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The efficacy and safety of high dose and low fractionated radiation therapy for locally advanced pancreatic cancer: a prospective, randomized, controlled, multicenter clinical trial

The efficacy and safety of high dose and low fractionated radiation therapy for locally advanced pancreatic cancer: a prospective, randomized, controlled, multicenter clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-16008875
Enrollment
Unknown
Registered
2016-07-22
Start date
2015-06-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic carcinoma

Interventions

CRT:conventional chemoradiotherapy

Sponsors

Department of radiotherapy and oncology, Air Force General Hospital of PLA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 Years; 2. Performance status: Karnofsky=70% (ECOG 0-2); 3. Histologically or cytologically confirmed adenocarcinoma of the pancreas; 4. Locally advanced, unresectable disease, defined by all of the following: (1) Obvious encasement of the celiac, hepatic, or superior mesenteric artery; (2) Encasement of the portal or superior mesenteric vein not amenable to surgical resection; (3) Extra pancreatic extension with or without regional lymph node involvement; (4) No evidence of distant metastatic disease by PET/CT and abdominal MRI; 5. Life expectancy: more than 3 months; 6. Tolerance fixed position for more than 30 minutes; 7. Hematological and Biochemical indexes: (1) Absolute neutrophil count = 1,500*10^9/L; (2) Platelet count =100*10^9/L; (3) Hemoglobin =9.0 g/dl; (4) Bilirubin = 1.5 times upper limit of normal; (5) AST and ALT = 2.5 times upper limit of normal; (6) Creatinine = 1.25 times upper limit of normal; (7) Creatinine clearance = 60 mL/min; 8. Other: If patients have biliary obstruction, they must have drainage prior to starting treatment.

Exclusion criteria

Exclusion criteria: 1.Prior therapy for pancreatic cancer. (includetargeted therapy, chemotherapy, radiotherapy, interventional therapy, etc.) 2.Complete or incomplete gastrointestinal obstruction. 3.Known allergies for gemcitabine or related ingredients. 4.Other history of malignant cancer in the past five years. Unless: 1) only surgical treatment of malignant tumor and its disease-free survival to 5 years; 2) had be curing skin basal cell carcinoma or the uterine cervix cancer in situ. 5.Pregnant or nursing female. 6.Fertile patients refuse to use effective contraception 7.Any unstable systemic disease. (includeHypertension, unstable angina pectoris, symptomatic congestive heart failure, cardiac arrhythmia, renal failure and so on) 8.Concurrent combination antiretroviral therapy for HIV-positive patients

Design outcomes

Secondary

MeasureTime frame
Clinical benefit rate;Local control rate;Objective remission rate;Progression free survival;Toxic and side effects;

Primary

MeasureTime frame
over survival;

Countries

China

Contacts

Public ContactXia Tingyi

Department of radiotherapy and oncology, Air Force General Hospital of PLA

xiatingyi1959@163.com+86 15611161157

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026