Neoadjuvant Chemoradiation in Patients With Borderline Resectable Pancreatic Cancer

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01458717
• Collaborator: (none)
• Enrollment: 58
• Locations: 5
• Arms: 2
• Duration (Months): 74
• Patients Per Site: 11.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline resectable pancreas cancer. This study is a multicenter prospective randomized phase II/III study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable pancreas cancer. The study is designed in 2 arms, one with upfront surgery and the other with neoadjuvant chemoradiation therapy.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Drug: Neoadjuvant chemoradiation; Procedure: Upfront surgery	Phase 2/Phase 3

Detailed Description

Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline resectable pancreas cancer.

This study is a multicenter prospective randomized phase II/III study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable pancreas cancer. The study is designed in 2 arms, one with upfront surgery and the other with neoadjuvant chemoradiation therapy.

This phase 2/3 multicenter randomized controlled trial was designed to enroll 110 patients with BRPC who were randomly assigned to gemcitabine-based neoadjuvant chemoradiation treatment (54 Gray external beam radiation) followed by surgery or upfront surgery followed by chemoradiation treatment from four large-volume centers in Korea. The primary endpoint was the 2-year survival rate (2-YSR). Interim analysis was planned at the time of 50% case enrollment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multicenter Prospective Randomized Phase II/III Study of Neoadjuvant Chemoradiation With Gemcitabine in Patients With Borderline Resectable Pancreatic Cancer
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Jan 1, 2018
• Actual Study Completion Date: Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neoadjuvant Neoadjuvant - operation - maintenance chemotherapy	Drug: Neoadjuvant chemoradiation; Neoadjuvant chemoradiation; 45Gy/25fx + 9Gy/5fx of radiation over 6 weeks with Gemcitabine 400mg/㎡ 4 weeks rest, re-evaluation for resectability operation start maintenance chemotherapy within 4~6 weeks after operation with Gemcitabine 1000mg/㎡ (D1, 8, 15) every 4 weeks, for 4 cycle
Active Comparator: Upfront surgery Operation - adjuvant chemoradiation - maintenance chemotherapy	Procedure: Upfront surgery; Operation at time of diagnosis Adjuvant chemoradiation; 45Gy/25fx + 9Gy/5fx of radiation over 6 weeks with Gemcitabine 400mg/㎡ start maintenance chemotherapy within 4~6 weeks after completion of adjuvant chemoradiation with Gemcitabine 1000mg/㎡ (D1, 8, 15) every 4 weeks, for 4 cycle

Outcome Measures

Primary Outcome Measures

1. 2-year survival rate [2-year actual survival outcome]

   2-year actual survival outcome

Secondary Outcome Measures

1. Median survival [after at least of 2-years follow up of all participants]

   calculated from overall survival with Kaplan-Meier method

2. 1-year survival rate [after at least of 1-year follow up of all participants]

   1-year actual survival rate

3. R0 resection rate [within 3 weeks after operation]

   according to pathology report after operation

4. curative resection rate [within 3 weeks after operation]

   according to pathology report after operation

5. local recurrence [within at least 2-years follow up]

   any point during the follow-up period

6. response rate after neoadjuvant chemoradiation [within 6 weeks after completion of neoadjuvant chemoradiation]

   comparison of imaging study findings at pre- and post-neoadjuvant chemoradiation

7. efficacy of imaging study after neoadjuvant chemoradiation [within 3 weeks after operation]

   comparison of pathology report and imaging study in patients who completed neoadjuvant chemoradiation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years old or <75 years old

• ECOG 0-2

• biopsy proven adenocarcinoma of the pancreas

• no history of previous chemotherapy

• borderline resectable pancreas cancer

• no distant metastasis

• WBC at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, Platelet count at least 125,000/mm3

• Bilirubin less than 2.5 mg/dL AST less than 5 times upper limit of normal

• Creatinine no greater than 1.5 times upper limit of normal

• informed consent

Exclusion Criteria:

• history of previous chemotherapy

• history of radiation at >25% area of bone marrow

• stage unspecified, with distant metastasis, recurrent pancreas cancer

• history of malignant neoplasm (except stage 0 cancer, skin in situ cancer except malignant melanoma). Patients who are NED after 5 years after treatment of malignant neoplasm can be candidate of this study

• pregnant, breast-feeding patient

• uncontrolled or active infection

• uncontrolled cardiopulmonary disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Liver Cancer, National Cancer Center	Goyang	Gyeonggi	Korea, Republic of	410-769
2	Seoul National University Bundang Hospital	Seongnam		Korea, Republic of	463-707
3	Seoul National University Hospital	Seoul		Korea, Republic of	110-744
4	Samsung Medical Center	Seoul		Korea, Republic of	135-710
5	Gangnam Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Jin-Young Jang, M.D., Ph.D., Seoul National University College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jin-Young Jang, Associate professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT01458717
• Other Study ID Numbers: BorderlinePancreas
• First Posted: Oct 25, 2011
• Last Update Posted: May 2, 2018
• Last Verified: Apr 1, 2018

• Keywords provided by Jin-Young Jang, Associate professor, Seoul National University Hospital: pancreas; cancer; borderline resectable; locally advanced; resectability; chemotherapy; radiation; chemoradiation; neoadjuvant; survival; prognosis; recurrence; response rate
• Additional relevant MeSH terms: Pancreatic Neoplasms

Study Results

No Results Posted as of May 2, 2018