Adaptive Radiotherapy, Cervical Cancer
Conditions
Keywords
Cervical Cancer, Moderated Hypofractionated Radiotherapy, Adaptive Radiotherapy, Randomized controlled trial
Brief summary
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.
Detailed description
This is a multicenter, non-inferiority, phase 3, randomized controlled study. This study investigates the role of moderated hypofractionated online adaptive radiotherapy by randomizing patients to this experimental regimen versus the standard of treatment.The purpose of this study is to access safety and efficacy of moderated hypofractionated online adaptive radiotherapy in combination with high-dose-rate brachytherapy in patients with cervical cancer, which based on the previous research (NCT05994300).
Interventions
COMBINATION_PRODUCTModerated hypofractionated online adaptive radiotherapy
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
COMBINATION_PRODUCTConventional radiotherapy
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
Sponsors
Peking University Cancer Hospital & Institute
Shandong Cancer Hospital and Institute
Ruijin Hospital
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. The patient is fully voluntary and has the capacity for autonomy, signing the informed consent form 30 days prior to enrollment 2. Age ≥18 and ≤75 years 3. FIGO stage IB-IIIB cervical cancer; IIIC1 (lymph node metastasis ≤2 cm, without common iliac lymph node metastasis) 4. Pathologically diagnosed as squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma 5. Concurrent weekly cisplatin therapy ± immunotherapy 6. Able to undergo brachytherapy 7. ECOG performance status of 0-1, with an expected ability to tolerate lying flat for half an hour.
Exclusion criteria
1. Patients who have undergone cervical cancer surgery, excluding pelvic lymphadenectomy or pelvic lymph node dissection, or cervical conization 2. FIGO stages IA, IIIC2, IVA, or IVB 3. FIGO stage IIIC1 with lymph nodes \>2 cm, or with common iliac lymph node metastasis 4. History of prior abdominal or pelvic radiotherapy 5. Pregnant or breastfeeding women 6. Patients with active infections or fever 7. Other severe diseases that may significantly affect clinical trial compliance, such as unstable heart disease, kidney disease, chronic hepatitis requiring treatment, poorly controlled diabetes, or mental disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 3 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute toxicity | 3 months | 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. |
| Late toxicity | 3 years | Late toxicities will be collected from 3 months after completion of radiation onwards until the end of follow-up. |
| Overall survival | 3 years | Defined as time from date of randomization to date of death from any cause, or date of last follow-up, whichever occurs first. |
| Quality of life (QoL) | 3 years | 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. |
| Quality of Life (QoL) | 3 years | QoL will be measured by the cervical cancer module (QLQ-CX24). QLQ-CX24 includes cancer - and treatment - related items and symptoms regarding sexuality. Acute and late vaginal and sexual QoL will be assessed using the QLQ-CX24 vaginal and sexual domains respectively. The QLQ-CX24 responses are regarding function and symptoms of sexual and vagina health. It is based on a scale of 1 (not at all) to 4 (very much). |
| Tumor response evaluation Complete remission rate | 3 months | Evaluated with RECIST 1.1 |
| Metastasis-free survival | 3 years | Defined as time from date of randomization to date of development of metastasis, date of death from any cause, or date of last follow-up, whichever occurs first. |
| Cervical cancer-specific survival | 3 years | Defined as time from date of randomization to date of death attributed to cervical cancer, or date of last-follow-up, whichever occurs first. |
| Treatment expense | 3 months | The treatment-related costs incurred during the course of treatment. |
| Locoregional progression-free survival | 3 years | Defined as time from date of randomization to date of locoregional progression, date of death from any cause, or date of last follow-up, whichever occurs first. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assessment of tumor regression throughout EBRT | 3 months | To be assessed through volumetric comparison of tumor volume in the pre-EBRT and post-EBRT MRI scans. |
Countries
China
Contacts
Primary ContactZheng Zeng, MD.
Outcome results
None listed