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Phase III Prospective Randomized Trial of Pre-Operative Intensity Modulated Radiation Therapy (IMRT) Plus Surgery Versus Surgery Alone For Primary Retroperitoneal Sarcoma


Phase 3
18 Years
N/A
Not Enrolling
Both
Sarcoma

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Trial Information

Phase III Prospective Randomized Trial of Pre-Operative Intensity Modulated Radiation Therapy (IMRT) Plus Surgery Versus Surgery Alone For Primary Retroperitoneal Sarcoma


Primary Objective: To ascertain whether patients with completely resected (R0 + R1), primary
retroperitoneal sarcoma who are randomized to pre-operative IMRT and surgery have a longer
recurrence-free survival compared to patients randomized to treatment with surgery alone.

Secondary Objectives: To ascertain whether patients with completely resected (R0 + R1),
primary retroperitoneal sarcoma randomized to pre-operative IMRT and surgery have longer
overall survival compared to patients randomized to treatment with surgery alone.

- To compare the resectability rate between the two arms

- Determine the variability of NMR biochemical profiles and the variability of expression
for genes/proteins involved in adipocyte differentiation, cell cycle control and
apoptosis within different regions of the primary retroperitoneal sarcoma in patients
treated with surgery alone and pre-operative radiotherapy.

- Analyze NMR biochemical patterns and expression patterns for genes/proteins involved in
adipocyte differentiation, cell cycle control and apoptosis to identify markers that
can provide an objective measure of sarcoma differentiation, proliferation, and
apoptosis.

- Predict the response of sarcoma to radiation therapy and the risk of local recurrence,
based on data derived from NMR biochemical and gene/protein expression patterns in
patient tumors that recurred compared to those without recurrence.

- Determine if diffusion-weighted MRI early in course of radiation therapy can predict
the ultimate pathologic response of sarcoma following resection and the risk of local
recurrence.

- Analyze plasma levels of VEGF, FGF, Ang-1, Ang-2 and endostatin prior to and following
therapy and correlate with treatment response, local and distant recurrence.


Inclusion Criteria:



- Patients with primary retroperitoneal/pelvic soft tissue sarcoma.

- Gross total resection (RO or R1) must be feasible.

- No prior chemotherapy, immunotherapy or radiotherapy is allowable.

- Patients should be over 18 years of age and capable of providing informed consent
indicating awareness of the investigational nature of this trial, in keeping with
hospital policy.

- Karnofsky performance status of >= 70 %

- No other concurrent chemotherapy, immunotherapy or radiotherapy is allowable.

- Adequate organ function defined as follows: absolute granulocytes >= 1,500/mm 3,
platelets >= 150,000/mm 3, serum bilirubin <= 1.5 mg/dl, serum creatinine <= 1.5
mg/dl.

- Written informed consent (study specific) must be obtained from each patient prior
to entering the study.

- Patients should be willing to be followed at Memorial Sloan-Kettering Cancer Center
during the course of treatment and follow-up.

- Patients must be able to get IMRT radiotherapy at Memorial Sloan-Kettering Cancer
Center

Exclusion Criteria:

- Patients presenting with primary non-retroperitoneal soft tissue sarcoma or recurrent
retroperitoneal sarcoma.

- Patients who are deemed unresectable by clinical/imaging criteria.

- Patients with histologic diagnosis of gastrointestinal stromal sarcoma, desmoplastic
small round cell tumor, desmoid, Ewing's sarcoma, PNET, adenosarcoma, granular cell
tumor, mesothelioma or rhabdomyosarcoma are excluded from the study.

- Patients with known metastatic disease, or those with radiologically evident
metastases.

- Patients with clinically significant heart disease (NYHA Class III/IV), history of
active angina or myocardial infarction within 6 months, history of significant
ventricular arrhythmia requiring medication with antiarrhythmics or a history of
clinically significant conduction system abnormality. Patients with any of the above
conditions who are seen by a cardiologist at MSKCC and are found to be an acceptable
risk for surgery will be allowed to participate in this study.

- Patients with any active concurrent malignancy other than non-melanoma skin cancers
or carcinoma-in situ of the cervix. Patients with previous malignancies but without
evidence of disease for > 5 years will be eligible.

- Women who are pregnant.

- Patients currently participating in other clinical trials the requirements of which
may preclude their complete involvement in this study

- Patients with serious intercurrent infections or non-malignant uncontrolled illnesses

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To ascertain whether patients with completely resected (R0 + R1), primary retroperitoneal sarcoma who are randomized to pre-operative IMRT and surgery have a longer recurrence-free survival compared to patients randomized to treatment with surgery alone.

Principal Investigator

Samuel Singer, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

03-050

NCT ID:

NCT00131898

Start Date:

May 2003

Completion Date:

September 2005

Related Keywords:

  • Sarcoma
  • IMRT+Surgery versus Surgery For Sarcoma
  • Sarcoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021