NeoplasmsPhase 2NCT03469531
Study of Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer
A Phase 2 study testing Nimotuzumab, Cisplatin and external-beam radiation in people with Neoplasms and Cervical Adenosquamous Cell Carcinoma, run by Zhujiang Hospital at 1 site in China.
Trial summary
The purpose of this phase II trial is to determine the feasibility and efficacy of nimotuzumab combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Neoplasms, Cervical Adenosquamous Cell Carcinoma, Cervical Squamous Cell Carcinoma in Situ
- What is being tested?
- Nimotuzumab, Cisplatin and external-beam radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2018to 30 Dec 2021
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All volunteers will sign the informed consent.
- Histologically confirmed squamous cell of the uterine cervix, EGFR(+).
- The FIGO stage (IIB-IVA) and was not available for surgical treatment.
- There is at least one tumor lesion that is measurable by RECIST.
- During the study, contraception should be ensured.
- Karnofsky performance status >60.
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- WBC >= 3,000/mm^3
- Absolute granulocyte count >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- INR < 1.5
- Total bilirubin =< 1.5 mg/dL
- Serum creatinine =< 1.5 mg/dL
- AST and ALT =< 2.5 times upper limit of normal (ULN)
- Serum calcium =< 1.3 times ULN
- Hemoglobin >= 9g/dL (transfusion allowed)
Who cannot join
- Positive para-aortic lymph nodes or positive lymph nodes beyond pelvic
- Prior invasive malignancy (except nonmelanomatous skin cancer)
- Contraindication of chemotherapy;
- Rare pathological subtype;
- Cervical cancer patients underwent hysterectomy, laparoscopic surgery or systemic chemotherapy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital
Guangzhou, Guangdong, 510282
junguo bu, MD, 13729810406, ljq821028@126.com
jiqiang li, MD, 13631317203, 13631317203@163.com
About this study
Official title: Efficacy and Safety of Nimotuzumab Combined With Radiotherapy and Concurrently Cisplatin in Patients With Stage IIB-IVA Cervical Squamous Cell Carcinoma
The purpose of this phase II trial is to determine the feasibility and efficacy of nimotuzumab combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical squamous cell carcinoma.
Read the detailed description
This phase II trial is studying how well giving nimotuzumab together with radiation therapy and cisplatin works in treating patients with previously untreated locally advanced cervical cancer. Monoclonal antibodies, such as nimotuzumab, a humanized anti-epidermal growth factor receptor (EGFR) monoclonal antibody that is approved in many countries for the treatment of EGFR-positive cancers. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Nimotuzumab also stop the growth of cervical cancer by increasing the effect of chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving nimotuzumab together with radiation therapy and cisplatin may kill more tumor cells.
- Conditions
- Neoplasms, Cervical Adenosquamous Cell Carcinoma, Cervical Squamous Cell Carcinoma in Situ, Stage IB Cervical Cancer, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer
- Being tested
- Nimotuzumab, Cisplatin, external-beam radiation, brachytherapy
- Keywords
- Cervical Cancer, Radiation Therapy, Chemotherapy, Nimotuzumab, Cisplatin
- Medical subject headings
- Neoplasms, Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
Also called EGFR monoclonal antibody
Patients receive nimotuzumab IV over 90 minutes on days 1, 8, 15, 22, 29, 36,43.
CisplatinDrug
Also called Cisplatin injection
Patients undergo cisplatin, 25-40 mg/m2 a week for 4 or 5weeks
external-beam radiationRadiation
Also called pelvic EBRT
Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45-50.4Gy
brachytherapyRadiation
Also called high-dose rate brachytherapy
high-dose rate brachytherapy,6Gy once weekly,for a total of 24-30Gy
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy as the patients in experimental group. Receives: Drug: Nimotuzumab; Drug: Cisplatin; Radiation: external-beam radiation; Radiation: brachytherapy |
| control group | Active comparator | Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group. Receives: Drug: Cisplatin; Radiation: external-beam radiation; Radiation: brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progress free survival rate
The rate of patient without progress disease in 3 years after treatment
Measured: 3 years
Secondary outcomes (4)
Overall survival rate
The rate of patient alive in 3 years after treatment
Measured: 3 years
Local area control rate.
The rate of patient without recurrence in 3 years after treatment
Measured: 3 years
No distant metastatic survival.
The rate of patient without metastatic disease in 3 years after treatment
Measured: 3 years
objective response rate
the percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment.
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 posted19 Mar 2018
- Study start20 Mar 2018
- Primary completion10 Mar 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Zhujiang 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- junguo bu, doctor, Principal investigator, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469531
- Sponsor's protocol ID
- 2017-ZLZX-002
- Status last verified
- Feb 2018
- First submitted
- 28 Feb 2018
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Nimotuzumab Combined With Radiotherapy and Concurrently Cisplatin in Patients With Stage IIB-IVA Cervical Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03469531
- Acronym / sponsor ID
- 2017-ZLZX-002
- Conditions
- Neoplasms, Cervical Adenosquamous Cell Carcinoma, Cervical Squamous Cell Carcinoma in Situ, Stage IB Cervical Cancer, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer
- Keywords
- Cervical Cancer, Radiation Therapy, Chemotherapy, Nimotuzumab, Cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 10 Mar 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 19 Mar 2018 (actual)
- 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 combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical squamous cell carcinoma.
Detailed description
This phase II trial is studying how well giving nimotuzumab together with radiation therapy and cisplatin works in treating patients with previously untreated locally advanced cervical cancer. Monoclonal antibodies, such as nimotuzumab, a humanized anti-epidermal growth factor receptor (EGFR) monoclonal antibody that is approved in many countries for the treatment of EGFR-positive cancers. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Nimotuzumab also stop the growth of cervical cancer by increasing the effect of chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving nimotuzumab together with radiation therapy and cisplatin may kill more tumor cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Nimotuzumab, Drug: Cisplatin, Radiation: external-beam radiation, Radiation: brachytherapyPatients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy as the patients in experimental group. |
| control group | Active comparator | Drug: Cisplatin, Radiation: external-beam radiation, Radiation: brachytherapyPatients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- All volunteers will sign the informed consent.
- Histologically confirmed squamous cell of the uterine cervix, EGFR(+).
- The FIGO stage (IIB-IVA) and was not available for surgical treatment.
- There is at least one tumor lesion that is measurable by RECIST.
- During the study, contraception should be ensured.
Key exclusion criteria (5 listed)
- Positive para-aortic lymph nodes or positive lymph nodes beyond pelvic
- Prior invasive malignancy (except nonmelanomatous skin cancer)
- Contraindication of chemotherapy;
- Rare pathological subtype;
- Cervical cancer patients underwent hysterectomy, laparoscopic surgery or systemic 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 |
|---|---|---|
| NimotuzumabAlso: EGFR monoclonal antibodyPatients receive nimotuzumab IV over 90 minutes on days 1, 8, 15, 22, 29, 36,43. | Drug | experimental group |
| CisplatinAlso: Cisplatin injectionPatients undergo cisplatin, 25-40 mg/m2 a week for 4 or 5weeks | Drug | control group, experimental group |
| external-beam radiationAlso: pelvic EBRTPatients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45-50.4Gy | Radiation | control group, experimental group |
| brachytherapyAlso: high-dose rate brachytherapyhigh-dose rate brachytherapy,6Gy once weekly,for a total of 24-30Gy | Radiation | control group, experimental group |
Primary outcome
progress free survival rate
Time frame: 3 years
The rate of patient without progress disease in 3 years after treatment
4 secondary outcomes
Overall survival rate
Time frame: 3 years
Local area control rate.
Time frame: 3 years
No distant metastatic survival.
Time frame: 3 years
objective response rate
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 13 Aug 2018.
- Individual participant dataSharing planned: No
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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.
junguo bu, doctor principal investigator
Zhujiang 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, Cisplatin and external-beam radiation in people with Neoplasms and Cervical Adenosquamous Cell Carcinoma, run by Zhujiang 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 15 inclusion and 5 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 13 Aug 2018. 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 junguo bu, doctor (+86 13729810406, bujunguo888@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progress free survival rate (time frame: 3 years). 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 13 Aug 2018.