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Moderated Hypofractionated Online Adaptive Radiotherapy in Cervical Cancer

ConditionsCervical CancerAdaptive Radiotherapy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorPeking Union Medical College Hospital

About this trial

The most common external beam radiotherapy fractionation scheme for cervical cancer is 45-50.4 Gy delivered in 25-28 fractions. However, prolonged treatment duration can lead to insufficient availability of medical resources. We hope to assess the safety and efficacy of moderated hypofractionated online adaptive radiotherapy in combination with brachytherapy in patients with cervical cancer in a multicenter study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient is fully voluntary and has the capacity for autonomy, signing the informed consent form 30 days prior to enrollment

Age ≥18 and ≤75 years

FIGO stage IB-IIIB cervical cancer; IIIC1 (lymph node metastasis ≤2 cm, without common iliac lymph node metastasis)

Pathologically diagnosed as squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma

Disqualifiers

Patients who have undergone cervical cancer surgery, excluding pelvic lymphadenectomy or pelvic lymph node dissection, or cervical conization

FIGO stages IA, IIIC2, IVA, or IVB

FIGO stage IIIC1 with lymph nodes >2 cm, or with common iliac lymph node metastasis

History of prior abdominal or pelvic radiotherapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Moderated hypofractionated online adaptive radiotherapy

    Combination product

    Radiation: Moderated hypofractionated online adaptive radiotherapy (oART)+ High-dose rate (HDR) Brachytherapy Experimental group: 43.35Gy/17F external beam radiotherapy with oART + HDR-Brachytherapy Drug: Concurrent Chemotherapy or immunotherapy Weekly cisplatin 40 mg/m2 or PD-1 inhibitors

  • Conventional radiotherapy

    Combination product

    Radiation: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Contral group: 45Gy/25F EBRT + HDR-Brachytherapy Drug: Concurrent Chemotherapy or immunotherapy Weekly cisplatin 40 mg/m2 or PD-1 inhibitors

Treatment groups

440 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression Free Survival

Defined as time from date of randomization to date of progression, date of death from any cause, or date of last follow-up, whichever occurs first. Cancer progression can be identified during physical exam, biopsy, or imaging of any kind.

Time frame
3 years

Secondary outcomes

1

Acute toxicity

This outcome is assessed by physicians during each follow-up appointment, and scored according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 . Clinically relevant toxicities of gastrointestinal, genitourinary, vaginal and non-specific general symptoms (i.e. fatigue, malaise and pain) will be collected. Hematological disorders will also be collected through weekly blood work checks. Acute toxicities will be collected at baseline, and then weekly during radiotherapy/chemoradiotherapy and at 3 months after completion of radiation.

Time frame
3 months
2

Late toxicity

Late toxicities will be collected from 3 months after completion of radiation onwards until the end of follow-up.

Time frame
3 years
3

Overall survival

Defined as time from date of randomization to date of death from any cause, or date of last follow-up, whichever occurs first.

Time frame
3 years
4

Quality of life (QoL)

QoL will evaluated by the EORTC QLQ-C30 questionnaire.QLQ-C30 questionnaire is used for all cancers and has several symptom scales, five functional scales (physical, emotional, social, role, cognitive) and a global health status scale. Response options are a four-point Likert scale from "not at all" to "very much" or a seven-point Likert scale from "very poor" to "excellent."

Time frame
3 years

Other outcomes

1

Assessment of tumor regression throughout EBRT

To be assessed through volumetric comparison of tumor volume in the pre-EBRT and post-EBRT MRI scans.

Time frame
3 months

Sponsors and contacts

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Peking Union Medical College Hospital

Lead sponsor

Peking University Cancer Hospital & Institute

Collaborator

Shandong Cancer Hospital and Institute

Collaborator

Ruijin Hospital

Collaborator

Source ClinicalTrials.gov
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