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New treatment option for Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma
Official title Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer
ClinicalTrials.gov ID: NCT06958328
What this study is testing
What is Capecitabine?
Capecitabine is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for locally advanced unresectable pancreatic ductal adenocarcinoma.
Also referred to as Ro 09-1978/000, Xeloda.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- At time of enrollment, the patient must have received 4-6 months of active chemotherapy with FOLFIRINOX or NALIRIFOX or gemcitabine/nab-paclitaxel...
- BASELINE PRE-ENTRY CHEMOTHERAPY REQUIREMENTS:
- Pathologically (histologically or cytologically) proven diagnosis of pancreatic ductal adenocarcinoma
- Locally advanced unresectable disease (as defined per the National Comprehensive Cancer Network [NCCN] guidelines and institutional tumor board...
- Patients must have baseline pre-chemotherapy scans for staging. Options include: CT chest/abdomen/pelvis, CT chest/MRI abdomen/pelvis, CT chest/CT...
See the full eligibility criteria
- At time of enrollment, the patient must have received 4-6 months of active chemotherapy with FOLFIRINOX or NALIRIFOX or gemcitabine/nab-paclitaxel. Patients are permitted to receive more than 1 type of chemotherapy for...
- BASELINE PRE-ENTRY CHEMOTHERAPY REQUIREMENTS:
- Pathologically (histologically or cytologically) proven diagnosis of pancreatic ductal adenocarcinoma
- Locally advanced unresectable disease (as defined per the National Comprehensive Cancer Network [NCCN] guidelines and institutional tumor board review)
- Patients must have baseline pre-chemotherapy scans for staging. Options include: CT chest/abdomen/pelvis, CT chest/MRI abdomen/pelvis, CT chest/CT pelvis/MRI abdomen, or PET/CT performed prior to enrollment
- Age ≥ 18 years
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
- Required initial laboratory values: All laboratory values must be obtained any time prior to initiation of chemotherapy up to 30 days post initiation of chemotherapy
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN)
- BASELINE CA19-9 AND BILIRUBIN REQUIREMENTS: The purpose is to obtain a baseline CA19-9 in the setting of a normal (or close to normal) bilirubin, since serologic response by serial CA19-9 measurements is part of...
- If baseline CA19-9 \> 37 U/mL the concurrent bilirubin must be ≤ 1.5 x ULN. (Note: if the bilirubin is not ≤ 1.5 x ULN both the CA19-9 and concurrent bilirubin can be repeated until bilirubin is ≤ 1.5 x ULN, as long as...
- If baseline CA19-9 U/mL ≤ 37, there are no restrictions on the required concurrent bilirubin level, and this can be the accepted baseline value
- Prior radiation treatment
- Has the patient had prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Prior non-overlapping radiation (e.g., breast, head and neck, extremity) is permitted
- If uncertain about prior overlap, please contact the study principal investigator, Dr. Nina Sanford
- POST PRE-ENTRY CHEMOTHERAPY REQUIREMENTS:
- If baseline CA19-9 is elevated (defined as \> 37 u/mL) the post-pre-entry chemotherapy CA19-9 must be less than 37 u/mL or a 50% decline from pre-chemotherapy level with absolute value less than 100u/mL
- If baseline CA19-9 is not elevated (defined as ≤ 37 u/mL) the post-pre-entry chemotherapy CA19-9 must remain ≤ 37 u/mL
- No active duodenal or gastric ulcers
- No direct tumor invasion of the bowel or stomach
- Restaging scans showing at least stable disease (no progression). Options for scans include: CT chest/abdomen/pelvis, CT chest/MRI abdomen/pelvis, or CT chest/CT pelvis/MRI abdomen, or PET/CT performed prior to...
- Not pregnant and not nursing
- No cardiac condition that was the primary reason for hospitalization in the last 6 months
- New York Heart Association Functional Classification II or better (NYHA Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of...
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Peoria, Arizona, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Surprise, Arizona, United States
- Tempe, Arizona, United States
- Jonesboro, Arkansas, United States
- Arroyo Grande, California, United States
- Bakersfield, California, United States
- Berkeley, California, United States
- Burlingame, California, United States
- Cameron Park, California, United States
- Fremont, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Modesto, California, United States
- Mountain View, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Roseville, California, United States
+ 228 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Peoria, Arizona, United States; Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Surprise, Arizona, United States; Tempe, Arizona, United States and 242 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.