Cervical CancerPhase 2NCT02705612
Phase II Clinical Trial of Concurrent Chemoradiotherapy Combined Nimotuzumab for Stage IIB-IVA Cervical Cancer
A Phase 2 study testing Cisplatin, External Beam Radiation Therapy and Internal Radiation Therapy in people with Cervical Cancer, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
The purpose of this phase II trial is to determine the feasibility and efficacy of nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Cisplatin, External Beam Radiation Therapy and Internal Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Sep 2018
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 Years to 70 Years，female
- Histological diagnosis of squamous cell carcinoma of cervix, FIGO stage IIB-IVA,with diameter 4-6 cm, without distant metastasis.
- no chance of surgery confirmed by more than two deputy chief doctors of gynecology.
- Moderate or high expression of EGFR
- The function of main organ is normal, including blood, heart, lung, liver, and kidney. Without history of hypertension, stroke. Blood pressure is normal before treatment.
- WBC≥3.5×10E9/L，ANC≥1.5×10E9/L；HB≥90g/L，PLT≥100×10E9/L
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- ALT, AST and Cr below 1.5 times of normal level
- Willing to accept treatment
- Ability to comply with trial requirements KPS≥70
Who cannot join
- Evidence of distance metastasis
- Impossible to measure the diameter of tumor, or the tumor is too huge (diameter>6cm)
- Couldn't examine with pelvic MRI due to a variety of reasons
- Used to treat with radiotherapy chemotherapy or molecular target therapy and immune therapy
- Diagnosed with another malignant tumor in 5 years
- Used to be a volunteer of other clinical trial.
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- Used to be allergic reaction with grade 3 or 4 degree to any experimental drugs
- Severe medical history of lung ,liver, kidney or heart.
- Active infection in any part of the whole body.
- Examination results showed radiotherapy contraindications
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
Mei Shi, MD, +86-029-84775425, mshifmmu@yahoo.com
Mei Shi, MD
About this study
Official title: Efficacy and Safety of Radiotherapy Concurrently Combined With Cisplatin and Nimotuzumab for Patients With Locally Advanced Cervical Cancer
The purpose of this phase II trial is to determine the feasibility and efficacy of nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical cancer.
Read the detailed description
For locally advanced cervical cancer, radical radiation with concurrent chemotherapy remains the standard treatment recommended by NCCN. However, in more than 35% of cases, tumor persistence recurrence or metastasis would occur after chemoradiation. Nimotuzumab, belongs to anti-EGFR monoclonal antibodies, has proved to be useful in multiple solid tumors, such as NPC, colorectal cancer, etc.
In recent years, nimotuzumab was also applied in recurrence or metastasis cervical cancer. It was proved to be well tolerated and might have a role in the treatment of advanced cervical cancer. However, there is no publication about nimotuzumab used in locally advanced cervical cancer.
- Conditions
- Cervical Cancer
- Being tested
- Cisplatin, External Beam Radiation Therapy, Internal Radiation Therapy, nimotuzumab
- Keywords
- Cervical cancer, cisplatin, nimotuzumab
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
External Beam Radiation TherapyRadiation
Internal Radiation TherapyRadiation
nimotuzumabDrug
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy. Receives: Drug: Cisplatin; Radiation: External Beam Radiation Therapy; Radiation: Internal Radiation Therapy |
| experimental group | Experimental | Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group. Patients also receive nimotuzumab during the external radiotherapy. Receives: Drug: Cisplatin; Radiation: External Beam Radiation Therapy; Radiation: Internal Radiation Therapy; Drug: nimotuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
Described with Kaplan-Meier curves and unadjusted logrank tests.
Measured: at 3 years
disease free survival rate
Measured: at 3 years
non-distant metastasis survival rate
Measured: at 3 years
survival period of non-progressive.
Measured: at 3 years
Secondary outcomes (3)
Quality of life
Measured: 3 years
Radiation protocol compliance
Measured: 3 years
Rate of acute and long-term toxicities
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei Shi, Air Force Military Medical University, China
- Investigators
- Mei Shi, MD, Principal investigator, department of radiation oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705612
- Sponsor's protocol ID
- XJFL-2016-02-LACC-Nimotuzumab
- Status last verified
- Mar 2016
- First submitted
- 5 Mar 2016
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Radiotherapy Concurrently Combined With Cisplatin and Nimotuzumab for Patients With Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT02705612
- Acronym / sponsor ID
- XJFL-2016-02-LACC-Nimotuzumab
- Conditions
- Cervical Cancer
- Keywords
- Cervical cancer, cisplatin, nimotuzumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 10 Mar 2016 (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 purpose of this phase II trial is to determine the feasibility and efficacy of nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical cancer.
Detailed description
For locally advanced cervical cancer, radical radiation with concurrent chemotherapy remains the standard treatment recommended by NCCN. However, in more than 35% of cases, tumor persistence recurrence or metastasis would occur after chemoradiation. Nimotuzumab, belongs to anti-EGFR monoclonal antibodies, has proved to be useful in multiple solid tumors, such as NPC, colorectal cancer, etc.
In recent years, nimotuzumab was also applied in recurrence or metastasis cervical cancer. It was proved to be well tolerated and might have a role in the treatment of advanced cervical cancer. However, there is no publication about nimotuzumab used in locally advanced cervical cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Drug: Cisplatin, Radiation: External Beam Radiation Therapy, Radiation: Internal Radiation TherapyPatients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy. |
| experimental group | Experimental | Drug: Cisplatin, Radiation: External Beam Radiation Therapy, Radiation: Internal Radiation Therapy, Drug: nimotuzumabPatients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group. Patients also receive nimotuzumab during the external radiotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 Years to 70 Years，female
- Histological diagnosis of squamous cell carcinoma of cervix, FIGO stage IIB-IVA,with diameter 4-6 cm, without distant metastasis.
- no chance of surgery confirmed by more than two deputy chief doctors of gynecology.
- Moderate or high expression of EGFR
- The function of main organ is normal, including blood, heart, lung, liver, and kidney. Without history of hypertension, stroke. Blood pressure is normal before treatment.
Key exclusion criteria (10 listed)
- Evidence of distance metastasis
- Impossible to measure the diameter of tumor, or the tumor is too huge (diameter>6cm)
- Couldn't examine with pelvic MRI due to a variety of reasons
- Used to treat with radiotherapy chemotherapy or molecular target therapy and immune therapy
- Diagnosed with another malignant tumor in 5 years
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 |
|---|---|---|
| Cisplatin | Drug | control group, experimental group |
| External Beam Radiation Therapy | Radiation | control group, experimental group |
| Internal Radiation Therapy | Radiation | control group, experimental group |
| nimotuzumab | Drug | experimental group |
Primary outcome
Overall survival rate
Time frame: at 3 years
Described with Kaplan-Meier curves and unadjusted logrank tests.
disease free survival rate
Time frame: at 3 years
non-distant metastasis survival rate
Time frame: at 3 years
survival period of non-progressive.
Time frame: at 3 years
3 secondary outcomes
Quality of life
Time frame: 3 years
Radiation protocol compliance
Time frame: 3 years
Rate of acute and long-term toxicities
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
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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.
Mei Shi, MD principal investigator
department of radiation oncology
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 Cisplatin, External Beam Radiation Therapy and Internal Radiation Therapy in people with Cervical Cancer, run by Air Force Military Medical University, China 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 10 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 10 Mar 2016. 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?
Contact Mei Shi, MD (0086-029-84775432, mshi82@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rate (time frame: at 3 years). The study lists 4 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 10 Mar 2016.