High-Dose Radiation + Chemotherapy for Pancreatic Cancer

(MAIBE Trial)

Not currently recruiting at 9 trial locations

Overseen By Christopher Crane, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: FOLFIRINOX, Gemcitabine, Nab-paclitaxel

Disqualifiers: Pregnancy, Heart failure, Angina, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a higher-than-usual dose of radiation combined with chemotherapy can make pancreatic cancer more treatable with surgery and extend patients' lives. Participants receive a special type of radiation therapy called HFA-IMRT along with the chemotherapy drug capecitabine (also known as Xeloda). Suitable candidates have pancreatic cancer that cannot be surgically removed and have completed at least three months of standard chemotherapy. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking advancements in pancreatic cancer treatment.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) of at least 2 weeks or 5 half-lives for any investigational (experimental) agents before starting radiation therapy. For other medications, the protocol does not specify if you need to stop taking them.

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

Studies have shown that a type of focused radiation therapy called hypofractionated ablative IMRT can effectively control pancreatic tumors. One study suggested that this treatment can manage the main tumor, offering promise for extending life. Another study found it provides good local control without causing major harm, although some patients experienced stomach and digestive issues.

Capecitabine, a chemotherapy drug tested in various cancers, including pancreatic cancer, has shown promise. Research indicates it helps reduce tumor symptoms and has a good response rate. When used with other treatments, it has been well tolerated, suggesting it is generally safe.

These findings suggest that combining high-dose radiation with capecitabine might be well-tolerated, though some side effects, such as stomach and digestive issues, could occur. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of high-dose radiation and capecitabine for pancreatic cancer because it offers a unique approach to attacking tumors. While traditional treatments often rely on standard radiation and chemotherapy, this method uses hypofractionated ablative IMRT (HFA-IMRT), which delivers higher doses of radiation in fewer sessions. This can potentially shrink tumors more effectively and faster, making them more likely to be surgically removed. Additionally, by combining this type of radiation with capecitabine, a chemotherapy drug that enhances the effects of radiation, there’s hope for improved outcomes compared to standard treatments.

What evidence suggests that high-dose radiation and chemotherapy could be effective for pancreatic cancer?

Research shows that a special type of focused radiation therapy, called hypofractionated ablative IMRT (HFA-IMRT), holds promise for controlling pancreatic tumors and improving survival rates. This treatment precisely targets the tumor while protecting nearby healthy organs. Studies have linked this method to better survival outcomes for patients. In this trial, participants will receive HFA-IMRT with concurrent Capecitabine, a chemotherapy drug effective in treating pancreatic cancer. Specifically, research has shown that Capecitabine can lead to a median survival of up to eight months and provide significant benefits for many patients. These findings suggest that combining high-dose radiation with Capecitabine might improve results for people with pancreatic cancer. ^{1 5 6 7 8}

Who Is on the Research Team?

Marsha Reyngold, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with advanced pancreatic cancer who've completed at least 3 months of standard chemotherapy without distant metastasis. They must have good organ function, no prior abdominal radiotherapy, and not be pregnant or breastfeeding. Men and women must agree to use contraception.

Inclusion Criteria

Your platelet count is higher than 75,000 per microliter.

My cancer is a type of pancreatic cancer confirmed by a biopsy.

My cancer has not spread to distant parts of my body after initial chemotherapy.

Exclusion Criteria

I cannot undergo surgery due to other health issues.

My cancer is at a stage where surgery might be possible.

I do not have any uncontrolled illnesses like infections or heart problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive HFA-IMRT to a total dose of 67.5 Gy in 15 fractions or 75 Gy in 25 fractions with concurrent capecitabine

3-5 weeks

Assessment

Cross-sectional imaging is repeated to assess for resectability

4-6 weeks after the end of CRT

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Capecitabine
• Hypofractionated ablative IMRT (HFA-IMRT)

Trial Overview The study tests if high-dose radiation therapy combined with capecitabine (a chemotherapy drug) can make patients eligible for surgery and extend their lives compared to the standard treatment.

How Is the Trial Designed?

Group I: HFA-IMRT Experimental Treatment 2 Interventions

Eligible patients will receive HFA-IMRT to a total dose of 67.5 Gy in 15 fractions or 75Gy in 25 fractions to areas of gross tumor with concurrent capecitabine. Cross-sectional imaging will be repeated 4-6 weeks after the end of CRT to assess for resectability.

Capecitabine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Xeloda for:

• Colorectal cancer
• Breast cancer

Approved in United States as Xeloda for:

• Colorectal cancer
• Breast cancer

Approved in Canada as Xeloda for:

• Colorectal cancer
• Breast cancer

Approved in Japan as Xeloda for:

• Colorectal cancer
• Breast cancer

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

In a study involving 15 patients with locally advanced pancreatic cancer, capecitabine combined with radiotherapy was found to be feasible, with a recommended dose of 800 mg/m2 bid for further evaluation.

While some patients experienced side effects like grade 3 diarrhea, the treatment showed potential efficacy with 20% achieving a partial response, suggesting that capecitabine could serve as a simpler alternative to intravenous fluorouracil for enhancing the effects of radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I study of capecitabine with concomitant radiotherapy for patients with locally advanced pancreatic cancer: expression analysis of genes related to outcome. Saif, MW., Eloubeidi, MA., Russo, S., et al.[2015]

In a phase I study involving 25 patients with localized, inoperable pancreatic adenocarcinoma, capecitabine was found to be well tolerated when given concurrently with radiotherapy, with a recommended dose of 825 mg/m².

The study identified only mild dose-limiting toxicities, such as grade 3 vomiting and fatigue, and no significant hematological toxicities, indicating a favorable safety profile for this treatment combination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I and pharmacokinetic study of capecitabine in combination with radiotherapy in patients with localised inoperable pancreatic cancer. Roxburgh, P., Lumsden, GR., Paul, J., et al.[2022]

In a pilot study involving 10 patients with unresectable pancreatic adenocarcinoma, hypofractionated intensity modulated radiotherapy (H-IMRT) demonstrated a high local control rate, with tumor response observed in 9 out of 10 patients.

The treatment was associated with manageable gastrointestinal toxicity, which correlated with the dose received by the duodenum, and resulted in promising 1-year overall and disease-free survival rates of 83.3% and 68.6%, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated intensity-modulated radiotherapy in locally advanced unresectable pancreatic cancer: A pilot study. De Felice, F., Benevento, I., Bulzonetti, N., et al.[2020]

In a study involving 9 patients with locally advanced pancreatic cancer, hypofractionated radiotherapy at 45 Gy in 15 fractions was well-tolerated, with no dose-limiting toxicities observed, allowing for timely initiation of full-dose gemcitabine chemotherapy.

However, the lower dose of 40 Gy in 8 fractions resulted in significant side effects, preventing timely chemotherapy initiation in most patients, indicating that this regimen is not feasible for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I study of hypofractionated radiotherapy followed by systemic chemotherapy with full-dose gemcitabine in patients with unresectable locally advanced pancreatic cancer. Furuse, J., Ishii, H., Kawashima, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3012429/

Capecitabine: an evidence-based review of its effectiveness in ... The median time to progression was 6 months, the median survival was 8 months, and 12-month survival was 35%. Similar results have been reported recently from ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11773165/

Phase II study of oral capecitabine in patients with ... Results: Ten (24%) of 42 patients experienced a clinical benefit response (95% confidence interval [CI], 12.1% to 39.5%) as evidenced by improvement in pain ...

3. gutnliver.org gutnliver.org/journal/view.html?doi=10.5009/gnl16307

Efficacy of Capecitabine Plus Oxaliplatin Combination ... The median progression-free and overall survival were 88 days (range, 35.1 to 140.9 days) and 158 days (range, 118.1 to 197.9 days), ...

4. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-13799-5

Efficacy and safety of triplet regimen capecitabine, oxaliplatin ... The XELOXIRI regimen demonstrated promising efficacy and manageable toxicity in the treatment of APC, providing a practical alternative to FOLFOXIRI.

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.24.01118

Long-Term Outcomes of Adjuvant Therapy in the ESPAC4 ... The 5-year survival estimates of patients in ESPAC4 was 25% (95% CI, 21 to 30) for those randomly assigned to gemcitabine and 32% (95% CI, 27 to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11905668/

Efficacy and safety of triplet regimen capecitabine, oxaliplatin ... The 5-fuorouracil, oxaliplatin and irinotecan (FOLFOXIRI) regimen is the standard first-line treatment for advanced pancreatic cancer (APC).

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.3_suppl.666

Results of the safety and tolerability of ivaltinostat plus ... Combination therapy of ival with cape has been well tolerated and the safety and PK/PD data support a RP2D of ival of 250 mg/m2.

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/020896s044s045s046s047s048s049s050s051lbl.pdf

XELODA® (capecitabine) tablets, for oral use The safety of XELODA for the treatment of patients with. HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma was consistent with ...