Cervical Squamous Cell CarcinomaNCT04976478
Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma
An observational study of Cervical Squamous Cell Carcinoma, run by Peking University Third Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Nimotuzumab combined with IMRT in elder patients with locally advanced cervical squamous cell carcinoma Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Cervical Squamous Cell Carcinoma
- What is being tested?
- Nimotuzumab and EBRT combined with brachytherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 125 participants
- Where
- 1 siteChina
- Study dates
- Jul 2021to Dec 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Study population: The elder patients with cervical squamous cell cancer received nimotuzumab combined with radiotherapy.
Who may be able to join
- Age≥65 years old
- Histologically confirmed primary cervical squamous cell carcinoma in stage IB3-IVA (FIGO 2018)
- At least one measurable lesion according to RECIST 1.1 guideline
- Patients are intolerant to or refuse chemotherapy.
- No serious hematopoietic dysfunction, nor abnormal heart, lung, liver and kidney function, nor immunity deficiency. And the results of lab test meet the following criteria:
- Hemoglobin ≥90g/L Absolute count of neutrophils≥2×109/L orwhite blood cell count≥4.0×109/L； Platelet count≥100×109/L； AST≤2.5×ULN ALT≤2.5×ULN TBIL≤1.5×ULN；
Show all 13Show fewer
- Serum creatinine≤1.5×ULN or CrCl> 60 mL/min(according toCockcroft-Gault):
- Serum creatinine≤1.5×ULN Female CrCl=(140-Age)×Weight（kg）×0.85 / (72×Scr mg/dl)
- ECOG score 0-2
- Expectancy of life is at least 3 months.
- Eligible for pelvic MRI examination.
- The patients voluntarily received nimotuzumab combined with radiotherapy.
- Patients can comply with the protocol and are willing to sign informed consent.
Who cannot join
- Patients who have received treatment for cervical cancer, including surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy
- Patients who have bilateral ureteral obstruction, who cannot be placed ureteral stents or perform pyelostomy.
- Patients with rectovaginal fistula/vaginovesical fistula/uncontrolled vaginal bleeding or with fistula risk.
- .4)Patients infected with HIV. 5)Active hepatitis B (HBV DNA quantitative test results exceed the detection threshold), or HCV infection (HCV RNA quantitative test results exceed the detection threshold) 6)Patients with severe underlying disease that makes it possible to safely receive the treatment. And the severe underlying disease include but not limited to active infections requiring systemic medication, decompensated heart failure (NYHA grade III and IV), unstable angina pectoris, and acute myocardial infarction occurred within the first 3 months of enrollment.
- 7)Patients with a history of prior malignancy other than cured basal cell carcinoma of the skin.
- 8)Patients with Crohn's disease and ulcerative colitis. 9)Patients are allergic to Nimotuzumab or its compounds. 10)Patients with neurological or psychiatric abnormalities that affect cognitive ability.
- 11)Intracavitary brachytherapy cannot be performed that was assessed by the investigator.
- 12)Other factors were assessed by investigators to be unsuitable to this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University 3rd Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: A Perspective, Multi-center, Single Arm Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma
To evaluate the efficacy and safety of Nimotuzumab combined with IMRT in elder patients with locally advanced cervical squamous cell carcinoma
Read the detailed description
This is a perspective, multi-center, open-label and single arm study.
- Conditions
- Cervical Squamous Cell Carcinoma
- Being tested
- Nimotuzumab, EBRT combined with brachytherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
Patients receive Nimotuzumab: 200mg, intravenous infusion, weekly for 6 weeks.
EBRT combined with brachytherapyRadiation
IMRT/VMAT are adopted. A total dose of 45-50.4 Gy, 1.8~2.0Gy/f, 25~ 28F in pelvic and/or extension filed. For patients with metastasis in pelvic lymph node and abdominal para-aortic lymph node, the dose of radiation in local lesion will be increased to 60~66Gy. For patients at stage IIIB, concurrent radiation will be given in parametrial extension or in the late course the dose will be increased to 60Gy.
Brachytherapy: Three dimensional high dose rate brachytherapy is used with HR-CTV D90 cumulative dose of 80~85Gy (EQD2); If the tumor diameter is ≥4cm, HR-CTV D90 cumulative dose is ≥87Gy (EQD2). Brachytherapy combined with external beam radiotherapy will be completed within 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| observation group | All patients will be treated with Nimotuzumab combined with radiotherapy. Receives: Drug: Nimotuzumab; Radiation: EBRT combined with brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease-free survival(DFS)
The rate of patient without disease in 3 years after treatment
Measured: up to 3 years
Secondary outcomes (7)
Complete response rate(CRR)
The percentage of subjects who achieve complete response by imaging assessment from the end of the treatment to disease progression
Measured: 3 months later after treatment
Objective response rate(ORR)
The percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment
Measured: 3 months later treatment
3-year overall survival(OS)
The rate of patient alive in 3 years after treatment
Measured: up to 3 years
The change of tumor related markers
the correlation of the value of SCC，Cyfra 21-1 and therapeutic effect [The changes of serum tumor markers (such as SCC-Ag and CYFRA21-1) were observed before and after treatment]
Measured: up to 3 years
The change of cervical tumor
the change of the volume of the cervical tumor at diagnosis and before brachytherapy
Measured: At diagnosis and before brachytherapy
QUALITY OF LIFE(QoL)
Quality of life assessed by EORTC QLQ-CX 24 [EORTC QLQ-CX 24 is a specific quality of life assessment scale based on EORTC QLQ-C 30, with 24 items]
Measured: up to 3 years
SAFETY
Including severity of adverse events, the incidence of adverse events and serious adverse events. Adverse events should be reported and graded according to CTCAE version 5.0
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study startJul 2021 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junjie Wang, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976478
- Sponsor's protocol ID
- ChiECRCT20210238
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2021
- Last updated
- 26 Jul 2021
- Results posted
- No
- 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 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Perspective, Multi-center, Single Arm Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04976478
- Acronym / sponsor ID
- ChiECRCT20210238
- Conditions
- Cervical Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Jul 2021 (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.
To evaluate the efficacy and safety of Nimotuzumab combined with IMRT in elder patients with locally advanced cervical squamous cell carcinoma
Detailed description
This is a perspective, multi-center, open-label and single arm study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observation group | – | Drug: Nimotuzumab, Radiation: EBRT combined with brachytherapyAll patients will be treated with Nimotuzumab combined with radiotherapy. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The elder patients with cervical squamous cell cancer received nimotuzumab combined with radiotherapy.
Key inclusion criteria (13 listed)
- Age≥65 years old
- Histologically confirmed primary cervical squamous cell carcinoma in stage IB3-IVA (FIGO 2018)
- At least one measurable lesion according to RECIST 1.1 guideline
- Patients are intolerant to or refuse chemotherapy.
- No serious hematopoietic dysfunction, nor abnormal heart, lung, liver and kidney function, nor immunity deficiency. And the results of lab test meet the following criteria:
Key exclusion criteria (8 listed)
- Patients who have received treatment for cervical cancer, including surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy
- Patients who have bilateral ureteral obstruction, who cannot be placed ureteral stents or perform pyelostomy.
- Patients with rectovaginal fistula/vaginovesical fistula/uncontrolled vaginal bleeding or with fistula risk.
- .4)Patients infected with HIV. 5)Active hepatitis B (HBV DNA quantitative test results exceed the detection threshold), or HCV infection (HCV RNA quantitative test results exceed the detection threshold) 6)Patients with severe underlying disease that makes it possible to safely receive the treatment. And the severe underlying disease include but not limited to active infections requiring systemic medication, decompensated heart failure (NYHA grade III and IV), unstable angina pectoris, and acute myocardial infarction occurred within the first 3 months of enrollment.
- 7)Patients with a history of prior malignancy other than cured basal cell carcinoma of the skin.
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 |
|---|---|---|
| NimotuzumabPatients receive Nimotuzumab: 200mg, intravenous infusion, weekly for 6 weeks. | Drug | observation group |
| EBRT combined with brachytherapyIMRT/VMAT are adopted. A total dose of 45-50.4 Gy, 1.8~2.0Gy/f, 25~ 28F in pelvic and/or extension filed. For patients with metastasis in pelvic lymph node and abdominal para-aortic lymph node, the dose of radiation in local lesion will be increased to 60~66Gy. For patients at stage IIIB, concurrent radiation will be given in parametrial extension or in the late course the dose will be increased to 60Gy. Brachytherapy: Three dimensional high dose rate brachytherapy is used with HR-CTV D90 cumulative dose of 80~85Gy (EQD2); If the tumor diameter is ≥4cm, HR-CTV D90 cumulative dose is ≥87Gy (EQD2). Brachytherapy combined with external beam radiotherapy will be completed within 8 weeks. | Radiation | observation group |
Primary outcome
3-year disease-free survival(DFS)
Time frame: up to 3 years
The rate of patient without disease in 3 years after treatment
7 secondary outcomes
Complete response rate(CRR)
Time frame: 3 months later after treatment
Objective response rate(ORR)
Time frame: 3 months later treatment
3-year overall survival(OS)
Time frame: up to 3 years
The change of tumor related markers
Time frame: up to 3 years
The change of cervical tumor
Time frame: At diagnosis and before brachytherapy
QUALITY OF LIFE(QoL)
Time frame: up to 3 years
SAFETY
Time frame: up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Cervical Squamous Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 3
Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer
Locally Advanced Cervical Adenocarcinoma, Locally Advanced Cervical Adenosquamous Carcinoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Squamous Cell Carcinoma, run by Peking University Third 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 13 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: opening soon, as of the sponsor's last update on 26 Jul 2021. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junjie Wang, MD (010-82266699 ext. 5920, junjiewang_edu@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease-free survival(DFS) (time frame: up to 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 26 Jul 2021.