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Not yet recruiting NCT07249957

Reducing Radiation Target Volume for Stage IIb Cervical Cancer

No phase Interventional Stage IIb Cervical Cancer Radical Radiotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The external irradiation area only covers the entire uterus (including the primary lesion in the cervix), bilateral parametrium, and 3 cm below the cervical/vaginal lesions..
Who it may be relevant to
Registry conditions: Stage IIb Cervical Cancer Radical Radiotherapy. Basic parameters: 50 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Reducing Radiation Target Volume in Radical Radiotherapy for Stage IIb Cervical Cancer: A Single-arm Exploratory Study

Overview

This is a domestic single-center prospective clinical trial. The study selected patients with histologically confirmed cervical squamous cell carcinoma, diagnosed as stage IIb according to the FIGO 2018 staging principle (tumor size \< 4 cm). The patients first received 6 cycles of induction chemotherapy (carboplatin (AUC2) + paclitaxel (80 mg/m2), q1w), followed by concurrent chemoradiotherapy with a platinum-based regimen. The external beam radiation field only covered the entire uterus (including the primary lesion of the cervix), the bilateral parametrium, and the lesion of the cervix/vagina extending 3 cm downward. A total of 60 participants are planned to be included in the study.

Interventions

  • Radiation The external irradiation area only covers the entire uterus (including the primary lesion in the cervix), bilateral parametrium, and 3 cm below the cervical/vaginal lesions.
    The external irradiation area only covers the entire uterus (including the primary lesion in the cervix), bilateral parametrium, and 3 cm below the cervical/vaginal lesions.

Primary outcome measures

  • 1."Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0" 2."Therapeutic Effect as Assessed by RECIST1.1" [Time frame: 4 years]

Eligibility criteria

Inclusion criteria

  • The patient voluntarily participated in this study and signed the informed consent form;
  • Age range: 50 to 75 years old;
  • Patients with cervical cancer who had not undergone surgery or chemotherapy and were initially diagnosed with squamous cell carcinoma by pathological histology, and were HPV high-risk positive;
  • According to the 2018 International Federation of Gynecology and Obstetrics (FIGO) staging system, it was stage IIb (tumor size < 4 cm);
  • ECOG score: 0 to 1, with an expected survival of more than 6 months;
  • Pregnant women must undergo a pregnancy test (serum or urine) 7 days before enrollment, and the result must be negative, and they are willing to use appropriate contraceptive methods during the trial;
  • According to the investigator's judgment, there are no absolute contraindications to radiotherapy and chemotherapy or surgery, and they can comply with the trial protocol.

Exclusion criteria

  • Active or uncontrolled severe infections;
  • Cirrhosis, decompensated liver disease;
  • History of immunodeficiency, including HIV positive or having other acquired congenital immune deficiency diseases;
  • Chronic renal insufficiency and renal failure;
  • Patients with other malignancies that require treatment and/or newly diagnosed within 5 years;
  • Myocardial infarction, severe arrhythmia, and ≥ grade 2 congestive heart failure (NYHA classification);
  • Patients who have undergone pelvic artery embolization;
  • Patients who have received radiotherapy for pelvic malignant tumors in the past;
  • Patients who have received partial hysterectomy or radical hysterectomy in the past;
  • Patients with a history of severe allergic reaction to platinum-based chemotherapy drugs;
  • Comorbidities, requiring the use of drugs that cause significant liver and kidney damage during treatment, such as tuberculosis, etc.;
  • Patients who cannot understand the experimental content and cannot cooperate, or who refuse to sign the informed consent form;
  • Patients with serious accompanying diseases or other special conditions that seriously endanger their safety or affect their ability to complete the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07249957 · CQGOG0116

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗