Induction Chemotherapy With Gemcitabine and Cisplatin Followed by CCRT for Unresectable Pancreatic Carcinoma

NCT01593475 | Completed Phase 2

• 1 other identifier: NCCCTS-11-567
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial chose the induction chemotherapy with gemcitabine and cisplatin followed by Chemoradiotherapy (CRT) with gemcitabine to optimize the treatment for pancreas cancer patients with locally advanced disease and the purpose of this trial is to evaluate the efficacy of induction CT with gemcitabine and cisplatin followed by CRT for unresectable pancreatic carcinoma.

Conditions

Pancreatic Carcinoma Non-resectable

Outcome Measures

Primary Outcomes (1)

• feasibility and compliance

  to evaluate acute and late toxicity of induction chemotherapy with gemcitabine and cisplatin followed by chemoradiotherapy for unresectable pancreatic cancer.

  Up to 1 year

Secondary Outcomes (2)

• overall survival

  Up to 3years until study closed

• disease-free survival.

  participants will be followed for the duration of disease free, an expected average of 9 months

Study Arms (1)

Induction chemotherapy followed by CCRT

EXPERIMENTAL

In one cycle (4-weeks), gemcitabine 1,000 mg/m2 will be given by 30-minute intravenous infusion on days 1, 8, and 15, and 1 hour infusion of CDDP was administered at a dose of 25 mg/m2 weekly diluted in 500 mL of normal saline to ensure adequate hydration 1 hour before the administration of gemcitabine. Gemcitabine 300mg/m2 will be given by 30-minute intravenous infusion weekly during RT and CRT will be started within 3 weeks after completion of 2 cycles of induction chemotherapy. Radiotherapy \- Total dose of PGTV and PCTV were 55 Gy, 22 fractions and 44 Gy, 22 fractions, respectively.

Radiation: Induction chemotherapy followed by CCRT

Interventions

Induction chemotherapy followed by CCRT RADIATION

Chemotherapy In one cycle (4-weeks), gemcitabine 1,000 mg/m2 will be given by 30-minute intravenous infusion on days 1, 8, and 15, and 1 hour infusion of CDDP was administered at a dose of 25 mg/m2 weekly diluted in 500 mL of normal saline to ensure adequate hydration 1 hour before the administration of gemcitabine. Gemcitabine 300mg/m2 will be given by 30-minute intravenous infusion weekly during CCRT will be started within 3 weeks after completion of 2 cycles of induction chemotherapy Radiotherapy \- Total dose of PGTV and PCTV were 55 Gy, 22 fractions and 44 Gy, 22 fractions, respectively.

Induction chemotherapy followed by CCRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed adenocarcinoma of the pancreas
• Unresectable locally advanced disease base on institutional standard criteria of unresectability disease following radical surgery. There is no evidence of metastatic disease in the major viscera and no peritoneal seeding
• Patients with biliary or gastroduodenal obstruction must have drainage prior to starting chemoradiation
• All malignant disease must be encompassable within a single irradiation field (15x15cm maximum)
• All patients must have radiographically assessable disease
• No previous irradiation to the planned field
• Age of ≥ 18 years
• performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) score
• Required Entry Laboratory Parameters WBC count ≥ 1,000/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 100,000/mm3; total bilirubin ≤ 3.0 mg/dL (Patients with elevated bilirubin due to obstruction should be stented and their bilirubin should be decrease ≤ 3.0 mg/dL prior to study entry); creatinine ≤ 3.0 mg/dL
• Oral intake (including J-tube feeding) of ≥ 1,500 calories/day should be maintained.
• Signed informed consent form prior to study entry

You may not qualify if:

• There is evidence of metastasis in the major viscera or peritoneal seeding.
• Age of \< 18 years
• Previous history of RT adjacent to planned field
• Poor performance status of 2 to 4 on the Eastern Cooperative Oncology Group (ECOG) score
• Pregnant or breast feeding status
• Previous history of uncontrolled other malignancies within 2 years

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Study Officials

• Woo Jin Lee, Ph.D

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2012
• First Posted: May 8, 2012
• Study Start: September 5, 2011
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: January 3, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)