Neoadjuvant ChemotherapyPhase 2NCT03963882
NAC Followed by RH for the Treatment of LACC
A Phase 2 study testing Two cycles of neoadjuvant chemotherapy, First imaging evaluation and Second imaging evaluation in people with Neoadjuvant Chemotherapy and Locally Advanced Cervical Cancer, run by Lei Li at 1 site in China.
Trial summary
This cohort study is to evaluate the role of neoadjuvant chemotherapy (NAC) in the treatment of locally advanced cervical cancer (LACC). Sixty patients with LACC (FIGO 2009 stage IB2 to IIB) will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Neoadjuvant Chemotherapy, Locally Advanced Cervical Cancer, Radical Hysterectomy
- What is being tested?
- Two cycles of neoadjuvant chemotherapy, First imaging evaluation and Second imaging evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2019to 1 Jun 2025
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix
- FIGO stage IB2 to IIB
- Type II or III radical hysterectomy or trachelectomy
- Performance status of Eastern Cooperative Oncology Group (ECOG) 0-1
- Aged 18 years to 45 years
- Well cardiopulmonary, liver and kidney functions for neoadjuvant chemotherapy
- Signed an approved informed consents
Who cannot join
- Not satisfying any of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 008613911988831, lileigh@163.com
About this study
Official title: Neoadjuvant Chemotherapy Followed by Radical Hysterectomy for the Treatment of Locally Advanced Cervical Cancer: A Prospective Cohort Study
This cohort study is to evaluate the role of neoadjuvant chemotherapy (NAC) in the treatment of locally advanced cervical cancer (LACC). Sixty patients with LACC (FIGO 2009 stage IB2 to IIB) will be enrolled. After informed consents, they would accept the imaging evaluation of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET). After excluding cases of distant metastasis, they will accept two cycles of NAC (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks). Then a second MRI is performed to evaluate the imaging response. For patients achieving objective response, radical hysterectomy (RH, via laparoscopy or laparotomy) and an evaluation of pathologic response are performed. For patients without objective imaging response, the choice of concurrent chemoradiotherapy or radical hysterectomy will be discussed. After RH, adjuvant therapy will be given according to the RH pathologic results.
The primary objectives consist of (1) the objective imaging response after NAC; (2) the objective pathologic response after RH.
The secondary objectives consist of (1) disease-free survival and overall survival after various therapy modalities; (2) severe adverse effects of NAC; (3) the effects of NAC on the surgical outcomes.
- Conditions
- Neoadjuvant Chemotherapy, Locally Advanced Cervical Cancer, Radical Hysterectomy, Objective Response, Laparoscopy, Laparotomy
- Being tested
- Two cycles of neoadjuvant chemotherapy, First imaging evaluation, Second imaging evaluation, The third cycles of neoadjuvant chemotherapy, RH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two cycles of neoadjuvant chemotherapyDrug
Two cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks).
First imaging evaluationDiagnostic test
First imaging evaluation consists of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET)
Second imaging evaluationDiagnostic test
Second imaging evaluation consists of pelvic magnetic resonance imaging
The third cycles of neoadjuvant chemotherapyDrug
The third cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks).
RHProcedure or surgery
Radical hysterectomy
RadiochemotherapyRadiation
Concurrent radiochemotherapy
Pathologic evaluationDiagnostic test
Pathologic evaluation for RH patients
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients in group A don't receive neoadjuvant chemotherapy Receives: Diagnostic Test: First imaging evaluation; Radiation: Radiochemotherapy |
| Group B | Experimental | Patients in group B receive neoadjuvant chemotherapy and achieve imaging response Receives: Drug: Two cycles of neoadjuvant chemotherapy; Diagnostic Test: First imaging evaluation; Diagnostic Test: Second imaging evaluation; Drug: The third cycles of neoadjuvant chemotherapy; Procedure: RH; Diagnostic Test: Pathologic evaluation |
| Group C | Experimental | Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept concurrent chemoradiotherapy Receives: Drug: Two cycles of neoadjuvant chemotherapy; Diagnostic Test: First imaging evaluation; Diagnostic Test: Second imaging evaluation; Radiation: Radiochemotherapy |
| Group D | Experimental | Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept radical hysterectomy Receives: Drug: Two cycles of neoadjuvant chemotherapy; Diagnostic Test: First imaging evaluation; Diagnostic Test: Second imaging evaluation; Procedure: RH; Diagnostic Test: Pathologic evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective pathologic response
Objective pathologic response for patients with radical hysterectomy
Measured: 3 years
Objective imaging response
Objective imaging response for patients with neoadjuvant chemotherapy
Measured: 3 years
Secondary outcomes (3)
Disease-free survival
Disease-free survival for patients with various therapy modalities
Measured: 3 years
Overall survival
Overall survival for patients with various therapy modalities
Measured: 3 years
Severe adverse events
Severe adverse events of neoadjuvant chemotherapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start19 Jun 2019
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant ChemotherapyStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- patients diagnosed with locally advanced cervical cancer of stage IB2 to IIB (FIGO 2009 system)
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Lei Li, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963882
- Sponsor's protocol ID
- NACC
- Status last verified
- Jun 2019
- First submitted
- 23 May 2019
- Last updated
- 20 Jun 2019
- 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 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy Followed by Radical Hysterectomy for the Treatment of Locally Advanced Cervical Cancer: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03963882
- Acronym / sponsor ID
- NACC
- Conditions
- Neoadjuvant Chemotherapy, Locally Advanced Cervical Cancer, Radical Hysterectomy, Objective Response, Laparoscopy, Laparotomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 28 May 2019 (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.
This cohort study is to evaluate the role of neoadjuvant chemotherapy (NAC) in the treatment of locally advanced cervical cancer (LACC). Sixty patients with LACC (FIGO 2009 stage IB2 to IIB) will be enrolled. After informed consents, they would accept the imaging evaluation of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET). After excluding cases of distant metastasis, they will accept two cycles of NAC (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks). Then a second MRI is performed to evaluate the imaging response. For patients achieving objective response, radical hysterectomy (RH, via laparoscopy or laparotomy) and an evaluation of pathologic response are performed. For patients without objective imaging response, the choice of concurrent chemoradiotherapy or radical hysterectomy will be discussed. After RH, adjuvant therapy will be given according to the RH pathologic results.
The primary objectives consist of (1) the objective imaging response after NAC; (2) the objective pathologic response after RH.
The secondary objectives consist of (1) disease-free survival and overall survival after various therapy modalities; (2) severe adverse effects of NAC; (3) the effects of NAC on the surgical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- patients diagnosed with locally advanced cervical cancer of stage IB2 to IIB (FIGO 2009 system)
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Diagnostic Test: First imaging evaluation, Radiation: RadiochemotherapyPatients in group A don't receive neoadjuvant chemotherapy |
| Group B | Experimental | Drug: Two cycles of neoadjuvant chemotherapy, Diagnostic Test: First imaging evaluation, Diagnostic Test: Second imaging evaluation, Drug: The third cycles of neoadjuvant chemotherapy, Procedure: RH, Diagnostic Test: Pathologic evaluationPatients in group B receive neoadjuvant chemotherapy and achieve imaging response |
| Group C | Experimental | Drug: Two cycles of neoadjuvant chemotherapy, Diagnostic Test: First imaging evaluation, Diagnostic Test: Second imaging evaluation, Radiation: RadiochemotherapyPatients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept concurrent chemoradiotherapy |
| Group D | Experimental | Drug: Two cycles of neoadjuvant chemotherapy, Diagnostic Test: First imaging evaluation, Diagnostic Test: Second imaging evaluation, Procedure: RH, Diagnostic Test: Pathologic evaluationPatients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept radical hysterectomy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix
- FIGO stage IB2 to IIB
- Type II or III radical hysterectomy or trachelectomy
- Performance status of Eastern Cooperative Oncology Group (ECOG) 0-1
- Aged 18 years to 45 years
Key exclusion criteria (1 listed)
- Not satisfying any of the inclusion criteria
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 |
|---|---|---|
| Two cycles of neoadjuvant chemotherapyTwo cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks). | Drug | Group B, Group C, Group D |
| First imaging evaluationFirst imaging evaluation consists of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET) | Diagnostic test | Group A, Group B, Group C, Group D |
| Second imaging evaluationSecond imaging evaluation consists of pelvic magnetic resonance imaging | Diagnostic test | Group B, Group C, Group D |
| The third cycles of neoadjuvant chemotherapyThe third cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks). | Drug | Group B |
| RHRadical hysterectomy | Procedure or surgery | Group B, Group D |
| RadiochemotherapyConcurrent radiochemotherapy | Radiation | Group A, Group C |
| Pathologic evaluationPathologic evaluation for RH patients | Diagnostic test | Group B, Group D |
Primary outcome
Objective pathologic response
Time frame: 3 years
Objective pathologic response for patients with radical hysterectomy
Objective imaging response
Time frame: 3 years
Objective imaging response for patients with neoadjuvant chemotherapy
3 secondary outcomes
Disease-free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
Severe adverse events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- 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.
Lei Li, M.D. principal investigator
Peking Union Medical College 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 Two cycles of neoadjuvant chemotherapy, First imaging evaluation and Second imaging evaluation in people with Neoadjuvant Chemotherapy and Locally Advanced Cervical Cancer, run by Lei Li 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 1 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 20 Jun 2019. 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 Lei Li, M.D. (+8613911988831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective pathologic response (time frame: 3 years). 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 20 Jun 2019.