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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 up to 8 weeks
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 belowSelect...
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 ~ up to 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 weeks
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 • NCT0100568051%
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
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Dyspnoea
1%
Cerebral infarction
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
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 2
~780
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,337 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,250 Previous Clinical Trials
1,007,151 Total Patients Enrolled
Shailaja Raj, MRCPPrincipal InvestigatorWake Forest University Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I agree to use effective birth control or abstain from sex during the study.My sarcoma is Grade II or III, can be surgically removed, and I am eligible for radiation before surgery.My sarcoma type has standard chemotherapy treatments available.I need an amputation for my condition.I am not on any cancer treatments except if I'm using hormonal contraceptives.I had unexpected surgery on the limb where my cancer is located.I can take care of myself and am up and about more than half of the day.I have had radiation treatment on my limb.
Research Study Groups:
This trial has the following groups:- Group 1: Neoadjuvant Chemotherapy Plus Radiation Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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