Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509724
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Comparison of Conventional and Hypofractionated IMRT in High-Risk Cervical Cancer Post-Radical Hysterectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Postoperative Conventional Versus Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer A Prospective Multicenter Randomized Phase III Trial POHIM_P3 Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POHIM-P3
Brief 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 therapyIMRT 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
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
Detailed Description:
This phase 3 multicenter randomized controlled trial evaluates two radiation therapy regiments in high-risk cervical cancer patients who have undergone radical hysterectomy Participants are randomly assigned in a 11 ratio to receive either conventional fractionated IMRTIntensity modulated radiation therapy or hypo fractionated IMRT both in combination with concurrent chemotherapy
The conventional fractionation group receives 18-20 Gy per session for a total of 25-28 sessions total 40-504 Gy with weekly chemotherapy total 5-6 sessions The hypofractionation group receives 25 Gy per session for a total of 16 sessions total 40 Gy with weekly chemotherapy total 3 sessions Brachytherapy is allowed in both group
Stratification factors for randomization include lymph node metastasis status and adenocarcinoma vs non-adenocarcinoma Blocked randomization will be used The study aims to assess local control rates overall survival disease-free survival and acute and late toxicity profiles
The conventional fractionation group receives 18-20 Gy per session for a total of 25-28 sessions total 40-504 Gy with weekly chemotherapy total 5-6 sessions The hypofractionation group receives 25 Gy per session for a total of 16 sessions total 40 Gy with weekly chemotherapy total 3 sessions Brachytherapy is allowed in both group
Stratification factors for randomization include lymph node metastasis status and adenocarcinoma vs non-adenocarcinoma Blocked randomization will be used The study aims to assess local control rates overall survival disease-free survival and acute and late toxicity profiles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None