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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorPeking University Third Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

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

    Other intervention

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

the nature of adverse events

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

Time frame
The time frame extends from the initiation of radiotherapy to 24 months after the completion of radiotherapy
2

the frequency of adverse events

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

Secondary outcomes

1

objective response rate

Time frame
The time frame extends from the initiation of radiotherapy to 12 months after the completion of radiotherapy
2

tumor control rate

Time frame
The time frame extends from the initiation of radiotherapy to 24 months after the completion of radiotherapy
3

local progression-free survival time

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

Other outcomes

Sponsors and contacts

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