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Uterine Cervical NeoplasmsPhase 3NCT05735145

Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy Treated Advanced Cervical Cancer

A Phase 3 study testing paclitaxel combined with platinum in people with Uterine Cervical Neoplasms and Chemoradiotherapy, run by Fourth Affiliated Hospital of Guangxi Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study carried out a prospective, randomized, controlled clinical study under the background of intensity-modulated radiation therapy and three-dimensional afterloading therapy. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
paclitaxel combined with platinum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteChina
Study dates
1 Jul 2022to 30 Jun 2027
Phase
Phase 3
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 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cervical cancer confirmed by histopathology incloud squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma
  • FIGO stage IB3, IIA2, IIB-IVA patients in 2018
  • Locally advanced cervical cancer patients received standard concurrent intensity-modulated chemoradiotherapy followed by three-dimensional afterloading treatment after diagnosis, and the effect reached CR after treatment
  • Aged 18-75 years
  • PS score 0-1
  • Serum hemoglobin >=100*10^9/L, blood platelet >= 100000/μL, absolute count of neutrophils>=1500/μL; 7.Serum creatinine <=1.5 UNL or creatinine clearance >= 60 ml/min; 8.Serum bilirubin <=1.5 UNL, AST (SGOT) and ALT (SGPT)<= 1.5 UNL
  • Sign a formal informed consent to show that they understand that the study is in line with hospital and national policies .Estimated total survival > 6 months.

Who cannot join

  • Locally advanced cervical cancer patients received standard concurrent intensity-modulated chemoradiotherapy followed by three-dimensional afterloading treatment after diagnosis, and the effect unreached CR after treatment
  • Patients who have received neoadjuvant chemotherapy and surgery
  • Patients with cognitive impairment
  • Patients with any distant metastases
  • Patients with any other malignancy within 5 years
  • Any other disease or condition is contraindications to chemoradiotherapy (e.g., active infection, 6 months after myocardial infarction, symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive therapy, etc.); 5.Pregnant or lactating women, or fertile women who do not use contraception
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  • Severe bone marrow dysfunction
  • Patients with bleeding tendency
  • Drug abusers or alcohol addicts
  • Those who are known to have a third or fourth degree allergic reaction to any treatment in the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Huang haixin contact

13507726193

13507726193@163.com

Feng chengjun contact

18877279562

leymj@163.com

China1 site, 1 recruiting

  • the Fourth Affiliated Hospital of Guangxi Medical University

    Liuzhou, Guangxi, 545005

    Chengjun Feng, Master, +86 18877279562, leymj@163.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective Randomized Controlled Trial for Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy in the Treatment of Advanced Cervical Cancer at 2018 FIGO Staging

This study carried out a prospective, randomized, controlled clinical study under the background of intensity-modulated radiation therapy and three-dimensional afterloading therapy. By comparing simultaneous intensity-modulated radiotherapy and chemotherapy combined with adjuvant chemotherapy and simultaneous intensity-modulated radiotherapy and chemotherapy alone, based on the 2018 FIGO staging The clinical efficacy of locally advanced cervical cancer further clarifies the role of adjuvant chemotherapy in locally advanced cervical cancer.

Read the detailed description

Concurrent chemoradiotherapy is the standard treatment for locally advanced cervical cancer, but there are still many patients with local recurrence or metastasis after treatment, and the 5-year survival rate is low. Concurrent chemoradiotherapy followed by adjuvant chemotherapy for locally advanced cervical cancer is still controversial in improving disease-free survival and overall survival, and previous studies were mostly based on traditional two-dimensional radiotherapy techniques, intensity-modulated radiotherapy and three-dimensional afterloading in dosimetry and radiotherapy. Compared with traditional radiotherapy, it has more advantages in terms of biological effects. In addition, after the adjustment of the new 2018 FIGO staging, it is possible to change the impact of the original treatment mode on overall survival. Therefore, more evidence-based medical evidence is needed to clarify the clinical value of adjuvant chemotherapy in the treatment of locally advanced cervical cancer. Therefore, this study carried out a prospective, randomized, controlled clinical study under the background of intensity-modulated radiation therapy and three-dimensional afterloading therapy. By comparing simultaneous intensity-modulated radiotherapy and chemotherapy combined with adjuvant chemotherapy and simultaneous intensity-modulated radiotherapy and chemotherapy alone, based on the 2018 FIGO staging The clinical efficacy of locally advanced cervical cancer further clarifies the role of adjuvant chemotherapy in locally advanced cervical cancer.

Being tested
paclitaxel combined with platinum
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.

  • paclitaxel combined with platinumDrug

    Also called Adjuvant chemotherapy with paclitaxel combined with platinum

    Adjuvant chemotherapy with paclitaxel combined with platinum

Study groups in NCT05735145
Study groupRoleWhat they receive
concurrent chemoradiotherapy combined with adjuvant chemotherapyExperimentalAdjuvant chemotherapy in patients with locally advanced cervical cancer who achieved CR after concurrent chemoradiotherapy
Receives: Drug: paclitaxel combined with platinum
concurrent chemoradiotherapyOtherObservation of patients with locally advanced cervical cancer who achieved CR after concurrent chemoradiotherapy
Receives: Drug: paclitaxel combined with platinum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS

    progression-free survival

    Measured: Refers to the time from randomization to the first occurrence of disease progression or death from any cause，whichever came first, assessed up to 1000 months

Secondary outcomes (1)

  1. OS

    Overall survival

    Measured: Refers to the time from randomization to death from any cause, assessed up to 1000 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2023
  2. Study start1 Jul 2022
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

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
Single blind
Who is masked
Participant
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05735145
Sponsor's protocol ID
124502004985979665
Status last verified
Feb 2023
First submitted
24 Jun 2022
Last updated
21 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing paclitaxel combined with platinum in people with Uterine Cervical Neoplasms and Chemoradiotherapy, run by Fourth Affiliated Hospital of Guangxi Medical University 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 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: looking for participants now, as of the sponsor's last update on 21 Feb 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.

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?

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 Huang haixin (13507726193, 13507726193@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: Refers to the time from randomization to the first occurrence of disease progression or death from any cause，whichever came first, assessed up to 1000 months). 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 NCT05735145.

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 21 Feb 2023.

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