Online Adaptive Radiotherapy for Cervical Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 2

Conditions: Cervical Cancer

Treatments: Radiation: online adaptive radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06562166

ART_cervical cancer

Details and patient eligibility

About

This study aims to evaluate the clinical efficacy and safety of online adaptive radiotherapy for cervical cancer patients received radical radiotherapy. By comparing with image-guided radiotherapy, the study explores the potential advantages of online adaptive radiotherapy in reducing treatment toxicity and improving local control.

Enrollment: 124 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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124 participants in 2 patient groups

ART

Experimental group

Treatment:

Radiation: online adaptive radiotherapy

IGRT

No Intervention group