Rectal CancerPhase 1NCT01474187
Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer
A Phase 1 study testing Irinotecan, Capecitabine and Radiotherapy in people with Rectal Cancer, run by Fudan University at 1 site in China.
Trial summary
Irinotecan is one of effective drugs for colorectal cancer. In neoadjuvant chemoradiotherapy (CRT), Irinotecan is prescribed in a low dose of 50mg/m2/week because of toxicity. Some current studies showed that irinotecan's dose can be increased significantly for those patients with 6/6 or 6/7 genotype of UGT1A1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Irinotecan, Capecitabine and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to Dec 2012
- Phase
- Phase 1
- 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
- Patients with rectal adenocarcinoma
- Clinical staged T3/4 or any node-positive disease
- Age of 18-75 years
- Karnofsky Performance Status > 80
- Adequate bone marrow reserve, renal and hepatic functions
- Without previous antitumoural chemotherapy
Show all 9Show fewer
- No evidence of metastatic disease
- Written informed consent before randomization
- UGT1A1's genotype of 6/6 or 6/7
Who cannot join
- Clinical staged I or IV
- Age of <18 or >75 years
- Karnofsky Performance Status < 80
- Previous pelvis radiotherapy
- Previous antitumoural chemotherapy
- Clinically significant internal disease
- Refuse to write informed consent before randomization
- UGT1A1's genotype of 7/7
Trial locations and contacts
1 site in 1 country.
Ji Zhu, MD contact
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Ji Zhu, MD, leo.zhu@126.com
Zhen Zhang, MD
About this study
Irinotecan is one of effective drugs for colorectal cancer. In neoadjuvant chemoradiotherapy (CRT), Irinotecan is prescribed in a low dose of 50mg/m2/week because of toxicity. Some current studies showed that irinotecan's dose can be increased significantly for those patients with 6/6 or 6/7 genotype of UGT1A1. therefore, the investigators designed this trial to explore the maximal tolerable dose (MTD) of Irinotecan in combined neoadjuvant CRT.
- Conditions
- Rectal Cancer
- Being tested
- Irinotecan, Capecitabine, Radiotherapy
- Keywords
- Neoadjuvant chemotherapy, rectal cancer, phase I study, irinotecan
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
initial from 50mg/m2/week and increased by 15mg/m2/week
CapecitabineDrug
Also called Xeloda
625mg/m2,bid,d1-5,qw
RadiotherapyRadiation
50Gy for whole pelvis
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan | Experimental | irinotecan dose initial from 50mg/m2/week, increased by 15mg/mg/week Receives: Drug: Irinotecan; Drug: Capecitabine; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
toxicity
- Grade 4 hemato-toxicity
- Grade 3 nonhemato-toxicity (not include grade 3 anal verge skin toxicity)
Measured: 5 weeks
Secondary outcomes (1)
pathological complete response (pCR)
Measured: within 14days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2011
- Study completionDec 2012 (estimated)
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 Fudan UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Ji, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474187
- Sponsor's protocol ID
- FDRT-003
- Status last verified
- Nov 2011
- First submitted
- 11 Nov 2011
- Last updated
- 18 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer
- ClinicalTrials.gov ID
- NCT01474187
- Acronym / sponsor ID
- FDRT-003
- Conditions
- Rectal Cancer
- Keywords
- Neoadjuvant chemotherapy, rectal cancer, phase I study, irinotecan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 18 Nov 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.
Irinotecan is one of effective drugs for colorectal cancer. In neoadjuvant chemoradiotherapy (CRT), Irinotecan is prescribed in a low dose of 50mg/m2/week because of toxicity. Some current studies showed that irinotecan's dose can be increased significantly for those patients with 6/6 or 6/7 genotype of UGT1A1. therefore, the investigators designed this trial to explore the maximal tolerable dose (MTD) of Irinotecan in combined neoadjuvant CRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irinotecan | Experimental | Drug: Irinotecan, Drug: Capecitabine, Radiation: Radiotherapyirinotecan dose initial from 50mg/m2/week, increased by 15mg/mg/week |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with rectal adenocarcinoma
- Clinical staged T3/4 or any node-positive disease
- Age of 18-75 years
- Karnofsky Performance Status > 80
- Adequate bone marrow reserve, renal and hepatic functions
Key exclusion criteria (8 listed)
- Clinical staged I or IV
- Age of <18 or >75 years
- Karnofsky Performance Status < 80
- Previous pelvis radiotherapy
- Previous antitumoural chemotherapy
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 |
|---|---|---|
| Irinotecaninitial from 50mg/m2/week and increased by 15mg/m2/week | Drug | Irinotecan |
| CapecitabineAlso: Xeloda625mg/m2,bid,d1-5,qw | Drug | Irinotecan |
| Radiotherapy50Gy for whole pelvis | Radiation | Irinotecan |
Primary outcome
toxicity
Time frame: 5 weeks
* Grade 4 hemato-toxicity * Grade 3 nonhemato-toxicity (not include grade 3 anal verge skin toxicity)
1 secondary outcome
pathological complete response (pCR)
Time frame: within 14days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2011.
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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.
Ji Zhu, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Irinotecan, Capecitabine and Radiotherapy in people with Rectal Cancer, run by Fudan University at 1 site in China.
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 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 18 Nov 2011. 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Ji Zhu, MD (leo.zhu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
toxicity (time frame: 5 weeks). 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 18 Nov 2011.