Cervical CancerNCT04588090
A Prospective Randomized Controlled Study of Radiotherapy and the Concurrent Three-week and Single-week TP Chemotherapy for Advanced Cervical Squamous Cell Carcinoma and the Correlation Between HPV Classification and Sensitivity.
A study testing The concurrent 3 weeks TP regimen, The concurrent weekly TP regimen and External radiation plus intraluminal after-loading irradiation in people with Cervical Cancer, run by Chongqing University Cancer Hospital at 1 site in China.
Trial summary
the main purpose for this experiments are as follows: 1. Patients with stage ⅡB-ⅢB cervical squamous cell carcinoma who received full dose radiotherapy will be randomly assigned to the combined TP regimen weekly treatment group and 3-week treatment group for the short-term efficacy and safety observation; 2. 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?
- The concurrent 3 weeks TP regimen, The concurrent weekly TP regimen and External radiation plus intraluminal after-loading irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 1 May 2021
- Phase
- Interventional
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient participated in this study voluntarily and all volunteers will sign the informed consent.
- New cervical squamous cell carcinoma cases between 18 and 70 years old;
- Clinical stages: stage ⅡB-stage ⅢB;
- PS score is less than 2 points;
- Expected survival is over 3 months;
- Blood routine: Hb≥70g/L, WBC≥3.5×10^9/L, ANC≥1.5×10^9/L, PLT≥80×10^9/L
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- Serum ALT and AST≤2×ULN; serum creatinine≤1.5×ULN;
- Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the trial;
- Patients who can comply with the trial protocol (judged by the investigator).
Who cannot join
- Active or uncontrolled serious infection;
- Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatments;
- A history of immunodeficiency, including HIV positive or other acquired congenital immunodeficiency diseases;
- Chronic renal insufficiency and renal failure;
- Pregnant woman;
- Myocardial infarction, severe arrhythmia and congestive heart failure ≥2 (New York Heart Association (NYHA) classification);
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- Patients receiving targeted therapy and pelvic artery embolism;
- Those who have had arterial/venous thrombosis within 6 months, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism;
- Those who have received radiotherapy for malignant pelvic tumors in the past;
- Patients with autoimmune system diseases such as systemic lupus erythematosus;
- Patients with comorbidities who need to take drugs with severe liver and kidney damage during treatment, such as tuberculosis;
- Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent;
- Those with concomitant diseases or other special circumstances that seriously endanger the safety of patients or affect the completion of the study.
Trial locations and contacts
1 site in 1 country.
About this study
the main purpose for this experiments are as follows: 1. Patients with stage ⅡB-ⅢB cervical squamous cell carcinoma who received full dose radiotherapy will be randomly assigned to the combined TP regimen weekly treatment group and 3-week treatment group for the short-term efficacy and safety observation; 2. All enrolled patients will be tested for HPV subtype infection; the relationship between the sensitivity and curative effect of concurrent radiotherapy and chemotherapy will be analyzed, and at the end of the test, HPV subtypes will be tested again and changes will be analyzed to provide more clinical evidence for the reasonable comprehensive treatment and precision medical treatment of advanced cervical squamous cell carcinoma.
- Conditions
- Cervical Cancer
- Being tested
- The concurrent 3 weeks TP regimen, The concurrent weekly TP regimen, External radiation plus intraluminal after-loading irradiation
- 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.
The concurrent 3 weeks TP regimenProcedure or surgery
paclitaxel + cisplatin regimen (TP-TAX: 150mg/m^2, DDP: 70mg/m^2 (35mg/m^2, d1, d2), 1 time/3 weeks) chemotherapy for 2 cycles.
The concurrent weekly TP regimenProcedure or surgery
paclitaxel + cisplatin regimen (TP regimen: TAX 50mg/m^2, DDP: 25mg/m^2) 6 cycles of chemotherapy
External radiation plus intraluminal after-loading irradiationRadiation
External radiotherapy of linear accelerator, CT simulation positioning, and intensity modulated radiotherapy will be applied for external radiotherapy. The prescribed dose is 95% PTV 45-50.8Gy/25-28 times (1.8Gy/time), the maximum and minimum in the target area do not exceed ±10% of the prescribed dose, and the increase in enlarged lymph nodes will reach 50-66GY. At the same time, the total dose of 192Ir high-dose rate intraluminal after-loading irradiation is 30-36Gy (EQD2: 40-48GY), and external pelvic irradiation is not available on the day of intraluminal after-loading irradiation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The concurrent 3 weeks treatment group（external radiation plus intraluminal after-loading irradiation+concurrent platinum-containing 3 weeks chemotherapy） Receives: Procedure: The concurrent 3 weeks TP regimen; Radiation: External radiation plus intraluminal after-loading irradiation |
| Standard chemoradiation group | Placebo comparator | Standard chemoradiation（external radiation plus intraluminal after-loading irradiation+concurrent platinum-containing weekly chemotherapy） Receives: Procedure: The concurrent weekly TP regimen; Radiation: External radiation plus intraluminal after-loading irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease control rate (DCR)
Including the percentage of patients with complete remission, partial remission or with stable disease state and maintained for more than 4 weeks among the patients with evaluable efficacy.
Measured: 1 month and 3 months
Objective response rate (ORR)
Including the percentage of patients with complete remission or partial remission and maintained for more than 4 weeks among the patients with evaluable efficacy.
Measured: 1 month and 3 months
Secondary outcomes (2)
progression-free survival (PFS)
the time from patient randomization to objective progression or death.
Measured: 2 years
overall survival (OS)
the time from the beginning of enrollment to death for any reason. For subjects who are lost to follow-up, the time of last follow-up is usually calculated as the time of death.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Jan 2016
- Primary completion1 Jan 2021 (estimated)
- Study completion1 May 2021 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588090
- Sponsor's protocol ID
- CQGOG0105
- Status last verified
- Oct 2020
- First submitted
- 30 Sep 2020
- Last updated
- 19 Oct 2020
- 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 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study of Radiotherapy and the Concurrent Three-week and Single-week TP Chemotherapy for Advanced Cervical Squamous Cell Carcinoma and the Correlation Between HPV Classification and Sensitivity.
- ClinicalTrials.gov ID
- NCT04588090
- Acronym / sponsor ID
- CQGOG0105
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 19 Oct 2020 (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.
the main purpose for this experiments are as follows: 1. Patients with stage ⅡB-ⅢB cervical squamous cell carcinoma who received full dose radiotherapy will be randomly assigned to the combined TP regimen weekly treatment group and 3-week treatment group for the short-term efficacy and safety observation; 2. All enrolled patients will be tested for HPV subtype infection; the relationship between the sensitivity and curative effect of concurrent radiotherapy and chemotherapy will be analyzed, and at the end of the test, HPV subtypes will be tested again and changes will be analyzed to provide more clinical evidence for the reasonable comprehensive treatment and precision medical treatment of advanced cervical squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: The concurrent 3 weeks TP regimen, Radiation: External radiation plus intraluminal after-loading irradiationThe concurrent 3 weeks treatment group（external radiation plus intraluminal after-loading irradiation+concurrent platinum-containing 3 weeks chemotherapy） |
| Standard chemoradiation group | Placebo comparator | Procedure: The concurrent weekly TP regimen, Radiation: External radiation plus intraluminal after-loading irradiationStandard chemoradiation（external radiation plus intraluminal after-loading irradiation+concurrent platinum-containing weekly chemotherapy） |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient participated in this study voluntarily and all volunteers will sign the informed consent.
- New cervical squamous cell carcinoma cases between 18 and 70 years old;
- Clinical stages: stage ⅡB-stage ⅢB;
- PS score is less than 2 points;
- Expected survival is over 3 months;
Key exclusion criteria (13 listed)
- Active or uncontrolled serious infection;
- Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatments;
- A history of immunodeficiency, including HIV positive or other acquired congenital immunodeficiency diseases;
- Chronic renal insufficiency and renal failure;
- Pregnant woman;
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 |
|---|---|---|
| The concurrent 3 weeks TP regimenpaclitaxel + cisplatin regimen (TP-TAX: 150mg/m^2, DDP: 70mg/m^2 (35mg/m^2, d1, d2), 1 time/3 weeks) chemotherapy for 2 cycles. | Procedure or surgery | Experimental group |
| The concurrent weekly TP regimenpaclitaxel + cisplatin regimen (TP regimen: TAX 50mg/m^2, DDP: 25mg/m^2) 6 cycles of chemotherapy | Procedure or surgery | Standard chemoradiation group |
| External radiation plus intraluminal after-loading irradiationExternal radiotherapy of linear accelerator, CT simulation positioning, and intensity modulated radiotherapy will be applied for external radiotherapy. The prescribed dose is 95% PTV 45-50.8Gy/25-28 times (1.8Gy/time), the maximum and minimum in the target area do not exceed ±10% of the prescribed dose, and the increase in enlarged lymph nodes will reach 50-66GY. At the same time, the total dose of 192Ir high-dose rate intraluminal after-loading irradiation is 30-36Gy (EQD2: 40-48GY), and external pelvic irradiation is not available on the day of intraluminal after-loading irradiation. | Radiation | Experimental group, Standard chemoradiation group |
Primary outcome
disease control rate (DCR)
Time frame: 1 month and 3 months
Including the percentage of patients with complete remission, partial remission or with stable disease state and maintained for more than 4 weeks among the patients with evaluable efficacy.
Objective response rate (ORR)
Time frame: 1 month and 3 months
Including the percentage of patients with complete remission or partial remission and maintained for more than 4 weeks among the patients with evaluable efficacy.
2 secondary outcomes
progression-free survival (PFS)
Time frame: 2 years
overall survival (OS)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The concurrent 3 weeks TP regimen, The concurrent weekly TP regimen and External radiation plus intraluminal after-loading irradiation 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 9 inclusion and 13 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 19 Oct 2020. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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 control rate (DCR) (time frame: 1 month and 3 months). 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 19 Oct 2020.