Comparison of Toxicities Between Proton Therapy and IMRT for Post Operative Treatment of Endometrial or Cervical Cancers.

Cervical Cancer Clinical Trial

— ROR1904  

Official title:

A Comparison of Acute Toxicities Between Patients Treated With Protons or Intensity-Modulated Radiation Therapy (IMRT) for Post-Operative Treatment of Endometrial or Cervical Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04745650
• Other study ID #: 19-004792
• Status: Recruiting
• Start date: December 7, 2020
• Est. completion date: December 2023

Study information

• Verified date: February 2021
• Source: Mayo Clinic
• Contact: Kayla Tottingham
• Phone: 507-293-1275
• Email: tottingham.kayla[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This trial is designed as a non-randomized pilot trial to study, in a preliminary fashion, whether proton radiation therapy (proton RT) reduces acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy (IMRT)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Age = 18 years 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

Documentation of history of:

• Smoking status

• Pelvic infection

• Pelvic Inflammatory Disease

• Endometriosis

Planned to receive either proton or IMRT radiation treatment, with use of rectal balloon, at an IRB-approved 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

CBC performed within 21 days prior to registration.

CT, MRI, PET/CT, or PET/MRI for staging before registration; may be pre-op or post-op

ECOG Performance Score (Appendix B) 0-2

Provide written informed consent

Willing to complete QOL questionnaires

Exclusion Criteria:

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

Patients with active and/or inflammatory irritable bowel disease

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 CDC definition; note that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be immunosuppressive.

Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years

Severe, active co-morbidity defined as follows:

• 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

Related Conditions & MeSH terms

• Cervical Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess whether proton RT is associated with lower acute gastrointestinal toxicities at the end of treatment compared to IMRT as measured with the EPIC bowel domain.		Through study completion, 3 years post treatment.
Secondary	To examine the association of bowel and bladder dose-volume histogram (DVH) with bowel and bladder toxicities, respectively.		Through study completion, 3 years post treatment.
Secondary	To assess whether urinary toxicity rate is improved with proton RT compared to IMRT as measured with the expanded prostate cancer index (EPIC) urinary domain.		Through study completion, 3 years post treatment.
Secondary	To determine if wellbeing is improved with proton RT compared to IMRT as measured by the functional assessment of cancer therapy (FACT) cervix domain.		Through study completion, 3 years post treatment.
Secondary	To determine if proton RT reduces grade 2+ hematologic toxicities (CTCAE v 4.0) compared to IMRT.		Through study completion, 3 years post treatment.
Secondary	Evaluate progression-free and overall survival between patients receiving proton RT and IMRT.		Through study completion, 3 years post treatment.
Secondary	To determine if proton RT improves overall patient quality of life compared to IMRT using the EQ-5D questionnaire.		Through study completion, 3 years post treatment.