Squamous Cell Carcinoma of Anal CanalPhase 2NCT01382745
Nimotuzumab With Radiotherapy in the Treatment of Anal Canal Cancers
A Phase 2 study testing Nimotuzumab and Intensity Modulated Radiation Therapy (IMRT) in people with Squamous Cell Carcinoma of Anal Canal, run by Dr. Te Vuong at 1 site in Canada.
Trial summary
The objective of this study is to demonstrate the feasibility of using Nimotuzumab and radiation in the treatment of squamous cell carcinomas of the anal canal in order to achieve a 65% local control rate with a better toxicity profile than the conventional treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Anal Canal
- What is being tested?
- Nimotuzumab and Intensity Modulated Radiation Therapy (IMRT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Jan 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For both step I and II:
- Patients with histologically confirmed squamous cell carcinoma of the anal canal
- Aged 18 years or older
- ECOG: 0-1-2
- Adequate contraception in women of child-bearing potential and for men
- Ability to understand and the willingness to sign a written informed consent document.
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- HIV-positive patients with T1-2 anal canal tumors, or
- Patients with anal canal tumors not eligible for conventional chemotherapy (for example, due to age and/or co-morbidities)
- Patients who have already started radiotherapy for anal canal cancer
- For step II:
- HIV-positive patients with T1, T2 anal canal tumors
- HIV-negative patients not eligible for conventional chemotherapy (for example, due to age and/or co-morbidities)
- HIV-negative patients with T1-2 anal canal cancer
Who cannot join
- For both step I and II:
- Patients receiving any other investigational agents
- Previous treatment with anti-EGFR drugs
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Nimotuzumab or other agents used in study.
- Previously treated with pelvic radiotherapy.
- Lesions not suitable for radiotherapy
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- Patients with uncontrolled hypercalcemia
- Uncontrolled intercurrent illness
- Pregnant or breast-feeding women
- Any concurrent active malignancy
- Patients with T3-4 anal canal tumors or patients with nodes positive.
- Step I:
- HIV-negative patients with anal canal tumors that are judged suitable for current treatment consisting in radiotherapy and 5-FU and MMC chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Clinical Study Using Nimotuzumab in Combination With External Beam Radiation Therapy in the Treatment of Patients With Carcinomas of the Anal Canal
The objective of this study is to demonstrate the feasibility of using Nimotuzumab and radiation in the treatment of squamous cell carcinomas of the anal canal in order to achieve a 65% local control rate with a better toxicity profile than the conventional treatment. Patients with high toxicity risks (HIV+ and fragile patients) will be selected for this study.
- Conditions
- Squamous Cell Carcinoma of Anal Canal
- Being tested
- Nimotuzumab, Intensity Modulated Radiation Therapy (IMRT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
200mg Nimotuzumab once a week for 12 weeks
Intensity Modulated Radiation Therapy (IMRT)Radiation
IMRT radiation therapy with doses varying from 45Gy-54Gy in 25-30 fractions
| Study group | Role | What they receive |
|---|---|---|
| Nimotuzumab | Experimental | Patients will receive weekly injections of Nimotuzumab (200mg/injection) for 12 weeks and standard external beam radiotherapy Receives: Drug: Nimotuzumab; Radiation: Intensity Modulated Radiation Therapy (IMRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity
Toxicity evaluation will include all toxicities occurring while the patient is receiving treatment, and will be monitored using the CTCAE guide version 3.0.
Measured: 1 month post end of treatment
Local tumor response rate
Tumor response rates will be evaluated using the MRI performed at 8-weeks post end of radiotherapy treatment.
Measured: 8 weeks post end of radiation treatment
Secondary outcomes (2)
Overall cancer-free survival
Measured: 5 years post end of treatment
Overall survival
Measured: 5 years post end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJan 2012
- Primary completionSep 2021 (estimated)
- Study completionJan 2022 (estimated)
Why it stopped: low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Anal CanalStudies 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Te Vuong
- Sponsor type
- University, hospital or other
- Collaborators
- YM BioSciences
- Responsible party
- Sponsor-investigator, Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital
- Investigators
- Te Vuong, MD, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382745
- Sponsor's protocol ID
- 11-044
- Status last verified
- Jan 2013
- First submitted
- 24 Jun 2011
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study Using Nimotuzumab in Combination With External Beam Radiation Therapy in the Treatment of Patients With Carcinomas of the Anal Canal
- ClinicalTrials.gov ID
- NCT01382745
- Acronym / sponsor ID
- 11-044
- Conditions
- Squamous Cell Carcinoma of Anal Canal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Dr. Te VuongUniversity, hospital or other
- Collaborators
- YM BioSciences
- Study start
- Jan 2012
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 27 Jun 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.
The objective of this study is to demonstrate the feasibility of using Nimotuzumab and radiation in the treatment of squamous cell carcinomas of the anal canal in order to achieve a 65% local control rate with a better toxicity profile than the conventional treatment. Patients with high toxicity risks (HIV+ and fragile patients) will be selected for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nimotuzumab | Experimental | Drug: Nimotuzumab, Radiation: Intensity Modulated Radiation Therapy (IMRT)Patients will receive weekly injections of Nimotuzumab (200mg/injection) for 12 weeks and standard external beam radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with histologically confirmed squamous cell carcinoma of the anal canal
- Aged 18 years or older
- ECOG: 0-1-2
- Adequate contraception in women of child-bearing potential and for men
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (13 listed)
- Patients receiving any other investigational agents
- Previous treatment with anti-EGFR drugs
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Nimotuzumab or other agents used in study.
- Previously treated with pelvic radiotherapy.
- Lesions not suitable for radiotherapy
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 |
|---|---|---|
| Nimotuzumab200mg Nimotuzumab once a week for 12 weeks | Drug | Nimotuzumab |
| Intensity Modulated Radiation Therapy (IMRT)IMRT radiation therapy with doses varying from 45Gy-54Gy in 25-30 fractions | Radiation | Nimotuzumab |
Primary outcome
Toxicity
Time frame: 1 month post end of treatment
Toxicity evaluation will include all toxicities occurring while the patient is receiving treatment, and will be monitored using the CTCAE guide version 3.0.
Local tumor response rate
Time frame: 8 weeks post end of radiation treatment
Tumor response rates will be evaluated using the MRI performed at 8-weeks post end of radiotherapy treatment.
2 secondary outcomes
Overall cancer-free survival
Time frame: 5 years post end of treatment
Overall survival
Time frame: 5 years post end of treatment
Results and safety
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 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.
Te Vuong, MD principal investigator
Jewish General Hospital
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 Nimotuzumab and Intensity Modulated Radiation Therapy (IMRT) in people with Squamous Cell Carcinoma of Anal Canal, run by Dr. Te Vuong at 1 site in Canada.
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 13 inclusion and 13 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: stopped early, as of the sponsor's last update on 28 Jan 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 Canada. 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?
The study was stopped early (reason given: low recruitment). 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?
Toxicity (time frame: 1 month post end of treatment). The study lists 2 primary outcomes in all. 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 28 Jan 2013.