Locally Advanced Rectal CancerPhase 2NCT01899118
Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer
A Phase 2 study testing Preoperative irradiation, Nimotuzumab and Oxaliplatin in people with Locally Advanced Rectal Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Neoadjuvant (preoperative) concomitant chemoradiotherapy (CRT) is now considered as a standard treatment of locally advanced rectal adenocarcinomas, which correlates better local control and higher sphincter preservation rate. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- Preoperative irradiation, Nimotuzumab and Oxaliplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Apr 2016
- 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
- Written informed consent
- Age:18-75 years
- Histologically confirmed locally advanced colorectal cancer (adenocarcinoma)
- The lower edge of the tumors located below 12 cm from the anal verge
- Karnofsky Performance Scale ≥70 points, Life expectancy ≥ 6 months
- No prior chemotherapy was used
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- No history of regional radiation treatment inthe pelvic cavity
- Adequate hematologic function: Hb ≥ 100 g/L , WBC≥3.5×109, ANC ≥ 1.5×109 /L，PLT ≥ 100×109 /L Adequate renal function: Cr ≤ 1.5×ULN, TB≤2.5 × ULN Adequate hepatic function: ALT/AST ≤ 2.5×ULN, Alkaline phosphatase ≤ 2.5×ULN
- Patients without peripheral neuropathy
Who cannot join
- Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
- Rectal cancer patients with concurrent colon cancer
- Pregnant or lactating women
- Fertile female patients without using any contraceptives
- Allergic to cisplatin and fluorouracil
- Patients with previous peripheral neuropathy
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- Serious complications: myocardial infarction, heart failure (NYHA Classification>II grade),psychiatric history and severe diabetes
- Treatment with other anti-cancer therapy(including Chinese herbal medicine)
- Organ transplant patients
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Jialin Luo, MD, 0086-571-88122062
Yuan Zhu, PhD
About this study
Official title: A Multicenter Phase II Trial of Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer
Neoadjuvant (preoperative) concomitant chemoradiotherapy (CRT) is now considered as a standard treatment of locally advanced rectal adenocarcinomas, which correlates better local control and higher sphincter preservation rate. Nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor (EGFR) has been reported to improve the therapeutic effect of radiotherapy in some cancers. This study is a clinical phase II trial designed to evaluate the efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer, and to further investigate its side-effect and toxicity.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- Preoperative irradiation, Nimotuzumab, Oxaliplatin, Capecitabine
- Keywords
- locally advanced rectal cancer, Neoadjuvant chemoradiotherapy, Nimotuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative irradiationRadiation
50.4Gy/28F/5.5w
NimotuzumabDrug
400mg/w，0-5w
OxaliplatinDrug
130mg/m2 d1
CapecitabineDrug
825mg/m2 bid d1-5/w,1-5w
| Study group | Role | What they receive |
|---|---|---|
| Nimotuzumab plus chemoradiotherapy | Experimental | Not described Receives: Radiation: Preoperative irradiation; Drug: Nimotuzumab; Drug: Oxaliplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathology complete remission rate
Pathology complete remission rate is the primary outcome measure.
Measured: 1 year
Secondary outcomes (5)
tumor regression rate
Measured: 1 year
local recurrence rate
Measured: 5 years
overall survival
Measured: 5 years
sphincter preservation rate
Measured: 3 years
Incidence of Adverse Events
Measured: up to 1 month after the last cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899118
- Sponsor's protocol ID
- ZhejiangCH-ARO2013
- Status last verified
- Jul 2013
- First submitted
- 10 Jul 2013
- Last updated
- 15 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Trial of Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT01899118
- Acronym / sponsor ID
- ZhejiangCH-ARO2013
- Conditions
- Locally Advanced Rectal Cancer
- Keywords
- locally advanced rectal cancer, Neoadjuvant chemoradiotherapy, Nimotuzumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2016 (estimated)
- First posted
- 15 Jul 2013 (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.
Neoadjuvant (preoperative) concomitant chemoradiotherapy (CRT) is now considered as a standard treatment of locally advanced rectal adenocarcinomas, which correlates better local control and higher sphincter preservation rate. Nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor (EGFR) has been reported to improve the therapeutic effect of radiotherapy in some cancers. This study is a clinical phase II trial designed to evaluate the efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer, and to further investigate its side-effect and toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nimotuzumab plus chemoradiotherapy | Experimental | Radiation: Preoperative irradiation, Drug: Nimotuzumab, Drug: Oxaliplatin, Drug: Capecitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent
- Age:18-75 years
- Histologically confirmed locally advanced colorectal cancer (adenocarcinoma)
- The lower edge of the tumors located below 12 cm from the anal verge
- Karnofsky Performance Scale ≥70 points, Life expectancy ≥ 6 months
Key exclusion criteria (9 listed)
- Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
- Rectal cancer patients with concurrent colon cancer
- Pregnant or lactating women
- Fertile female patients without using any contraceptives
- Allergic to cisplatin and fluorouracil
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 irradiation50.4Gy/28F/5.5w | Radiation | Nimotuzumab plus chemoradiotherapy |
| Nimotuzumab400mg/w，0-5w | Drug | Nimotuzumab plus chemoradiotherapy |
| Oxaliplatin130mg/m2 d1 | Drug | Nimotuzumab plus chemoradiotherapy |
| Capecitabine825mg/m2 bid d1-5/w,1-5w | Drug | Nimotuzumab plus chemoradiotherapy |
Primary outcome
Pathology complete remission rate
Time frame: 1 year
Pathology complete remission rate is the primary outcome measure.
5 secondary outcomes
tumor regression rate
Time frame: 1 year
local recurrence rate
Time frame: 5 years
overall survival
Time frame: 5 years
sphincter preservation rate
Time frame: 3 years
Incidence of Adverse Events
Time frame: up to 1 month after the last cycle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2013.
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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.
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 Preoperative irradiation, Nimotuzumab and Oxaliplatin in people with Locally Advanced Rectal Cancer, run by Zhejiang Cancer Hospital 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 9 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 15 Jul 2013. 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathology complete remission rate (time frame: 1 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 15 Jul 2013; AzTrials last refreshed its copy on 8 Nov 2026.