Uterine Cervical NeoplasmPhase 3NCT03308591
Clinical Efficacy of the Neoadjuvant Chemotherapy for IB2 and IIA2 Stage Cervical Cancer Patients
A Phase 3 study testing NACT, RT+PLND and Adjuvant chemotherapy in people with Uterine Cervical Neoplasm and Cervical Cancer, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
In recent years, the patients with IB2 and IIA2 stage cervical cancer are still treated with radiotherapy and chemotherapy based treatment, but the radiotherapy will severely damage the function of ovary, cause endocrine dyscrasia and the sexual function of vagina. Read more about this study
- Who is it for?
- Ages Up to 65 years, women only
- Conditions the study is for
- Uterine Cervical Neoplasm, Cervical Cancer, Uterine Cervical Cancer
- What is being tested?
- NACT, RT+PLND and Adjuvant chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 774 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2016to 1 Feb 2022
- Phase
- Phase 3
- 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 Up to 65 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- clinical diagnosis IB2 or IIA2 stage cervical cancer;
- age less than or equal to 65 years old;
- laboratory examination results: WBC ≥ 4*10^9/L, NEU ≥ 20*10^9/L, PLT ≥ 80*10^9/L, serum bilirubin ≤ 2 multiples of the upper normal limit, aminopherase ≤ 2 multiples of the upper normal limit. BUN ≤ normal limit, CR ≤ normal limit;
- KARNOFSKY score ≥ 60;
- No prior treatment;
- pathological diagnosis before surgery is invasive squamous cell carcinoma of cervix;
- well-compliance and willing to keep in touch;
- willing to participate in this study, and sign the informed consent;
Who cannot join
- participate in other drug clinical trials at the same time;
- respiratory depression, airway obstruction and hypoxia;
- heart diseases (cardiac function at grade II, III or above);
- hematological diseases;
- obvious dysfunction of liver and kidney (above 3 multiples of the upper normal limit);
- a history of brain dysfunction;
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- unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy;
- drug abuse or a history of drug abuse;
- unable or unwilling to sign informed consents;
- unable or unwilling to follow the protocols;
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Clinical Efficacy of the Neoadjuvant Chemotherapy for IB2 and IIA2 Stage Cervical Cancer Patients, A Multicenter, Prospective and Randomized Controlled Trial
In recent years, the patients with IB2 and IIA2 stage cervical cancer are still treated with radiotherapy and chemotherapy based treatment, but the radiotherapy will severely damage the function of ovary, cause endocrine dyscrasia and the sexual function of vagina. So we want to study whether neoadjuvant chemotherapy without radiotherapy will achieve the same outcome compared with traditional therapy including radiotherapy. So we randomly divide IB2 and IIA2 stage cervical cancer patients into two groups. The neoadjuvant chemotherapy group will receive two courses of chemotherapy basically composed of platinum, and then undergo surgery, after that, doctors will add more courses of chemotherapy according to the situations of the patients, including whether the patients have the adverse prognostic factors. The control group will undergo surgery directly, and then receive chemotherapy and radiotherapy at the same time. Then we will compare the outcomes of these two groups, and analyze the therapeutic effect, the impact on survival rate and the effect on improving the living quality of patient from two groups. All the outcomes will be fed back to clinical doctors and instruct them to choose better treatment for patients.
- Being tested
- NACT, RT+PLND, Adjuvant chemotherapy
- 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.
NACTDrug
Platin based chemotherapy
RT+PLNDProcedure or surgery
radical hysterectomy+pelvic lymphadenectomy
Adjuvant chemotherapyDrug
Platin based chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| NACT | Experimental | The patients will receive 2 courses of platinum based chemotherapy before surgery, 2-3 weeks after each course, doctors will appraise the effect of the chemotherapy. Patients who are sensitive to the treatment will undergo radical hysterectomy and pelvic lymph node dissection 3 weeks after chemotherapy. And 2-3weeks after the surgery, patients will receive adjuvant chemotherapy according to the pathological risk factors. Receives: Drug: NACT; Procedure: RT+PLND; Drug: Adjuvant chemotherapy |
| PST | Active comparator | The patients in this group will undergo radical hysterectomy and pelvic lymph node dissection directly, and 2-6 weeks after the surgery, they will receive adjuvant chemotherapy according to the pathological risk factors. Receives: Procedure: RT+PLND; Drug: Adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival (DFS) of the neoadjuvant chemotherapy Group
DFS was definite as the time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence.
Measured: Up to 3-year
Secondary outcomes (1)
DSF of the synchro-chemoradiotheraphy group
Measured: Up to 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start11 Jan 2016
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical NeoplasmStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 774 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Ma, Huazhong University of Science and Technology
- Investigators
- Ding Ma, MD PhD, Study chair, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308591
- Sponsor's protocol ID
- CSEM GOG-005B
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2017
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: The individual participants data will be preserved in the hospital, and all the chemical or physical examination results will be kept in the medical records, the researches, ethics committee and the drug administration will be permitted to look up all the records as we planned. And all the reports or papers about this research will not relate to the patients' identity. But we do not decide whether the information be available to others, the final decision maybe decided by all the patients in this research.
Publications
Hu Y, Han Y, Shen Y, Chen J, Chen Y, Chen Y, Tang J, Xue M, Hong L, Cheng W, Wang D, Liang Z, Wang Y, Zhang Q, Xing H, Zhang Y, Yi C, Yu Z, Chen Y, Cui M, Ma C, Yang H, Li R, Long P, Zhao Y, Qu P, Tao G, Yang L, Wu S, Liu Z, Yang P, Lv W, Xie X, Ma D, Wang H, Li K. Neoadjuvant chemotherapy for patients with international federation of gynecology and obstetrics stages IB3 and IIA2 cervical cancer: a multicenter prospective trial. BMC Cancer. 2022 Dec 5;22(1):1270. doi: 10.1186/s12885-022-10355-3.
PubMed 36471257
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of the Neoadjuvant Chemotherapy for IB2 and IIA2 Stage Cervical Cancer Patients, A Multicenter, Prospective and Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03308591
- Acronym / sponsor ID
- CSEM GOG-005B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 774 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 11 Jan 2016 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 12 Oct 2017 (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.
In recent years, the patients with IB2 and IIA2 stage cervical cancer are still treated with radiotherapy and chemotherapy based treatment, but the radiotherapy will severely damage the function of ovary, cause endocrine dyscrasia and the sexual function of vagina. So we want to study whether neoadjuvant chemotherapy without radiotherapy will achieve the same outcome compared with traditional therapy including radiotherapy. So we randomly divide IB2 and IIA2 stage cervical cancer patients into two groups. The neoadjuvant chemotherapy group will receive two courses of chemotherapy basically composed of platinum, and then undergo surgery, after that, doctors will add more courses of chemotherapy according to the situations of the patients, including whether the patients have the adverse prognostic factors. The control group will undergo surgery directly, and then receive chemotherapy and radiotherapy at the same time. Then we will compare the outcomes of these two groups, and analyze the therapeutic effect, the impact on survival rate and the effect on improving the living quality of patient from two groups. All the outcomes will be fed back to clinical doctors and instruct them to choose better treatment for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NACT | Experimental | Drug: NACT, Procedure: RT+PLND, Drug: Adjuvant chemotherapyThe patients will receive 2 courses of platinum based chemotherapy before surgery, 2-3 weeks after each course, doctors will appraise the effect of the chemotherapy. Patients who are sensitive to the treatment will undergo radical hysterectomy and pelvic lymph node dissection 3 weeks after chemotherapy. And 2-3weeks after the surgery, patients will receive adjuvant chemotherapy according to the pathological risk factors. |
| PST | Active comparator | Procedure: RT+PLND, Drug: Adjuvant chemotherapyThe patients in this group will undergo radical hysterectomy and pelvic lymph node dissection directly, and 2-6 weeks after the surgery, they will receive adjuvant chemotherapy according to the pathological risk factors. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- clinical diagnosis IB2 or IIA2 stage cervical cancer;
- age less than or equal to 65 years old;
- laboratory examination results: WBC ≥ 4*10^9/L, NEU ≥ 20*10^9/L, PLT ≥ 80*10^9/L, serum bilirubin ≤ 2 multiples of the upper normal limit, aminopherase ≤ 2 multiples of the upper normal limit. BUN ≤ normal limit, CR ≤ normal limit;
- KARNOFSKY score ≥ 60;
- No prior treatment;
Key exclusion criteria (10 listed)
- participate in other drug clinical trials at the same time;
- respiratory depression, airway obstruction and hypoxia;
- heart diseases (cardiac function at grade II, III or above);
- hematological diseases;
- obvious dysfunction of liver and kidney (above 3 multiples of the upper normal limit);
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 |
|---|---|---|
| NACTPlatin based chemotherapy | Drug | NACT |
| RT+PLNDradical hysterectomy+pelvic lymphadenectomy | Procedure or surgery | NACT, PST |
| Adjuvant chemotherapyPlatin based chemotherapy | Drug | NACT, PST |
Primary outcome
disease-free survival (DFS) of the neoadjuvant chemotherapy Group
Time frame: Up to 3-year
DFS was definite as the time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence.
1 secondary outcome
DSF of the synchro-chemoradiotheraphy group
Time frame: Up to 3-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Derived from this study: PubMed 36471257Hu Y, Han Y, Shen Y, Chen J, Chen Y, Chen Y, Tang J, Xue M, Hong L, Cheng W, Wang D, Liang Z, Wang Y, Zhang Q, Xing H, Zhang Y, Yi C, Yu Z, Chen Y, Cui M, Ma C, Yang H, Li R, Long P, Zhao Y, Qu P, Tao G, Yang L, Wu S, Liu Z, Yang P, Lv W, Xie X, Ma D, Wang H, Li K. Neoadjuvant chemotherapy for patients with international federation of gynecology and obstetrics stages IB3 and IIA2 cervical cancer: a multicenter prospective trial. BMC Cancer. 2022 Dec 5;22(1):1270. doi: 10.1186/s12885-022-10355-3.
- Individual participant dataSharing planned: Undecided. The individual participants data will be preserved in the hospital, and all the chemical or physical examination results will be kept in the medical records, the researches, ethics committee and the drug administration will be permitted to look up all the records as we planned. And all the reports or papers about this research will not relate to the patients' identity. But we do not decide whether the information be available to others, the final decision maybe decided by all the patients in this research.
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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.
Ding Ma, MD PhD study chair
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NACT, RT+PLND and Adjuvant chemotherapy in people with Uterine Cervical Neoplasm and Cervical Cancer, run by Huazhong University of Science and Technology 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 8 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: finished, as of the sponsor's last update on 31 Oct 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (DFS) of the neoadjuvant chemotherapy Group (time frame: Up to 3-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03308591, which also lists 1 linked publication.
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 31 Oct 2024.