Testing Higher Dose Radiation for Locally Advanced Pancreatic Cancer

Trial details

Who runs it

NRG Oncology

Trial code

NCT06958328

Record updated

25 August 2026

Original description

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 4-8 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.Read full original descriptionShow less

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

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 4-8 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.

Inclusion: At time of enrollment, the patient must have received 4-8 months of active chemotherapy with FOLFIRINOX or NALIRIFOX or gemcitabine/nab-paclitaxel. Patients are permitted to receive more than 1 type of chemotherapy for reasons other than radiographic progression by Response Evaluation Criteria in Solid Tumors (RECIST) (i.e. chemotherapy regimen switch is allowed for toxicity, and/or switch is allowed for toxicity and/or CA19-9 level not declining). Patients are allowed to receive chemotherapy after restaging scans, as long as 1) restaging scans are performed after at least 4 months of chemotherapy and 2) the total chemotherapy duration does not exceed 8 months; "Active chemotherapy" refers to time on chemotherapy not counting treatment breaks (i.e. if a patient had 1 month of chemotherapy followed by 1 month break, this would count as 1 month chemotherapy). Study registration must occur within 45 days of last day of pre-study entry chemotherapy; 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 post-chemotherapy eligibility criteria; 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 done within specified timeframe [up to 30 days post chemotherapy initiation]); 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 200 u/mL OR a 70% decline from pre-chemotherapy level (i.e. a patient with post induction chemotherapy CA199 value ≥ 200 u/mL would qualify, as long as they had at least 70% drop from baseline CA199 value; similarly, a patient with less than a 70% decline would qualify as long as absolute value post induction chemotherapy is under 200 u/mL) (must be completed any time post month 4 of chemotherapy and prior to study entry); If baseline CA19-9 is not elevated (defined as ≤ 37 u/mL) the post-pre-entry chemotherapy CA19-9 must remain ≤ 37 u/mL (must be completed any time post month 4 of chemotherapy and prior to study entry); 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 enrollment, with restaging CT showing at least stable disease; 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 treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.); HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

ClinicalTrials.gov NCT06958328