Online adaptive radiotherapy for cervical cancer treatment

Online Adaptive Radiotherapy (oART) in Radical Radiotherapy for Cervical Cancer - A Multi-center Randomized Controlled Study

This study tests if a new online adaptive radiotherapy can help women with cervical cancer get better results and experience fewer side effects compared to standard treatment.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 124 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Female
• Sponsor: Peking Union Medical College Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT06562166 on ClinicalTrials.gov

What this trial studies

This study evaluates the clinical efficacy and safety of online adaptive radiotherapy in patients with cervical cancer undergoing radical radiotherapy. It compares this approach with traditional image-guided radiotherapy to assess potential benefits in reducing treatment toxicity and enhancing local control of the cancer. The trial includes patients aged 18-70 with confirmed cervical squamous carcinoma and specific FIGO stages, who will receive concurrent chemotherapy. The study aims to provide insights into the effectiveness of adaptive radiotherapy in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with pathologically confirmed cervical squamous carcinoma at specific FIGO stages who are eligible for radical pelvic radiotherapy.

Not a fit: Patients with non-squamous types of cervical cancer or those not meeting the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to reduced treatment side effects and improved cancer control for cervical cancer patients.

How similar studies have performed: Previous studies have shown promise in adaptive radiotherapy approaches, suggesting potential benefits, though this specific application may be novel.

Eligibility criteria

Inclusion Criteria:

1. 18-80 years old;
2. Pathologically confirmed diagnosis of cervical cancer and pathological type of cervical squamous carcinoma;
3. 2018 FIGO Stage Ib3, II, IIIB and IIIC1
4. Proposed radical pelvic radiotherapy + concurrent sensitizing chemotherapy (platinum-based (cisplatin 30-40mg/m2 or carboplatin alone), starting concurrently in the first week, ≥5 courses)
5. ECOG score 0-2
6. Life expectancy greater than 6 months
7. Ability to remain lying down for more than 30 minutes
8. Patients were fully voluntary and autonomous and co-operated in signing the study informed consent form
9. Complete blood count and basal metabolic indexes within 14 days before enrolment must meet the following requirements: NEUT ≥ 1.5\*109/L, HGB ≥ 60g/L, platelets ≥ 100×109/, blood creatinine \<1.5 mg/dL. AST and ALT are within 2 times the upper limit of normal
10. Must complete baseline assessments and investigations required before treatment before enrolment
11. be eligible for regular follow-up

Exclusion Criteria:

1. Have received radiotherapy or chemotherapy in the past
2. Have undergone radical surgery for cervical cancer
3. Have a previous history of malignant tumor
4. Pregnant or lactating women
5. Presence of other serious co-morbidities such as poorly controlled cardiovascular, urinary, digestive, respiratory, hematological and central nervous system diseases.

Where this trial is running

Beijing

• Peking union medical college hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Shuai Sun

Conditions: Cervical Cancer, cervical cancer, adaptive radiotherapy