Clinical trial NCT01333124: Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma
Official title: A Phase 2 Study of Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Resectable Pancreatic Carcinoma
Keywords: Preoperative chemoradiotherapy with Gemcitabine
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2011-04-11
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase II study is to evaluate the efficacy of preoperative chemoradiotherapy with gemcitabine (400mg/m2, weekly) for resectable pancreatic cancer.

Detailed description: The primary objective of this study is to evaluate the complete (R0) resection rate for patients with and resectable pancreatic cancer treated with preoperative chemoradiotherapy and curative surgery. An experimental arm that result a complete resection rate of at least 90% would merit further study. With 90% power to reject that null hypothesis that the true complete resection rate is ≤75% with a type I error level of 5%, evaluable 53 patients are required. Considering the 20% unevaluable patients due to the immediate distant metastasis after treatment7, 8, 17 and 10% follow up loss, a total of 64 eligible patients will be enrolled.

Eligibility criteria: Inclusion Criteria:

* Patients with resectable pancreatic adenocarcinoma
* Age over 18 years old and younger than 70 year old
* Performance status (ECOG scale): 0-1
* Adequate organ functions

  * Hb ≥9.0 g/dl
  * ANC ≥1,500/mm3
  * PLT ≥100,000/mm3
  * Liver function: Total Bilirubin ≤3.0 mg/dl AST/ALT/ALP ≤3× upper limit of normal
  * Creatinine ≤1.5 ULN
* Patients should sign a written informed consent before study entry.

Exclusion Criteria:

* Tumor type other than adenocarcinoma
* Unresectable for resection on preoperative evaluation
* Other primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
* Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy)
* Prior radiotherapy
* Major surgery within 4 weeks prior to study treatment
* Serious illness or medical conditions, as follows;

  * congestive heart failure (NYHA class III or IV)
  * unstable angina or myocardial infarction within the past 6 months,
  * significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block
  * uncontrolled hypertension
  * hepatic cirrhosis( ≥ Child class B)
  * interstitial pneumonia, pulmonary adenomatosis
  * psychiatric disorder that may interfere with and/or protocol compliance
  * unstable diabetes mellitus
  * uncontrolled ascites or pleural effusion
  * active infection
* Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug
* Pregnant or lactating woman
* Women of child bearing potential not using a contraceptive method
* Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
* Any patients judged by the investigator to be unfit to participate in the study

Primary outcomes:
measure: Complete resection rate
timeFrame: Within the first 30 days after surgery
Secondary outcomes:
measure: Clinical outcomes
timeFrame: Up to 3years from a initial follow-up
measure: The association between biomolecular markers and clinical outcomes
timeFrame: Up to 3years until study closed
measure: The feasibility and compliance
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center, Korea
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center, Korea
name: Sang-Jae Park, M.D.
role: PRINCIPAL_INVESTIGATOR
References: