Cervical CancerNCT05749887
The Efficacy of Salvage Surgery in Patients With Residual Tumor After Concurrent Chemoradiation for Locally Advanced Cervical Cancer.
A study testing salvage surgery in people with Cervical Cancer, run by Chongqing University Cancer Hospital at 1 site in China.
Trial summary
This is a single-center single-arm study. The main purpose of this study is to study the efficacy of surgical treatment for patients with locally advanced cervical cancer (FIGO IB3, IIA2-IVA) who still have residual tumor after concurrent radiotherapy and chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- salvage surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2023to 31 Dec 2032
- Phase
- Interventional
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage Ib3 and IIA2-IVA (FIGO2018) cervical cancer with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma.
- Complete standard CCRT(Pelvic EBRT+ concurrent platinum-containing chemotherapy+ brachytherapy).
- After 4-12 weeks of treatment, the cervical biopsy pathology confirmed residual cancer, or the cervical biopsy was negative, but PET /CT showed that SUVmax of the residual lesions in the cervical and/or pelvic lymph nodes were ≥ 2.5, two or more gynaecological oncologists with Grade IV operation qualification and the title of deputy director or above have gynecological examination, and the multidisciplinary team(MDT) evaluation recommended surgical treatment.
- ECOG score:0 ~ 1.
- The expected survival time>6 months;
- There is no absolute contraindication of surgery and the patients with good compliance.
Who cannot join
- The radiotherapy and chemotherapy are not completed or the radiotherapy dose is not reached.
- PET /CT and/or pathological indicates that there is a distant metastasis including para-aortic lymph nodes.
- Other malignancies were diagnosed within five years or needed treatments.
- History of important organ transplantation.
- History of immune disease who need to take immunosuppressive drugs.
- History of serious mental illness and brain functional disorder.
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- Drug abuse or drug use history.
- Participants in other clinical trials at the same time.
- Those who are unable or unwilling to accept surgical treatment/sign informed consent/comply with research requirements.
- Without surgical conditions: 1) Chronic renal insufficiency or renal failure; 2) Liver insufficiency; 3)Chronic lung disease with restrictive respiratory dysfunction; 4) Cardiac dysfunction (patients with relative and absolute contraindications to surgery after consultation by cardiac physicians.
- Patients who cannot understand the research regimen and refuse to sign the informed consent form.
- Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dongling Zou, PH.D contact
China1 site, 1 recruiting
- Recruiting
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Zou Dongling, PH.D., +8613657690699, cqzl_zdl@163.com
About this study
Official title: Salvage Surgery for Patients With Residual Disease After Concurrent Chemoradiation Therapy for Locally Advanced Cervical Cancer: A Prospective, Single-arm Clinical Study.
This is a single-center single-arm study. The main purpose of this study is to study the efficacy of surgical treatment for patients with locally advanced cervical cancer (FIGO IB3, IIA2-IVA) who still have residual tumor after concurrent radiotherapy and chemotherapy.
- Conditions
- Cervical Cancer
- Being tested
- salvage surgery
- Keywords
- Locally advanced cervical cancer, chemoradiotherapy, redsidual tumor, salvage sugery, OS
- 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.
salvage surgeryProcedure or surgery
Open/minimally invasive salvage surgery performed when cervical biopsy and/or PET/CT scan ( SUVmax ≥2.5 ) indicate patients with residual tumor intrapelvic 4-12 weeks after standard CCRT.
Surgery type:
- No parametrial involvement, extrafascial hysterectomy;
- There is parametrial involvement, extensive hysterectomy(Q-MC);
- Only bladder invasion, anterior pelvic exenteration;
- Only rectal invasion, posterior pelvic exenteration or total pelvic exenteration;
- Invasion of bladder and rectum, total exenteration.
- The pelvic lymph nodes are removed at the same time when 18F -FDG PET /CT indicates that the SUVmax is ≥ 2.5.
| Study group | Role | What they receive |
|---|---|---|
| salvage sugery | Other | Salvage surgery for patients diagnosed locally advanced cervical cancr with residual tumor after standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy+ brachytherapy) Receives: Procedure: salvage surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
5 years overall survival
Measured: 5 years
Secondary outcomes (1)
PFS
Progression-free survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start25 Aug 2023
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing University Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongling Zou, Chongqing University Cancer Hospital
- Investigators
- Dongling Zou, PH.D, Principal investigator, Chongqing University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749887
- Sponsor's protocol ID
- CQGOG0112
- Status last verified
- Oct 2023
- First submitted
- 20 Feb 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salvage Surgery for Patients With Residual Disease After Concurrent Chemoradiation Therapy for Locally Advanced Cervical Cancer: A Prospective, Single-arm Clinical Study.
- ClinicalTrials.gov ID
- NCT05749887
- Acronym / sponsor ID
- CQGOG0112
- Conditions
- Cervical Cancer
- Keywords
- Locally advanced cervical cancer, chemoradiotherapy, redsidual tumor, salvage sugery, OS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 1 Mar 2023 (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 is a single-center single-arm study. The main purpose of this study is to study the efficacy of surgical treatment for patients with locally advanced cervical cancer (FIGO IB3, IIA2-IVA) who still have residual tumor after concurrent radiotherapy and chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| salvage sugery | Other | Procedure: salvage surgerySalvage surgery for patients diagnosed locally advanced cervical cancr with residual tumor after standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy+ brachytherapy) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stage Ib3 and IIA2-IVA (FIGO2018) cervical cancer with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma.
- Complete standard CCRT(Pelvic EBRT+ concurrent platinum-containing chemotherapy+ brachytherapy).
- After 4-12 weeks of treatment, the cervical biopsy pathology confirmed residual cancer, or the cervical biopsy was negative, but PET /CT showed that SUVmax of the residual lesions in the cervical and/or pelvic lymph nodes were ≥ 2.5, two or more gynaecological oncologists with Grade IV operation qualification and the title of deputy director or above have gynecological examination, and the multidisciplinary team(MDT) evaluation recommended surgical treatment.
- ECOG score:0 ~ 1.
- The expected survival time>6 months;
Key exclusion criteria (12 listed)
- The radiotherapy and chemotherapy are not completed or the radiotherapy dose is not reached.
- PET /CT and/or pathological indicates that there is a distant metastasis including para-aortic lymph nodes.
- Other malignancies were diagnosed within five years or needed treatments.
- History of important organ transplantation.
- History of immune disease who need to take immunosuppressive drugs.
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 |
|---|---|---|
| salvage surgeryOpen/minimally invasive salvage surgery performed when cervical biopsy and/or PET/CT scan ( SUVmax ≥2.5 ) indicate patients with residual tumor intrapelvic 4-12 weeks after standard CCRT. Surgery type: 1. No parametrial involvement, extrafascial hysterectomy; 2. There is parametrial involvement, extensive hysterectomy(Q-MC); 3. Only bladder invasion, anterior pelvic exenteration; 4. Only rectal invasion, posterior pelvic exenteration or total pelvic exenteration; 5. Invasion of bladder and rectum, total exenteration. 6. The pelvic lymph nodes are removed at the same time when 18F -FDG PET /CT indicates that the SUVmax is ≥ 2.5. | Procedure or surgery | salvage sugery |
Primary outcome
OS
Time frame: 5 years
5 years overall survival
1 secondary outcome
PFS
Time frame: 2 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 10 Oct 2023.
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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.
Dongling Zou, PH.D contact
Dongling Zou, PH.D principal investigator
Chongqing University Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing salvage surgery in people with Cervical Cancer, run by Chongqing University Cancer 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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 10 Oct 2023. 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 Dongling Zou, PH.D (13657690699, cqzl_zdl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: 5 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 10 Oct 2023.