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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by National Cancer Center, Korea.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Woojin Lee, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01593475
First received: May 1, 2012
Last updated: May 9, 2012
Last verified: May 2012

May 1, 2012
May 9, 2012
March 2012
August 2014   (final data collection date for primary outcome measure)
feasibility and compliance [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
to evaluate acute and late toxicity of induction chemotherapy with gemcitabine and cisplatin followed by chemoradiotherapy for unresectable pancreatic cancer.
Same as current
Complete list of historical versions of study NCT01593475 on ClinicalTrials.gov Archive Site
  • overall survival [ Time Frame: Up to 3years until study closed ] [ Designated as safety issue: No ]
    To evaluate the impact of induction chemotherapy with gemcitabine and cisplatin followed by concurrent chemoradiotherapy
  • disease-free survival. [ Time Frame: participants will be followed for the duration of disease free, an expected average of 9 months ] [ Designated as safety issue: No ]
    To investigate the association between tumor response of induction chemotherapy with gemcitabine and cisplatin followed by concurrent chemoradiotherapy and clinical outcomes
  • overall survival [ Time Frame: Up to 3years until study closed ] [ Designated as safety issue: No ]
    To evaluate the impact of induction chemotherapy with gemcitabine and cisplatin followed by concurrent chemoradiotherapy
  • disease-free survival. [ Time Frame: until desease free without any progression from a initial follow-up ] [ Designated as safety issue: No ]
    To investigate the association between tumor response of induction chemotherapy with gemcitabine and cisplatin followed by concurrent chemoradiotherapy and clinical outcomes
Not Provided
Not Provided
 
Induction Chemotherapy With Gemcitabine and Cisplatin Followed by CCRT for Unresectable Pancreatic Carcinoma
A Phase II Study of Induction Chemotherapy With Gemcitabine and Cisplatin Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Pancreatic Carcinoma

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.

The primary endpoint is feasibility and compliance of induction chemotherapy with gemcitabine and cisplatin followed by CRT for locally advanced unresectable pancreatic cancer. Previous studies showed that approximately 20% of patients with locally advanced disease developed the early distant metastasis.[6, 7] Thus, it will be expected that at least 80% of total patients will be eligible for induction chemotherapy after completion of induction chemotherapy. An experimental arm that result a compliance of 80% would merit further study. If the true compliance rate of the patients who will eligible for CRT is ≤ 60%, null hypothesis will be rejected with a power of 80% and a type I error of 5%. Thus, the required number of evaluable patients is 24. Considering the 10% follow-up loss and 20% distant metastasis rate after induction chemotherapy, a total of 34 eligible patients will be enrolled.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Carcinoma Non-resectable
Radiation: Induction Chemotherapy with CCRT
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
Experimental: induction CTx followed by CCRT
Intervention: Radiation: Induction Chemotherapy with CCRT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
34
August 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact: Tae Hyun Kim, Ph.D +82-31-920-1725 k2onco@ncc.re.kr
Korea, Republic of
 
NCT01593475
NCCCTS-11-567
No
Woojin Lee, National Cancer Center, Korea
National Cancer Center, Korea
Not Provided
Principal Investigator: Woo Jin Lee, Ph.D National Cancer Center, Korea
National Cancer Center, Korea
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP