Optimal Margin Evaluation of Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer

NCT05682950Active, Not RecruitingPHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Peking Union Medical College Hospital

Enrollment

15

Start Date

2022-09-12

Completion Date

2023-02-06

Study Type

INTERVENTIONAL

Official Title

A Prospective Study to Evaluate Optimal Margin of Iterative Cone-beam Computed Tomography Guided Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer

Interventions

online adaptive radiotherapy

Conditions

Uterine Cervical NeoplasmEndometrial Neoplasms

Eligibility

Age Range

18 Years – 70 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

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.

Time frame: Through study completion, total an average of six month

A minimum PTV margin could encompass CTV

Expansions were applied to the pretreatment PTV to assess required minimum margin required to encompass the postreatment CTV.

Time frame: Through study completion, toral an average of six month

Secondary Outcomes

Safety for treatment as assessed by organs at risk doses

Safety for treatment was mainly evaluated by the organs at risk doses, including bladder, rectum, bone marrow, etc

Time frame: Through study completion, total an average of six month

Number of participants with acute toxicity as assessed by CTCAE 5.0

Evaluated with CTCAE 5.0

Time frame: From the start of treatment to 3 months after treatment

Adaptive time data

For each treatment in each fraction, adaptive time was recorded from first cone beam computed tomography (CBCT) to the selection of the preferred plan for the treatment.

Time frame: Through study completion, total an average of six month

Target 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.

Time frame: Through study completion, total an average of six month

Organs at risk contouring accuracy

For every organs at risk in each fraction, the evaluation of accuracy for organs at risk contouring are categorized as follows: no edits, minor edits, moderate edits, major edits and not applicable.

Time frame: Through study completion, total an average of six month

Late toxicity evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme

Evaluated every three months with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme

Time frame: total an average of 2-year

Locations

Peking Union Medical College Hospital, Beijing, China

Optimal Margin Evaluation of Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer