To hear about similar clinical trials, please enter your email below
Trial Title:
Online Adaptive Radiotherapy Cervical Cancer With Reduced Margin for Cervical Cancer
NCT ID:
NCT05880485
Condition:
Uterine Cervical Neoplasm
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
Uterine Cervical Neoplasm
Online Adaptive Radiotherapy
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
online adaptive radiotherapy
Description:
PTV with 5-10 margins covers CTV
Arm group label:
Online Adaptive Radiotherapy
Summary:
Online adaptive radiotherapy (oART) has demonstrated to be feasible to reduce planning
target volume (PTV) margins for cervical cancer. To explore the value of reduced margins
in oART for cervical cancer, we conducted a prospective clinical trial to determine the
clinical efficacy and toxicity of reduced margins.
Detailed description:
This is an investigator-initiated efficacious, single-center, open-label clinical trial
study. This study hypothesizes that the use of reduced PTV margins in oART for cervical
cancer could decrease toxicity and achieve more accurate dosimetric coverage. A dose of
50.4 Gy is delivered to clinical target volume (CTV) with reduced margin oART. Patients
receive cisplatin based concurrent chemotherapy. The primary endpoint is acute toxicity.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients must be informed of the investigational nature of this study and give
written informed consent before treatment.
2. Age ≥18 years and ≤ 75 years.
3. Patients with newly histologically confirmed cervical cancer, including squamous
cell carcinoma, adenocarcinoma and adenosquamous carcinoma, et al.
4. No evidence of para-aortic metastatic lymph nodes (MLNs) and inguinal lymph nodes on
CT, MRI or positron emission tomograph (PET)/CT.
5. No contraindications to CT scanning.
6. No evidence of distant metastasis (FIGO stage IVB).
7. Adequate marrow: neutrophile granulocyte count ≥1.5*10^9/L, hemoglobin ≥ 80 g/L,
platelet count ≥100*10^9/L.
8. Normal liver and kidney function: Creatinine (Cr) < 1.5 mg/dl, Alanine
Aminotransferase (ALT), Aspartate Aminotransferase (AST) < 2*upper limit of normal
(ULN).
Exclusion Criteria:
1. With common iliac MLNs.
2. Tumor extended to the lower third of the vagina.
3. Tumor spread to mucosa of the bladder or rectum.
4. Prior surgery (including pelvic or para-aortic lymph nodes resection, except for
tumor biopsy), radiotherapy or chemotherapy to primary tumor or nodes.
5. Prior malignancy.
6. History of previous radiotherapy to the abdomen or pelvis.
7. Pregnancy or lactation.
8. Active inflammatory bowel disease, or history of severe stomach or duodenal ulcer.
9. Active infection with fever.
10. Patients with unacceptable risk that intracavitary brachytherapy can not be
conducted.
11. Any severe disease which may bring unacceptable risk or affect the compliance of the
trial, for example, unstable cardiac disease requiring treatment, renal disease,
chronic hepatitis, diabetes with poor control, and emotional disturbance.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Start date:
February 2, 2023
Completion date:
November 2025
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05880485
