Early Radiation Therapy for Cancer

Recruiting at 8 trial locations

Overseen By Malcolm Mattes, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Castrate-sensitive prostate, Breast, Endometrial, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 months

156 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if early radiation therapy, combined with standard cancer care, can enhance the quality of life for individuals with certain cancer types. Participants will receive either standard cancer care or standard care with early involvement from a radiation oncologist. The trial targets those with cancer that has spread and is not curable, particularly if they experience symptoms or challenges from the spread. It is best suited for individuals actively receiving treatments like chemotherapy or immunotherapy, excluding those with certain cancers such as leukemia or brain cancer. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking advancements in cancer treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial includes patients who are either planned or actively receiving systemic therapy (like chemotherapy or hormonal therapy), it seems likely that you can continue your current treatments.

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

Research has shown that radiation therapy is generally safe for cancer patients. For example, one study found that only 3.2% of patients experienced serious side effects, indicating that most people tolerate radiation well. Another study found that radiation therapy often improves quality of life compared to other treatments. These findings suggest that starting radiation treatment early in cancer care is likely to be well-tolerated. However, discussing potential risks with a doctor is important for each individual. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about early radiation therapy for cancer because it integrates radiation oncology involvement earlier in the treatment process, potentially improving patient outcomes. Unlike standard care that typically involves radiation at later stages or after significant progression, this approach involves a radiation oncologist from the start to closely monitor symptoms and tailor interventions proactively. This early involvement could help in managing symptoms more effectively and providing timely educational support to patients, allowing them to identify and address issues sooner.

What evidence suggests that early radiation oncology involvement could be effective for cancer?

Research has shown that radiation therapy plays a crucial role in cancer treatment, with about half of all cancer patients receiving it. Studies have found that patients who fully respond to this treatment have a 78.6% chance of living for at least five more years. For early-stage breast cancer, a shorter course of radiation proves just as safe and effective as a longer one. In this trial, one group of participants will receive early radiation oncology involvement alongside standard oncologic care. These findings suggest that starting radiation treatment early can improve patient outcomes by relieving symptoms sooner and possibly enhancing quality of life. ^{1 5 6 7 8}

Who Is on the Research Team?

Malcolm Mattes, MD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Are You a Good Fit for This Trial?

Adults over 18 with cancer outside the brain, receiving or planning to receive systemic therapy, and not expected to be cured. They must understand and consent to the study, have a life expectancy of 6-24 months but not longer than that for certain cancers. Excluded are those with specific types of responsive cancers, leukemia, CNS cancers, uncontrolled illnesses, pregnant/breastfeeding women, cognitively impaired adults without decision-making capacity.

Inclusion Criteria

My cancer has spread and cannot be cured, so my treatment is aimed at comfort.

I can take care of myself and am up and about more than 50% of my waking hours.

My cancer is confirmed by tests and did not start in my brain or spinal cord.

Exclusion Criteria

I have leukemia or a primary brain cancer.

I am currently being followed by a radiation oncologist after having radiation therapy for symptom relief.

My endometrial cancer responds to hormone treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard oncologic care and early radiation oncology involvement, with assessments using EORTC QLQ-C30, EQ-5D-5L, PTPQ, and FAMCARE-P16 questionnaires

6 months

Monthly visits for assessments

Follow-up

Participants are monitored for health-related quality of life (HRQL) and other metrics using questionnaires

6 months

Every 3 months for EORTC QLQ-C30, PTPQ, FAMCARE-P16; monthly for EQ-5D-5L

Extension

Optional continuation of monitoring and care for participants who wish to continue beyond the initial 12 months

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Early Radiation Oncology Involvement Alongside Standard Oncologic Care

Trial Overview The trial is testing if adding early radiation oncology consultations to standard cancer care improves quality of life at six months compared to just standard care alone. This is measured using a quality-of-life questionnaire (EORTC QLQ-C30).

How Is the Trial Designed?

Group I: Arm 2 Experimental Treatment 1 Intervention

Patients enrolled in Arm 2 will also be seen be a radiation oncologist during the course of the study. The RO will review the patient's most recently completed EQ 5D-5L questionnaires and perform a complete History and Physical evaluation to determine if there is any immediate role for PRT. Based on the patient's type of cancer and areas of spread, the RO will also discuss types of symptoms that could develop in the future, and give instructions and educational materials to the patient so he/she can better identify those symptoms early on.

Group II: Arm 1 Experimental Treatment 1 Intervention

All enrolled patients will receive standard oncologic care at the discretion of the treating physicians, but will also complete the EORTC QLQ-C30, EQ-5D-5L, PTPQ, FAMCARE-P16 at baseline before randomization. Follow-up assessment using EORTC QLQ-C30, PTPQ, FAMCARE-P16 will occur every 3 months, and using EQ-5D-5L will occur every 1 month, for a total of 12 months. These will be administered during standard-of-care clinic or infusion center visits.

Early Radiation Oncology Involvement Alongside Standard Oncologic Care is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiation Therapy for:

• Breast cancer
• Lung cancer
• Colorectal cancer
• Prostate cancer
• Brain tumors
• Spinal tumors

Approved in United States as Radiation Therapy for:

• Breast cancer
• Lung cancer
• Colorectal cancer
• Prostate cancer
• Brain tumors
• Spinal tumors
• Gynecologic cancers

Approved in Canada as Radiation Therapy for:

• Breast cancer
• Lung cancer
• Colorectal cancer
• Prostate cancer
• Brain tumors
• Spinal tumors

Approved in Japan as Radiation Therapy for:

• Breast cancer
• Lung cancer
• Colorectal cancer
• Prostate cancer
• Brain tumors
• Spinal tumors

Approved in China as Radiation Therapy for:

• Breast cancer
• Lung cancer
• Colorectal cancer
• Prostate cancer
• Brain tumors
• Spinal tumors

Approved in Switzerland as Radiation Therapy for:

• Breast cancer
• Lung cancer
• Colorectal cancer
• Prostate cancer
• Brain tumors
• Spinal tumors

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Published Research Related to This Trial

The PRO-CTCAE tool allows breast cancer patients to report their own symptoms during chemotherapy, providing real-time feedback to clinicians, which could improve patient care.

This national study aims to assess the impact of electronic PRO-CTCAE reporting on critical treatment outcomes such as dose reduction, hospitalization, and febrile neutropenia, marking a significant step in understanding patient-reported outcomes in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Routine surveillance for symptomatic toxicities with real-time clinician reporting in Danish breast cancer patients-Organization and design of the first national, cluster randomized trial using the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE). Pappot, H., Baeksted, C., Knoop, A., et al.[2019]

In a study of 331 breast cancer patients undergoing radiation therapy, those reporting severe adverse effects (grade ≥3 PRO-CTCAE) experienced a significant decline in their quality of life, with an average reduction of 10.4 points in their overall quality-of-life scores.

The use of hypofractionated radiation therapy was associated with improved quality of life, while a higher body mass index (BMI) was linked to worse quality of life outcomes, highlighting the importance of considering these factors in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes version of the common terminology criteria for adverse events and quality-of-life linear analogue self-assessment in breast cancer patients receiving radiation therapy: single-institution prospective registry. Thorpe, CS., DeWees, TA., Golafshar, MA., et al.[2022]

In a study of 295 patients with early-stage, node-positive breast cancer, the timing of radiotherapy in relation to chemotherapy significantly affected breast failure rates, with a 41% failure rate for those receiving all chemotherapy before radiotherapy compared to much lower rates for other sequences.

Patients who started radiotherapy within 16 weeks after surgery had a 5% local failure rate, while those who delayed beyond 16 weeks had a much higher rate of 35%, suggesting that timely initiation of radiotherapy may be crucial for reducing local recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integration of conservative surgery, radiotherapy, and chemotherapy for the treatment of early-stage, node-positive breast cancer: sequencing, timing, and outcome. Recht, A., Come, SE., Gelman, RS., et al.[2022]

A study involving 77 cancer patients (37 with gynaecological cancer and 40 with prostate cancer) found that both electronic and paper formats of patient-reported toxicity questionnaires yielded consistent and reliable results in measuring treatment-related side effects after radiotherapy.

Patients generally found both formats clear and easy to use, with nearly half having no preference, indicating that electronic data capture for reporting toxicity is feasible and acceptable in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of data capture for patient-reported toxicity following radiotherapy for prostate or cervical cancer. Farnell, DJ., Routledge, J., Hannon, R., et al.[2022]

In a study of 75 patients with low rectal cancers who underwent preoperative radiotherapy (PRT), the most common adverse events were leukocytopenia (12%) and diarrhea (24%), primarily classified as mild to moderate (grade 1-2).

Interestingly, patients who experienced these adverse events had a significantly better 5-year relapse-free survival rate (94% for those with leukocytopenia or diarrhea vs. 49% for those without), suggesting that these side effects may indicate a more favorable prognosis and should not deter the use of PRT in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic significance of adverse events associated with preoperative radiotherapy for rectal cancer. Ishihara, S., Watanabe, T., Akahane, T., et al.[2021]

In a study involving 244 early-stage breast cancer patients, the timing of chemotherapy (CT-first vs. RT-first) showed no significant differences in outcomes such as time to any event, distant metastasis, or death after a median follow-up of 135 months.

The results suggest that there is no clear advantage to administering radiation therapy before chemotherapy, but the study's design may not have been powerful enough to completely rule out potential survival benefits for either treatment sequence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequencing of chemotherapy and radiation therapy in early-stage breast cancer: updated results of a prospective randomized trial. Bellon, JR., Come, SE., Gelman, RS., et al.[2013]

Regional radiotherapy targeting the internal mammary and medial supraclavicular lymph nodes significantly improves overall survival (OS) in breast cancer patients, with a hazard ratio of 0.88 across multiple trials involving over 7,000 participants.

In addition to improving OS, regional radiotherapy also enhances disease-free survival (DFS) and distant metastasis-free survival (DMFS), indicating its effectiveness in reducing cancer recurrence and spread.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant radiotherapy of regional lymph nodes in breast cancer - a meta-analysis of randomized trials. Budach, W., Kammers, K., Boelke, E., et al.[2022]

Concomitant radiochemotherapy may enhance treatment efficacy for early-stage breast cancer by improving local control and potentially reducing the time between surgery and radiotherapy, which is crucial since delays over 6 months can diminish the benefits of radiotherapy.

Current studies suggest that combining chemotherapy with radiotherapy can lead to better outcomes and shorter treatment durations, but ongoing trials are needed to confirm its effectiveness as a standard treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Respective roles of radiotherapy and chemotherapy in adjuvant treatment of cancer of the breast: theoretical importance and feasibility of chemoradiotherapy]. Freyer, G., Romestaing, P.[2019]

Recent advancements in radiation therapy for early breast cancer, including shorter treatment schedules and improved delivery techniques, enhance local control and reduce side effects, leading to better patient outcomes.

Future research should aim to identify molecular markers that indicate how sensitive a tumor is to radiation, which could help in developing targeted treatments that improve the effectiveness of radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation therapy (RT) after breast-conserving surgery (BCS) in 2015--The year of radiation therapy advances. Kirova, YM.[2018]

In a study of 331 breast cancer patients undergoing adjuvant radiotherapy, 75% reported at least one patient-reported outcome (PRO) grade ≥2, indicating significant side effects, while 28% reported grade ≥3, which reflects more severe adverse effects.

Patients receiving hypofractionated (HF) radiotherapy had a significantly lower risk of experiencing severe side effects (PRO-CTCAE grade ≥3) compared to those receiving conventional fractionation (CF), suggesting that HF may be a safer option for minimizing treatment-related toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes for patients with breast cancer undergoing radiotherapy: A single-center registry experience. Laughlin, BS., Bhangoo, RS., Thorpe, CS., et al.[2022]

Radiotherapy (RT) is recommended after conservative surgery for early invasive breast cancer, particularly in young patients, to improve local control of the disease.

For locally advanced breast cancer, RT is a standard treatment following mastectomy, as it significantly reduces the risk of local relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Indications of radiation therapy in non metastatic breast cancer]. Sozzi, WJ., Mirimanoff, RO.[2007]

The timing of chemotherapy (CT) and radiation therapy (RT) in early-stage breast cancer is crucial, as delaying either treatment can negatively impact patient outcomes; concurrent CT and full-dose RT may reduce these risks but increases toxicity.

Current regimens that deliver CT quickly, such as four 3-week cycles of Adriamycin and Cytoxan, may be effective in balancing the need for prompt systemic therapy while allowing RT to start within 3 months of surgery, but more randomized clinical trials are needed to determine the best treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Why and how to combine chemotherapy and radiation therapy in breast cancer patients. Dubey, AK., Recht, A., Come, S., et al.[2019]

In a study of 590 early-stage breast cancer patients, those who received radiotherapy within 90 days of surgery had significantly lower local recurrence rates (7.2%) compared to those who received it after 90 days (18.2%).

Chemotherapy can effectively reduce local failure rates in patients who must wait more than 90 days for radiotherapy, with a local recurrence rate of 12.3% for delayed treatment compared to 6.6% for those treated sooner.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local recurrence in breast cancer after conservative surgery: timing of radiotherapy and sequencing of chemotherapy. Donato, V., Monaco, A., Messina, F., et al.[2013]

Citations

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Cancer and Radiation Therapy: Current Advances and ... Radiation therapy remains an important component of cancer treatment with approximately 50% of all cancer patients receiving radiation therapy during their ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2452109424002100

Treatment Outcomes and Prognostic Factors of ... After treatment, the 5-year overall survival rate was 78.6% in complete response patients versus 44.9% in noncomplete response patients (P = .003). For patients ...

3. cancer.gov cancer.gov/news-events/cancer-currents-blog/2022/early-breast-cancer-shorter-radiation-therapy

Shorter Radiation Course for Some with Early Breast Cancer For some people with early-stage breast cancer, a condensed course of radiation therapy is as safe and effective as a longer standard course ...

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Targeted RT study: results on early toxicity of targeted ... The objective of this prospective study was to assess the feasibility and toxicity of pairing RT with concurrent TT in cancer patients.

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2207586

Breast-Conserving Surgery with or without Irradiation in ... Overall survival at 10 years was almost identical in the two groups, at 80.8% (95% CI, 77.2 to 84.3) with no radiotherapy and 80.7% (95% CI, ...

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Study shows high-precision radiation therapy is safe for ... News · Study shows high-precision radiation therapy is safe for patients with cancer that has spread throughout body · More from ecancer.

7. sciencedirect.com sciencedirect.com/science/article/pii/S240563082300112X

Efficacy and safety analysis in metastatic cancer patients ... Response to radiotherapy was observed in 548 (83.0 %) cases and CTCAE toxicity grade > 3 was observed in 21 (3.2 %) cases. •. An increasing number of RT courses ...

8. cancernetwork.com cancernetwork.com/view/exclusive-radiation-therapy-improves-qol-and-safety-outcomes-in-breast-cancer

Exclusive Radiation Therapy Improves QOL and Safety ... When compared with endocrine therapy, radiation therapy improved quality of life and adverse effects data, the phase 3 EUROPA study showed.