NCT03955367

Pelvic RT Versus Prophylactic Extended-field RT in Patients With Cervical Cancer

Status unknown Phase 3 Last updated 23 February 2022

What this trial tests

Phase 3 trial testing Prophylactic extended-field Irradiation in Uterine Cervical Neoplasms in 638 participants. Status unknown.

Timeline

17 June 2019

Primary endpoint
1 June 2022

1 June 2025

Quick facts

Lead sponsor	Peking Union Medical College Hospital
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	638
Start date	17 June 2019
Primary completion	1 June 2022
Estimated completion	1 June 2025
Sites	2 locations across China

Drugs / interventions tested

• Prophylactic extended-field Irradiation
• Pelvic irradiation
• Intracavitary brachytherapy
• Concurrent chemotherapy — full drug profile →

Conditions studied

• Uterine Cervical Neoplasms — all drugs for Uterine Cervical Neoplasms →

Sponsor

Peking Union Medical College Hospital

Who can join

Adults 18 to 70, female only, with Uterine Cervical Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To investigate the value of prophylactic extended-field irradiation (EFI), we conduct a randomized clinical trial to compare the efficacy and toxicity of pelvic irradiation and prophylactic EFI in selected patients with cervical cancer treated with definitive concurrent chemoradiotherapy. External beam radiation therapy is delivered with intensity-modulated radiation therapy (IMRT).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prophylactic Extended-Field Irradiation in Patients With Cervical Cancer: A Literature Review.
   Wang W, Zhou Y, Wang D, Hu K, et al · · 2020 · cited 11× · PMID 33123482 · DOI 10.3389/fonc.2020.579410
2. Controversies in the Staging of Patients with Locally Advanced Cervical Cancer.
   Nasioudis D, George EM, Tanyi JL. · · 2023 · cited 6× · PMID 37238231 · DOI 10.3390/diagnostics13101747
3. Risk factors associated with Para-Aortic Lymph Node Failure after pelvic irradiation in patients with Cervical Cancer.
   Wang W, Wang D, Liu X, Zhou Y, et al · · 2020 · cited 6× · PMID 32742457 · DOI 10.7150/jca.45520
4. Reduction of dose to duodenum with a refined delineation method of Para-aortic region in patients with locally advanced cervical Cancer receiving prophylactic extended-field radiotherapy.
   Yang B, Liu X, Hu K, Qiu J, et al · · 2019 · cited 6× · PMID 31703705 · DOI 10.1186/s13014-019-1398-6
5. A modified delineation method of para-aortic nodal clinical target volume in patients with locally advanced cervical cancer.
   Wang D, Wang W, Liu X, Ren K, et al · · 2022 · cited 5× · PMID 34783168 · DOI 10.1002/cam4.4418
6. The 100 Most Cited Papers in Radiotherapy or Chemoradiotherapy for Cervical Cancer: 1990-2020.
   Wang W, Liu X, Wang D, Ren K, et al · · 2021 · cited 4× · PMID 34540655 · DOI 10.3389/fonc.2021.642018
7. Current Paradigm and Future Directions in the Management of Nodal Disease in Locally Advanced Cervical Cancer.
   Cheung ES, Wu PY. · · 2025 · cited 3× · PMID 39857985 · DOI 10.3390/cancers17020202