Clinical efficacy of IORT on patients with pancreatic body-tail carcinoma after R0 resection: a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-11001453

Enrollment

Unknown

Registered

2011-07-18

Start date

2011-09-01

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 body-tail carcinoma

Interventions

R0 resection with I and II TNM stage:natural light

R0 resection with I and II TNM stage:IORT

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female aged 18 to 70 years old. Patients who are clinically diagnosed as pancreatic body-tail carcinoma have good body situation and basic normal nutrition condition. They haven't undergone any preoperative chemotherapy or radiotherapy. They haven't severe dysfunction of heart, lung, liver and kidney,and no Jaundice, ascites, obstructive alimentary tract and acute infection. The routine blood test is normal with WBC>=4,000/mm^3, Hb>=100g/L and plt>=100,000/mm3. The coagulation mechanism is normal with PT, KPTT and TT in normal range. Quality of life grading (Karnofsky criteria) is over 80 scores. Operative endurance is good to endure operation and chemo-radiotherapy; 2. Patients are able and willing to provide signed informed consent; 3. R0 resection of pancreatic body-tail cancer with I and II TNM stage.

Exclusion criteria

Exclusion criteria: 1. Patients have bad body situation with uncontrolled heart failure, infection or Mental illness. They have some organ dysfunction of heart, lung, liver or kidney. Patients have undergone previous chemotherapy or radiotherapy. Patients wouldn't receive operation or chemo-radiotherapy; 2. Pregnant or lactating women; 3. Patients refused to sign agreement or receive therapy and following-up according to our research approach; 4. Patients with pancreatic body-tail cancer have distal lymph node metastasis; 5. Patients are diagnosed as non-pancreatic carcinoma by the postoperative pathological examination; 6. Life expectancy less than 6 months.

Design outcomes

Primary

Measure	Time frame
Postoperative survival time;Quality of life scores;disease free survival time;	—

Secondary

Measure	Time frame
Safety Assessment;	—

Countries

China

Contacts

Public ContactBai-yong Shen

shenbaiyong@medmail.com.cn+86 13901943778

Outcome results

None listed

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