Phase I/II study of gemcitabine and nab-paclitaxel with radiation therapy in patients with pancreatic cancer.

Phase I/II study of gemcitabine and nab-paclitaxel with radiation therapy in patients with pancreatic cancer. - Phase I/II study of GEM + nab-PTX + radiation therapy in patients with pancreatic cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017751

Enrollment

Registered

2015-05-31

Start date

2015-05-20

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

pancreatic cancer

Interventions

(GEM,nab-PTX) GEM and nab-PTX are administered intravenously in each dosage of level at day 1,8,22 and 29. (Radiation) Radiation is delivered a total dose of 50.4 Gy(28 fractions of1.8 Gy).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) locally advanced pancreatic cancer without distant metastasis (2) with no prior treatment(chemotherapy or radiation therapy) to pancreatic cancer (3) Radiotherapist judges that we can include primary tumor and all lymph node metastases in the radiation field of 10cm *10cm by abdominal CT or MRI. (4) evaluable lesion is confirmed with objective documents such as CT or MRI, the X-ray examination within 28 days before registration. (5) age: >=20,80< (6) ECOG P.S. 0-1 (7) sufficient function of important organs WBC: >=3,500/mm3 Neut:>=2000/mm3 Platelet: >=100,000/mm3 Hem: >=9.0g/dl Alb:>=3.0g/dL AST, ALT: <= 100IU/l((or 150U/L if biliary drainage were present) sT.bil: <=2.0mg/dl(or <=3.0mg/dl if biliary drainage were present) serum Cr: <= Upper limit of normal (8)no abnormal finding by cardiac electrogram within 28 days before registration. (9)written informed consent

Exclusion criteria

Exclusion criteria: (1)bowel movement control is difficult, because of watery diarrhea and chronic diarrhea. (2)Interstitial pneumonia or pulmonary fibrosis diagnosed by chest X-ray and with symptom (3)Pleural effusion or ascitic fluid accumulates (4)with clinically important infection (5)has active carcinoma except carcinoma in situ (6)with gastrointestinal active ulcer (7)sever complication(heart failure, renal failure,liver failure,intestinal paralysis,uncontrollable diabetes etc) (8)severe mental disorder (9)severe drug allergy (10)pregnant women or during the nursing, women who like be pregnant and willing to get pregnant (11)doctors decision not to be registered to this study

Design outcomes

Primary

Measure	Time frame
(PhaseI) Estimate the maximum tolerated dose(MTD) and recommended dose(RD) (PhaseII) Response rate	—

Countries

Japan

Contacts

Public ContactMinoru Kitago

Department of Surgery, Keio University School of Medicine Department of Surgery

contact@keio-hbpts.jp0333531211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026