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A Pilot Study to Evaluate the Efficacy and Safety of Neoadjuvant Chemoradiotherapy With Capecitabine, . . .

NCT01130701 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-03-17

No results posted yet for this study

Summary

In this study, a new chemotherapeutic agent, panitumumab, will be tested in combination with another chemotherapeutic drug, capecitabine, along with external radiotherapy, to find out whether this combination is effective and safe to use before surgery.

Conditions

Interventions

OTHER

Neoadjuvant capecitabine, panitumumab and radiation

Patients will receive six weekly doses of panitumumab (2.5mg/kg) in conjunction oral capecitabine 825 mg/m2 PO bid Mon-Friday and external beam radiation therapy. Panitumumab and oral capecitabine will begin on the first week of external beam radiotherapy and will continue throughout the course of external beam radiation therapy, and will be discontinued following the conclusion of external beam radiation therapy. Patients will be reevaluated for surgical resection 4-6 weeks after completion of neoadjuvant therapy. After surgical resection, adjuvant systemic chemotherapy with gemcitabine for six months is strongly recommended for all patients.

Sponsors & Collaborators

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Bilal Piperdi, MD · University of Massachusetts, Worcester

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01130701 on ClinicalTrials.gov