TERMINATED

Gemcitabine and Docetaxel With Radiation in Adults With Soft Tissue Sarcoma of the Extremities

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Conditions

Soft Tissue SarcomaGrade II sarcomaGrade III sarcoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this Phase 1 research study is to obtain data or information on the safety and effectiveness of the combination of gemcitabine, docetaxel with radiation.

Official Title

Phase I Trial Study of Gemcitabine and Docetaxel With Radiation in Adult Patients With High Grade and Greater Than 5 cm Soft Tissue Sarcoma of the Extremities

Quick Facts

Study Start:2020-08-18
Study Completion:2024-06-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT04037527

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must have a histologically or cytologically confirmed Grade II or III soft tissue sarcoma that is considered to be resectable and are candidates for pre-op radiation.
  2. * Age greater than or equal to 18 years. No children will be enrolled on this protocol.
  3. * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
  4. * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or double-barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  5. * Ability to understand and the willingness to sign a written informed consent document.
  1. * Patients taking concurrent hormonal therapy, biologic or other chemotherapy are excluded except women on hormonal contraceptives.
  2. * Patients taking an investigational agent are excluded.
  3. * Pregnant and nursing women are excluded.
  4. * Patients who require amputation for local control.
  5. * Patients who underwent unplanned excision or other previous surgery involving the affected extremity.
  6. * Patients with sarcoma subtypes for which established chemotherapeutic regimens exist.
  7. * History of radiation to the limb.

Contacts and Locations

Principal Investigator

Shailaja Raj, MRCP
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Shailaja Raj, MRCP, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-18
Study Completion Date2024-06-18

Study Record Updates

Study Start Date2020-08-18
Study Completion Date2024-06-18

Terms related to this study

Keywords Provided by Researchers

  • Grade II sarcoma
  • Grade III sarcoma

Additional Relevant MeSH Terms

  • Soft Tissue Sarcoma