Cervical Carcinoma study: Quality-of-Life Assessment vs Radiation Therapy
Official title Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer
ClinicalTrials.gov ID: NCT04567771
What this study is testing
- What it's testing
- The study aims to find out if proton radiation causes fewer short-term stomach and bowel problems than standard radiation.
- Who it's for
- This study is for people who have had surgery for endometrial (uterine) or cervical cancer.
- What's involved
- Participants will receive either proton radiation or intensity-modulated radiation therapy and fill out questionnaires about their health and side effects.
- Time commitment
- The study lasts for the duration of the radiation treatment and follow-up assessments.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Histologically confirmed diagnosis of cervical or endometrial cancer
- Must have undergone an open or robotic hysterectomy (total abdominal, vaginal, radical, or total laparoscopic) for carcinoma of the cervix or...
- History and physical prior to registration
- Smoking status
- Pelvic infection
You likely can't join if
- Receiving external beam boost dose during RT
- Distant metastases
- Gross disease at time of RT
- Histology of endometrial stromal sarcoma, leiomyosarcoma, melanoma or small cell carcinomas
- Patients who exceed the weight/size limits of the treatment table
- Positive or close surgical margins (=\< 3 mm)
See the full eligibility criteria
- Histologically confirmed diagnosis of cervical or endometrial cancer
- Must have undergone an open or robotic hysterectomy (total abdominal, vaginal, radical, or total laparoscopic) for carcinoma of the cervix or endometrium
- History and physical prior to registration
- Smoking status
- Pelvic infection
- Pelvic inflammatory disease
- Endometriosis
- Planned to receive either proton or IMRT radiation treatment, with use of rectal balloon, at any Mayo Clinic site
- Plan for RT to pelvis with or without para-aortic lymph node irradiation
- If received high-dose chemotherapy prior to registration, last dose must have been given \>= 21 days prior to start of RT
- Complete blood count (CBC) performed within 21 days prior to registration
- Computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET)/CT, or PET/MRI for staging before registration; may be pre-operative (op) or post-op
- Eastern Cooperative Oncology Group (ECOG) performance score 0-2
- Provide written informed consent
- Willing to complete quality of life (QOL) questionnaires
- Receiving external beam boost dose during RT
- Distant metastases
- Gross disease at time of RT
- Histology of endometrial stromal sarcoma, leiomyosarcoma, melanoma or small cell carcinomas
- Patients who exceed the weight/size limits of the treatment table
- Positive or close surgical margins (=\< 3 mm)
- Prior RT to the pelvis
- Planned to receive inguinal node RT
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Other major medical illness which requires hospitalization or precludes study therapy at the time of registration
- Patients unwilling to have rectal balloon placed on a daily basis during RT
The study team makes the final eligibility decision.
Where it is enrolling
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Rochester, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.