Trial to Compare MRI-guided Precision Prone Irradiation (PPI) Versus CT-guided Breast Irradiation

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05731791
• Collaborator: (none)
• Enrollment: 380
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 70
• Patients Per Site Per Month: 5.4

Study Details

Study Description

Brief Summary

The Investigators are investigating the potential role of MRI-guided Radiation Therapy for patients receiving breast radiotherapy in the prone position with a MRI-Linac radiotherapy system, the Precision Prone Irradiation (PPI) technique.

Hypothesis: The investigators would like to hypothesize that breast radiation therapy using MRI-guided system including the MRI-Linac (Arm 2) is comparable to the current standard of treatment using conventional CT-based system (Arm 1), in terms of local control of the disease at 2 year time point.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Radiation: Radiation Therapy to partial breast	Phase 3

Detailed Description

Breast conserving surgery and adjuvant whole breast radiotherapy is a standard treatment option for most patients with early-stage invasive breast cancer. Recent technological advances in radiotherapy have enabled shorter treatment courses, smaller radiation fields, prone positioning, and fewer side effects associated with breast cancer treatment. To further improve target accuracy in breast radiation delivery, an emerging radiotherapy technology takes advantage of on-table MRI imaging and daily adaptive planning during the radiation delivery process.

The objectives of the study are to compare side effects in patients treated under either of these treatment settings and to compare recurrence (if the cancer comes back) rates at a 2-year time point. Patients will have annual follow ups up to 10 years and recurrence rates will be measured at 5-year and at 10-year time points.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 380 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Phase 3 two-armed randomized clinical trial for localized favorable breast cancer patients, randomizing to CT-based radiation treatment vs. MRI-based radiation treatmentPhase 3 two-armed randomized clinical trial for localized favorable breast cancer patients, randomizing to CT-based radiation treatment vs. MRI-based radiation treatment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized Trial to Compare MRI-guided Precision Prone Irradiation (PPI) Versus CT-guided Breast Irradiation
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2026
• Anticipated Study Completion Date: Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ARM 1 - CT-based breast radiation treatment Patients randomized to ARM 1 will receive 3000 cGy in 5 fractions partial breast radiotherapy with CT-based breast radiation treatment.	Radiation: Radiation Therapy to partial breast; Patients randomized to ARM 1 will receive 3000 cGy in 5 fractions partial breast radiotherapy with CT-based breast radiation treatment (Arm 1) and patients randomized to ARM 2 will receive 3000 cGy in 5 fractions partial breast radiotherapy with MRI-based breast radiation treatment (Arm 2).
Active Comparator: ARM 2 - MRI-based breast radiation treatment Patients randomized to ARM 2 will receive 3000 cGy in 5 fractions partial breast radiotherapy with MRI-based breast radiation treatment.	Radiation: Radiation Therapy to partial breast; Patients randomized to ARM 1 will receive 3000 cGy in 5 fractions partial breast radiotherapy with CT-based breast radiation treatment (Arm 1) and patients randomized to ARM 2 will receive 3000 cGy in 5 fractions partial breast radiotherapy with MRI-based breast radiation treatment (Arm 2).

Outcome Measures

Primary Outcome Measures

1. Comparing local recurrence rates between patients receiving Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2) [24months]

Secondary Outcome Measures

1. Comparing local recurrence rates between patients receiving Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2) [60 months]

2. Comparing number of participants with local recurrence between patients treated on Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2) [120 months]

3. Comparing clinical and planning target volumes (CTV and PTV volumes) for CT-based planning vs. MRI-based planning [60 months]

4. Comparing patient reported cosmetic outcomes between patients treated on Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2) [60 months]

   Comparing patient reported cosmetic outcomes between patients treated on Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2) using the Breast Cancer Treatment Outcome Scale (BCTOS). BCTOS is a widely used questionnaire that is used to compare outcomes of treated and untreated breast by the patient. The questionnaire includes a cosmetic, functional and breast sensitivity questions. BCTOS Cosmesis scores range from 1 (excellent) to 4 (poor), and scores of 3 (fair) or more indicate adverse cosmetic outcomes.

5. Comparing the number of treatment related acute skin toxicities observed in patients who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2) [6 months]

   Comparing the number of treatment related acute skin toxicities observed in patients who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2) using the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 5.0 (NCI CTCAEv5.0).

6. Comparing the number of treatment related acute skin toxicities observed in patients who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2) [12 months]

   Comparing the number of treatment related acute skin toxicities observed in patients who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2) using the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 5.0 (NCI CTCAEv5.0).

7. Comparing the number of treatment related acute skin toxicities observed in patients who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2) [24 months]

   Comparing the number of treatment related acute skin toxicities observed in patients who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2) using the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 5.0 (NCI CTCAEv5.0).

8. Comparing the number of treatment related late skin toxicities who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2) [6 months]

   Comparing the number of treatment related late skin toxicities who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2) using the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 5.0 (NCI CTCAEv5.0).

9. Comparing the number of treatment related late skin toxicities who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2) [12 months]

   Comparing the number of treatment related late skin toxicities who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2) using the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 5.0 (NCI CTCAEv5.0).

10. Comparing the number of treatment related late skin toxicities who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2) [24 months]

    Comparing the number of treatment related late skin toxicities who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2) using the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 5.0 (NCI CTCAEv5.0).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 90 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Patients ≥ 50 yrs with histologically confirmed unilateral DCIS or Stage I invasive breast cancer; received breast conserving surgery (pN0 or pNx) with tumor pathology ≤ 2 cm and excision margin ≥ 1 mm

Inclusion Criteria:

• Women status post segmental mastectomy

• If unilateral, pT1 breast cancer excised with negative margins AND/OR pTis excised with negative margins.

• If bilateral, pT1 breast cancer excised with negative margins AND/OR pTis excised with negative margins.

• Clinically N0 or pN0 or sentinel node negative

• Ductal carcinoma in situ DCIS with negative margins (no DCIS on inked margins).

Exclusion Criteria:

• Previous radiation therapy to the ipsilateral breast.

• 90 days from last surgery, unless s/p adjuvant chemotherapy

• 60 days from last chemotherapy

• Patients unable to tolerate MRI or are otherwise unsuitable for MRI-based RT treatment

• Metastatic disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medicine	New York	New York	United States	10065

Sponsors and Collaborators

• Weill Medical College of Cornell University

Investigators

• Principal Investigator: John Ng, M.D., Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT05731791
• Other Study ID Numbers: 22-01024342
• First Posted: Feb 16, 2023
• Last Update Posted: Feb 24, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

No Results Posted as of Feb 24, 2023