Rectal CancerPhase 2KROG 11-02NCT01431599
Short-course Preoperative Chemoradiotherapy for Rectal Cancer
A Phase 2 study testing short-course radiation in people with Rectal Cancer, run by Jong Hoon Lee at 3 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the early clinical outcome of the short-course preoperative chemoradiotherapy, 33Gy/10 fx and delayed operation after chemoradiation, the investigators initiated the clinical trial of KROG 11-02. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- short-course radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Sep 2011to Oct 2017
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- histologically confirmed adenocarcinoma
- distal margin of the tumor located < 8 cm above the anal verge
- cT3-4 or cN+ classification as determined by endorectal ultrasonography (EUS) and CT
- patient older than age 18 years
- Karnofsky performance score >= 70
Who cannot join
- distant metastasis identified during staging workup
- previous or concurrent malignancy
- pregnant or breast-feeding women
- impending rectal obstruction
- familial adenomatous polyposis
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
National Cancer Center, Korea
Goyang
Dae Yong Kim, MD, radiopiakim@hanmail.net
- Recruiting
Samsung Medical Center
Seoul
Hee Chul Park, MD, hee.ro.park@samsung.com
- Recruiting
Seoul National University Hospital
Seoul
Eui Kyu Chie, MD, ekchie93@SNU.ac.kr
About this study
Official title: Two Week-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Rectal Cancer: Phase II Multicenter Clinical Trial (KROG 11-02)
The purpose of this study is to evaluate the early clinical outcome of the short-course preoperative chemoradiotherapy, 33Gy/10 fx and delayed operation after chemoradiation, the investigators initiated the clinical trial of KROG 11-02.
- Conditions
- Rectal Cancer
- Being tested
- short-course radiation
- Keywords
- Locally advanced rectal cancer
- 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 radiationRadiation
33Gy/10 fractions
| Study group | Role | What they receive |
|---|---|---|
| short-course | Experimental | Not described Receives: Radiation: short-course radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
downstaging effect of tumor
Comparison of clinical T staging and pathologic T staging example> cT4 --> pT1 after chemoradiation: down staging (+)
Measured: an expected average of 6 weeks after chemoradiation
Secondary outcomes (1)
bladder and small bowel toxicity after chemoradiation
The incidence of grade 3 or higher small bowel and bladder toxicity according to the RTOG and EORTC toxicity criteria (reference: Cox JD et al. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1341-6)
Measured: Participants will be followed for an expected average of 3 months after chemoradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2012
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jong Hoon Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital, Samsung Medical Center, National Cancer Center, Korea
- Responsible party
- Sponsor-investigator, Jong Hoon Lee, Seoul St. Mary's Hospital
- Investigators
- Hong Seok Jang, MD, Principal investigator, Department fo Radiation Oncology, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431599
- Sponsor's protocol ID
- KROG 11-02
- Acronym
- KROG 11-02
- Status last verified
- Oct 2017
- First submitted
- 6 Sep 2011
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Swedish Rectal Cancer Trial; Cedermark B, Dahlberg M, Glimelius B, Pahlman L, Rutqvist LE, Wilking N. Improved survival with preoperative radiotherapy in resectable rectal cancer. N Engl J Med. 1997 Apr 3;336(14):980-7. doi: 10.1056/NEJM199704033361402.
PubMed 9091798Gerard A, Buyse M, Nordlinger B, Loygue J, Pene F, Kempf P, Bosset JF, Gignoux M, Arnaud JP, Desaive C, et al. Preoperative radiotherapy as adjuvant treatment in rectal cancer. Final results of a randomized study of the European Organization for Research and Treatment of Cancer (EORTC). Ann Surg. 1988 Nov;208(5):606-14. doi: 10.1097/00000658-198811000-00011.
PubMed 3056288Lee JH, Kim JG, Oh ST, Lee MA, Chun HG, Kim DY, Kim TH, Kim SY, Baek JY, Park JW, Oh JH, Park HC, Choi DH, Park YS, Kim HC, Chie EK, Jang HS. Two-week course of preoperative chemoradiotherapy followed by delayed surgery for rectal cancer: a phase II multi-institutional clinical trial (KROG 11-02). Radiother Oncol. 2014 Jan;110(1):150-4. doi: 10.1016/j.radonc.2013.11.013. Epub 2014 Jan 7.
PubMed 24411228
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Week-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Rectal Cancer: Phase II Multicenter Clinical Trial (KROG 11-02)
- ClinicalTrials.gov ID
- NCT01431599
- Acronym / sponsor ID
- KROG 11-02 / KROG 11-02
- Conditions
- Rectal Cancer
- Keywords
- Locally advanced rectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jong Hoon LeeUniversity, hospital or other
- Collaborators
- Seoul National University Hospital, Samsung Medical Center, National Cancer Center, Korea
- Study start
- Sep 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2017 (estimated)
- First posted
- 9 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 evaluate the early clinical outcome of the short-course preoperative chemoradiotherapy, 33Gy/10 fx and delayed operation after chemoradiation, the investigators initiated the clinical trial of KROG 11-02.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| short-course | Experimental | Radiation: short-course radiation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- histologically confirmed adenocarcinoma
- distal margin of the tumor located < 8 cm above the anal verge
- cT3-4 or cN+ classification as determined by endorectal ultrasonography (EUS) and CT
- patient older than age 18 years
- Karnofsky performance score >= 70
Key exclusion criteria (5 listed)
- distant metastasis identified during staging workup
- previous or concurrent malignancy
- pregnant or breast-feeding women
- impending rectal obstruction
- familial adenomatous polyposis
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 radiation33Gy/10 fractions | Radiation | short-course |
Primary outcome
downstaging effect of tumor
Time frame: an expected average of 6 weeks after chemoradiation
Comparison of clinical T staging and pathologic T staging example> cT4 --> pT1 after chemoradiation: down staging (+)
1 secondary outcome
bladder and small bowel toxicity after chemoradiation
Time frame: Participants will be followed for an expected average of 3 months after chemoradiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2017.
- Background: PubMed 9091798Swedish Rectal Cancer Trial; Cedermark B, Dahlberg M, Glimelius B, Pahlman L, Rutqvist LE, Wilking N. Improved survival with preoperative radiotherapy in resectable rectal cancer. N Engl J Med. 1997 Apr 3;336(14):980-7. doi: 10.1056/NEJM199704033361402.
- Background: PubMed 3056288Gerard A, Buyse M, Nordlinger B, Loygue J, Pene F, Kempf P, Bosset JF, Gignoux M, Arnaud JP, Desaive C, et al. Preoperative radiotherapy as adjuvant treatment in rectal cancer. Final results of a randomized study of the European Organization for Research and Treatment of Cancer (EORTC). Ann Surg. 1988 Nov;208(5):606-14. doi: 10.1097/00000658-198811000-00011.
- Derived from this study: PubMed 24411228Lee JH, Kim JG, Oh ST, Lee MA, Chun HG, Kim DY, Kim TH, Kim SY, Baek JY, Park JW, Oh JH, Park HC, Choi DH, Park YS, Kim HC, Chie EK, Jang HS. Two-week course of preoperative chemoradiotherapy followed by delayed surgery for rectal cancer: a phase II multi-institutional clinical trial (KROG 11-02). Radiother Oncol. 2014 Jan;110(1):150-4. doi: 10.1016/j.radonc.2013.11.013. Epub 2014 Jan 7.
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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.
Hong Seok Jang, MD principal investigator
Department fo Radiation Oncology, Seoul St. Mary's Hospital
3 sites 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 radiation in people with Rectal Cancer, run by Jong Hoon Lee at 3 sites in South Korea.
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 5 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 10 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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 Jong Hoon Lee, MD (82-010-8607-1269, koppul@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
downstaging effect of tumor (time frame: an expected average of 6 weeks after chemoradiation). 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 NCT01431599, which also lists 3 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 10 Oct 2017.