Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-25 @ 3:57 PM
Study NCT ID:
NCT05139368
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-18
First Post:
2021-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hypofractionated Radiotherapy for the Treatment of Cervical or Endometrial Cancer
Sponsor:
University of Utah
Organization:
Study Overview
Official Title:
RT-PACE: A Pilot Study of Adjuvant Hypo-Fractionated Radiotherapy for Non-Metastatic Cervical and Endometrial Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RT-PACE
Brief Summary:
This clinical trial studies the feasibility of using hypo-fractionated radiotherapy for the treatment of cervical or endometrial cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
Detailed Description:
PRIMARY OBJECTIVE:
I. To establish the trial as feasible and to assess the impact upon acute gastrointestinal toxicity in the third week of pelvic radiotherapy following a hypo-fractionated schedule.
SECODARY OBJECTIVES:
I. To estimate impact upon acute urinary toxicity. II. To estimate impact upon patient reported gastrointestional toxicity. III. To assess acute quality of life following treatment. IV. To quantify acute financial toxicity following treatment. V. To assess satisfaction with decision-making following treatment. VI. To assess the overall survival throughout 3 years of post-treatment follow-up.
OUTLINE:
Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1, 3, and 6 months and then at 1, 2, and 3 years.
I. To establish the trial as feasible and to assess the impact upon acute gastrointestinal toxicity in the third week of pelvic radiotherapy following a hypo-fractionated schedule.
SECODARY OBJECTIVES:
I. To estimate impact upon acute urinary toxicity. II. To estimate impact upon patient reported gastrointestional toxicity. III. To assess acute quality of life following treatment. IV. To quantify acute financial toxicity following treatment. V. To assess satisfaction with decision-making following treatment. VI. To assess the overall survival throughout 3 years of post-treatment follow-up.
OUTLINE:
Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1, 3, and 6 months and then at 1, 2, and 3 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2021-12258 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| HCI144462 | OTHER | Huntsman Cancer Institute/University of Utah | View | |
| P30CA042014 | NIH | None | https://reporter.nih.gov/quic… | View |