Adaptive Radiotherapy in Patients With Gynecological Tumors

NCT ID: NCT06230549

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2026-12-15

Brief Summary

Prospective randomized evaluation of adaptive radiotherapy in the definitive radiotherapy of locally advanced gynecologic carcinoma (e.g. cervical carcinoma, endometrial carcinoma, vaginal carcinoma), in the postoperative situation or first series of external beam radiotherapy and in patients in whom radical surgery or HDR brachytherapy as dose boost is not an option.

Detailed Description

Online-adaptive radiotherapy (ART) makes it possible to adapt the dose distribution to the anatomical changes online immediately before each radiation fraction. Adaptive radiotherapy is a further development of image-guided radiotherapy (IGRT), which is now standard in radiotherapy. Here, a cone-beam CT (CBCT) is also performed at the beginning of each fraction, which is used to position the patients in relation to the radiation field arrangement of the initial radiation plan approved for the series. In contrast to ART, with IGRT the radiation plan cannot be adapted to deformations in the body from radiation fraction to radiation fraction, e.g. due to different rectum and bladder fillings.

In ART mode, the online adaptive treatment plan for the current treatment is then selected and approved by the specialist online onboard in all cases in which the current target volume for the tumor expansion is not sufficiently covered by the initial treatment plan pre-planned for the series with its planned tolerances, or surrounding normal tissue is exposed too much. If the ART plan does not show any clear dosimetric advantages over the reference plan, especially if the initial plan covers the target volume of the day well, there are no dose increases and the normal tissues are spared as intended, the initial radiation plan from the planning CT can also be used as in IGRT. The aim of this study is to treat at least 15 patients with locally advanced gynecological carcinoma (mainly cervical carcinoma, endometrial carcinoma, vaginal carcinoma), who are to receive definitive radiotherapy at the Department for Radiotherapy at the University Hospital Essen, in ART mode on the Ethos therapy device over an initial 10 radiation fractions. The dose distribution is always compared with the adaptive and the initial plan for the radiation series on the anatomy of the day by the specialist and medical physics expert. The aim of this study is to prospectively investigate what percentage of patients benefit from ART when using standard PTV margins and how to recognize the corresponding patients early in the series. Secondarily, it will be investigated in what proportion of patients the risk organ burden and the safety margins around the clinical target volume can be reduced with ART compared to IGRT and how large this reduction can be.

The EORTC and CTC AE toxicitiy scales and further assessment scales will be evaluated in order to quantify objective and subjective side effects.

Conditions

Gynecological Tumor; Adaptive Radiotherapy; Radiation; Curative Treatment; Optimization; Adaptive Radiation Therapy; Image Guided Radiotherapy; Cervical Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Interventional Arm

Adaptive Radiotherapy

Group Type: EXPERIMENTAL

Adaptive Radiotherapy

Intervention Type: RADIATION

Adaptive Radiotherapy, online onboard adaptation of dose distribution with a specialist radiation oncologist and a medical physicist

Standard conventional Treatment Arm, IGRT

Standard conventional Treatment Arm, IGRT

Group Type: ACTIVE_COMPARATOR

Adaptive Radiotherapy

Intervention Type: RADIATION

Adaptive Radiotherapy, online onboard adaptation of dose distribution with a specialist radiation oncologist and a medical physicist

Interventions

Adaptive Radiotherapy

Adaptive Radiotherapy, online onboard adaptation of dose distribution with a specialist radiation oncologist and a medical physicist

Intervention Type: RADIATION

Other Intervention Names

Adaptive Radiation Therapy

Eligibility Criteria

Inclusion Criteria

ECOG 0-1 confirmation by histophatology MR of the pelvis staging

Exclusion Criteria

Recurrent disease Prior Radiotherapy in pelvic region stage pM1 or cM1

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Essen

OTHER

Sponsor Role: lead

Responsible Party

Maja Guberina

PD Dr. med. (MD) M. Guberina (senior consultant, specialist)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases (NCT) West

Essen, Germany / NRW, Germany

Site Status: RECRUITING

Countries

Germany

Facility Contacts

Maja Guberina, PD Dr. med. (MD), specialist

Role: primary

maja.guberina@uk-essen.de

+492017232321

Ina Grübel

Role: backup

References

Guberina M, Santiago Garcia A, Khouya A, Pottgen C, Holubyev K, Ringbaek TP, Lachmuth M, Alberti Y, Hoffmann C, Hlouschek J, Gauler T, Lubcke W, Indenkampen F, Stuschke M, Guberina N. Comparison of Online-Onboard Adaptive Intensity-Modulated Radiation Therapy or Volumetric-Modulated Arc Radiotherapy With Image-Guided Radiotherapy for Patients With Gynecologic Tumors in Dependence on Fractionation and the Planning Target Volume Margin. JAMA Netw Open. 2023 Mar 1;6(3):e234066. doi: 10.1001/jamanetworkopen.2023.4066.

Reference Type: BACKGROUND

PMID: 36947038 (View on PubMed)

Other Identifiers

23-11675-BO

Identifier Type: -

Identifier Source: org_study_id