Rectal CancerPhase 3NCT01186081
Comparison of Preoperative and Postoperative Radiotherapy and Capecitabine in Locally Advanced Rectal Cancer
A Phase 3 study testing Preoperative chemoradiotherapy and Postoperative chemoradiotherapy in people with Rectal Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Based on the potential advantaged of preoperative chemoradiotherapy and oral fluoropyrimidine, the investigators planned a prospective randomized phase III trial which compares preoperative chemoradiotherapy and postoperative chemoradiotherapy with conventional radiation schedule and oral fluoropyrimidine to establish… Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Preoperative chemoradiotherapy and Postoperative chemoradiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2004to Aug 2009
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed rectal adenocarcinoma
- Tumor located below 10 cm from the anal verge
- Clinical stage T3 or potentially resectable T4, or N+ on endorectal ultrasonography (EUS) and computed tomography (CT)
- Patients must be > 18 years and < 76 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate bone marrow reserve
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- Adequate renal function
- Adequate liver function
- Signed informed consent prior to randomization
Who cannot join
- Evidence of distant metastasis
- Previous history of chemotherapy or radiotherapy
- History of malignancy during recent 5 years other than skin cancer
- Pregnant or lactating woman
- Familial history of colorectal cancer
Trial locations and contacts
1 site in 1 country.
About this study
Based on the potential advantaged of preoperative chemoradiotherapy and oral fluoropyrimidine, the investigators planned a prospective randomized phase III trial which compares preoperative chemoradiotherapy and postoperative chemoradiotherapy with conventional radiation schedule and oral fluoropyrimidine to establish new standard neo-adjuvant therapy regimen in locally advanced rectal cancer.
Read the detailed description
Although there have been no confirmative data which favored preoperative chemoradiotherapy, preoperative chemoradiation have many theoretical advantage compared with postoperative one. Preoperative radiotherapy with intensive short course regimen showed significant improvement in local control even with TME, but there has been no large prospective randomized trial which proved the efficacy of preoperative chemoradiotherapy compared with the standard postoperative chemoradiotherapy. Although the final result of the German Trial may give the answer for this question, there has been no randomized controlled trial which investigated the efficacy of preoperative chemoradiotherapy using oral fluoropyrimidine which have many theoretical and clinical advantages mentioned above; the German Trial used 5-day continuous infusion of 5-FU. The investigators think that preoperative chemoradiotherapy with oral capecitabine could be new standard regimen in locally advanced rectal cancer, but this regimen must be compared with the standard postoperative chemoradiotherapy through well designed prospective randomized trial. Based on the potential advantaged of preoperative chemoradiotherapy and oral fluoropyrimidine, the investigators planned prospective randomized phase III trial which compares preoperative chemoradiotherapy and postoperative chemoradiotherapy with conventional radiation schedule and oral fluoropyrimidine to establish new standard neo-adjuvant therapy regimen in locally advanced rectal cancer.
- Conditions
- Rectal Cancer
- Being tested
- Preoperative chemoradiotherapy, Postoperative chemoradiotherapy
- Keywords
- Rectal cancer, Preoperative CCRT, Postoperative CCRT, Capecitabine
- 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 chemoradiotherapyRadiation
Also called Preoperative CCRT
Preoperative chemoradiation with conventional radiotherapy (46 Gy in 23 fractions to the whole pelvis followed by a boost dose of 4 Gy in 2 fractions) and oral fluoropyrimidine (capecitabine 825 mg/m2 twice per day without weekend breaks during whole radiotherapy period)
Postoperative chemoradiotherapyRadiation
Also called Postoperative CCRT
Postoperative radiotherapy with conventional radiation schedule (50 Gy in 25 fractions to the whole pelvis) and oral fluoropyrimidine (capecitabine 825 mg/m2 twice per day without weekend breaks during whole radiotherapy period)
| Study group | Role | What they receive |
|---|---|---|
| Preoperative chemoradiotherapy | Experimental | Preoperative chemoradiotherapy with conventional radiation schedule and oral fluoropyrimidine (capecitabine) Receives: Radiation: Preoperative chemoradiotherapy |
| Postoperative chemoradiotherapy | Active comparator | Postoperative chemoradiotherapy with conventional radiation schedule and oral fluoropyrimidine (capecitabine) Receives: Radiation: Postoperative chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Measured: Three year
Secondary outcomes (4)
Overall survival
Measured: Three year
Local relapse-free survival
Measured: Three year
Sphincter preservation rate
Measured: Three year
Treatment related toxicities
Measured: Three year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startMar 2004
- Primary completionApr 2009
- Study completionAug 2009
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.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Jong Hoon Kim, M.D., Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186081
- Sponsor's protocol ID
- AMC Rectal Pre Vs Post 2004
- Status last verified
- Aug 2010
- First submitted
- 18 Aug 2010
- Last updated
- 23 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Preoperative and Postoperative Radiotherapy and Capecitabine in Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT01186081
- Acronym / sponsor ID
- AMC Rectal Pre Vs Post 2004
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, Preoperative CCRT, Postoperative CCRT, Capecitabine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Apr 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 23 Aug 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.
Based on the potential advantaged of preoperative chemoradiotherapy and oral fluoropyrimidine, the investigators planned a prospective randomized phase III trial which compares preoperative chemoradiotherapy and postoperative chemoradiotherapy with conventional radiation schedule and oral fluoropyrimidine to establish new standard neo-adjuvant therapy regimen in locally advanced rectal cancer.
Detailed description
Although there have been no confirmative data which favored preoperative chemoradiotherapy, preoperative chemoradiation have many theoretical advantage compared with postoperative one. Preoperative radiotherapy with intensive short course regimen showed significant improvement in local control even with TME, but there has been no large prospective randomized trial which proved the efficacy of preoperative chemoradiotherapy compared with the standard postoperative chemoradiotherapy. Although the final result of the German Trial may give the answer for this question, there has been no randomized controlled trial which investigated the efficacy of preoperative chemoradiotherapy using oral fluoropyrimidine which have many theoretical and clinical advantages mentioned above; the German Trial used 5-day continuous infusion of 5-FU. The investigators think that preoperative chemoradiotherapy with oral capecitabine could be new standard regimen in locally advanced rectal cancer, but this regimen must be compared with the standard postoperative chemoradiotherapy through well designed prospective randomized trial. Based on the potential advantaged of preoperative chemoradiotherapy and oral fluoropyrimidine, the investigators planned prospective randomized phase III trial which compares preoperative chemoradiotherapy and postoperative chemoradiotherapy with conventional radiation schedule and oral fluoropyrimidine to establish new standard neo-adjuvant therapy regimen in locally advanced rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative chemoradiotherapy | Experimental | Radiation: Preoperative chemoradiotherapyPreoperative chemoradiotherapy with conventional radiation schedule and oral fluoropyrimidine (capecitabine) |
| Postoperative chemoradiotherapy | Active comparator | Radiation: Postoperative chemoradiotherapyPostoperative chemoradiotherapy with conventional radiation schedule and oral fluoropyrimidine (capecitabine) |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed rectal adenocarcinoma
- Tumor located below 10 cm from the anal verge
- Clinical stage T3 or potentially resectable T4, or N+ on endorectal ultrasonography (EUS) and computed tomography (CT)
- Patients must be > 18 years and < 76 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Key exclusion criteria (5 listed)
- Evidence of distant metastasis
- Previous history of chemotherapy or radiotherapy
- History of malignancy during recent 5 years other than skin cancer
- Pregnant or lactating woman
- Familial history of colorectal cancer
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 chemoradiotherapyAlso: Preoperative CCRTPreoperative chemoradiation with conventional radiotherapy (46 Gy in 23 fractions to the whole pelvis followed by a boost dose of 4 Gy in 2 fractions) and oral fluoropyrimidine (capecitabine 825 mg/m2 twice per day without weekend breaks during whole radiotherapy period) | Radiation | Preoperative chemoradiotherapy |
| Postoperative chemoradiotherapyAlso: Postoperative CCRTPostoperative radiotherapy with conventional radiation schedule (50 Gy in 25 fractions to the whole pelvis) and oral fluoropyrimidine (capecitabine 825 mg/m2 twice per day without weekend breaks during whole radiotherapy period) | Radiation | Postoperative chemoradiotherapy |
Primary outcome
Disease-free survival
Time frame: Three year
4 secondary outcomes
Overall survival
Time frame: Three year
Local relapse-free survival
Time frame: Three year
Sphincter preservation rate
Time frame: Three year
Treatment related toxicities
Time frame: Three year
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 23 Aug 2010.
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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.
Jong Hoon Kim, M.D., Ph.D. principal investigator
Asan Medical Center
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 Preoperative chemoradiotherapy and Postoperative chemoradiotherapy in people with Rectal Cancer, run by Asan Medical Center 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 9 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: finished, as of the sponsor's last update on 23 Aug 2010. 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 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?
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?
Disease-free survival (time frame: Three year). 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 23 Aug 2010.