NCT00010166

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Gemcitabine may make tumor cells more sensitive to radiation therapy. Combining chemotherapy with radiation therapy after surgery may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with radiation therapy in treating patients who have undergone surgery to remove cancer of the pancreas.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_2 pancreatic-cancer

Timeline
Completed

Started Dec 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2001

Completed
2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2003

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

2.8 years

First QC Date

February 2, 2001

Last Update Submit

September 7, 2021

Conditions

Pancreatic Cancer

Keywords

stage I pancreatic canceradenocarcinoma of the pancreas

Interventions

gemcitabine hydrochlorideDRUG
adjuvant therapyPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed invasive adenocarcinoma of the pancreas * Prior gross total resection via a pancreaticoduodenectomy (Whipple resection or total pancreatectomy) within the past 2 months * No clinical evidence of gross residual disease at time of surgery * No focally positive margins (tumor at the margin) * No unresected nodal disease or metastatic disease to the liver, peritoneal surfaces, or elsewhere PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-2 Life expectancy: * More than 6 months Hematopoietic: * Granulocyte count greater than 1,500/mm3 * Hemoglobin greater than 10 g/dL * Platelet count greater than 100,000/mm3 Hepatic: * Bilirubin less than 2.0 mg/dL Renal: * Creatinine less than 2.0 mg/dL Other: * Able to maintain adequate oral nutrition * Documented stable weight (no more than 5 lbs weight loss) for at least 2 weeks prior to study * No other malignancy within the past 2 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix or breast * Non-metastatic prostate cancer allowed if more than 2 year survival likely * No other serious medical or psychiatric illness that would preclude study or limit survival to less than 2 years * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent routine growth factors Chemotherapy: * No prior chemotherapy for pancreatic cancer Endocrine therapy: * Not specified Radiotherapy: * No prior abdominal radiotherapy for pancreatic cancer Surgery: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Related Publications (1)

  • Blackstock AW, Mornex F, Partensky C, Descos L, Case LD, Melin SA, Levine EA, Mishra G, Limentani SA, Kachnic LA, Tepper JE. Adjuvant gemcitabine and concurrent radiation for patients with resected pancreatic cancer: a phase II study. Br J Cancer. 2006 Aug 7;95(3):260-5. doi: 10.1038/sj.bjc.6603270. Epub 2006 Jul 25.

    PMID: 16868545RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

GemcitabineChemotherapy, AdjuvantRadiotherapy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Arthur William Blackstock, MD

    Wake Forest University Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2001

First Posted

January 27, 2003

Study Start

December 1, 2000

Primary Completion

October 3, 2003

Study Completion

October 3, 2003

Last Updated

September 9, 2021

Record last verified: 2021-09

Locations

US(1)