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

Breast Cancer Clinical Trial

— PPI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05731791
• Other study ID #: 22-01024342
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2023
• Est. completion date: December 2028

Study information

• Verified date: March 2024
• Source: Weill Medical College of Cornell University
• Contact: Lhaden Tshering, B.S.
• Phone: 646-962-3118
• Email: lht4002[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: December 2028
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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).

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparing local recurrence rates between patients receiving Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)		24months
Secondary	Comparing local recurrence rates between patients receiving Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)		60 months
Secondary	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
Secondary	Comparing clinical and planning target volumes (CTV and PTV volumes) for CT-based planning vs. MRI-based planning		60 months
Secondary	Comparing patient reported cosmetic outcomes between patients treated on Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)	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.	60 months
Secondary	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)	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 months
Secondary	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)	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).	12 months
Secondary	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)	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).	24 months
Secondary	Comparing the number of treatment related late skin toxicities who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)	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).	6 months
Secondary	Comparing the number of treatment related late skin toxicities who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)	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).	12 months
Secondary	Comparing the number of treatment related late skin toxicities who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)	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).	24 months