NCT02046304

Brief Summary

The goal of this clinical research study is to find the highest safe dose of gemcitabine that can be given with radiotherapy before surgery to treat sarcoma. This study will also look at how well this treatment controls sarcoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2001

Longer than P75 for phase_1

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, 2001

Completed
12.2 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

13.3 years

First QC Date

January 23, 2014

Last Update Submit

April 4, 2016

Conditions

Sarcoma

Keywords

SarcomaSoft Tissue SarcomasSTSExtremity and TrunkGemcitabineGemcitabine HydrochlorideGemzarExternal beam radiation therapyEBRTRadiotherapyXRT

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose of Preoperative Gemcitabine with External-Beam Radiation Therapy

    The maximum tolerated dose (MTD) defined as the dose having posterior expected toxicity importance score (TIS) closest to the target 1.65 at the end of the trial.

    6 weeks

Secondary Outcomes (1)

  • Response to Preoperative Gemcitabine with External-Beam Radiation Therapy

    3 months after completion of all treatment

Study Arms (1)

Gemcitabine + Radiation Therapy

EXPERIMENTAL

Patients receive concurrent chemoradiation (days 1 - 33) consisting of external beam radiotherapy (EBRT) plus gemcitabine, administered in a phase I dose escalation format until MTD is reached. EBRT delivered preoperatively (for patients with measurable disease) or postoperatively (for patients who have undergone pre-referral excisional biopsy) to a dose of 50 Gy in 25 fractions at 2.0 Gy per fraction. Radiotherapy given once daily (Monday through Friday) for 5 weeks. Surgical resection of the post-treatment tumor mass performed 4 to 8 weeks after the final dose of gemcitabine. Gemcitabine administered intravenously (IV) on days 1, 8, 22, 29, 43, and 50, concurrently with radiotherapy. Starting dose of gemcitabine 400 mg/m2 by vein once a week.

Drug: GemcitabineRadiation: Radiation Therapy

Interventions

GemcitabineDRUG

Starting dose: 400 mg/m2 by vein on days 1, 8, 22, 29, 43, and 50.

Also known as: Gemcitabine Hydrochloride, Gemzar
Gemcitabine + Radiation Therapy
Radiation TherapyRADIATION

Radiation therapy dose of 50 Gy in 25 fractions at 2.0 Gy per fraction. Radiotherapy given once daily (Monday through Friday) for 5 weeks.

Also known as: XRT, EBRT, Radiotherapy
Gemcitabine + Radiation Therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with cytologic or histologic proof of Grade II or III resectable soft tissue sarcoma of the extremity or trunk.
  • Patients with both measurable and non-measurable disease. Patients who are S/P pre-referral excision will be eligible.
  • Patients must have a Zubrod Point Scale of 0 or 1.
  • Absolute neutrophil count must be \> 1,500 cells/mm; platelet count greater than or equal to 100,000 platelets/ml; serum creatinine less than or equal to 1.8 mg/dl, serum glutamate oxaloacetate transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) less than or equal to 3 x normal, total bilirubin less then or equal to 1.5 mg/dl.
  • Patients must have no uncontrolled coexisting medical conditions.
  • Women of childbearing potential must not be pregnant or breast feeding and must practice adequate contraception.
  • All patients must sign an informed consent.

You may not qualify if:

  • \) Patients with a history of prior radiotherapy in the area of the primary tumor or those in whom the anticipated radiation field would include the perineum, scrotum, or vaginal introitus will not be eligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Sarcoma

Interventions

GemcitabineRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTherapeutics

Study Officials

  • Peter W. Pisters, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2014

First Posted

January 27, 2014

Study Start

December 1, 2001

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations

US(1)