CLINICAL TRIAL

Doxorubicin for Stage IV Soft Tissue Sarcoma AJCC v7

Waitlist Available · Any Age · All Sexes · Dallas, TX

This study is evaluating whether a combination of radiation therapy and chemotherapy with or without pazopanib is better than radiation therapy alone in treating patients with non-rhabdomyosarcoma soft tissue sarcomas.

See full description

About the trial for Stage IV Soft Tissue Sarcoma AJCC v7

Eligible Conditions
Stage IV Soft Tissue Sarcoma AJCC v7 · Undifferentiated High Grade Pleomorphic Sarcoma of Bone · Sclerosing Epithelioid Fibrosarcoma · Stage IB Soft Tissue Sarcoma AJCC v7 · Osteosarcoma · Nerve Sheath Neoplasms · Chondrosarcoma · Sarcoma, Alveolar Soft Part · Atypical Fibroxanthoma · Low Grade Myofibroblastic Sarcoma · Leiomyosarcoma · Neurofibrosarcoma · Histiocytoma · Sarcoma, Clear Cell · Angiomatoid Fibrous Histiocytoma · Fibrohistiocytic Neoplasm · Myxoinflammatory Fibroblastic Sarcoma · Plexiform Fibrohistiocytic Tumor · Chondrosarcoma, Mesenchymal · Liposarcoma · Glomus Tumor · Granular Cell Tumor · Clear Cell Sarcoma of Soft Tissue · Epithelioid Malignant Peripheral Nerve Sheath Tumor · Extraskeletal osteosarcomas · Liver Embryonal Sarcoma · Low Grade Fibromyxoid Sarcoma · Myxofibrosarcoma · Myxoid Chondrosarcoma · PEComas · Skin Glomus Tumor · Neoplasms · Sarcoma · Sarcoma, Synovial · Fibrosarcoma · Histiocytoma, Benign Fibrous · Histiocytoma, Malignant Fibrous · Alveolar Soft Part Sarcoma (ASPS) · Epithelioid Sarcoma (ES) · Extra Skeletal Myxoid Chondrosarcomas · Inflammatory Myofibroblastic Tumors · Intimal Sarcoma · Malignant Cutaneous Granular Cell Tumor · Malignant Peripheral Nerve Sheath Tumour (MPNST) · Malignant Triton Tumor · Pericytic Neoplasm · Stage IIB Soft Tissue Sarcoma AJCC v7 · Stage III Soft Tissue Sarcoma AJCC v7 · Synovial Sarcoma

Treatment Groups

This trial involves 4 different treatments. Doxorubicin is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Experimental Group 1
Therapeutic Conventional Surgery
PROCEDURE
+
Pazopanib Hydrochloride
DRUG
+
Pazopanib
DRUG
+
Radiation Therapy
RADIATION
Experimental Group 2
Therapeutic Conventional Surgery
PROCEDURE
+
Radiation Therapy
RADIATION
Experimental Group 3
Therapeutic Conventional Surgery
PROCEDURE
+
Ifosfamide
DRUG
+
Doxorubicin
DRUG
+
Pazopanib Hydrochloride
DRUG
+
Pazopanib
DRUG
+
Doxorubicin Hydrochloride
DRUG
+
Radiation Therapy
RADIATION
Show More

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Conventional Surgery
2014
Completed Phase 3
~8360
Ifosfamide
FDA approved
Doxorubicin
FDA approved
Pazopanib
FDA approved
Pazopanib
FDA approved
Doxorubicin
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7080

Eligibility

This trial is for patients born any sex of any age. You must have received newly diagnosed for Stage IV Soft Tissue Sarcoma AJCC v7 or one of the other 48 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The text discusses a stage of cancer in which the tumor is greater than 5 cm in size and is either grade 2 or 3. show original
Patients who are eligible for and can swallow whole tablets are those with a body surface area >= 0.5 square meters. show original
The extremities are the upper and lower parts of the body show original
Soft tissue sarcomas that have not been classified and do not fit into a specific category are often called undifferentiated soft tissue sarcomas or soft tissue sarcomas not otherwise specified. show original
An incisional biopsy is a better option than a fine needle aspiration biopsy when trying to determine if a tumor is cancerous. show original
The following areas are ineligible for treatment: the head and neck, the visceral organs (with the exception of embryonal sarcoma of the liver), the retroperitoneum, the peritoneum, and the pelvis within the confines of the bony pelvis. show original
of a vertebrate The trunk is the body wall of a vertebrate show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From enrollment up to 60 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From enrollment up to 60 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Doxorubicin will improve 5 primary outcomes, 4 secondary outcomes, and 5 other outcomes in patients with Stage IV Soft Tissue Sarcoma AJCC v7. Measurement will happen over the course of Up to 48 hours after the end of infusion.

Mean Pharmacokinetic Parameters of Doxorubicin and Pazopanib
UP TO 48 HOURS AFTER THE END OF INFUSION
Pharmacokinetic parameters such as the clearance of doxorubicin and pazopanib will be estimated.
Change in Fludeoxyglucose F 18 (FDG) Positron Emission Tomography (PET) Maximum Standard Uptake Value (SUVmax)
FROM ENROLLMENT TO WEEK 10 OR 13 PRIOR TO TUMOR RESECTION
To evaluate change in FDG PET maximum standard uptake value (SUVmax) from baseline to Week 10 or 13 in patients with unresected tumors and to correlate this change with pathologic response and EFS.
Prevalence of Circulating Tumor DNA (ctDNA)
AT DIAGNOSIS
Descriptive analyses will be performed to summarize the prevalence of ctDNA.
Feasible Dose: Pediatric
AFTER THE FIRST 6 WEEKS OF INDUCTION
The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in pediatric unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and < 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered.
Percentage of Radiotherapy Patients With Positive Pathologic Response at Week 10
WEEK 10 AFTER INDUCTION
A responder is defined by more than 90% tumor necrosis at week 10. A non-responder has less than 90% necrosis or progressive disease before week 10.
Percentage of Chemoradiotherapy Patients With Positive Pathologic Response at Week 13
WEEK 13 AFTER INDUCTION
A responder is defined by more than (90% tumor necrosis at week 13). A non-responder has less than 90% necrosis or progressive disease before week 13.
See More

Patient Q & A Section

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

Can myxoid chondrosarcoma be cured?

With the appropriate surgical treatment including gross total removal of the tumor and adequate margins, high local tumor control can be achieved and may be helpful for long-lasting survival for patients with myxoid chondrosarcomas.

Anonymous Patient Answer

How many people get myxoid chondrosarcoma a year in the United States?

Myxoid chondrosarcoma accounts for less than 5% of all cancers of the skeletal system. We report 4 cases of myxoid chondrosarcoma of bone. In a recent study, findings highlights the need to educate surgeons and the general population regarding myxoid chondrosarcoma.

Anonymous Patient Answer

What causes myxoid chondrosarcoma?

The specific cause of myxoid chondrosarcoma remains unknown, but these tumors are known to occur most frequently in young males with local lesions or tumors and often in the extremities/extrascapular regions. Clinicians should remember the association of myxoid chondrosarcoma and chondrostereum (also called "osteochondrosis"). Myxoid chondrosarcoma is most often associated with myxochectomy or exostosis of an epiphyseal zone. This benign lesion often occurs in adolescent males from the ages of 10 to 16 years. Patients with this disease may also present with a tumor.

Anonymous Patient Answer

What is myxoid chondrosarcoma?

Myxoid chondrosarcoma is a rare intraosseous neoplasm with a distinctive gross appearance. The histology, biochemistry, and immunohistochemistry of this tumor are also unique. It is usually a slow growing tumor with an early recurrence rate in less than one year. Surgery was the sole therapy and has been the recommended treatment for most cases of this tumor. A well-defined concept for classification needs to be developed because there are variations of this tumor. The exact etiopathogenesis of myxoid chondrosarcoma is not yet identified.

Anonymous Patient Answer

What are the signs of myxoid chondrosarcoma?

Myxoid chondrosarcoma may present with mass effect of tumors, and may involve the liver, peritoneum and/or heart. Although myxoid chondrosarcoma usually has a good prognosis, the diagnosis may become more challenging in a highly aggressive primary tumor involving the joint. These tumors may have a peculiar pattern of cellular differentiation, with focal, irregular, bizarre nuclei containing many nucleoli, a nuclear-cytoplasmic ratio that is < or = 2, a pseudo-cleistosome arrangement, prominent heterochromatin, and large, rounded nucleoli; however, the clinical significance of this pattern is not yet established.

Anonymous Patient Answer

What are common treatments for myxoid chondrosarcoma?

The treatment for both myxoid chondrosarcoma and benign chondromuscular tumors has been improved in recent years due to the development of new drugs, including radiation, hormonal, and chemotherapy therapies. Tumor types may respond to these treatments differently, depending on the location and stage of the disease prior to this treatment. Furthermore, the chemotherapy treatment remains an important adjunct of treatment for both malignant and benign tumors. Currently, no treatment for myxoid chondrosarcoma has been proven to be curative. Therefore, it is important to identify and treat patients with this disease as early as possible.

Anonymous Patient Answer

Who should consider clinical trials for myxoid chondrosarcoma?

Patients with myxoid [chondrosarcoma](https://www.withpower.com/clinical-trials/chondrosarcoma) are more likely to wish to participate in clinical trials than are other adult patients with bone sarcoma. They are less likely than patients from other regions to feel that the research was of interest when compared with patients of other regions. When asked who would want to participate in a clinical trial, most patients would name their spouse and/or family members. Patients from other regions were less likely than patients from other regions to see the clinical trial as interesting, or to see it as important. In general, patients who were aware of the trial did not feel a need to know more about it, but felt it benefited the society more for patients to know about clinical trials.

Anonymous Patient Answer

What is the survival rate for myxoid chondrosarcoma?

The 1-year and 5-year survival rates for patients with myxoid chondrosarcoma were 89% and 82%, respectively. Survival was significantly longer in females (p = 0.019), patients who had local treatment only (p = 0.0008), and patients with no residual tumor after resection (p < 0.01).

Anonymous Patient Answer

Have there been any new discoveries for treating myxoid chondrosarcoma?

[No significant improvements have been made in the treatment of myxoid chondrosarcomas] at this time. The only way to make any improvement is to continue with the recent clinical trials and hopefully, a cure will be found.

Anonymous Patient Answer

What is the latest research for myxoid chondrosarcoma?

The latest research on MFH is sparse. Clinical trials are under way to determine whether targeted therapy and radiation therapy are more effective treatments. Clinical trials of these therapies are ongoing. MFH cases are rare; the median number of observed cases is 27 (range 0–72) per 10,000 population/year.

Anonymous Patient Answer

Does myxoid chondrosarcoma run in families?

Results from a recent paper, the first description of a multiplex case, indicates that myxoid chondrosarcomas are probably genetic in nature and are associated with a familial mode of transmission. A larger genetic study is thus needed to confirm or reject the presence of a genetic contribution to myxoid chondrosarcoma.

Anonymous Patient Answer

What are the common side effects of doxorubicin?

The most common common adverse effects of doxorubicin and carboplatin are the same; they include hair loss, nausea and vomiting, fatigue, nausea, and weakness. However, doxorubicin has also been reported causing other side effects such as aplastic anemia during treatment, myelosuppression including neutropenia, gastrointestinal disorders such as diarrhea, bleeding, ulcerations, hemorrhage, perforations, ulcerations, and bleeding as well as cardiovascular problems such as [congestive heart failure](https://www.withpower.com/clinical-trials/congestive-heart-failure), low blood pressure, increased risk of valvular disease, and low output heart failure.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Stage IV Soft Tissue Sarcoma AJCC v7 by sharing your contact details with the study coordinator.