A Clinical Study of Pelvic Concurrent Chemoradiotherapy Combined with CT-guided Intracavitary Brachytherapy with Adaptive Simultaneous Dose Escalation for Locally Advanced Cervical Cancer

NCT06882473 | Not Yet Recruiting

• 1 other identifier: 797-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The standard treatment for locally advanced cervical cancer is cisplatin-based concurrent chemoradiotherapy with external beam radiotherapy (EBRT) and Brachytherapy (BT). overall treatment time (OTT) has been found to be an important predictor of treatment response. Some studies have shown that the acceleration of tumor cell regeneration during the extension of radiotherapy leads to poor local control. Prolonging the overall treatment time of cervical cancer radiotherapy for more than 8 weeks leads to an increase in pelvic local control failure. Therefore, shortening OTT has great potential benefits from both clinical efficacy and social benefits. Shortening OTT in radical cervical cancer radiotherapy includes hypofractionated EBRT and shortening the interval between BT and EBRT. However, further shortening OTT may lead to an increase in acute and late toxicity. Adaptive radiotherapy (ART) strategies systematically monitor variations in target and neighbouring structures to inform treatment-plan modification during radiotherapy. The application of image-guided adaptive brachytherapy (IGABT) has clearly demonstrated the advantages of this approach in the treatment of cervical cancer. Previous studies have shown that the implementation of IGABT can achieve personalized treatment, dose increase, improve clinical efficacy, reduce normal tissue toxicity and side effects, and strengthen international standardized quality control. In this study, online adaptive pelvic EBRT combined with IGABT based on uRT-linac was performed under online CT guidance. The aim of this study is to evaluate the safety and efficacy of pelvic concurrent chemoradiotherapy combined with CT-guided intracavitary brachytherapy with adaptive simultaneous dose escalation in locally advanced cervical cancer.

Conditions

Locally Advanced Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• the nature of adverse events

  the nature of adverse events is assessd by RTOG/EORTC radiation toxicity grading

  The time frame extends from the initiation of radiotherapy to 24 months after the completion of radiotherapy

• the frequency of adverse events

  The time frame extends from the initiation of radiotherapy to 24 months after the completion of radiotherapy

Secondary Outcomes (3)

• objective response rate

  The time frame extends from the initiation of radiotherapy to 12 months after the completion of radiotherapy

• tumor control rate

  The time frame extends from the initiation of radiotherapy to 24 months after the completion of radiotherapy

• local progression-free survival time

  The time frame extends from the initiation of radiotherapy until the first recorded local recurrence, with an initial assessment period of 24 months.

Study Arms (1)

treatment group

EXPERIMENTAL

External beam radiation therapy: The patients are irradiated with 6MV X-rays at 1.8Gy per fraction, 5 fractions per week, with a total dose of 45-50.4Gy in 25-28 fractions for 5-6 weeks. Brachytherapy: CT-guided 192Ir high dose rate brachytherapy is used, twice a week, on the same day as external beam radiation therapy, 6Gy per fraction, a total dose of 30Gy. The total radiotherapy dose shouldn't be less than 85Gy EQD2. The overall treatment time ≤ 45 days. Chemotherapy: Cisplatin 40 mg/m2, d1, i.v. weekly. Six cycles of concurrent chemotherapy should be completed. Treatment continued until disease progression, unacceptable toxic effects happened, or a decision by the investigator and/or patient to discontinue treatment.

Other: Brachytherapy and CT-guided online adaptive external beam pelvic radiotherapy are delivered on the same day

Interventions

Brachytherapy and CT-guided online adaptive external beam pelvic radiotherapy are delivered on the same day OTHER

Brachytherapy and CT-guided online adaptive external beam pelvic radiotherapy are delivered on the same day.

treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the informed consent;
• Age :18 to 75 years old;
• Histologically or cytologically confirmed cervical cancer;
• According to the International Federation of Gynecology and Obstetrics (FIGO 2018) stage IB3, IIA2, IIB, III, IV (local advanced), and had not received treatment before enrollment;
• Measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
• ECOG physical performance score 0-2;
• Expected survival time \>= 3 months;
• LVEF \>= 55%;
• Bone marrow function: neutrophil \>= 1.5×109/L, platelet ≥ 100×109/L, white blood cell 4.0-10.0×109/L, hemoglobin \>= 90 g/L;
• Liver and kidney function: serum creatinine \<= 1.5 times upper limit of normal; AST and ALT≤2.5 times upper limit of normal (ULN) or \<= 5 times ULN in the presence of liver metastasis; Total bilirubin \<=1.5 times upper limit of normal, or \<= 2.5 times upper limit of normal if the patient has Gilbert's syndrome;
• Subjects of childbearing age must agree to use effective contraception during the trial, and women of childbearing age must have a negative serum or urine pregnancy test;
• Non-lactating patients;

You may not qualify if:

• Patients with prior abdominal or pelvic radiotherapy;
• being mentally ill and unable to cooperate with treatment;
• Serious uncontrolled medical diseases, such as serious internal medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
• Unable to tolerate cisplatin chemotherapy;
• receiving other experimental drugs or participating in clinical trials for other anticancer treatment purposes within 30 days before the first radiotherapy;
• Severe infection within 4 weeks before study treatment, including but not limited to infectious complications requiring hospitalization, bacteremia, or severe pneumonia;
• Human immunodeficiency virus (HIV) -positive persons;
• Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) antibody positive and HCV RNA test positive;
• Patients judged by the investigator to be ineligible for the study.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Interventions

Brachytherapy

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Ping Jiang

  Peking University Third Hospital

  STUDY DIRECTOR

Central Study Contacts

Junjie Wang professor

CONTACT

0086-17355240686; junjiewang@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: March 18, 2025
• Study Start: March 15, 2025
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)