Proton vs IMRT After Surgery for Endometrial or Cervical Cancer
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
Disqualifiers: Distant metastases, AIDS, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This early phase I trial compares the side effects between patients treated with proton radiation therapy versus intensity modulated radiation therapy after surgery for the treatment of endometrial or cervical cancer. Radiation therapy uses high energy protons or x-rays to kill tumor cells and shrink tumors. Using quality of life questionnaires and adverse event assessments may help doctors learn whether proton radiation therapy is associated with lower acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy in patients with endometrial or cervical cancer.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have received high-dose chemotherapy, the last dose must have been given at least 21 days before starting radiation therapy.
What data supports the effectiveness of the treatment Intensity Modulated Radiation Therapy (IMRT) and Proton Therapy for endometrial or cervical cancer?
Research shows that proton therapy can reduce the radiation dose to surrounding organs like the kidneys, spinal cord, and bowel compared to IMRT, which may help protect these organs during treatment for cervical and endometrial cancer.
12345Is proton therapy safe for humans?
Proton therapy has been shown to reduce the dose to normal organs compared to traditional radiation therapy, which may lead to less damage to surrounding tissues. Studies in prostate cancer patients suggest minimal toxicity with proton therapy, indicating it is generally safe for humans.
16789How does Proton vs IMRT treatment differ from other treatments for endometrial or cervical cancer?
Proton therapy and IMRT are advanced radiation treatments that can target cancer more precisely, reducing damage to surrounding healthy organs like the kidneys, spinal cord, and bowel compared to traditional radiation methods. This precision makes them particularly beneficial for patients with cervical and endometrial cancer, especially in areas like the para-aortic region.
134510Eligibility Criteria
This trial is for individuals with confirmed cervical or endometrial cancer who've had surgery. They should be in decent physical condition, not have severe infections or bowel disease, and must not have received pelvic radiation before. Participants need to agree to quality of life questionnaires and use a rectal balloon during radiation therapy.Inclusion Criteria
Willing to complete quality of life (QOL) questionnaires
I have been diagnosed with cervical or endometrial cancer.
Complete blood count (CBC) performed within 21 days prior to registration
+9 more
Exclusion Criteria
My surgery showed cancer cells close to the edge of the removed tissue.
I have been cancer-free for at least 3 years, except for non-melanoma skin cancer.
I am getting an extra dose of radiation during my treatment.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation Therapy
Participants undergo standard of care proton or intensity modulated radiation therapy
5 weeks
5 visits (in-person, weekly)
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 years
Visits at 1 month, 1 year, and 3 years post-radiation therapy
Participant Groups
The study compares two types of post-surgery radiation treatments for endometrial or cervical cancer: proton radiation therapy versus intensity modulated radiation therapy (IMRT). It aims to see which causes fewer gastrointestinal side effects by using patient questionnaires and monitoring adverse events.
1Treatment groups
Experimental Treatment
Group I: Treatment (radiation therapy, questionnaires)Experimental Treatment3 Interventions
Patients undergo standard of care proton or intensity modulated radiation therapy. Patients also complete quality of life questionnaires and adverse event assessments over 10-15 minutes each at baseline, at the end of radiation therapy, and at 1 month, 1 year, and 3 years post-radiation therapy.
Intensity Modulated Radiation Therapy is already approved in United States, European Union, Canada, Japan, China for the following indications:
🇺🇸 Approved in United States as Intensity Modulated Radiation Therapy for:
- Various types of cancer, including but not limited to prostate cancer, head and neck cancer, lung cancer, breast cancer, brain tumors, and spinal tumors
🇪🇺 Approved in European Union as Intensity Modulated Radiation Therapy for:
- Various types of cancer, including but not limited to prostate cancer, head and neck cancer, lung cancer, breast cancer, brain tumors, and spinal tumors
🇨🇦 Approved in Canada as Intensity Modulated Radiation Therapy for:
- Various types of cancer, including but not limited to prostate cancer, head and neck cancer, lung cancer, breast cancer, brain tumors, and spinal tumors
🇯🇵 Approved in Japan as Intensity Modulated Radiation Therapy for:
- Various types of cancer, including but not limited to prostate cancer, head and neck cancer, lung cancer, breast cancer, brain tumors, and spinal tumors
🇨🇳 Approved in China as Intensity Modulated Radiation Therapy for:
- Various types of cancer, including but not limited to prostate cancer, head and neck cancer, lung cancer, breast cancer, brain tumors, and spinal tumors
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
Mayo Clinic in FloridaJacksonville, FL
Mayo Clinic in ArizonaScottsdale, AZ
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Which cervical and endometrial cancer patients will benefit most from intensity-modulated proton therapy? [2018]In this dosimetric comparison study it was shown that IMPT with robust planning reduces dose to surrounding organs in cervical and endometrial cancer treatment compared with IMRT. Especially for the para-aortic region, clinically relevant dose reductions were obtained for kidneys, spinal cord and bowel, justifying the use of proton therapy for this indication.
Dosimetric comparison study between intensity modulated radiation therapy and three-dimensional conformal proton therapy for pelvic bone marrow sparing in the treatment of cervical cancer. [2021]The objective was to compare intensity-modulated radiation therapy (IMRT) with 3D conformal proton therapy (3DCPT) in the treatment of cervical cancer. In particular, each technique's ability to spare pelvic bone marrow (PBM) was of primary interest in this study. A total of six cervical cancer patients (3 postoperative and 3 intact) were planned and analyzed. All plans had uniform 1.0 cm CTV-PTV margin and satisfied the 95% PTV with 100% isodose (prescription dose = 45 Gy) coverage. Dose-volume histograms (DVH) were analyzed for comparison. The overall PTV and PBM volumes were 1035.9 ± 192.2 cc and 1151.4 ± 198.3 cc, respectively. In terms of PTV dose conformity index (DCI) and dose homogeneity index (DHI), 3DCPT was slightly superior to IMRT with 1.00 ± 0.001, 1.01 ± 0.02, and 1.10 ± 0.02, 1.13 ± 0.01, respectively. In addition, 3DCPT demonstrated superiority in reducing lower doses (i.e., V30 or less) to PBM, small bowel and bladder. Particularly in PBM, average V10 and V20 reductions of 10.8% and 7.4% (p = 0.001 and 0.04), respectively, were observed. However, in the higher dose range, IMRT provided better sparing (> V30). For example, in small bowel and PBM, average reductions in V45 of 4.9% and 10.0% (p = 0.048 and 0.008), respectively, were observed. Due to its physical characteristics such as low entrance dose, spread-out Bragg peak and finite particle range of protons, 3DCPT illustrated superior target coverage uniformity and sparing of the lower doses in PBM and other organs. Further studies are, however, needed to fully exploit the benefits of protons for general use in cervical cancer.
Which technique for radiation is most beneficial for patients with locally advanced cervical cancer? Intensity modulated proton therapy versus intensity modulated photon treatment, helical tomotherapy and volumetric arc therapy for primary radiation - an intraindividual comparison. [2018]To compare highly sophisticated intensity-modulated radiotherapy (IMRT) delivered by either helical tomotherapy (HT), RapidArc (RA), IMRT with protons (IMPT) in patients with locally advanced cervical cancer.
Dosimetric Comparison of Pencil-Beam Scanning and Photon-Based Radiation Therapy as a Boost in Carcinoma of Cervix. [2022]Brachytherapy is essential for local treatment in cervical carcinoma, but some patients are not suitable for it. Presently, for these patients, the authors prefer a boost by using intensity-modulated radiation therapy (IMRT). The authors evaluated the dosimetric comparison of proton-modulated radiation therapy versus IMRT and volumetric-modulated arc therapy (VMAT) as a boost to know whether protons can replace photons.
Assessment of organ motion in postoperative endometrial and cervical cancer patients treated with intensity-modulated radiation therapy. [2016]Intensity-modulated radiation therapy (IMRT) may be useful to reduce toxicity in gynecologic cancer patients requiring postoperative pelvic irradiation. This study was undertaken to quantify vaginal wall organ motion during the course of postoperative pelvic irradiation using pelvic IMRT.
Comparative toxicity outcomes of proton-beam therapy versus intensity-modulated radiotherapy for prostate cancer in the postoperative setting. [2020]Despite increasing utilization of proton-beam therapy (PBT) in the postprostatectomy setting, no data exist regarding toxicity outcomes relative to intensity-modulated radiotherapy (IMRT). The authors compared acute and late genitourinary (GU) and gastrointestinal (GI) toxicity outcomes in patients with prostate cancer (PC) who received treatment with postprostatectomy IMRT versus PBT.
Minimal toxicity after proton beam therapy for prostate and pelvic nodal irradiation: results from the proton collaborative group REG001-09 trial. [2018]Proton beam therapy (PBT) reduces normal organ dose compared to intensity modulated radiation therapy (IMXT) for prostate cancer patients who receive pelvic radiation therapy. It is not known whether this dosimetric advantage results in less gastrointestinal (GI) and genitourinary (GU) toxicity than would be expected from IMXT.
A case-matched study of toxicity outcomes after proton therapy and intensity-modulated radiation therapy for prostate cancer. [2022]The authors assessed whether proton beam therapy (PBT) for prostate cancer (PCa) was associated with differing toxicity compared with intensity-modulated radiation therapy (IMRT) using case-matched analysis.
Long-term outcomes of intensity-modulated radiation therapy (IMRT) and high dose rate brachytherapy as adjuvant therapy after radical hysterectomy for cervical cancer. [2021]Compared with 3D-planned pelvic radiation, intensity-modulated radiation therapy (IMRT) has been shown to reduce acute toxicity in cervical cancer patients after radical hysterectomy. This study evaluated late toxicity and patterns of failure after post-operative pelvic IMRT interdigitated weekly with high dose rate brachytherapy.
Postradiation damage to the pelvic girdle in cervical cancer patients: is intensity-modulated radiation therapy safer than conventional radiation? [2018]Intensity-modulated radiation therapy (IMRT) is frequently utilized in the treatment of cervical cancer. Our study compared instances of pelvic fractures, osteonecrosis, and osteomyelitis posttreatment with conventional radiation therapy (RT) versus IMRT in patients with cervical carcinomas.