Clinical trial NCT05869123: Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer
Official title: A Prospective Study to Evaluate Online Adaptive Radiotherapy in Postoperative Treatment of Endometrial and Cervical with Reduced Margin
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Uterine Cervical Neoplasm
Endometrial Neoplasms
Keywords: Uterine Cervical Neoplasm
Endometrial Neoplasms
Online Adaptive Radiotherapy
Adjuvant Radiotherapy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
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 postoperative treatment of endometrial and cervical cancer. To explore the value of reduced margins in oART for postoperative treatment of endometrial and 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 postoperative treatment of endometrial and cervical cancer could decrease toxicity and achieve more accurate dosimetric coverage. A dose of 45 or 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. The first 10 patients were included in the study that have demonstrated the feasibility of reducing the margin (ClinicalTrials.gov ID: NCT05682950).

Eligibility criteria: Inclusion Criteria:

1. Patients must be informed of the investigational nature of this study and give written informed consent before treatment.
2. Postoperative endometrial and cervical cancer patients with pathologically confirmed no residual tumor at the resection margin and no evidence of distant metastasis (FIGO stage IVB).
3. Pathological findings indicate risk factors and adjuvant radiotherapy are prescribe.
4. Karnofsky score ≥ 70.
5. Subjects aged ≥ 18 years and ≤ 70 years.
6. No evidence of para-aortic metastatic lymph nodes.
7. No contraindications to CT scanning.
8. Subjects must be able to cooperate in completing the entire study.
9. Adequate marrow: neutrophile granulocyte count ≥1.5\*10\^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100\*10\^9/L.
10. 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. Subjects who have received prior pelvic radiotherapy.
2. Subjects with other primary malignancies.
3. Subjects with contraindications to radiotherapy, as determined by the investigators.
4. 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.
5. Active infection with fever.
6. Active inflammatory bowel disease.

Primary outcomes:
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 dose coverage of target volume as assessed by planing tumor volume V100%
timeFrame: Through study completion, an average of five month
measure: Target automatically contouring accuracy
timeFrame: Through study completion, an average of five month
measure: Organs at risk contouring accuracy
timeFrame: Through study completion, an average of five month
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: Schiff JP, Stowe HB, Price A, Laugeman E, Hatscher C, Hugo GD, Badiyan SN, Kim H, Robinson CG, Henke LE. In Silico Trial of Computed Tomography-Guided Stereotactic Adaptive Radiation Therapy (CT-STAR) for the Treatment of Abdominal Oligometastases. Int J Radiat Oncol Biol Phys. 2022 Dec 1;114(5):1022-1031. doi: 10.1016/j.ijrobp.2022.06.078. Epub 2022 Jun 26.