Clinical trial · Interventional
Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study
NCT05857631CI-TRIAL-00088538PARCERIIrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary aim of the trial is to investigate the late effects of hypofractionated external radiation (39 Gy in 13 fractions) in patients requiring post-operative radiation for early-stage cervical and endometrial cancers.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Hypofractionated Image guided External Beam Radiation Therapy (EBRT) | Radiation | — | UNRESOLVED |
| Vaginal brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypofractionated Image guided External Beam Radiation
- description
- Adjuvant hypofractionated external beam radiotherapy for post operative patients with cervical or endometrial cancer.
- interventionNames
- Radiation: Hypofractionated Image guided External Beam Radiation Therapy (EBRT)
- Drug: Cisplatin
- Radiation: Vaginal brachytherapy
Primary outcomes (1)
- measure
- 3-year cumulative incidence of grade ≥2 gastrointestinal or genitourinary toxicity
- timeFrame
- Median follow up of 3 years
- description
- To evaluate the 3-year cumulative incidence of late grade ≥2 gastrointestinal or genitourinary toxicity using CTCAE version 5 scoring receiving radiation with hypo fractionation.
Secondary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 2. Histologically confirmed diagnosis of cervical cancer post hysterectomy with intermediate or high-risk features, requiring adjuvant EBRT ± concurrent chemotherapy OR histologically confirmed diagnosis of endometrial cancer post hysterectomy requiring adjuvant (chemo)radiotherapy to pelvis with/without vaginal brachytherapy. Exclusion Criteria: 1. Patients with macroscopic residual disease (R+ resection) postoperatively 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 the assessment of genitourinary or gastrointestinal toxicity (This includes patients with irritable bowel syndrome, subacute intestinal obstruction, anal incontinence, hemorrhoids precluding analysis of gastro-intestinal toxicities, urinary incontinence, recurrent urinary tract infections)
References
Publications (0)
Data not yet available
No reference posted for this study.