Higher Dose Radiation Therapy for Pancreatic Cancer

(LAP100 Trial)

Recruiting at 97 trial locations

Overseen By Nina Sanford

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: NRG Oncology

Must be taking: Chemotherapy

Disqualifiers: Pregnancy, Cardiac condition, 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: 3

356 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase III trial compares the effect of dose-escalated radiation therapy to usual care in patients with locally advanced unresectable pancreatic ductal adenocarcinoma who have received an initial 4-6 months of chemotherapy. Usual care options include additional chemotherapy, observation, or standard lower-dose radiation therapy. These treatments may delay tumor growth but have not been shown to improve survival. Radiation therapy uses high energy X-rays to kill cancer cells and shrink tumors. Dose-escalated radiation therapy involves the precise delivery of higher doses to the tumor, often over a shorter period of time. This trial assesses whether using dose-escalated radiation therapy can prolong survival.

Who Is on the Research Team?

Nina N Sanford

Principal Investigator

NRG Oncology

Are You a Good Fit for This Trial?

This trial is for patients with locally advanced pancreatic cancer that can't be surgically removed. They must have completed 4-6 months of specific chemotherapy regimens and enroll within 45 days after their last chemo cycle. Participants need to have a certain performance status, normal bilirubin levels, and meet specific criteria regarding the CA19-9 tumor marker.

Inclusion Criteria

I am able to get out of bed or chair and move around.

My liver enzymes AST and ALT are within normal limits.

My CA19-9 levels have stayed normal before and after chemotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Chemotherapy

Participants receive an initial 4-6 months of chemotherapy before randomization

4-6 months

Radiation Therapy

Participants undergo either standard or dose-escalated radiation therapy, with or without concurrent chemotherapy

5-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Every 3 months for 2 years, then annually for 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Dose-escalated Radiation Therapy

Trial Overview The study compares higher dose radiation therapy to usual care (additional chemo or standard lower-dose radiation) in patients who've had initial chemotherapy. The goal is to see if this intensified radiation approach can extend survival by delivering more precise, higher doses over a shorter period.

How Is the Trial Designed?

Group I: Arm II (dose-escalated RT) Experimental Treatment 8 Interventions

Patients undergo dose-escalated RT daily, every other day, or twice weekly for 5 fractions or daily for 25 fractions (with or without concurrent fluorouracil or capecitabine for 25 fractions only). The 5-fraction regimen is preferred when feasible. After completing dose-escalated RT, patients who received less than 6 months of chemotherapy at study entry are encouraged to receive the remaining chemotherapy to total 6 months of chemotherapy. Patients may continue chemotherapy treatment beyond 6 months at physician's discretion. Additionally, patients undergo blood sample collection, CT, MRI and tumor tissue biopsy throughout the study.

Group II: Arm I (Options 1, 2, or 3) Active Control 15 Interventions

See Detailed Description.

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+