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Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Closed for enrollment	View complete study & contact information

Radiation Therapy with or without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer

Jacksonville, FL, Rochester, MN, La Crosse, WI, Albert Lea, MN, Mankato, MN

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Radiation Therapy with or without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective when given alone or together with cetuximab in treating patients with head and neck cancer that has been removed by surgery.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with cetuximab in treating patients who have undergone surgery for locally advanced head and neck cancer.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information
La Crosse, Wis.	Closed for enrollment
Mankato, Minn.	Closed for enrollment
Jacksonville, Fla.	Closed for enrollment
Albert Lea, Minn.	Closed for enrollment

Print study details

Site IRB:
- Rochester, Minnesota: 10-004511
- La Crosse, Wisconsin: 10-004511
- Mankato, Minnesota: 10-004511
- Jacksonville, Florida: 10-004511
- Albert Lea, Minnesota: 10-004511
NCT ID:
NCT00956007
Sponsor Protocol Number:
RTOG 0920

FRACTIONATE

Rochester, MN, Scottsdale/Phoenix, AZ, Jacksonville, FL, Albert Lea, MN, Eau Claire, WI, La Crosse, WI, Mankato, MN

See Details

FRACTIONATE

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

All lesions 4.0 cm to 6.0 cm will receive 32.5 Gy/5 fractions and will be analyzed separately. The portion of the trial is written as a phase II study without randomization noting the rarity of unresected brain metastasis of this size and the lack of comfort of treating radiation oncologist and neurosurgeons with single fraction SRS for tumors this large. However, noting the paucity of prospective data for this patient population enrolling patients on a clinical trial will provide a more accurate historical control for future trials. Although this cohort was enrolled on the prospective phase I trial from Emory and the fractionation of 32.5 Gy in 5 fraction appeared safe and efficacious, a larger cohort of patients is needed to better evaluate the therapeutic ratio of this regimen for this patient population.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed-enrolling by invitation What is this? (?)	View complete study & contact information
La Crosse, Wis.	Closed-enrolling by invitation What is this? (?)
Mankato, Minn.	Closed-enrolling by invitation What is this? (?)
Jacksonville, Fla.	Closed-enrolling by invitation What is this? (?)
Eau Claire, Wis.	Closed-enrolling by invitation What is this? (?)
Scottsdale/Phoenix, Ariz.	Closed-enrolling by invitation What is this? (?)
Albert Lea, Minn.	Closed-enrolling by invitation What is this? (?)

Print study details

Site IRB:
- Rochester, Minnesota: 21-003768
- La Crosse, Wisconsin: 21-003768
- Mankato, Minnesota: 21-003768
- Jacksonville, Florida: 21-003768
- Eau Claire, Wisconsin: 21-003768
- Scottsdale/Phoenix, Arizona: 21-003768
- Albert Lea, Minnesota: 21-003768
NCT ID:
NCT05222620
Sponsor Protocol Number:
GMROR2163

A Study to Evaluate Daratumumab/rHuPh20 +/- Lenalidomide as Post-ASCT Maintenance for Multiple Myeloma with Minimal Residual Disease (MRD) to Direct Therapy Duration

Eau Claire, WI, Rochester, MN, Scottsdale/Phoenix, AZ

See Details

A Study to Evaluate Daratumumab/rHuPh20 +/- Lenalidomide as Post-ASCT Maintenance for Multiple Myeloma with Minimal Residual Disease (MRD) to Direct Therapy Duration

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The primary purpose of this study is to compare overall survival between two treatment arms, with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm, in post-autologous transplant multiple myeloma (MM) patients.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information
Eau Claire, Wis.	Closed for enrollment
Scottsdale/Phoenix, Ariz.	Closed for enrollment

Print study details

Site IRB:
- Rochester, Minnesota: 19-009968
- Eau Claire, Wisconsin: 19-009968
- Scottsdale/Phoenix, Arizona: 19-009968
NCT ID:
NCT04071457
Sponsor Protocol Number:
S1803

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Radiation Therapy with or without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer

FRACTIONATE

A Study to Evaluate Daratumumab/rHuPh20 +/- Lenalidomide as Post-ASCT Maintenance for Multiple Myeloma with Minimal Residual Disease (MRD) to Direct Therapy Duration

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