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Taxane

Gemcitabine + Docetaxel + Radiation for Soft Tissue Sarcoma

Phase 1

Recruiting

Led By Shailaja Raj, MRCP

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age greater than or equal to 18 years. No children will be enrolled on this protocol

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study Summary

This trial is testing a new combination of gemcitabine, docetaxel, and radiation to see if it is safe and effective.

Who is the study for?

Adults over 18 with Grade II or III soft tissue sarcoma that can be surgically removed and are eligible for pre-op radiation. They must have an ECOG performance status of 2 or less, agree to use contraception, and not be pregnant. Excluded are those on other cancer treatments, prior unplanned surgery on the limb, needing amputation, or with specific sarcoma subtypes.Check my eligibility

What is being tested?

The trial is testing the safety and effectiveness of combining gemcitabine and docetaxel drugs with radiation therapy before surgical removal of the tumor in adults with soft tissue sarcoma of the limbs.See study design

What are the potential side effects?

Potential side effects may include reactions at the infusion site, fatigue, nausea, low blood cell counts leading to increased infection risk or bleeding problems, hair loss from chemotherapy drugs like Docetaxel and Gemcitabine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Select...

My sarcoma is Grade II or III, can be surgically removed, and I am eligible for radiation before surgery.

Select...

I can take care of myself and am up and about more than half of the day.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose Chemotherapy and Radiation

Number of Toxicity Incidences

Secondary outcome measures

Number of Immunological Changes in Blood

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

51%

Neutropenia

47%

Leukopenia

46%

Nausea

43%

Vomiting

35%

Anaemia

31%

Decreased appetite

26%

Haemoglobin decreased

26%

Fatigue

25%

Constipation

25%

White blood cell count decreased

24%

Neutrophil count decreased

19%

Alanine aminotransferase increased

13%

Platelet count decreased

12%

Rash

10%

Aspartate aminotransferase increased

10%

Thrombocytopenia

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Ischaemic stroke

Cerebral infarction

Dyspnoea

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Neoadjuvant Chemotherapy Plus Radiation TherapyExperimental Treatment5 Interventions

Up to 6 cycles (once a week) of chemotherapy with a 3+3 dose escalating plan (from 100 mg to 300 mg for Gemcitabine; 10 mg to 25 mg for Docetaxel) along with radiation (five days a week) for up to 6 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~5620

Gemcitabine

2017

Completed Phase 3

~2070

Surgical Resection

2018

Completed Phase 2

~420

Radiation

2003

Completed Phase 3

~1020

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,307 Total Patients Enrolled

Wake Forest University Health SciencesLead Sponsor

1,241 Previous Clinical Trials

1,004,210 Total Patients Enrolled

Shailaja Raj, MRCPPrincipal InvestigatorWake Forest University Health Sciences

Media Library

Docetaxel (Taxane) Clinical Trial Eligibility Overview. Trial Name: NCT04037527 — Phase 1

Soft Tissue Sarcoma Research Study Groups: Neoadjuvant Chemotherapy Plus Radiation Therapy

Soft Tissue Sarcoma Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT04037527 — Phase 1

Docetaxel (Taxane) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04037527 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA officially sanctioned Gemcitabine for public use?

"The safety profile of Gemcitabine is considered low, as evidenced by its score of 1 on the Power scale. This reflects that it is a Phase 1 trial with minimal clinical data regarding efficacy and safety."

Answered by AI

Are investigators actively seeking participants for this trial?

"Clinicialtrials.gov provides information that this trial is currently recruiting patients. The advertised research was initially released on August 18th 2020 and edited recently on August 26th 2022."

Answered by AI

Are there any documented investigations involving Gemcitabine?

"As of now, 727 medical trials utilizing Gemcitabine are actively running with 246 at the last stage. Most tests occur in Woolloongabba, Queensland but there are 42152 sites around the world where this medication is being tested."

Answered by AI

What illnesses has Gemcitabine been proven to alleviate?

"Gemcitabine is frequently utilized to address neoplasm metastasis. It has also displayed efficacy in treating advanced directives, urinary bladder and metastatic bladder cancer."

Answered by AI

How many individuals are participating in the clinical trial?

"Affirmative. According to clinicaltrials.gov, this experiment was initially posted on August 18th 2020 and is still actively seeking applicants. The research site needs 27 patients for the trial which will be conducted at a singular location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Gemcitabine and Docetaxel With Radiation in Adults With Soft Tissue Sarcoma of the Extremities". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04037527.

All > Soft Tissue Sarcoma