Rectal CancerPhase 2NCT01129700
Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer
A Phase 2 study testing Radiation: short-course preoperative chemoradiotherapy in people with Rectal Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
Concurrent chemoradiotherapy (CRT) Radiotherapy 25 ㏉/5 fractions (start concomitantly at D1) ↓ ↓ ↓ ↓ ↓ Radical surgery 6 weeks after completion of chemoradiotherapy ↑ ↑ ↑ ↑ ↑ D1 - - - - - D5 5-Fluorouracil 400㎎/㎡/day + LV 20㎎/㎡/day IV bolus during the radiotherapy 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?
- Radiation: short-course preoperative chemoradiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2010to Feb 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
- Pathologically proven diagnosis of adenocarcinoma of the rectum (located within 8㎝ above the anal verge)
- Locally advanced and curatively resectable tumor(cT3-4 classification) evaluated with magnetic resonance imaging(MRI) with or without transrectal ultrasonography(TRUS)
- Age ≥18
- Performance Status(ECOG) 0-2
- CBC/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows: Hemoglobin ≥ 10 g/dl, Absolute neutrophil count(ANC) ≥ 1,500 cells/㎣, Platelets ≥ 100,000cells/㎣
- Metabolic panel within 14 days prior to registration on study, with adequate liver and renal function defined as follows: AST and ALT ≤ 60 IU/L, bilirubin ≤ 1.5 mg/dl, serum creatinine ≤ 1.5 mg/dl
- Patient must provide study-specific informed consent prior to study entry
Who cannot join
- Any evidence of distant metastases(M1)
- Prior invasive malignancy (except non-melanomatous skin cancer and uterine cervical cancer in situ) unless disease free to a minimum of 3 years
- Hereditary rectal cancer; Familial adenomatous polyposis(FAP), Hereditary non-polyposis colorectal cancer(HNPCC), etc.
- Impending obstruction (except the case with colostomy)
- Severe, active comorbidity inappropriate to CRT as follows; Acute bacterial or fungal infection, transmural myocardial infarction within the last 6 months, unstable arrhythmia, angina and/or congestive heart failure, unstable arrhythmia
- Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
- Unresected synchronous colon carcinoma
- Clinically unresectable rectal cancer
Trial locations and contacts
1 site in 1 country.
South Korea1 site
National Cancer Center Korea
Goyang-si, Gyeonggi-do, 410-769
About this study
Official title: Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer: Phase II Multi-institutional Study
Concurrent chemoradiotherapy (CRT)
- Radiotherapy 25 ㏉/5 fractions (start concomitantly at D1)
- ↓ ↓ ↓ ↓ ↓
- Radical surgery 6 weeks after completion of chemoradiotherapy
- ↑ ↑ ↑ ↑ ↑ D1 - - - - - D5
- 5-Fluorouracil 400㎎/㎡/day + LV 20㎎/㎡/day IV bolus during the radiotherapy
Read the detailed description
Radiotherapy using tomotherapy is delivered in 5 Gy daily fractions for a total of 25 Gy in 5 fractions.
A bolus injection of 5-fluorouracil (400 mg/m2/d)and leucovorin (20 mg/m2/d) is delivered concurrently on day 1-5 during radiotherapy.
Total mesorectal excision is performed within 6±2 weeks. The pathological response of downstaing is the study endpoint.
- Conditions
- Rectal Cancer
- Being tested
- Radiation: short-course preoperative chemoradiotherapy
- Keywords
- rectal cancer, short-course, chemoradiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation: short-course preoperative chemoradiotherapyRadiation
Drug: 5-Fluorouracil 5-Fluorouracil is administered intravenously at a dose of 400 mg/m2 once daily continuous regimen during RT(5 days).
Radiation: Localization, simulation and immobilization Radiation dose and planning Total dose 25Gy, 5 fractions (5 Gy/day).
| Study group | Role | What they receive |
|---|---|---|
| short-course CRT-5FU | Experimental | Not described Receives: Radiation: Radiation: short-course preoperative chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the pathologic response
downstaging(ypT0-2N0M0)rate
Measured: After surgery with pathology data
Secondary outcomes (2)
Tumor regression grade & MR volumetry
To evaluate the tumor regression grade \& MR volumetry
Measured: After surgery with pathology data for TRG, at the pretreatment work-up and 1-4 days befor surgery
Acute/ late toxicities
To evaluate the acute and late toxicities
Measured: preoperative CCRT to 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, DAE YONG KIM, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129700
- Sponsor's protocol ID
- NCCCTS-10-458
- Status last verified
- Apr 2012
- First submitted
- 13 May 2010
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer: Phase II Multi-institutional Study
- ClinicalTrials.gov ID
- NCT01129700
- Acronym / sponsor ID
- NCCCTS-10-458
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, short-course, chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Feb 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 25 May 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.
Concurrent chemoradiotherapy (CRT)
- Radiotherapy 25 ㏉/5 fractions (start concomitantly at D1)
- ↓ ↓ ↓ ↓ ↓
- Radical surgery 6 weeks after completion of chemoradiotherapy
- ↑ ↑ ↑ ↑ ↑ D1 - - - - - D5
- 5-Fluorouracil 400㎎/㎡/day + LV 20㎎/㎡/day IV bolus during the radiotherapy
Detailed description
Radiotherapy using tomotherapy is delivered in 5 Gy daily fractions for a total of 25 Gy in 5 fractions.
A bolus injection of 5-fluorouracil (400 mg/m2/d)and leucovorin (20 mg/m2/d) is delivered concurrently on day 1-5 during radiotherapy.
Total mesorectal excision is performed within 6±2 weeks. The pathological response of downstaing is the study endpoint.
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 CRT-5FU | Experimental | Radiation: Radiation: short-course preoperative chemoradiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically proven diagnosis of adenocarcinoma of the rectum (located within 8㎝ above the anal verge)
- Locally advanced and curatively resectable tumor(cT3-4 classification) evaluated with magnetic resonance imaging(MRI) with or without transrectal ultrasonography(TRUS)
- Age ≥18
- Performance Status(ECOG) 0-2
- CBC/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows: Hemoglobin ≥ 10 g/dl, Absolute neutrophil count(ANC) ≥ 1,500 cells/㎣, Platelets ≥ 100,000cells/㎣
Key exclusion criteria (8 listed)
- Any evidence of distant metastases(M1)
- Prior invasive malignancy (except non-melanomatous skin cancer and uterine cervical cancer in situ) unless disease free to a minimum of 3 years
- Hereditary rectal cancer; Familial adenomatous polyposis(FAP), Hereditary non-polyposis colorectal cancer(HNPCC), etc.
- Impending obstruction (except the case with colostomy)
- Severe, active comorbidity inappropriate to CRT as follows; Acute bacterial or fungal infection, transmural myocardial infarction within the last 6 months, unstable arrhythmia, angina and/or congestive heart failure, unstable arrhythmia
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 |
|---|---|---|
| Radiation: short-course preoperative chemoradiotherapyDrug: 5-Fluorouracil 5-Fluorouracil is administered intravenously at a dose of 400 mg/m2 once daily continuous regimen during RT(5 days). Radiation: Localization, simulation and immobilization Radiation dose and planning Total dose 25Gy, 5 fractions (5 Gy/day). | Radiation | short-course CRT-5FU |
Primary outcome
To evaluate the pathologic response
Time frame: After surgery with pathology data
downstaging(ypT0-2N0M0)rate
2 secondary outcomes
Tumor regression grade & MR volumetry
Time frame: After surgery with pathology data for TRG, at the pretreatment work-up and 1-4 days befor surgery
Acute/ late toxicities
Time frame: preoperative CCRT to 3 months after surgery
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 27 Apr 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Radiation: short-course preoperative chemoradiotherapy in people with Rectal Cancer, run by National Cancer Center, Korea at 1 site 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 7 inclusion and 8 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 27 Apr 2012. 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 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?
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?
To evaluate the pathologic response (time frame: After surgery with pathology data). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2012.