Rectal NeoplasmsPhase 2ERBIRIXNCT00506844
Preoperative Chemoradiotherapy With Cetuximab in Rectal Cancer
A Phase 2 study testing Cetuximab, Irinotecan, Capecitabine in people with Rectal Neoplasms and Neoadjuvant Treatment, run by National Cancer Center, Korea at 4 sites in South Korea.
Trial summary
This study is to estimate the pathologic complete response rate of cetuximab, irinotecan, and capecitabine concurrent with radiotherapy given preoperatively in patients with resectable rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Neoplasms, Neoadjuvant Treatment
- What is being tested?
- Cetuximab, Irinotecan, Capecitabine
- How many people
- 40 participants
- Where
- 4 sitesSouth Korea
- Study dates
- May 2006to May 2010
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the rectum
- Distal margin of tumor located from 0 to 8 cm from anal verge
- Stage T3/T4 ± N+ by MRI ± endorectal ultrasonography
- ECOG performance status 0-2
- No prior chemotherapy, radiotherapy to pelvis, immunotherapy, and EGFR pathway targeting therapy
- Adequate organ functions
- Patients must sign the informed consent
Who cannot join
- Malignant disease of the rectum other than adenocarcinoma or arisen from chronic inflammatory bowel disease
- Any defined hereditary colorectal cancer
- Any unresected synchronous colon cancer
- R0 resection of tumor is not clinically possible
- Any distant metastasis
- Intestinal obstruction or impending obstruction, but decompressing colostomy is permitted
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- Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix
- Any other morbidity or situation with contraindication for chemoradiotherapy
- Patients with history of significant gastric or small bowel resection, or malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may compromise the absorption of capecitabine
- History of severe pulmonary disease
- Pregnant or lactating women or patients of childbearing potential not predicting adequate contraception
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
National Cancer Center Korea
Goyang-si, Gyeonggi-do, 410-769
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Seoul National University Hospital
Seoul, 110-744
Asan Medical Center
Seoul, 138-736
About this study
Official title: A Phase II Study of Pre-Operative Concurrent Chemoradiotherapy With Cetuximab, Irinotecan, and Capecitabine in Resectable Rectal Cancer
This study is to estimate the pathologic complete response rate of cetuximab, irinotecan, and capecitabine concurrent with radiotherapy given preoperatively in patients with resectable rectal cancer.
Read the detailed description
Daily fractions of radiotherapy at 1.8 Gy to total of 45 Gy to tumor and draining lymph nodes and followed by a coned-down boost of 5.4 Gy to the tumor are delivered concurrently with chemotherapy.
Cetuximab 400 mg/m2 is given intravenously on D-6 (1 week before radiation), followed by 250 mg/m2 once a week (D 1, 8, 15, 22 \& 29).
Administration of irinotecan and capecitabine starts on day 1 of radiotherapy. Capecitabine is administered orally at a dose of 825 mg/m2 twice daily during weekdays (Monday to Friday) during radiotherapy. Irinotecan 40 mg/m2 is given intravenously once a week (D 1, 8, 15, 22 \& 29).
Four to eight weeks after completion of chemoradiotherapy, curative surgery is performed.
Safety evaluation of the study will be performed after the first 6 patients treated. If more than 1 out of 6 patients received less than 70-80% of planned dose of capecitabine or irinotecan, the dosage of chemotherapy in the further study patients will be adjusted by a protocol amendment.
- Conditions
- Rectal Neoplasms, Neoadjuvant Treatment
- Being tested
- Cetuximab, Irinotecan, Capecitabine
- Keywords
- Rectal neoplasms, Neoadjuvant treatment, Cetuximab, Irinotecan, Capecitabine, Radiotherapy, Combination chemotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetuximab, Irinotecan, CapecitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic stage Tumor regression grade
Measured: After operation
Secondary outcomes (2)
Toxicity measured by NCICTC v3
Measured: During chemoradiation
Disease-free survival
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 posted25 Jul 2007 (estimated)
- Study startMay 2006
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Investigators
- Kyung Hae Jung, M.D.Ph.D, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506844
- Sponsor's protocol ID
- NCCCTS-06-165
- Acronym
- ERBIRIX
- Status last verified
- Jul 2007
- First submitted
- 23 Jul 2007
- Last updated
- 25 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Pre-Operative Concurrent Chemoradiotherapy With Cetuximab, Irinotecan, and Capecitabine in Resectable Rectal Cancer
- ClinicalTrials.gov ID
- NCT00506844
- Acronym / sponsor ID
- ERBIRIX / NCCCTS-06-165
- Conditions
- Rectal Neoplasms, Neoadjuvant Treatment
- Keywords
- Rectal neoplasms, Neoadjuvant treatment, Cetuximab, Irinotecan, Capecitabine, Radiotherapy, Combination chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- May 2006
- Study completion
- May 2010 (estimated)
- First posted
- 25 Jul 2007 (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.
This study is to estimate the pathologic complete response rate of cetuximab, irinotecan, and capecitabine concurrent with radiotherapy given preoperatively in patients with resectable rectal cancer.
Detailed description
Daily fractions of radiotherapy at 1.8 Gy to total of 45 Gy to tumor and draining lymph nodes and followed by a coned-down boost of 5.4 Gy to the tumor are delivered concurrently with chemotherapy.
Cetuximab 400 mg/m2 is given intravenously on D-6 (1 week before radiation), followed by 250 mg/m2 once a week (D 1, 8, 15, 22 \& 29).
Administration of irinotecan and capecitabine starts on day 1 of radiotherapy. Capecitabine is administered orally at a dose of 825 mg/m2 twice daily during weekdays (Monday to Friday) during radiotherapy. Irinotecan 40 mg/m2 is given intravenously once a week (D 1, 8, 15, 22 \& 29).
Four to eight weeks after completion of chemoradiotherapy, curative surgery is performed.
Safety evaluation of the study will be performed after the first 6 patients treated. If more than 1 out of 6 patients received less than 70-80% of planned dose of capecitabine or irinotecan, the dosage of chemotherapy in the further study patients will be adjusted by a protocol amendment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed adenocarcinoma of the rectum
- Distal margin of tumor located from 0 to 8 cm from anal verge
- Stage T3/T4 ± N+ by MRI ± endorectal ultrasonography
- ECOG performance status 0-2
- No prior chemotherapy, radiotherapy to pelvis, immunotherapy, and EGFR pathway targeting therapy
Key exclusion criteria (11 listed)
- Malignant disease of the rectum other than adenocarcinoma or arisen from chronic inflammatory bowel disease
- Any defined hereditary colorectal cancer
- Any unresected synchronous colon cancer
- R0 resection of tumor is not clinically possible
- Any distant metastasis
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 |
|---|---|---|
| Cetuximab, Irinotecan, Capecitabine | Drug | – |
Primary outcome
Pathologic stage Tumor regression grade
Time frame: After operation
2 secondary outcomes
Toxicity measured by NCICTC v3
Time frame: During chemoradiation
Disease-free survival
Time frame: Three year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2007.
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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.
Kyung Hae Jung, M.D.Ph.D principal investigator
4 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 Cetuximab, Irinotecan, Capecitabine in people with Rectal Neoplasms and Neoadjuvant Treatment, run by National Cancer Center, Korea at 4 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 7 inclusion and 11 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 25 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
Pathologic stage Tumor regression grade (time frame: After operation). 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 25 Jul 2007.