Clinical trial · Interventional
Reducing Radiation Target Volume for Stage IIb Cervical Cancer
Reducing Radiation Target Volume in Radical Radiotherapy for Stage IIb Cervical Cancer: A Single-arm Exploratory Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IIb Cervical Cancer Radical Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 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. | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radical radiotherapy for IIb cervical cancer to reduce the irradiation area
- interventionNames
- 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.
Primary outcomes (1)
- measure
- 1."Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0" 2."Therapeutic Effect as Assessed by RECIST1.1"
- timeFrame
- 4 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patient voluntarily participated in this study and signed the informed consent form; 2. Age range: 50 to 75 years old; 3. 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; 4. According to the 2018 International Federation of Gynecology and Obstetrics (FIGO) staging system, it was stage IIb (tumor size \< 4 cm); 5. ECOG score: 0 to 1, with an expected survival of more than 6 months; 6. 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; 7. 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: 1. Active or uncontrolled severe infections; 2. Cirrhosis, decompensated liver disease; 3. History of immunodeficiency, including HIV positive or having other acquired congenital immune deficiency diseases; 4. Chronic renal insufficiency and renal failure; 5. Patients with other malignancies that require treatment and/or newly diagnosed within 5 years; 6. Myocardial infarction, severe arrhythmia, and ≥ grade 2 congestive heart failure (NYHA classification); 7. Patients who have undergone pelvic artery embolization; 8. Patients who have received radiotherapy for pelvic malignant tumors in the past; 9. Patients who have received partial hysterectomy or radical hysterectomy in the past; 10. Patients with a history of severe allergic reaction to platinum-based chemotherapy drugs; 11. Comorbidities, requiring the use of drugs that cause significant liver and kidney damage during treatment, such as tuberculosis, etc.; 12. Patients who cannot understand the experimental content and cannot cooperate, or who refuse to sign the informed consent form; 13. Patients with serious accompanying diseases or other special conditions that seriously endanger their safety or affect their ability to complete the study.
References
Publications (0)
Data not yet available