Short-Course Radiation for Breast Cancer
(TRIO Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Stay on Your Current Meds
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?Patients with high risk breast cancers (any locally advanced breast cancer patient defined as Stages IIB-III \[excluding inflammatory breast cancer\] with stage IIA being eligible for triple negative and HER2-positive breast cancers) will receive neoadjuvant radiation to any portion of their tumour in three fractions in order to act as an immune primer. Radiation will be delivered to a portion of the tumour in three fractions. The patient will be positioned prone as per the SIGNAL 2.0 protocol. The patient will then go on to standard of care treatment (neoadjuvant chemotherapy and surgery) followed by whole-breast radiation as needed. Pathologic complete response will be the primary outcome. Immune markers will also be evaluated.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves neoadjuvant chemotherapy and radiation, it's best to discuss your current medications with the trial team to ensure there are no interactions.
What data supports the idea that Short-Course Radiation for Breast Cancer is an effective treatment?
The available research shows that preoperative short-course radiation therapy for breast cancer is becoming more common and is seen as a promising approach. It is part of a shift in treatment strategies that aim to improve outcomes by using radiation before surgery. This approach can lead to more conservative surgeries and potentially increase the chances of patients living longer without the disease returning. Advances in technology and understanding of how radiation works have made this treatment more precise and effective, allowing it to be safely combined with other cancer-fighting methods.
12345What safety data exists for short-course radiation treatment for breast cancer?
The safety data for short-course radiation treatment for breast cancer includes findings from a Canadian randomized trial, which showed no statistical differences in efficacy or adverse effects between conventional and short-course radiotherapy. However, this trial only included patients with favorable prognoses and excluded those with carcinoma involving the inked margin of excision. The trial also did not use additional boost irradiation and had a low percentage of patients treated with systemic chemotherapy. There is a concern that large fraction doses may cause more severe late toxicities in normal breast tissue. Further clinical studies are recommended to confirm the feasibility of this method for broader patient groups.
678910Is neoadjuvant radiotherapy a promising treatment for breast cancer?
Yes, neoadjuvant radiotherapy, also known as short-course radiotherapy, is a promising treatment for breast cancer. It offers a shorter treatment time, which can be more convenient for patients, and has been shown to be as effective as traditional long-term radiotherapy. This approach can improve the quality of life for patients by reducing treatment costs and saving medical resources.
1291112Eligibility Criteria
This trial is for adults over 18 with high-risk, non-inflammatory breast cancer at stages IIB-III (IIA if triple negative or HER2-positive). Participants must be able to undergo MRI scans, tolerate needle biopsies, and have not received prior treatment for their current breast cancer. They should also plan to receive standard neoadjuvant chemotherapy.Inclusion Criteria
I am scheduled for chemotherapy before surgery.
My breast cancer is at an advanced stage but not the most severe form.
My breast cancer is not lobular, sarcomatous, metaplastic, or has lobular features.
+5 more
Exclusion Criteria
You cannot handle having a core needle biopsy.
Pregnant or lactating
I have health conditions that prevent me from receiving standard cancer treatments.
+13 more
Participant Groups
The study tests whether three fractions of radiation before standard care can prime the immune system in patients with advanced breast cancer. The primary goal is to see if this leads to a complete response where no signs of cancer are found after treatment.
1Treatment groups
Experimental Treatment
Group I: Neoadjuvant radiotherapyExperimental Treatment1 Intervention
3 doses of stereotactic radiotherapy administered prior to neoadjuvant chemotherapy in high-risk breast cancers.
Neoadjuvant radiotherapy is already approved in United States, European Union, China for the following indications:
🇺🇸 Approved in United States as Neoadjuvant radiotherapy for:
- Locally advanced breast cancer (LABC)
- T4 breast cancer
🇪🇺 Approved in European Union as Preoperative radiotherapy for:
- Locally advanced breast cancer (LABC)
- T4 breast cancer
🇨🇳 Approved in China as Neoadjuvant radiotherapy for:
- Locally advanced breast cancer (LABC)
- T4 breast cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
London Regional Cancer ProgramLondon, Canada
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Who Is Running the Clinical Trial?
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph'sLead Sponsor
London Health Sciences Centre OR Lawson Research Institute of St. Joseph'sLead Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sLead Sponsor
Lawson Health Research InstituteLead Sponsor
References
What is the optimal timing of surgery after short-course radiotherapy for rectal cancer? [2023]Short-course neoadjuvant radiotherapy is a valuable tool in managing rectal cancers and has improved local recurrence rates. However, limited and conflicting data has resulted in variable usage and a lack of consensus on the optimal timing of surgery following short-course radiotherapy. This review aims to provide a contemporary summation of the available evidence regarding the optimal time interval between short-course neoadjuvant radiotherapy and surgery.
Response to treatment and interval to surgery after preoperative short-course radiotherapy in rectal cancer. [2017]Preoperative short-course radiotherapy with immediate surgery improves local control in patients with rectal cancer. Tumor responses are smaller than those described with radiochemotherapy. Preliminary data associate this lower response to the short period until surgery. The aim of this study is to analyze the response to preoperative short-course radiotherapy and its correlation with the interval to surgery especially analyzing patients with mesorectal fascia involvement.
Preoperative Radio(Chemo)Therapy in Breast Cancer: Time to Switch the Perspective? [2023]Radiation therapy represents, together with surgery and systemic treatment, the triad on which the current management of patients with breast cancer is based, achieving high control and survival rates. In recent years we have witnessed a (r)evolution in the conception of breast cancer treatment. The classic scheme of surgery followed by systemic treatment and radiotherapy is being subverted and it is becoming more and more frequent to propose the primary administration of systemic treatment before surgery, seeking to maximize its effect and favoring not only the performance of more conservative surgeries but also, in selected cases, increasing the rates of disease-free survival and overall survival. Radiotherapy is also evolving toward a change in perspective: considering preoperative primary administration of radiotherapy may be useful in selected groups. Advances in radiobiological knowledge, together with technological improvements that are constantly being incorporated into clinical practice, support the administration of increasingly reliable, precise, and effective radiotherapy, as well as its safe combination with antitumor drugs or immunotherapy in the primary preoperative context. In this paper, we present a narrative review of the usefulness of preoperative radiotherapy for breast cancer patients and the possibilities for its combination with other therapies.
Fraction size in radiation treatment for breast conservation in early breast cancer. [2020]Shortening the duration of radiation therapy would benefit women with early breast cancer treated with breast conserving surgery. It may also improve access to radiation therapy by improving efficiency in radiation oncology departments globally. This can only happen if the shorter treatment is as effective and safe as conventional radiation therapy. This is an updated version of the original Cochrane Review published in Issue 3, 2008.
Preoperative short-course radiotherapy in rectal cancer patients: results and prognostic factors. [2022]The purpose of this study was to evaluate the clinical outcome of preoperative short-course radiotherapy for rectal cancer patients.
Prospective randomized clinical trial: protoadjuvant chemotherapy vs. protoadjuvant radiotherapy in breast cancer stages T3/4, N+/-, M0. [2007]Patients selected for neo-adjuvant therapy in this trial suffered from breast cancer stages T3/4, N0/+, M0. Selected patients were stratified and assigned to either pre- and post-operative chemotherapy (tamoxifen, fluorouracil, vincristine, methotrexate, cyclophosphamide, mitoxantrone) or radiotherapy by randomization. This interim report deals with side-effects and response rates of pre-operative therapy only. For this subgroup from 41 centres, 67 patients have so far been accepted for protocol treatment. 36 received peri-operative chemotherapy and 31 perioperative radiotherapy. We have completed reports of 66 pre-operative chemotherapeutic cycles pointing out only low side-effects in spite of a combination consisting of 5 different cytotoxic agents plus hormonal therapy. It is remarkable that 79% had no hair loss and 74% no gastrointestinal side-effects; in the chemotherapy-group 24 patients so far have been operated. Response rates were as follows: 1 (4%) complete remission, 9 (38%) partial remission, 7 (29%) minor response, 2 (8%) no response and 2 (8%) progression. In 2 patients response could not be determined. In the perioperative radiotherapy-group 10 patients have been operated with similar response rates. It is interesting to note, that both therapies influenced receptor values in different ways: Chemotherapy decreased receptor values, whereas radiotherapy insignificantly increased them. The purpose of this study is to establish a rational base for post-operative cytotoxic treatment of patients as only patients who objectively respond to preoperative treatment are likely to benefit from postoperative drug administration. The study is open for enrollment until a total of 200 patients is reached.
Acute Adverse Events and Postoperative Complications in a Randomized Trial of Preoperative Short-course Radiotherapy Versus Long-course Chemoradiotherapy for T3 Adenocarcinoma of the Rectum: Trans-Tasman Radiation Oncology Group Trial (TROG 01.04). [2022]To compare acute adverse events (AE) and postoperative complication rates in a randomized trial of short-course (SC) versus long-course (LC) preoperative radiotherapy.
Retrospective study of acute toxicity following short-course preoperative radiotherapy. [2004]The use of short-course preoperative radiotherapy (25 Gy in five fractions over 1 week) in resectable rectal cancer reduces local recurrence but is associated with an increased risk of postoperative complications and late toxicity. This study aimed to identify those patients who are unlikely to benefit from short-course preoperative radiotherapy and the factors associated with acute toxicity.
Short-course radiotherapy for the whole breast after breast conserving surgery. [2008]Short-course radiotherapy for the whole breast after breast conserving surgery is an alternative to conventional fractionation schedules for radiotherapy. This method shortens the treatment period by increasing the daily fraction dose from 2 to 2.5 Gy or more, and is already being used in Canada and parts of Europe as a more convenient treatment for breast cancer patients than conventional long-term radiotherapy. An important randomized trial in Canada found that there were no statistical differences in efficacy or adverse effects between conventional radiotherapy and short-course radiotherapy. However, that trial included only breast cancer patients with the most favorable prognoses and excluded patients who had carcinoma involving the inked margin of excision. In that trial, additional boost irradiation to the lumpectomy site was not used, and only 11% of patients were treated with systemic chemotherapy. It is also possible that irradiation using large fraction doses cause more severe late toxicities in normal breast tissue than conventional fraction irradiation. Therefore, while short-course radiotherapy may also prove more convenient, further clinical studies should be performed to confirm the feasibility of the new method for Japanese women, before being put into general clinical use in Japan. The present paper is a review of short-course radiotherapy for the whole breast after breast conserving surgery.
Radiation Dermatitis: A Prevention Protocol for Patients With Breast Cancer. [2019]Patients with breast cancer undergoing radiation therapy can experience dermatologic adverse events. Oncology nurses can advocate for radiation dermatitis (RD) prophylaxis to minimize dermatologic adverse events.
Point: short-course radiation therapy is preferable in the neoadjuvant treatment of rectal cancer. [2022]There are 2 types of neoadjuvant radiation regimens accepted as standard for resectable rectal cancer: short-course (5 × 5 Gy) radiation therapy alone with immediate surgery and long-course combined chemoradiation therapy with delayed surgery. A Polish randomized study (n = 312) and an Australian randomized study (n = 326) compared these 2 schedules. Both trials showed a lower rate of early adverse effects using a short-course radiation regimen and no differences in long-term oncologic outcomes and late toxicity rates between groups. The small number of fractions makes short-course radiation less expensive and more convenient than chemoradiation therapy. These facts indicate that short-course radiation is preferable to chemoradiation for resectable cancers. Additionally, short-course preoperative radiation with a long interval to surgery is a valuable option for patients unfit for chemotherapy, with unresectable cancer or with a small tumor that is amenable to local excision. Moreover, short-course radiation enables the intensification of both radiotherapy and chemotherapy in patients with metastatic rectal cancer with potentially resectable synchronous metastatic disease.
Progress of clinical study on hypofractionated radiotherapy after breast-conserving surgery. [2020]Whole-breast radiotherapy after breast-conserving surgery (BCS) can improve patient survival while reducing local tumor recurrence. Although standard breast radiotherapy can achieve good tumor control and cosmetic effects with low toxicity, the 5- to 7-week treatment time is relatively long for patients and can result in wasted medical resources. Therefore, there is a growing trend toward hypofractionated radiotherapy (HFRT), which accelerates partial-breast irradiation. Both short-course radiotherapy and conventional fractionated radiotherapy are safe and effective treatment modes, with similar survival and local tumor control effects as those of conventional radiotherapy (CRT), and adverse reactions can be tolerated. Compared with conventional fractionated radiotherapy, short-course radiotherapy saves medical resources and has a shorter total treatment time, reduced treatment costs, and an improved quality of life for patients.