x5 Gy) and surgery on long term overall survival (5 years), local and distant recurrence rate, downstaging rate, sphincter saving procedures, radical resection rate (R0) in patients with… 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?
- Preoperative radiotherapy and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 sitePoland
- Study dates
- Jan 1999to Dec 2010
- Phase
- Interventional
- 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 rectal cancer
- tumor localised in middle or lower rectum
- age > 18 years
- locally advanced cancer
Who cannot join
- previous pelvis radiotherapy
- lack of patient's consent
- lack of possibility to begin radiotherapy during 14 days after inclusion to the study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to establish the influence of time-interval between preoperative hyperfractionated radiotherapy (5x5 Gy) and surgery on long term overall survival (5 years), local and distant recurrence rate, downstaging rate, sphincter saving procedures, radical resection rate (R0) in patients with locally advanced rectal cancer operated on according to TME technique. In particular 3D endosonography and 3rd generation ultrasonic contrast agents are evaluated to assess response to radiotherapy.
Read the detailed description
The treatment group comprises patients with locally advanced rectal cancer who were operated on in the 1st Department of General Surgery, Jagiellonian University, Cracow. The data on survival has been systematically collected using national census registry. Patients are qualified to preoperative radiotherapy 5x5 Gy and then randomly assigned to subgroups with different time interval between radiotherapy and surgery: one subgroup consists of patients operated on 7-10 days after the end of irradiation, the second subgroup consists of patients operated on after 4-5 weeks. Both should be homogenous in sex, age, cancer stage and localization, distal and circumferential resection margins, number of resected lymph nodes. 3D endorectal ultrasound and endorectal ultrasound with SonoVue are performed to assess the tumor before and after preoperative radiotherapy.
- Conditions
- Rectal Cancer
- Being tested
- Preoperative radiotherapy, Surgery
- Keywords
- rectal cancer, radiotherapy, overall survival, recurrence rate, downstaging
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative radiotherapyRadiation
Also called Neoadjuvant radiotherapy
Preoperative radiotherapy 5x5 Gy (total dose of 25 Gy)
SurgeryProcedure or surgery
Also called Operative treatment
Total mesorectal excision of rectal cancer
| Study group | Role | What they receive |
|---|---|---|
| Short time interval | Active comparator | Patients operated on 7-10 days after completing preoperative radiotherapy 5x5Gy. Receives: Radiation: Preoperative radiotherapy; Procedure: Surgery |
| Long time interval | Experimental | Patients operated on 4-5 weeks after completing preoperative radiotherapy 5x5Gy. Receives: Radiation: Preoperative radiotherapy; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
local and systemic recurrence rate
Rate of local and sytemic recurrences in patients included to the protocol.
Measured: 5 years
Secondary outcomes (4)
radical resections rate (R0)
Rate of R0, R1 and R2 procedures according to Hermanek.
Measured: 1 month
sphincter saving (sparing) procedures
Rate of sphincter saving operations in both arms.
Measured: 1 month
overall survival
Overall survival and disease specific survival at 5 years follow-up
Measured: 5 years
downstaging of rectal cancer
Downstaging of the rectal cancer after preoprearite radiotherapy - assessed by comparison of preoperative ERUS, 3D ERUS, contrast enhanced ERUS and postoperative histologic staging
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startJan 1999
- Primary completionJun 2008
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radoslaw Pach, MD, PhD, Jagiellonian University
- Investigators
- Jan Kulig, Prof., Study chair, First Department of General Surgery, Jagiellonian UniversityRadoslaw Pach, Ph.D., Principal investigator, First Department of General Surgery, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444495
- Sponsor's protocol ID
- Cracow Rectal Cancer Trial
- Status last verified
- Feb 2023
- First submitted
- 29 Sep 2011
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pach R, Kulig J, Richter P, Gach T, Szura M, Kowalska T. Randomized clinical trial on preoperative radiotherapy 25 Gy in rectal cancer--treatment results at 5-year follow-up. Langenbecks Arch Surg. 2012 Jun;397(5):801-7. doi: 10.1007/s00423-011-0890-8. Epub 2011 Dec 15.
PubMed 22170083Pach R, Kulig J, Richter P, Gach T, Szura M, Kowalska T. Erratum to: Randomized clinical trial on preoperative radiotherapy 25 Gy in rectal cancer-treatment results at 5 year follow-up. Langenbecks Arch Surg. 2019 Sep;404(Suppl 1):19-20. doi: 10.1007/s00423-012-0940-x. No abstract available.
PubMed 22398435Pach R, Sierzega M, Szczepanik A, Popiela T, Richter P. Preoperative radiotherapy 5 x 5 Gy and short versus long interval between surgery for resectable rectal cancer: 10-Year follow-up of the randomised controlled trial. Radiother Oncol. 2021 Nov;164:268-274. doi: 10.1016/j.radonc.2021.10.006. Epub 2021 Oct 13.
PubMed 34653526Pach R, Richter P, Sierzega M, Papp N, Szczepanik A. Preoperative Short-Course Radiotherapy and Surgery versus Surgery Alone for Patients with Rectal Cancer: A Propensity Score-Matched Analysis at 18-Year Follow-Up. Biomedicines. 2021 Jun 24;9(7):725. doi: 10.3390/biomedicines9070725.
PubMed 34202691Pach R, Szczepanik AM, Sierzega M, Daniluk M, Richter P. Prognostic value of lymph node ratio in resectable rectal cancer after preoperative short-course radiotherapy-results from randomized clinical trial. Langenbecks Arch Surg. 2022 Nov;407(7):2969-2980. doi: 10.1007/s00423-022-02603-8. Epub 2022 Jul 4.
PubMed 35788774
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer
- ClinicalTrials.gov ID
- NCT01444495
- Acronym / sponsor ID
- Cracow Rectal Cancer Trial
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, radiotherapy, overall survival, recurrence rate, downstaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- Jan 1999
- Primary completion
- Jun 2008 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 30 Sep 2011 (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.
The purpose of this study is to establish the influence of time-interval between preoperative hyperfractionated radiotherapy (5x5 Gy) and surgery on long term overall survival (5 years), local and distant recurrence rate, downstaging rate, sphincter saving procedures, radical resection rate (R0) in patients with locally advanced rectal cancer operated on according to TME technique. In particular 3D endosonography and 3rd generation ultrasonic contrast agents are evaluated to assess response to radiotherapy.
Detailed description
The treatment group comprises patients with locally advanced rectal cancer who were operated on in the 1st Department of General Surgery, Jagiellonian University, Cracow. The data on survival has been systematically collected using national census registry. Patients are qualified to preoperative radiotherapy 5x5 Gy and then randomly assigned to subgroups with different time interval between radiotherapy and surgery: one subgroup consists of patients operated on 7-10 days after the end of irradiation, the second subgroup consists of patients operated on after 4-5 weeks. Both should be homogenous in sex, age, cancer stage and localization, distal and circumferential resection margins, number of resected lymph nodes. 3D endorectal ultrasound and endorectal ultrasound with SonoVue are performed to assess the tumor before and after preoperative radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short time interval | Active comparator | Radiation: Preoperative radiotherapy, Procedure: SurgeryPatients operated on 7-10 days after completing preoperative radiotherapy 5x5Gy. |
| Long time interval | Experimental | Radiation: Preoperative radiotherapy, Procedure: SurgeryPatients operated on 4-5 weeks after completing preoperative radiotherapy 5x5Gy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- histologically confirmed rectal cancer
- tumor localised in middle or lower rectum
- age > 18 years
- locally advanced cancer
Key exclusion criteria (3 listed)
- previous pelvis radiotherapy
- lack of patient's consent
- lack of possibility to begin radiotherapy during 14 days after inclusion to the study
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 |
|---|---|---|
| Preoperative radiotherapyAlso: Neoadjuvant radiotherapyPreoperative radiotherapy 5x5 Gy (total dose of 25 Gy) | Radiation | Long time interval, Short time interval |
| SurgeryAlso: Operative treatmentTotal mesorectal excision of rectal cancer | Procedure or surgery | Long time interval, Short time interval |
Primary outcome
local and systemic recurrence rate
Time frame: 5 years
Rate of local and sytemic recurrences in patients included to the protocol.
4 secondary outcomes
radical resections rate (R0)
Time frame: 1 month
sphincter saving (sparing) procedures
Time frame: 1 month
overall survival
Time frame: 5 years
downstaging of rectal cancer
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Results publication: PubMed 22170083Pach R, Kulig J, Richter P, Gach T, Szura M, Kowalska T. Randomized clinical trial on preoperative radiotherapy 25 Gy in rectal cancer--treatment results at 5-year follow-up. Langenbecks Arch Surg. 2012 Jun;397(5):801-7. doi: 10.1007/s00423-011-0890-8. Epub 2011 Dec 15.
- Results publication: PubMed 22398435Pach R, Kulig J, Richter P, Gach T, Szura M, Kowalska T. Erratum to: Randomized clinical trial on preoperative radiotherapy 25 Gy in rectal cancer-treatment results at 5 year follow-up. Langenbecks Arch Surg. 2019 Sep;404(Suppl 1):19-20. doi: 10.1007/s00423-012-0940-x. No abstract available.
- Results publication: PubMed 34653526Pach R, Sierzega M, Szczepanik A, Popiela T, Richter P. Preoperative radiotherapy 5 x 5 Gy and short versus long interval between surgery for resectable rectal cancer: 10-Year follow-up of the randomised controlled trial. Radiother Oncol. 2021 Nov;164:268-274. doi: 10.1016/j.radonc.2021.10.006. Epub 2021 Oct 13.
- Results publication: PubMed 34202691Pach R, Richter P, Sierzega M, Papp N, Szczepanik A. Preoperative Short-Course Radiotherapy and Surgery versus Surgery Alone for Patients with Rectal Cancer: A Propensity Score-Matched Analysis at 18-Year Follow-Up. Biomedicines. 2021 Jun 24;9(7):725. doi: 10.3390/biomedicines9070725.
- Results publication: PubMed 35788774Pach R, Szczepanik AM, Sierzega M, Daniluk M, Richter P. Prognostic value of lymph node ratio in resectable rectal cancer after preoperative short-course radiotherapy-results from randomized clinical trial. Langenbecks Arch Surg. 2022 Nov;407(7):2969-2980. doi: 10.1007/s00423-022-02603-8. Epub 2022 Jul 4.
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Jan Kulig, Prof. study chair
First Department of General Surgery, Jagiellonian University
Radoslaw Pach, Ph.D. principal investigator
First Department of General Surgery, Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative radiotherapy and Surgery in people with Rectal Cancer, run by Jagiellonian University 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: finished, as of the sponsor's last update on 15 Feb 2023. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local and systemic recurrence rate (time frame: 5 years). 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 NCT01444495, which also lists 5 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 Feb 2023.