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Trial Title:
Moderately Hypofractionated Adaptive Radiotherapy for Cervical Cancer
NCT ID:
NCT05994300
Condition:
Cervical Neoplasm
Adaptive Radiotherapy
Radiotherapy; Adverse Effect
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
moderately hypofractionated radiotherapy
adaptive radiotherapy
cervical cancer.
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Moderately hypofractionated adaptive radiotherapy (ART)+ High-dose rate (HDR) Brachytherapy
Description:
Experimental: 43.35Gy/17F external beam radiotherapy (EBRT) with adaptive radiotherapy
(ART) + HDR-Brachytherapy
Drug: Concurrent Chemotherapy
Weekly cisplatin 40 mg/m2
Arm group label:
Moderately Hypofractionated Adaptive Radiotherapy
Summary:
External radiation given in 25 fractions or so together with weekly chemotherapy and
followed by 5 or 6 fractions of brachytherapy is the standard of care for patients with
locally advanced cervical cancer. We hope to develop external moderately hypofractionated
radiotherapy of cervical cancer based on adaptive radiotherapy.The objective of this
study is to evaluate the efficacy and treatment-related toxicity of moderately
hypofractionated adaptive radiotherapy in the treatment of cervical cancer.
Detailed description:
This is an investigator-initiated efficacious, single-center, open-label clinical trial
study. This study hypothesizes that the use of external moderately hypofractionated
radiotherapy of cervical cancer based on adaptive radiotherapy. A dose of 43.35Gy in 17
fractions is delivered to clinical target volume (CTV). Patients receive cisplatin based
concurrent chemotherapy. The primary endpoint is acute toxicity.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Age 18 years to 70 years
FIGO Stage IB1, IB2, IB3, IIA or IIB cervical cancers
FIGO stage IIIC1 cervical cancers are candidates but must meet all the following
criteria:largest node is less than 1.5 cm,less than 3 pathological nodes,No nodes located
in the common iliac chain
Histology: squamous
Candidate for definitive chemoradiotherapy to be delivered with weekly cisplatin
Brachytherapy candidate
Functional State Eastern Cooperative Oncology Group (ECOG)0-2
Exclusion Criteria:
Patients who had chemotherapeutic, surgical and/or radiotherapy treatment
FIGO stage IIIA, IIIB, IIIC2, IVA or IVB
FIGO stage IIIC1 with node greater than 1.5 cm, common iliac node or greater than 2
pathological nodes
Previous pelvic or abdominal radiotherapy
Patient unable to undergo MR scan
ECOG performance status greater than 2
Not a cisplatin candidate
Other factors that contraindicate experimental therapy
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100010
Country:
China
Status:
Recruiting
Contact:
Last name:
Fuquan Zhang, prof
Phone:
86-10-69155485
Email:
Zhangfq@pumch.cn
Start date:
September 19, 2023
Completion date:
December 31, 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/NCT05994300
