Reducing Radiation Target Volume for Stage IIb Cervical Cancer

ConditionStage IIb Cervical Cancer Radical Radiotherapy

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age50-75

SponsorChongqing University Cancer Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

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
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.

Treatment groups

60 Participants

are divided into 1 treatment group

Group A: Radical radiotherapy for IIb cervical cancer to reduce the irradiation areaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chongqing University Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: