Rectal NeoplasmPhase 2NCT00506623
Preoperative Chemoradiotherapy With Capecitabine Plus Irinotecan in Rectal Cancer
A Phase 2 study testing Capecitabine, Irinotecan in people with Rectal Neoplasm and Neoadjuvant Therapy, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
This study is to evaluate the pathologic complete response rate to pre-operative concurrent chemoradiotherapy with capecitabine plus irinotecan in resectable rectal cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Neoplasm, Neoadjuvant Therapy
- What is being tested?
- Capecitabine, Irinotecan
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2004to Dec 2008
- 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
- Tumor must be clinically resectable by surgery and R0 resection must be most likely
- ECOG performance status 0-2
- No prior chemotherapy, radiotherapy to pelvis, and immunotherapy
- Adequate organ functions
- Patients must sign an informed consent
Who cannot join
- Malignant disease of the rectum other than adenocarcinoma or arisen from chronic inflammatory bowel disease
- Any unresected synchronous colon cancer
- Any distant metastasis
- Intestinal obstruction or impending obstruction, but decompressing colostomy is permitted
- 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 have 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
- Pregnant or lactating women or patients of childbearing potential not practicing adequate contraception
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: A Phase Ⅱ Study of Pre-Operative Concurrent Chemoradiotherapy With Capecitabine Plus Irinotecan in Resectable Rectal Cancer.
This study is to evaluate the pathologic complete response rate to pre-operative concurrent chemoradiotherapy with capecitabine plus irinotecan in resectable rectal cancer
Read the detailed description
This study is an open-label, single center, nonrandomized phase II study. 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 were delivered concurrently with chemotherapy.
Chemotherapy starts at day 1 of radiotherapy. Capecitabine is administered orally at a dose of 825 mg/m2 twice daily during weekdays (Monday to Friday) every week during radiotherapy. Irinotecan 40 mg/m2 is given intravenously once a week (D 1, 8, 15, 22 \& 29).
Six ± 2 weeks after completion of chemoradiotherapy, curative surgery is performed.
Post-operative chemotherapy with capecitabine will be given to all patients 3-6 weeks after surgery. Capecitabine 1,250 mg/m2 twice daily on days 1-14 every 21 days will be administered for 18 weeks.
- Conditions
- Rectal Neoplasm, Neoadjuvant Therapy
- Being tested
- Capecitabine, Irinotecan
- Keywords
- Rectal neoplasm, Neoadjuvant therapy, Radiotherapy, Combination chemotherapy, Irinotecan, 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.
Capecitabine, IrinotecanDrug
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 (1)
Toxicity
Measured: During chemoradiation
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 startJul 2004
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Investigators
- Kyung Hae Jung, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506623
- Sponsor's protocol ID
- NCCCTS 04-088
- 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 Capecitabine Plus Irinotecan in Resectable Rectal Cancer.
- ClinicalTrials.gov ID
- NCT00506623
- Acronym / sponsor ID
- NCCCTS 04-088
- Conditions
- Rectal Neoplasm, Neoadjuvant Therapy
- Keywords
- Rectal neoplasm, Neoadjuvant therapy, Radiotherapy, Combination chemotherapy, Irinotecan, Capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Jul 2004
- Study completion
- Dec 2008 (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 evaluate the pathologic complete response rate to pre-operative concurrent chemoradiotherapy with capecitabine plus irinotecan in resectable rectal cancer
Detailed description
This study is an open-label, single center, nonrandomized phase II study. 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 were delivered concurrently with chemotherapy.
Chemotherapy starts at day 1 of radiotherapy. Capecitabine is administered orally at a dose of 825 mg/m2 twice daily during weekdays (Monday to Friday) every week during radiotherapy. Irinotecan 40 mg/m2 is given intravenously once a week (D 1, 8, 15, 22 \& 29).
Six ± 2 weeks after completion of chemoradiotherapy, curative surgery is performed.
Post-operative chemotherapy with capecitabine will be given to all patients 3-6 weeks after surgery. Capecitabine 1,250 mg/m2 twice daily on days 1-14 every 21 days will be administered for 18 weeks.
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
- Tumor must be clinically resectable by surgery and R0 resection must be most likely
- ECOG performance status 0-2
- No prior chemotherapy, radiotherapy to pelvis, and immunotherapy
Key exclusion criteria (8 listed)
- Malignant disease of the rectum other than adenocarcinoma or arisen from chronic inflammatory bowel disease
- Any unresected synchronous colon cancer
- Any distant metastasis
- Intestinal obstruction or impending obstruction, but decompressing colostomy is permitted
- Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix
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 |
|---|---|---|
| Capecitabine, Irinotecan | Drug | – |
Primary outcome
Pathologic stage Tumor regression grade
Time frame: After operation
1 secondary outcome
Toxicity
Time frame: During chemoradiation
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. principal investigator
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 Capecitabine, Irinotecan in people with Rectal Neoplasm and Neoadjuvant Therapy, 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: 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 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?
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.