Role of abbreviated radiotherapy schedule in treatment of post-operative cervical and endometrial cancer

Postoperative hypofrActionated Radiation in Cervical and Endometrial TumouRs: Phase II Study (PARCER II) - PARCER II

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/050123

Enrollment

Registered

2023-02-27

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

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: C53- Malignant neoplasm of cervix uteri Health Condition 3: D- Radiation Therapy

Interventions

Intervention1: Hypofractionated radiotherapy to pelvis: External beam radiotherapy (Intensity modulated radiotherapy / arc technique) to pelvis 39Gy in 13 fractions at 3Gy per fraction, delivered once

Eligibility

Inclusion criteria

Inclusion criteria: 1.Eastern Cooperative Oncology Group (ECOG) performance status of =2 2.Carcinoma of the cervix post-surgery with intermediate or high-risk features or needing adjuvant RT ± concurrent chemotherapy OR Carcinoma of the endometrium post-surgery requiring adjuvant (chemo)radiotherapy to pelvis with/without vaginal brachytherapy.

Exclusion criteria

Exclusion criteria: 1. Patients with macroscopic residual disease (R+ resection) post operatively 2. Patients requiring extended field radiotherapy (patients with involved para-aortic lymph nodes in cervical or endometrial cancer) 3. Patients treated with chemotherapy for any prior malignancy at any time 4. Patients treated with pelvic radiation previously 5. Patients with human immunodeficiency virus infection 6. Any preexisting medical conditions that may interfere with assessment of GU or GI toxicity (This includes patients with irritable bowel syndrome, subacute intestinal obstruction, anal incontinence, hemarrhoids precluding analysis of gastro-intestinal toxicities, and urinary incontinence, recurrent urinary tract infections)

Design outcomes

Primary

Measure	Time frame
To evaluate 3-year cumulative incidence of late grade =2 gastrointestinal or genitourinary toxicity using CTCAE version 5 scoring in patients receiving radiation with hypo fractionation.Timepoint: 3 years	—

Secondary

Measure	Time frame
To assess quality of life in using EORTC QLQC30, Cx24, EN24Timepoint: 3 years;To report 3 years overall survivalTimepoint: 3 years;To report acute toxicities using CTCAETimepoint: 3 months (90 days);To report cumulative toxicity score as assessed by C-MOSES scoringTimepoint: 3 years;To report disease free survival in patients receiving hypo fractionated radiotherapyTimepoint: 3 years;To report pelvic control rate (local and pelvic nodal) in patients receiving hypo fractionated ra- diotherapyTimepoint: 3 years	—

Measure

Time frame

To assess quality of life in using EORTC QLQC30, Cx24, EN24Timepoint: 3 years;To report 3 years overall survivalTimepoint: 3 years;To report acute toxicities using CTCAETimepoint: 3 months (90 days);To report cumulative toxicity score as assessed by C-MOSES scoringTimepoint: 3 years;To report disease free survival in patients receiving hypo fractionated radiotherapyTimepoint: 3 years;To report pelvic control rate (local and pelvic nodal) in patients receiving hypo fractionated ra- diotherapyTimepoint: 3 years

—

Countries

India

Contacts

Public ContactPrachi Mittal

Tata Memorial Hospital

mittalprachi@gmail.com9004938871

Outcome results

None listed

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