156 Participants Needed

Early Radiation Therapy for Cancer

Recruiting at 8 trial locations
MM
Overseen ByMalcolm Mattes, MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Rutgers, The State University of New Jersey
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial
Approved in 6 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.678910

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.79111213

Who Is on the Research Team?

MM

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.
See 4 more

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.
See 12 more

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?
2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment1 Intervention
Group II: Arm 1Experimental Treatment1 Intervention

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

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Approved in European Union as Radiation Therapy for:
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Approved in United States as Radiation Therapy for:
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Approved in Canada as Radiation Therapy for:
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Approved in Japan as Radiation Therapy for:
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Approved in China as Radiation Therapy for:
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Approved in Switzerland as Radiation Therapy for:

Find a Clinic Near You

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

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.
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.
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.
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]

Citations

Adjuvant radiotherapy of regional lymph nodes in breast cancer - a meta-analysis of randomized trials. [2022]
Integration of conservative surgery, radiotherapy, and chemotherapy for the treatment of early-stage, node-positive breast cancer: sequencing, timing, and outcome. [2022]
Sequencing of chemotherapy and radiation therapy in early-stage breast cancer: updated results of a prospective randomized trial. [2013]
[Respective roles of radiotherapy and chemotherapy in adjuvant treatment of cancer of the breast: theoretical importance and feasibility of chemoradiotherapy]. [2019]
Radiation therapy (RT) after breast-conserving surgery (BCS) in 2015--The year of radiation therapy advances. [2018]
Patient-reported outcomes for patients with breast cancer undergoing radiotherapy: A single-center registry experience. [2022]
Efficacy of data capture for patient-reported toxicity following radiotherapy for prostate or cervical cancer. [2022]
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]
Prognostic significance of adverse events associated with preoperative radiotherapy for rectal cancer. [2021]
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]
Local recurrence in breast cancer after conservative surgery: timing of radiotherapy and sequencing of chemotherapy. [2013]
[Indications of radiation therapy in non metastatic breast cancer]. [2007]
Why and how to combine chemotherapy and radiation therapy in breast cancer patients. [2019]
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