Clinical trial NCT05880485: Online Adaptive Radiotherapy Cervical Cancer With Reduced Margin for Cervical Cancer
Official title: A Prospective Study to Evaluate Online Adaptive Radiotherapy in Cervical Cancer With Reduced Margin
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Uterine Cervical Neoplasm
Keywords: Uterine Cervical Neoplasm
Online Adaptive Radiotherapy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Patient-reported acute toxicity
timeFrame: From the start of treatment to 3 months after treatment
measure: Physician-reported acute toxicity
timeFrame: From the start of treatment to 3 months after treatment
Secondary outcomes:
measure: Late toxicity evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme
timeFrame: 2-year
measure: The irradiated doses of organs at risk
timeFrame: Through study completion, an average of eight month
measure: The dose coverage of target volume as assessed by planing tumor volume V100%
timeFrame: Through study completion, an average of eight month
measure: Target volume contouring accuracy
timeFrame: Through study completion, an average of eight month
measure: Response evaluation evaluated with RECIST 1.1
timeFrame: One month after treatment
measure: Movement of the uterus during per radiotherapy fractions
timeFrame: Through study completion, an average of eight month
measure: Movement of the cervix during per radiotherapy fractions
timeFrame: Through study completion, an average of eight month
measure: Progression-free survival
timeFrame: 2-year
measure: Personalized margin for cervical cancer
timeFrame: Six month after treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Fuquan Zhang, M.D.
role: STUDY_CHAIR
References:
citation: 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.
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-Apr;13(2):e176-e183. doi: 10.1016/j.prro.2022.10.009. Epub 2022 Nov 7.