At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed cervical cancer
- ✓Squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma histology
- ✓Radical hysterectomy and pelvic lymphadenectomy completed
- ✓Pathological high-risk features: lymph node metastasis, parametrial involvement, or positive margins
- ✕Distant metastasis including ovarian and para-aortic lymph nodes
- ✕Prior pelvic radiotherapy
- ✕Radical hysterectomy more than 3 months prior
- ✕Untreated serious acute illness other than cervical cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Postoperative Conventional Versus Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer: A Prospective Multicenter Randomized Phase III Trial (POHIM_P3 Trial)
In Brief
A Phase 3 clinical trial evaluating Conventional Fractionated IMRT and Hypofractionated IMRT for Uterine Cervical Neoplasms. Currently recruiting, targeting 248 participants across 1 site.
Detailed Summary
Radical hysterectomy and radiation therapy are standard treatments for cervical cancer. However, there are no reported studies on the frequency of side effects and treatment outcomes when hypofractionated radiation therapy and intensity modulated radiation therapy(IMRT) are used during radiation therapy. Hypofractionated radiation therapy increases the daily dose and reduces the number of treatment sessions, which may increase the risk of side effects, but its safety has been confirmed in some cases of early cervical cancer and endometrial cancer. Additionally, applying IMRT, a technique designed to protect normal tissue, during concurrent chemoradiotherapy has shown positive results in reducing the incidence of acute side effects. Investigators previously demonstrated that combining hypofractionated IMRT with chemotherapy for high-risk postoperative cervical cancer patients resulted in high survival rates and low toxicity in a phase 2 exploratory study. Base on this result, this study aimed to compare the efficacy and safety of conventional fractionated radiation therapy and hypofractionated radiation therapy.
Study Details
Timeline
Interventions
* Dose: 1.8-2.0 Gy per session, total 25-28 sessions (40-50.4Gy) * Chemotherapy: Weekly, total 5-6 sessions
* Dose: 2.5 Gy per session, total 16 sessions (40Gy) * Chemotherapy: Weekly, total 3 sessions