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

Summary

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.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Procedure
  Biopsy Procedure

  Undergo tumor tissue biopsy

• Procedure
  Biospecimen Collection

  Undergo blood sample collection

• Drug
  Capecitabine

  Given capecitabine

• Procedure
  Computed Tomography

  Undergo CT or PET/CT

• Radiation
  Dose-escalated Radiation Therapy

  Undergo dose-escalated radiation using intensity-modulated radiation therapy treatment planning

• Drug
  Fluorouracil

  Given fluorouracil

• Drug
  Gemcitabine

  Given gemcitabine

• Drug
  Irinotecan Hydrochloride

  Given irinotecan hydrochloride

• Drug
  Irinotecan Sucrosofate

  Given liposomal irinotecan

• Drug
  Leucovorin Calcium

  Given leucovorin calcium

• Procedure
  Magnetic Resonance Imaging

  Undergo MRI

• Drug
  Nab-paclitaxel

  Given nab-paclitaxel

• Other
  Observation Activity

  Undergo observation

• Drug
  Oxaliplatin

  Given oxaliplatin

• Procedure
  Positron Emission Tomography

  Undergo PET/CT

• Other
  Questionnaire Administration

  Ancillary studies

• Radiation
  Radiation Therapy

  Undergo standard radiation therapy

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