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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05880485
Other study ID # pumch-ART2
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date February 2, 2023
Est. completion date November 2025

Study information

Verified date November 2023
Source Peking Union Medical College Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date November 2025
Est. primary completion date November 6, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
online adaptive radiotherapy
PTV with 5-10 margins covers CTV

Locations

Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

de Jong R, Visser J, van Wieringen N, Wiersma J, Geijsen D, Bel A. Feasibility of Conebeam CT-based online adaptive radiotherapy for neoadjuvant treatment of rectal cancer. Radiat Oncol. 2021 Jul 23;16(1):136. doi: 10.1186/s13014-021-01866-7. — View Citation

Yen A, Choi B, Inam E, Yeh A, Lin MH, Park C, Hrycushko B, Nwachukwu C, Albuquerque K. Spare the Bowel, Don't Spoil the Target: Optimal Margin Assessment for Online Cone Beam Adaptive Radiation Therapy (OnC-ART) of the Cervix. Pract Radiat Oncol. 2023 Mar — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Patient-reported acute toxicity Patient-reported acute toxicity evaluated with European Organization for Research and Treatment of Cancer Quality of Life C30 (EORTC QLQ-C30) 3.0 questionnaire From the start of treatment to 3 months after treatment
Primary Physician-reported acute toxicity Physician-reported acute toxicity evaluated with Common Terminology Criteria for Adverse Events (CTCAE) 5.0 From the start of treatment to 3 months after treatment
Secondary Late toxicity evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme Evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme 2-year
Secondary The irradiated doses of organs at risk The organs at risk includes bladder, rectum, bone marrow, femur head left, femur head right and bowel that may be irradiated near the target volume Through study completion, an average of eight month
Secondary The dose coverage of target volume as assessed by planing tumor volume V100% Planing tumor volume V100%, defined as the planing tumor volume receiving at least 100% of the prescribed dose (V100%), is used to evaluate the dose coverage of target volume. Through study completion, an average of eight month
Secondary Target volume contouring accuracy For every target in each fraction, the evaluation of accuracy for target contouring are categorized as follow: no edits, minor edits, moderate edits, major edits and not applicable. Through study completion, an average of eight month
Secondary Response evaluation evaluated with RECIST 1.1 Evaluated with RECIST 1.1 One month after treatment
Secondary Movement of the uterus during per radiotherapy fractions The pre- and post-treatment CBCT scans will be obtained during per treatment. The uterus intra-fractional motion were evaluated by comparison of uterus centroid from pre-treatment CBCT and uterus centroid from post-treatment images. Through study completion, an average of eight month
Secondary Movement of the cervix during per radiotherapy fractions The pre- and post-treatment CBCT scans will be obtained during per treatment. The cervix intra-fractional motion were evaluated by comparison of cervix centroid from pre-treatment CBCT and cervix centroid from post-treatment images. Through study completion, an average of eight month
Secondary Progression-free survival Progression-free survival is defined as the time from randomization to disease progression or death from any cause, whichever is first. 2-year
Secondary Personalized margin for cervical cancer Pre- and post-treatment images are uploaded to the online adaptive radiotherapy simulator to re-delineate the target volume and determine the personalized margin range. Six month after treatment
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