Online Adaptive Radiotherapy Cervical Cancer With Reduced Margin for Cervical Cancer

Uterine Cervical Neoplasm Clinical Trial

Official title:

A Prospective Study to Evaluate Online Adaptive Radiotherapy in Cervical Cancer With Reduced Margin

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05880485
• Other study ID #: pumch-ART2
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Uterine Cervical Neoplasm
• Uterine Cervical Neoplasms

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