IGIMRT Dosing Schedules for Cancer Spread to Bone/Spine

Not currently recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Prior radiotherapy, Pregnancy, Chemotherapy, 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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best method for delivering high-dose radiation therapy to treat cancer that has spread to the bones, spine, soft tissue, or lymph nodes. It compares two radiation schedules: one involves three sessions over three days, and the other delivers all the radiation in a single session. Both treatments use IG-IMRT (Image-Guided Intensity-Modulated Radiation Therapy), which targets the cancer directly while minimizing damage to healthy tissue. People with stage IV cancer that has spread to the specified areas and who haven't received prior radiation in those areas might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the chance to contribute to the development of a potentially groundbreaking 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, chemotherapy cannot be given on the day of the planned radiotherapy treatment.

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

Research has shown that both treatment schedules of image-guided intensity-modulated radiotherapy (IGIMRT) for cancer that has spread to the bone and spine are generally well-tolerated by patients. One study found that administering 27 Gy over three days or a single 24 Gy dose in one day causes few severe side effects.

For the 27 Gy over three days approach, patients typically handle the treatment well, with side effects usually mild. Similarly, evidence indicates that the single 24 Gy dose carries a low risk of serious side effects and effectively controls tumor growth.

Both methods target the cancer directly, protecting healthy tissue and reducing the chances of unwanted effects. Overall, past studies have shown that both treatments have promising safety profiles. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore two different dosing schedules of image-guided radiation therapy (IGIMRT) for cancer that has spread to the bone or spine. Unlike traditional treatments that may require multiple visits over several weeks, this trial investigates a more condensed schedule: one option administers 27 Gy over three sessions, while the other delivers a single, high dose of 24 Gy. This approach could offer patients quicker relief and more convenient treatment options, potentially improving quality of life by reducing the number of hospital visits.

What evidence suggests that this trial's treatments could be effective for cancer spread to bone or spine?

In this trial, participants will receive one of two dosing schedules for hypofractionated image-guided radiation therapy (IGIMRT) to treat cancer spread to the bone, spine, soft tissue, and lymph nodes. One group will receive 27 Gy in three sessions. Studies have shown that this schedule provides good pain relief and effectively controls the disease. Another group will receive a single dose of 24 Gy. Research indicates that this method offers strong local control of the cancer spread and relieves pain in 50% to 80% of patients, with some experiencing complete pain relief. Both treatment methods target the cancer site precisely, minimizing harm to healthy tissues. ^{3 4 5 6 7}

Who Is on the Research Team?

Yoshiya Yamada, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with Stage IV cancer that has spread to bone, spine, soft tissue, or lymph nodes. They must have a confirmed diagnosis of cancer like carcinoma, sarcoma, or melanoma and measurable disease. Participants need good physical functioning (KPS ≥ 80) and normal bone marrow function. Pregnant women or those breastfeeding are excluded.

Inclusion Criteria

Measurable disease defined as: ≥ 10mm for soft-tissue lesions, ≥ 15mm on the short axis of lymph nodes

My cancer has spread to my bones, spine, soft tissues, or lymph nodes.

My cancer is at stage IV and has spread to distant parts of my body.

Exclusion Criteria

I have had radiation therapy on the cancer area before.

My disease is close to my spinal cord, less than 2 mm away.

I will receive chemotherapy on the same day as my radiotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive either 27 Gy in three fractions over 3 days or 24 Gy in one fraction over 1 day using image-guided intensity-modulated radiotherapy (IG-IMRT)

1-3 days

1-3 visits (in-person)

MRI Assessment

Participants may undergo up to 3 MRIs with standard contrast injection to assess changes in blood flow to the cancer

1 day

Up to 3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in tumor perfusion and SUV uptake

2 years

What Are the Treatments Tested in This Trial?

Interventions

• IGIMRT 27 Gy in 3 fractions
• IGIMRT using a single dose of 24 Gy

Trial Overview The study compares two ways of delivering high-dose radiation using IG-IMRT: one group receives a single dose of 24 Gy in one day; the other gets 27 Gy across three days. The goal is to see which method is more effective for treating metastatic cancer at specific sites.

How Is the Trial Designed?

Group I: stereotactic IGIMRT using a single dose of 24 Gy Experimental Treatment 1 Intervention

This is a phase III, multicenter, randomized, study comparing two dosing schedules for hypofractionated image-guided radiation therapy to bone, spine, soft tissue, and lymph nodes in patients with metastatic disease

Group II: stereotactic IGIMRT 27 Gy in 3 fractions Experimental Treatment 1 Intervention

This is a phase III, multicenter, randomized, study comparing two dosing schedules for hypofractionated image-guided radiation therapy to bone, spine, soft tissue, and lymph nodes in patients with metastatic disease

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

University of Pisa

Collaborator

Trials

153

Recruited

84,700+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

The Champalimaud Centre, Lisbon, Portugal

Collaborator

Trials

2

Recruited

330+

Published Research Related to This Trial

In a trial involving 40 glioblastoma patients, the maximum tolerated dose (MTD) of intensity-modulated radiotherapy (IMRT) was determined to be 70 Gy, delivered in 25 fractions, without unacceptable acute toxicity.

The study demonstrated that this high dose of radiation, combined with standard doses of temozolomide (TMZ), did not result in significant late neurological toxicity after a median follow-up of 25 months, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated intensity-modulated radiotherapy plus temozolomide in patients with glioblastoma: a phase I dose-escalation study (ISIDE-BT-1). Massaccesi, M., Ferro, M., Cilla, S., et al.[2022]

In a Phase I clinical trial involving 19 patients with glioblastoma, the maximum tolerated dose of fractionated intensity-modulated radiotherapy (IMRT) combined with temozolomide (TMZ) was determined to be 65 Gy, delivered in 25 fractions over 5 weeks, without any dose-limiting toxicities observed.

The treatment was well tolerated, with only mild to moderate (Grade 1-2) neurologic and skin toxicities reported, and no severe late neurologic toxicities, indicating a favorable safety profile for this combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I dose-escalation study (ISIDE-BT-1) of accelerated IMRT with temozolomide in patients with glioblastoma. Morganti, AG., Balducci, M., Salvati, M., et al.[2018]

In a phase I clinical trial involving nine patients with glioblastoma, simultaneous integrated-boost intensity-modulated radiotherapy (SIB-IMRT) combined with temozolomide was found to be feasible and well tolerated up to a maximum dose of 80Gy.

No dose-limiting toxicities were observed at the highest dose level, indicating that this treatment combination may be safe for patients with malignant glioma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I dose escalation study using simultaneous integrated-boost IMRT with temozolomide in patients with unifocal glioblastoma. Truc, G., Bernier, V., Mirjolet, C., et al.[2018]

In a study comparing two radiotherapy regimens for spinal metastases, the dose-escalation group receiving 60-66 Gy showed significantly better pain relief outcomes after one and three months compared to the 30-Gy group, with complete pain relief rates of 73.69% and 41.38%, respectively.

The dose-escalation regimen not only improved pain relief but also demonstrated a trend towards longer overall survival and lower acute radiation toxicities, while no late radiation toxicities were observed in either group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose escalation by image-guided intensity-modulated radiotherapy leads to an increase in pain relief for spinal metastases: a comparison study with a regimen of 30 Gy in 10 fractions. He, J., Xiao, J., Peng, X., et al.[2022]

Patients treated with image-guided intensity modulated radiation therapy (IG-IMRT) received significantly lower radiation doses to critical organs like the anorectum, anal canal, and bladder compared to those treated with 3D conformal radiation therapy (3D-CRT), which can lead to better safety outcomes.

IG-IMRT resulted in lower rates of acute gastrointestinal and genitourinary toxicity, with grade ≥2 GI toxicity at 29% compared to 49% for 3D-CRT, and GU toxicity at 38% compared to 48%, indicating that IG-IMRT may provide a safer treatment option for prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute toxicity after image-guided intensity modulated radiation therapy compared to 3D conformal radiation therapy in prostate cancer patients. Wortel, RC., Incrocci, L., Pos, FJ., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01223248

Randomized Study Comparing Two Dosing Schedules for ... This study will look at the effects, good and/or bad, of giving 27 Gy in three fractions (3 days) or 24 Gy in one fraction (1 day) using image-guided intensity- ...

2. withpower.com withpower.com/trial/phase-3-9-2010-8be40

IGIMRT Dosing Schedules for Cancer Spread to Bone/Spine In a study comparing two radiotherapy regimens for spinal metastases, the dose-escalation group receiving 60-66 Gy showed significantly better pain relief ...

3. researchgate.net researchgate.net/publication/339568705_Single_fraction_radiosurgery_fractionated_radiosurgery_and_conventional_radiotherapy_for_spinal_oligometastasis_SAFFRON_A_systematic_review_and_meta-analysis

A systematic review and meta-analysis | Request PDF Two single-institution studies comparing single-fraction SRS (mostly 24 Gy in 1 fraction) and multifraction SRS (27) (28)(29)(30) Gy in 3 fractions) reported ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5737630/

Local disease control for spinal metastases following ... The authors examine the outcomes of postoperative image-guided intensity-modulated radiation therapy (IG-IMRT) delivered as single-fraction or hypofractionated ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/21925682241229665

Advanced Radiotherapy Technologies in Spine Tumors Typical prescription doses of SBRT ranges from 18-24 Gy in 1 fraction, 24-28 Gy in 2 fractions, 24-27 Gy in 3 fractions and 30-36 Gy in 4-5 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12360861/

Advances in Radiotherapy in the Treatment of Metastatic ... A randomized phase-3 study compared the outcomes of fractionated SBRT (27 Gy in 3 fractions) and single-dose SBRT (24 Gy in a single fraction).

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12332343/

Efficacy and Safety of Simultaneous Integrated Boost ... This study evaluated the clinical efficacy and safety of simultaneous integrated boost (SIB) followed by selective sequential boost ...