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

Trial Summary

What is the purpose of this trial?

To determine if the experimental approach of early radiation oncology involvement alongside standard oncologic care will result in higher HRQL at 6 months compared to the control arm receiving standard oncologic care alone, based on the global subscale score of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire.

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.

What data supports the effectiveness of early radiation therapy for cancer?

Research on breast cancer shows that starting radiation therapy soon after surgery can reduce the chance of cancer returning. Combining radiation with chemotherapy can also enhance treatment effects and improve survival rates. ^{1 2 3 4 5}

Is early radiation therapy generally safe for humans?

Research on radiation therapy for various cancers, like breast, rectal, prostate, and cervical cancer, shows that while there can be side effects, they are often monitored and reported by patients. These studies help ensure that any adverse effects are managed, suggesting that radiation therapy is generally safe when used under medical supervision. ^{6 7 8 9 10}

How is the Early Radiation Therapy treatment different from other treatments for cancer?

Early Radiation Therapy involves starting radiation treatment sooner alongside standard cancer care, which may help improve local control of the cancer and potentially reduce the risk of recurrence. This approach is different because it emphasizes the timing and integration of radiation with other treatments, aiming to optimize outcomes by minimizing delays. ^{3 4 11 12 13}

Research Team

Malcolm Mattes, MD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Eligibility Criteria

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

I am 18 years old or older.

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.

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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 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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Adjuvant radiotherapy of regional lymph nodes in breast cancer - a meta-analysis of randomized trials. [2022]

2. United States 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Sequencing of chemotherapy and radiation therapy in early-stage breast cancer: updated results of a prospective randomized trial. [2013]

4. France 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]. [2019]

5. England pubmed.ncbi.nlm.nih.gov

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

6. Switzerland pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes for patients with breast cancer undergoing radiotherapy: A single-center registry experience. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy of data capture for patient-reported toxicity following radiotherapy for prostate or cervical cancer. [2022]

8. United States 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). [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Prognostic significance of adverse events associated with preoperative radiotherapy for rectal cancer. [2021]

10. Germany 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. [2022]

11. Greece pubmed.ncbi.nlm.nih.gov

Local recurrence in breast cancer after conservative surgery: timing of radiotherapy and sequencing of chemotherapy. [2013]

12. Switzerland pubmed.ncbi.nlm.nih.gov

[Indications of radiation therapy in non metastatic breast cancer]. [2007]

13. Germany pubmed.ncbi.nlm.nih.gov

Why and how to combine chemotherapy and radiation therapy in breast cancer patients. [2019]