Locally Advanced Cervical CancerPhase 2NCT01938105
Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer
A Phase 2 study testing Nimotuzumab+chemoradiotherapy in people with Locally Advanced Cervical Cancer, run by People's Hospital of Guangxi Zhuang Autonomous Region at 1 site in China.
Trial summary
The purpose of this study is to determine the feasibility and efficacy of preoperative 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 75 years
- Conditions the study is for
- Locally Advanced Cervical Cancer
- What is being tested?
- Nimotuzumab+chemoradiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Jun 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
- Histologically or cytologically proven squamous cell cervical cancer
- Stages IB2-IIIB according to FIGO Staging System
- Age:18-75
- ECOG<2
- Normal bone marrow function
- Initial assessed and considered not candidates for operation
- Signed study-specific consent form
Who cannot join
- Pregnant or lactating women
- Patients with other malignancies
- Patients who received radiotherapy or chemotherapy previously
- Presence of uncontrolled life-threatening illness
- Allergy to platinum or monoclonal antibody
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021
Heming Lu, MS, +86-771-218-6503, gxheminglu@sina.com
Heming Lu, MS
About this study
Official title: Preoperative Concurrent Chemoradiotherapy Combined With Nimotuzumab Injection for Locally Advanced Cervical Cancer: a Phase II Study
The purpose of this study is to determine the feasibility and efficacy of preoperative nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable, locally advanced cervical cancer.
- Conditions
- Locally Advanced Cervical Cancer
- Being tested
- Nimotuzumab+chemoradiotherapy
- Keywords
- Cervical cancer, Nimotuzumab, Intensity-modulated radiation therapy, Concurrent chemoradiotherapy
- 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.
Nimotuzumab+chemoradiotherapyOther
Nimotuzumab 200mg per week will be administered concurrent with platinum-based chemotherapy and intensity-modulated radiation therapy. After the preoperative treatment, patients will be assessed for tumor response and operability. For those who are considered to be candidates for operation, radical surgery will be performed.
--------------------------------------------------------------------------------
| Study group | Role | What they receive |
|---|---|---|
| Nimotuzumab+chemoradiotherapy | Experimental | Not described Receives: Other: Nimotuzumab+chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment related toxicities
Acute and chronic toxicities.
Measured: at 1 year
Tumor response after preoperative treatment
Measured: assessed at 4-5 weeks after the completion of preoperative treatment
Secondary outcomes (2)
Progression-free survival
Measured: at 1 year
Overall survival
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2015 (estimated)
- Study completionJun 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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- People's Hospital of Guangxi Zhuang Autonomous Region
- Sponsor type
- University, hospital or other
- Collaborators
- Wu Jieping Medical Foundation
- Responsible party
- Principal investigator, Heming Lu, People's Hospital of Guangxi Zhuang Autonomous Region
- Investigators
- Heming Lu, MS, Study chair, People's Hospital of Guangxi Zhuang Autonomous RegionHeming Lu, MS, Principal investigator, People's Hospital of Guangxi Zhuang Autonomous RegionYun Mo, MS, Principal investigator, People's Hospital of Guangxi Zhuang Autonomous Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938105
- Sponsor's protocol ID
- WJPMF-2013-428-2081
- Status last verified
- Sep 2013
- First submitted
- 4 Sep 2013
- Last updated
- 26 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Concurrent Chemoradiotherapy Combined With Nimotuzumab Injection for Locally Advanced Cervical Cancer: a Phase II Study
- ClinicalTrials.gov ID
- NCT01938105
- Acronym / sponsor ID
- WJPMF-2013-428-2081
- Conditions
- Locally Advanced Cervical Cancer
- Keywords
- Cervical cancer, Nimotuzumab, Intensity-modulated radiation therapy, Concurrent chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- People's Hospital of Guangxi Zhuang Autonomous RegionUniversity, hospital or other
- Collaborators
- Wu Jieping Medical Foundation
- Study start
- Jul 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 10 Sep 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.
The purpose of this study is to determine the feasibility and efficacy of preoperative nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable, locally advanced cervical cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nimotuzumab+chemoradiotherapy | Experimental | Other: Nimotuzumab+chemoradiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically proven squamous cell cervical cancer
- Stages IB2-IIIB according to FIGO Staging System
- Age:18-75
- ECOG<2
- Normal bone marrow function
Key exclusion criteria (5 listed)
- Pregnant or lactating women
- Patients with other malignancies
- Patients who received radiotherapy or chemotherapy previously
- Presence of uncontrolled life-threatening illness
- Allergy to platinum or monoclonal antibody
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 |
|---|---|---|
| Nimotuzumab+chemoradiotherapyNimotuzumab 200mg per week will be administered concurrent with platinum-based chemotherapy and intensity-modulated radiation therapy. After the preoperative treatment, patients will be assessed for tumor response and operability. For those who are considered to be candidates for operation, radical surgery will be performed. -------------------------------------------------------------------------------- | Other | Nimotuzumab+chemoradiotherapy |
Primary outcome
Treatment related toxicities
Time frame: at 1 year
Acute and chronic toxicities.
Tumor response after preoperative treatment
Time frame: assessed at 4-5 weeks after the completion of preoperative treatment
2 secondary outcomes
Progression-free survival
Time frame: at 1 year
Overall survival
Time frame: at 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2013.
Related trials for Locally Advanced Cervical Cancer
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
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
Not yet recruitingPhase 1/2
Intravenously Administered PROMITIL Combined With Radiotherapy in Patients With Cisplatin-Ineligible Head and Neck Cancer Patients
Head & Neck Squamous Cell Carcinoma, Locally Advanced Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 2
Soylent in Reducing Gastrostomy Tube Rates in Patients With Locally Advanced Head and Neck Cancer Undergoing Chemoradiotherapy
Locally Advanced Head and Neck 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. This study is not recruiting at the moment.
Heming Lu, MS study chair
People's Hospital of Guangxi Zhuang Autonomous Region
Heming Lu, MS principal investigator
People's Hospital of Guangxi Zhuang Autonomous Region
Yun Mo, MS principal investigator
People's Hospital of Guangxi Zhuang Autonomous Region
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+chemoradiotherapy in people with Locally Advanced Cervical Cancer, run by People's Hospital of Guangxi Zhuang Autonomous Region 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 7 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 26 Sep 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?
Contact Heming Lu, MS (+86-771-218-6503, gxheminglu@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment related toxicities (time frame: at 1 year). 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 26 Sep 2013.