Higher Dose Radiation Therapy for Pancreatic Cancer

(LAP100 Trial)

Recruiting at 184 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 trial tests whether higher doses of radiation can extend the lives of people with a specific type of pancreatic cancer. It targets those whose cancer cannot be surgically removed and who have already undergone 4-6 months of chemotherapy. Participants should have stable disease post-chemotherapy and no significant ulcers or bowel issues. The trial compares high-dose radiation (dose-escalated radiation therapy) precisely aimed at the tumor with usual care options, which may include additional chemotherapy or standard radiation. The study aims to determine if the high-dose approach more effectively slows cancer growth. As a Phase 3 trial, this treatment represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking cancer therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that dose-escalated radiation therapy is likely to be safe for humans?

Research has shown that increasing the dose of radiation therapy is generally safe. Studies have found that new radiation techniques can deliver higher doses directly to the tumor safely. This approach targets cancer cells more effectively while minimizing damage to nearby healthy tissues. Some side effects, such as tiredness or skin irritation at the treatment area, may occur but are usually manageable. Importantly, patients have not experienced a significant rise in serious side effects with higher doses compared to standard radiation. This suggests that higher-dose radiation is a safe option for treating pancreatic cancer. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for pancreatic cancer?

Researchers are excited about dose-escalated radiation therapy for pancreatic cancer because it pushes the boundaries of traditional radiation treatments by delivering higher doses in fewer sessions. Unlike the standard radiation treatments that often involve long, drawn-out schedules, this method can potentially shorten treatment time, especially with the preferred 5-fraction regimen. Additionally, when combined with chemotherapy agents like fluorouracil or capecitabine, it could enhance the overall effectiveness, offering a more potent attack on cancer cells. This approach aims to maximize the impact on tumors while minimizing the burden of long-term treatment schedules for patients.

What evidence suggests that dose-escalated radiation therapy might be an effective treatment for pancreatic cancer?

Research has shown that higher doses of radiation therapy might benefit people with pancreatic cancer. In this trial, participants in Arm II will receive dose-escalated radiation therapy, which delivers more precise and stronger doses directly to the tumor. Studies have found that this approach can shrink tumors more effectively than traditional methods. In some cases, it has slowed tumor growth and possibly extended survival times. While the results are promising, researchers are still determining the best radiation dose for pancreatic cancer. This treatment targets cancer cells more aggressively, potentially making it a better option for those with advanced, inoperable tumors. ^{6 7 8 9 10}

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+

Citations

1. redjournal.org redjournal.org/article/S0360-3016(25)03612-0/fulltext

Early Outcomes of Dose-Escalated Radiation Therapy for ... We retrospectively reviewed all localized pancreatic cancer patients who were diagnosed between 2022 and 2023 and were treated with multi-agent chemotherapy ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7423616/

Dose-Escalated Radiation Therapy for Pancreatic Cancer To provide a detailed description of practical approaches to dose escalation in pancreatic cancer. The current paper represents an international ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0360301625036120

Early Outcomes of Dose-Escalated Radiation Therapy for ... We retrospectively reviewed all localized pancreatic cancer patients who were diagnosed between 2022 and 2023 and were treated with multi-agent chemotherapy ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.750

Dose-escalated radiation for locally advanced ... This study retrospectively reviews the long term outcomes of patients receiving dose escalated radiation for unresectable localized pancreatic cancer.

5. jgo.amegroups.org jgo.amegroups.org/article/view/2321/html

The influence of radiation therapy dose escalation on overall ... Conclusions: Lack of benefit to OS with conventionally delivered RT above 40 Gy is shown. Optimal RT dose escalation methods in unresectable PAC remain an ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4792191/

Focal Radiation Therapy Dose Escalation Improves Overall ... Radiation dose escalation during consolidative chemoradiation therapy after induction chemotherapy for LAPC patients improves OS and local-regional RFS.

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/cam4.7434

Escalated‐dose radiotherapy for unresected locally ... Mortality for patients with LAPC is driven by both early metastatic spread and uncontrolled local growth; an estimated 30% of patients with LAPC ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06958328

NCT06958328 | Testing Higher Dose Radiation Therapy ... This phase III trial compares the effect of dose-escalated radiation therapy to usual care in patients with locally advanced unresectable pancreatic ductal ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2405630824000302

Dose-escalated SBRT for borderline and locally advanced ... The radiation dose for pancreatic cancer commonly employs non-ablative doses to avoid surpassing the radiation tolerance of gastrointestinal organs [40].

10. dmr.amegroups.org dmr.amegroups.org/article/view/9181/html

Ablative radiation therapy advances in pancreatic cancer - Chin Advancements within the field of radiation oncology has enabled safe delivery of dose escalated and ablative radiation therapy for pancreatic adenocarcinomas.