Proton vs IMRT After Surgery for Endometrial or Cervical Cancer

Recruiting at 2 trial locations

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Distant metastases, AIDS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether proton radiation therapy causes fewer side effects than intensity modulated radiation therapy (IMRT) after surgery for endometrial or cervical cancer. Both treatments use high-energy beams to kill cancer cells, but researchers aim to determine if one results in fewer digestive system issues. Participants will complete quality of life questionnaires to track side effects over time. Ideal candidates have undergone surgery for cervical or endometrial cancer and plan to receive radiation therapy at a Mayo Clinic location. As an unphased trial, this study allows patients to contribute to important research that may enhance future cancer treatments.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that proton radiation therapy is safe for patients with uterine and cervical cancer. Studies have found that it usually causes only mild side effects, including short-term and long-term mild reactions. Specifically, proton therapy may lead to less diarrhea and a lower risk of bowel control issues compared to other radiation types.

Similarly, intensity modulated radiation therapy (IMRT) is a safe choice. Reports indicate it causes fewer short-term stomach and bowel problems than some older radiation methods. Patients treated with IMRT often experience fewer significant stomach issues during and after treatment.

Both proton therapy and IMRT are generally well-tolerated, with side effects that are usually mild and manageable. These therapies are promising options for those receiving treatment after surgery for endometrial or cervical cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about comparing proton radiation therapy and intensity modulated radiation therapy (IMRT) for endometrial or cervical cancer because these methods offer targeted approaches to post-surgical treatment. Unlike traditional radiation therapies that can affect surrounding healthy tissues, proton therapy delivers a more precise dose of radiation, potentially reducing side effects and sparing healthy tissues. IMRT, on the other hand, uses advanced technology to modulate the intensity of radiation beams, also aiming to minimize damage to non-cancerous cells. By assessing these treatments, researchers hope to determine which method provides better outcomes in terms of both effectiveness and quality of life for patients.

What evidence suggests that this trial's treatments could be effective for endometrial or cervical cancer?

This trial compares Proton Radiation Therapy with Intensity Modulated Radiation Therapy (IMRT) for uterine and cervical cancers. Research has shown that proton radiation therapy might be effective and may cause fewer stomach and bowel side effects than IMRT. Proton therapy also appears to lower the risk of cancer recurrence and may improve quality of life. Conversely, IMRT is a well-established treatment known for reducing long-term stomach issues. Both treatments in this trial aim to target cancer cells while preserving healthy tissues. ^{1 4 6 7 8}

Who Is on the Research Team?

Allison E. Garda, M.D.

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Intensity Modulated Radiation Therapy
• Proton Radiation Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment (radiation therapy, questionnaires) Experimental Treatment 3 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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Intensity-modulated proton therapy (IMPT) significantly reduces radiation exposure to surrounding organs compared to intensity-modulated radiation therapy (IMRT) in the treatment of cervical and endometrial cancers.

Notably, IMPT achieved clinically relevant dose reductions for critical areas such as the kidneys, spinal cord, and bowel, supporting its use as a safer treatment option for these cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which cervical and endometrial cancer patients will benefit most from intensity-modulated proton therapy? van de Sande, MA., Creutzberg, CL., van de Water, S., et al.[2018]

In a study involving six cervical cancer patients, 3D conformal proton therapy (3DCPT) was found to be superior to intensity-modulated radiation therapy (IMRT) in sparing lower doses to pelvic bone marrow and other organs, demonstrating significant reductions in V10 and V20 doses to PBM.

While 3DCPT showed better conformity and lower dose exposure, IMRT was more effective in sparing higher doses (> V30) to organs like the small bowel and PBM, indicating that both techniques have unique advantages that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Song, WY., Huh, SN., Liang, Y., et al.[2021]

In a study of 53 cervical cancer patients treated with post-operative intensity-modulated radiation therapy (IMRT) and high dose rate brachytherapy, there were no acute severe toxicities (grade >3) reported, indicating a high safety profile for this treatment approach.

The 5-year overall survival rate was 85%, with low rates of late toxicity (only 3.8% experienced late grade >3 toxicities), suggesting that this combined treatment is effective and well-tolerated in managing cervical cancer post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes of intensity-modulated radiation therapy (IMRT) and high dose rate brachytherapy as adjuvant therapy after radical hysterectomy for cervical cancer. Contreras, J., Srivastava, A., Chundury, A., et al.[2021]

Proton-beam therapy (PBT) significantly reduced low-range doses to the bladder and rectum compared to intensity-modulated radiotherapy (IMRT) in patients treated post-prostatectomy, indicating a potential advantage in minimizing radiation exposure to surrounding tissues.

Despite the dosimetric benefits of PBT, there were no significant differences in acute or late genitourinary (GU) and gastrointestinal (GI) toxicities reported by clinicians between the two treatment modalities, suggesting that both therapies have similar safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative toxicity outcomes of proton-beam therapy versus intensity-modulated radiotherapy for prostate cancer in the postoperative setting. Santos, PMG., Barsky, AR., Hwang, WT., et al.[2020]

Proton-modulated radiation therapy (PBS) provides comparable coverage and homogeneity for the treatment of cervical carcinoma, similar to intensity-modulated radiation therapy (IMRT) and volumetric-modulated arc therapy (VMAT), with optimal planning target volume (PTV) coverage of around 20 Gy.

PBS significantly reduces the integral dose to critical organs at risk, such as the bladder and rectum, compared to IMRT and VMAT, suggesting it may be a safer alternative for patients unsuitable for brachytherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric Comparison of Pencil-Beam Scanning and Photon-Based Radiation Therapy as a Boost in Carcinoma of Cervix. Sharma, MK., Hug, EB., Bhushan, M., et al.[2022]

In a study involving 20 cervical cancer patients, intensity-modulated proton therapy (IMPT) significantly reduced the mean dose to the small bowel by 38-52% compared to conventional IMRT, helical tomotherapy (HT), and RapidArc (RA), indicating better organ sparing.

IMPT also decreased the mean dose to the bladder and rectum by 7-9 Gy, suggesting that proton therapy could lead to lower acute and late toxicity in cervical cancer treatment while maintaining effective target coverage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Marnitz, S., Wlodarczyk, W., Neumann, O., et al.[2018]

In a study of 22 gynecologic cancer patients undergoing postoperative intensity-modulated radiation therapy (IMRT), the median vaginal wall organ motion was found to be 5.8 mm, with significant motion observed in some cases, indicating the need for careful treatment planning.

To effectively account for this organ motion during therapy, a planning target volume margin of 16 mm is recommended, which should help ensure accurate targeting and minimize radiation exposure to surrounding healthy tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of organ motion in postoperative endometrial and cervical cancer patients treated with intensity-modulated radiation therapy. Harris, EE., Latifi, K., Rusthoven, C., et al.[2016]

In a study involving 394 patients with localized prostate cancer, proton beam therapy (PBT) showed lower dosimetry for bladder and rectum compared to intensity-modulated radiation therapy (IMRT), suggesting a potential for reduced exposure to surrounding tissues.

However, after matching patients on risk factors and adjusting for confounders, there were no significant differences in the rates of acute or late gastrointestinal and genitourinary toxicities between PBT and IMRT, indicating similar safety profiles for both treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case-matched study of toxicity outcomes after proton therapy and intensity-modulated radiation therapy for prostate cancer. Fang, P., Mick, R., Deville, C., et al.[2022]

Proton beam therapy (PBT) for prostate cancer patients receiving pelvic radiation significantly reduces acute gastrointestinal (GI) toxicity compared to intensity modulated radiation therapy (IMXT), with rates of grade 1, 2, and 3 GI toxicity at 16.4%, 2.4%, and 0%, respectively.

The study involved 85 patients with a median follow-up of 14.5 months, and while GU toxicity was higher, the results suggest that PBT may spare the small bowel, leading to less GI side effects, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal toxicity after proton beam therapy for prostate and pelvic nodal irradiation: results from the proton collaborative group REG001-09 trial. Chuong, MD., Hartsell, W., Larson, G., et al.[2018]

In a study of 166 patients (83 treated with IMRT and 83 with conventional RT), IMRT was linked to a significantly lower incidence of pelvic complications, with only 4% of IMRT patients experiencing sacral fractures compared to 17% in the conventional RT group.

The results suggest that IMRT reduces the risk of serious posttreatment issues like fractures, osteonecrosis, and osteomyelitis, making it a safer option for cervical cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postradiation damage to the pelvic girdle in cervical cancer patients: is intensity-modulated radiation therapy safer than conventional radiation? Ioffe, YJ., Hillen, TJ., Zhou, G., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3903584/

Uptake and Outcomes of Intensity-Modulated Radiation ... In conclusion, our findings suggest that the use of IMRT has increased over time for women with uterine cancer undergoing pelvic radiotherapy. Despite the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10789959/

Intensity-Modulated Radiation Therapy for Uterine Cervical ... The PARCER trial also reports oncologic outcome and there is no significant difference in 3-year pelvic relapse-free survival (81.8% vs. 84%, p=0.55) and DFS ( ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X25000404

Long-term outcomes of intensity-modulated radiation ... Postoperative pelvic intensity-modulated radiation therapy reduced the incidence of late gastrointestinal complications for uterine cervical cancer patients.

4. practicalradonc.org practicalradonc.org/article/S1879-8500(22)00273-9/fulltext

Radiation Therapy for Endometrial Cancer: An American ... With the results of several recently published clinical trials, this guideline informs on the use of adjuvant radiation therapy (RT) and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01672892

Standard Versus Intensity-Modulated Pelvic Radiation ... This randomized phase III trial is studying two different methods of radiation and their side effects and comparing how well they work in treating endometrial ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2331518023002354

Outcomes of Proton Beam Therapy Compared With ... Our data show PT may decrease the frequency of diarrhea at the end of radiation therapy and lower the risk of bowel incontinence at 12 months as compared with ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33999750/

Outcome and safety analysis of endometrial cancer ... Acute grade ≥2 GI toxicity was significantly less in patients treated with IMRT compared to those treated with 3DCRT (11.0% vs. 19.2%, p=.004).

8. tandfonline.com tandfonline.com/doi/full/10.1080/0284186X.2021.1926537

Outcome and safety analysis of endometrial cancer ... We found that IMRT-treated EC patients showed comparable clinical outcomes but with a lower incidence of GI toxicities compared with those treated with 3DCRT.