Radiotherapy to Patients With CA19-9-elevated Advanced Pancreatic Cancer

Sponsor
Fudan University
Study ID
NCT06250972
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine, Nab-paclitaxel, Irinotecan — DRUG
    continuing chemotherapy using the previous regimen until disease progression
  • Intensity-Modulated Radiation Therapy (IMRT) — RADIATION
    Receive Intensity-Modulated Radiation Therapy (IMRT) after about 2\~6 cycles of chemotherapy.

Study Details

The purpose of this study is to evaluate the efficacy of chemotherapy plus radiotherapy to patients with CA19-9-elevated Advanced Pancreatic Cancer who are not refractory to chemotherapy.

Key Dates

Start date
May 15, 2024
Status verified
Feb 2025
Primary completion
May 1, 2027
Completion
May 1, 2028

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: chemotherapy
    Continuing chemotherapy using the previous regimen
  • Experimental: Radiotherapy
    Patients will be recommended to receive Intensity-Modulated Radiation Therapy (IMRT) after about 2\~6 cycles of chemotherapy. Other radiation therapies include stereotactic body radiotherapy (SBRT) and proton could be administered.

Primary Outcome Measure

progression-free survival, PFS [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]

Central Contacts

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