Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma

NCT01333124 | Terminated Phase 2

• 1 other identifier: NCCCTS-10-500
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Resectable Pancreatic Carcinoma

Keywords

Preoperative chemoradiotherapy with Gemcitabine

Outcome Measures

Primary Outcomes (1)

• Complete resection rate

  To evaluate the impact of preoperative chemoradiotherapy with gemcitabine by analyzing complete resection rate (R0).

  Within the first 30 days after surgery

Secondary Outcomes (3)

• Clinical outcomes

  Up to 3years from a initial follow-up

• The association between biomolecular markers and clinical outcomes

  Up to 3years until study closed

• The feasibility and compliance

  Up to 1 year

Study Arms (1)

Radiation: chemoradiotherapy with Gemcitabine

EXPERIMENTAL

Radiation: chemoradiotherapy with Gemcitabine All patients will receive gemcitabine 400 mg/m2 as an intravenous 30-min infusion on day 1, 8, 15, 22, and 29 with radiotherapy.After 4-6 week from end date of chemoradiotherapy, patients undergo preoperative evaluation including CT, PET, CA19-9, CEA. If the patient is feasible for resection on this evaluation, the surgery is performed in 1 to 2 weeks. After surgery, patients will receive gemcitabine 1000 mg/m2 as an intravenous 30-min infusion on day 1, 8, and 15 for every 28 days. Subjects will be treated for at least 1 cycle and to a maximum of four cycles of adjuvant chemotherapy unless there is documented relapse, unacceptable adverse events or withdrawal of consent.

Radiation: chemoradiotherapy with Gemcitabine; Radiation: Radiation: chemoradiotherapy with Gemcitabine

Interventions

chemoradiotherapy with Gemcitabine RADIATION

All patients will receive gemcitabine 400 mg/m2 as an intravenous 30-min infusion on day 1, 8, 15, 22, and 29 with radiotherapy.After 4-6 week from end date of chemoradiotherapy, patients undergo preoperative evaluation including CT, PET, CA19-9, CEA. If the patient is feasible for resection on this evaluation, the surgery is performed in 1 to 2 weeks. After surgery, patients will receive gemcitabine 1000 mg/m2 as an intravenous 30-min infusion on day 1, 8, and 15 for every 28 days. Subjects will be treated for at least 1 cycle and to a maximum of four cycles of adjuvant chemotherapy unless there is documented relapse, unacceptable adverse events or withdrawal of consent.

Radiation: chemoradiotherapy with Gemcitabine

Radiation: chemoradiotherapy with Gemcitabine RADIATION

Radiation: chemoradiotherapy with Gemcitabine

Radiation: chemoradiotherapy with Gemcitabine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, South Korea

Location

MeSH Terms

Interventions

Chemoradiotherapy; Gemcitabine

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Sang-Jae Park, M.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: April 1, 2011
• First Posted: April 11, 2011
• Study Start: September 28, 2011
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: April 6, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)