Faster radiation treatment for pelvic cancer patients with dose and side effects evaluation.

Not yet recruiting

Conditions: Malignant neoplasm of endocervix, (2) ICD-10 Condition: C541||Malignant neoplasm of endometrium, (3) ICD-10 Condition: C61||Malignant neoplasm of prostate, (4) ICD-10 Condition: C20||Malignant neoplasm of rectum,

Registration Number: CTRI/2025/06/089176

Lead Sponsor: Department of Radiation Oncology,Kasturba Medical College,Kasturba Hospital,Manipal 576104

Brief Summary: Patients meeting the eligibilitycriteria will be screened for the study and included after informed consent.Patients with pelvic cancers considered for radiotherapy will be planned withtwo plans—standard VMAT and FFF VMAT with MCO. The planning time will berecorded for both techniques. All planned cases will be subjected topretreatment review in terms of dose per fraction, monitor units, volumehistogram analysis, conformity index, Homogeneity index for targets, and OARsdose parameters as per standard reports. The pretreatment review board willcomprise of at least 2 senior radiation oncologists (>10 years’ experience)and one senior physicist. Based on the discussion, the best plan will be chosenfor treatment. The comments of the review group will be prospectively recorded.The feasibility of choosing a FFF VMAT plan will be recorded prospectively overtwo years.

The standard VMAT and FFF VMATplans will be compared in terms of dosimetricoutcomes, planning time and delivery time (Monitor units). The DVH parameterssuch as target dose coverage, dose to OAR, and normal tissue with all VMATplans, will be collected for each pelvic cases after approval, and derived valuesof Conformity index, HI for target, and Gradient index, treatment planningtime, beam on time, monitor units will be recorded/estimated for analysis. The patients for whom Standard VMAT or FFF VMAT areapproved will be included in the study after informed consent. The patientswill receive treatment as per standard practice for the pelvic sites.

Patient specific quality assurancewill be carried out for planned case prior to implementation. Point dose andFluence maps from RTPS for all optimized plans will be transferred to pelvicphantom to deliver and to match delivered fluence against planned fluence with3% 3mm criteria and 3% for point dose.

The implementation time fortreatment delivery (treatment planning to treatment delivery including QA time)will be recorded.

The acute toxicity will be assessed using theCommon Terminology Criteria for Adverse Events (CTCAE) version 5.0 at baseline,weekly during treatment, and post-treatment at one, three and 6 months. The quality of life will be assessed using EORTC QLQ C30at baseline, radiotherapycompletion, and post-treatment at one, three and 6 months.

The quality of life (QoL) ofcancer patients will be assessed using the European Organization for Researchand Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Thisassessment will be conducted at multiple points: baseline (before the start ofradiotherapy), at the completion of radiotherapy, and post-treatment at one,three, and six months.

Baseline Assessment

At baseline, patients willcomplete the EORTC QLQ-C30 to establish their initial QoL status. This initialassessment will provide a reference point to measure changes in QoL over time.

Radiotherapy Completion

Upon completion of theradiotherapy treatment, patients will again complete the EORTC QLQ-C30. Thisassessment aims to capture the immediate effects of the treatment on thepatients’ QoL, including any acute toxicities or immediate improvements.

Post-Treatment Assessments

Further assessments will beconducted at one, three-, and six-month post-treatment. These follow-upassessments are crucial for monitoring the long-term effects of theradiotherapy, including any late-onset side effects and the overall recoveryprocess. The repeated measures allow for tracking the trajectory of QoL changesover time.

EORTC QLQ-C30 Components

The EORTC QLQ-C30 is acomprehensive tool that evaluates various dimensions of QoL, including Globalhealth status/QoL: Overall perception of health and quality of life. Functionalscales: Physical, role, emotional, cognitive, and social functioning.

Symptom scales/items: Fatigue,nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation,diarrhea, and financial difficulties.

**Implementation**

Patients will complete the EORTCQLQ-C30 through self-administration, with assistance available if needed. Thedata collected will be used to identify trends and patterns in QoL changes,helping to understand the impact of radiotherapy treatment on patients’ lives.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 282

Inclusion Criteria

Patients diagnosed with pelvic cancer cervix, endometrium, rectum and prostate 2.
Patient planned for radiation with radical intent- definitive, neoadjuvant or adjuvant.
Patients with performance status 0 to 2.
Patients with pelvic cancers diagnosed in stage I-IV.

Exclusion Criteria

Patients treated with SBRT.
Patients with prior history of radiotherapy.
Patients with metastatic cancer at presentation.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The standard VMAT and FFF VMAT plans for pelvic cancers, focusing on dosimetric outcomes, planning, and delivery times. DVH parameters, including target coverage, OAR dose, and normal tissue exposure, will be analyzed. Derived indices (CI, HI, GI), planning time, beam-on time, and monitor units will be recorded. Patients will be included after informed consent and treated per standard protocols after approval by review	At baseline only.

Secondary Outcome Measures

Name	Time	Method
The acute toxicity will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 at baseline, weekly during treatment, & post-treatment at one, three & 6 months. The quality of life will be assessed using EORTC QLQ C30 at baseline, radiotherapy completion, & post-treatment at one, three & 6 months.

Trial Locations

Locations (1): KASTURBA HOSPITAL
🇮🇳
Udupi, KARNATAKA, India
KASTURBA HOSPITAL
🇮🇳Udupi, KARNATAKA, India
SRINIDHI G CHANDRAGUTHI
Principal investigator
9731689095
shrinidhi.gc@manipal.edu