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

Dosimetric assessment and clinical implementation of flattening filter- free (FFF) Volumetric Modulated Arc Therapy(VMAT) with toxicity evaluation in pelvic cancers - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/06/089176
Enrollment
282
Registered
2025-06-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C530- Malignant neoplasm of endocervix Health Condition 2: C541- Malignant neoplasm of endometrium Health Condition 3: C61- Malignant neoplasm of prostate Health Condition 4: C20- Malignant neoplasm of rectum

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: Nil: Nil

Sponsors

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

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with pelvic cancer cervix, endometrium, rectum and prostate 2. Patient planned for radiation with radical intent- definitive, neoadjuvant or adjuvant. 3. Patients with performance status 0 to 2. 4. Patients with pelvic cancers diagnosed in stage I-IV.

Exclusion criteria

Exclusion criteria: 1. Patients treated with SBRT. 2. Patients with prior history of radiotherapy. 3. Patients with metastatic cancer at presentation.

Design outcomes

Primary

MeasureTime frame
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 reviewTimepoint: At baseline only.

Secondary

MeasureTime frame
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. The quality of life (QoL) of cancer patients will be assessed using the European Organization for Research & Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This assessment will be conducted at multiple points: baseline (before the start of radiotherapy), at the completion of radiotherapy, & post-treatment at one, three, & six months. Timepoint: Acute Toxicity at baseline, weekly during treatment & at 1,3 & 6 months post treatment. QoL at baseline,radiotherapy completion & 1,3 & 6months

Countries

India

Contacts

Public ContactSrinidhi G Chandraguthi

Kasturba Medical College Manipal/Manipal Academy of Higher Education

shrinidhi.gc@manipal.edu9731689095

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026