Clinical Trials

What are Clinical Trials?

Clinical trials are research studies with human participants. The purpose of these studies is to find better ways to treat health conditions.

Arizona Center for Cancer Care is a leader in cancer treatment and participates in clinical trials to test new medications to treat cancer or relieve side effects, helping advance care and management for cancer patients.

Arizona Center for Cancer Care is also a national site for the National Surgical Breast and Bowel Project (NSABP), a National Institute of Health-funded cooperative research group.

Available Clinical Trials: Open NRG / Alliance Clinical Trials

Research Webpage Study Summaries

NRG-GI011 — LAP100

Study Title: A Phase III Randomized Trial of Dose Escalated Radiation in Locally Advanced Pancreas Cancer (LAPC) Patients (LAP100)

Cancer Type: Locally advanced pancreatic cancer

Phase: Phase III

ClinicalTrials.gov: NCT06958328

Sponsor: NRG Oncology

About the Study

This study is for patients with locally advanced pancreatic cancer that has not progressed after initial chemotherapy. The study compares standard radiation therapy with a higher-dose form of radiation therapy. Researchers want to determine whether delivering a higher radiation dose to the pancreatic tumor can improve outcomes while maintaining quality of life.

Key Inclusion Criteria

• Age 18 or older
• Confirmed pancreatic ductal adenocarcinoma
• Locally advanced disease that is considered unresectable
• ECOG performance status of 0–2
• Must have received the study-required initial chemotherapy
• No disease progression following initial chemotherapy
• Must meet required laboratory and organ-function criteria

Key Exclusion Criteria

• Metastatic or progressive disease
• Prior radiation to the pancreatic cancer area that would interfere with study treatment
• Certain medical conditions that would make study treatment unsafe
• Pregnancy

NRG-CC013

Study Title: A Randomized, Masked, Placebo Controlled, Phase II Trial of Concurrent Chemoradiation with BMX-001 in Patients with Head and Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation

Cancer Type: Head and neck squamous cell carcinoma

Phase: Phase II

ClinicalTrials.gov: NCT06532279

Sponsor: NRG Oncology

About the Study

This study is for patients with head and neck cancer receiving chemotherapy and radiation therapy. It is evaluating BMX-001, an investigational drug designed to help protect healthy tissue during treatment. Researchers are studying whether adding BMX-001 to standard chemoradiation can reduce severe oral mucositis, including painful inflammation and sores in the mouth and throat.

Key Inclusion Criteria

• Age 18 or older
• Confirmed squamous cell carcinoma of the head and neck
• No evidence of distant metastatic disease
• Planned treatment with definitive radiation therapy and concurrent cisplatin
• ECOG/Zubrod performance status of 0–2
• Adequate blood counts and organ function
• Must meet the study’s radiation treatment requirements

Key Exclusion Criteria

• Metastatic disease
• Planned postoperative/adjuvant chemoradiation
• Certain prior treatments that interfere with study therapy
• Certain medications or medical conditions that could interfere with BMX-001 or make treatment unsafe
• Pregnancy

Alliance A222301 — HOPE

Study Title: High-Dose Prophylactic Gabapentin (HOPE) to Prevent Opioid Use for Oral Mucositis Pain During Head and Neck Chemoradiotherapy: A Phase III Clinical Trial

Cancer Type: Head and neck squamous cell carcinoma

Phase: Phase III

ClinicalTrials.gov: NCT TBD (as listed in the attached protocol)

Sponsor: Alliance for Clinical Trials in Oncology

About the Study

This study is for patients with head and neck cancer receiving chemotherapy and radiation therapy. These treatments can cause painful mouth and throat sores known as oral mucositis. The study is evaluating whether starting gabapentin can help control treatment-related pain and reduce the need for opioid pain medications.

Key Inclusion Criteria

• Age 18 or older
• Stage I–IV squamous cell carcinoma of the head and neck
• Planned cisplatin-based chemotherapy and radiation therapy
• ECOG performance status of 0–2
• Able to swallow capsules whole
• Adequate kidney function
• Able to read, speak, and understand English or Spanish

Key Exclusion Criteria

• Allergy or hypersensitivity to gabapentin
• Prior surgery or radiation for the current head and neck cancer and/or recurrent head and neck cancer
• Known brain metastases
• Dialysis or organ transplant
• Nonprescribed opioid use within 6 months before registration
• Current medications for chronic or long-term pain or neuropathy
• Certain uncontrolled medical conditions
• Pregnancy or breastfeeding

What are the types of clinical trials?

There are several types of clinical trials. Most of the trials involve the study of a new drug or treatment.

Types of clinical trials include:

Phase I trials

Phase I trials are research studies that test the newest drugs or treatments for cancer. The purpose of phase I trials is to understand the side effects of the new drug and determine the safest and most effective dose.

Some phase I trials may combine a new drug with a standard drug or treatment.

Phase II trials

Phase II trials aim to answer the question: “How active is this drug in a particular form of cancer?” The goal of this phase is to determine whether the drug is worth further study.

Phase III trials

Phase III trials are the most advanced studies. During these trials, researchers compare the effectiveness of the new drug or treatment to the standard treatment. The results of phase III clinical trials determine whether the new drug or treatment is better than the older treatments, paving the way for FDA approval.

Supportive care trials

Supportive care clinical trials focus on treatments that reduce the side effects of cancer care.

Who can participate in clinical trials?

Arizona Center for Cancer Care physicians determine who can participate in clinical trials after completing an informed consent session. During this session, they review the who, what, where, when, why, and how of the trial.

After the review, if you’re interested in participating, you move on to the screening process, which includes a review of your medical records, cancer treatment, lab studies, and radiology results. Arizona Center for Cancer Care uses this information to determine if you’re a candidate for the trial.

Arizona Center for Cancer Care does its best to make clinical trials available to cancer patients. To find out more about the current clinical trials, call the nearest office or request to schedule an appointment.

Website Disclaimer: The eligibility criteria listed above are a general summary and do not include all study requirements. Eligibility for a clinical trial is determined by the study physician and research team after a complete review of the patient’s medical history and study-specific criteria.