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Radiotherapy Plus Chemotherapy to Patients With CA19-9-elevated Advanced Pancreatic Cancer Who Are Not Refractory to Chemotherapy

Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• Ability to understand and the willingness to sign a written informed consent document.

• Age ≥ 18 years and ≤ 80 years.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

• Histologically or cytologically confirmed advanced pancreas adenocarcinoma.

• Patients who are not refractory to previous chemotherapy and who have not received radiotherapy.

• Locally advanced pancreatic cancer.

• Baseline serum CA19-9 \> 37 U/mL, and CA19-9 level within normal range (≤37 U/mL) after chemotherapy .

• Presence of at least of one measurable lesion in agreement to RECIST criteria.

• The expected survival ≥ 3 months.

• Adequate organ performance based on laboratory blood tests.

• Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

Locations
Other Locations
China
Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Ying Yang, MD
yangying@fudanpci.org
86 64175590
Backup
Guopei Luo, MD
luoguopei@fudanpci.org
Time Frame
Start Date: 2024-05-15
Estimated Completion Date: 2028-05-01
Participants
Target number of participants: 210
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov