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

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05682950

Collaborator

(none)

Enrollment

Location

Arm

6.6

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Online adaptive radiotherapy has demonstrated to be feasible to reduce inter-fractional radiotherapy errors as it re-optimizes treatment plan every fraction. To investigate the extent and value of margin reduction，we conduct a prospective clinical trial to determine the optimal margin and toxicity of smaller margin.

Condition or Disease	Intervention/Treatment	Phase
Uterine Cervical Neoplasm Endometrial Neoplasms	Radiation: online adaptive radiotherapy	Phase 2

Detailed Description

This is a prospective phase II clinical trial with an anticipated total of more than 380 radiotherapy fractions of 15 patients to evaluate optimal margin of iterative cone-beam computed tomography（iCBCT） guided online adaptive radiotherapy （oART） for postoperative treatment of endometrial and cervical cancer. Postoperative endometrial and cervical cancer patients with following characteristics are included in the present study:（a）underwent radical surgery （b）no residual tumor at the resection margin by postoperative pathology（c）pathological findings indicate risk factors but no metastasis (d) adjuvant radiotherapy are prescribe (e)without evidence of para-aortic metastatic lymph nodes. Five patients （almost 125 fractions）treated with oART have the target volume contoured on pre-treatment iCBCTs and end-treatment iCBCTs. Anterior-posterior, lateral, and superior-inferior shifts were calculated and the average shift in all directions was calculated. A clinical target volume (CTV) to planing tumor volume (PTV) expansion is determined and verifies on a validation cohort of 10 patients (almost 250 fractions) treated with oART. Record acute toxicity from the start of treatment to 3 months after treatment.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 12, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Online Adaptive Radiotherapy Patients receive online adaptive radiotherapy. The CTV contours of the following areas: vaginal cuff, obturator nodal chain, internal iliac nodal chain, external iliac nodal chain, presacral nodal chain and common iliac nodal chain. The upper border of CTV is at the level of aortic bifurcation. A dose of 45-50.4Gy is delivered to CTV with online adaptive radiotherapy.	Radiation: online adaptive radiotherapy CTV covers pelvis.

Arm

Intervention/Treatment

Experimental: Online Adaptive Radiotherapy

Patients receive online adaptive radiotherapy. The CTV contours of the following areas: vaginal cuff, obturator nodal chain, internal iliac nodal chain, external iliac nodal chain, presacral nodal chain and common iliac nodal chain. The upper border of CTV is at the level of aortic bifurcation. A dose of 45-50.4Gy is delivered to CTV with online adaptive radiotherapy.

Radiation: online adaptive radiotherapy

CTV covers pelvis.

Outcome Measures

Primary Outcome Measures

The dose coverage of target volume as assessed by planing tumor volume V100% [Through study completion, an average of six month]
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.

Secondary Outcome Measures

Safety for treatment as assessed by organs at risk doses [Through study completion, an average of six month]
Safety for treatment was mainly evaluated by the organs at risk doses, including bladder, rectum, bone marrow, etc
Number of participants with acute toxicity as assessed by CTCAE 5.0 [From the start of treatment to 3 months after treatment]
Evaluated with CTCAE 5.0
Adaptive time data [Through study completion, an average of six month]
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.
Target contouring accuracy [Through study completion, an average of six month]
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.
Organs at risk contouring accuracy [Through study completion, an average of six month]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients must be informed of the investigational nature of this study and give written informed consent before treatment.
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).
Pathological findings indicate risk factors and adjuvant radiotherapy are prescribe.
Karnofsky score ≥ 70.
Subjects aged ≥ 18 years and ≤ 70 years.
No evidence of para-aortic metastatic lymph nodes.
No contraindications to CT scanning.
Subjects must be able to cooperate in completing the entire study.
Adequate marrow: neutrophile granulocyte count ≥1.510^9/L, hemoglobin ≥ 80 g/L, platelet count ≥10010^9/L.
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:

Subjects who have received prior pelvic radiotherapy.
Subjects with other primary malignancies.
Subjects with contraindications to radiotherapy, as determined by the investigators.
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.
Active infection with fever.
Active inflammatory bowel disease.