TerminatedPhase 2

Preoperative Thalidomide With Radiation Therapy For Patients With Low-Grade Primary Soft Tissue Sarcoma or Thalidomide With Radiation Therapy and Chemotherapy For Patients With High-Grade or Intermediate-Grade Primary Soft Tissue Sarcoma of the Arm, Leg, or Body Wall

United States23 participantsStarted 2004-06-17

Plain-language summary

Thalidomide may stop the growth of soft tissue sarcoma by stopping blood flow to the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as doxorubicin, ifosfamide, and dacarbazine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving thalidomide together with radiation therapy and/or chemotherapy before surgery may shrink the tumor so that it can be removed. This phase II trial is studying how well giving preoperative (before surgery) thalidomide together with radiation therapy works in treating patients with low-grade primary soft tissue sarcoma, and how well giving thalidomide together with radiation therapy, doxorubicin, ifosfamide, and dacarbazine works in treating patients with high-grade or intermediate-grade primary soft tissue sarcoma of the arm, leg, chest wall, or abdominal wall.

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of primary soft tissue sarcoma * T2a or T2b disease * Superficial or deep tumor * Grade 1, 2, 3, or 4 * Tumor located on the upper extremity (including shoulder), lower extremity (including hip), or trunk * Meets 1 of the following criteria: * Tumor ? 8 cm in maximal diameter and grade 3 or 4 (intermediate or high grade) (cohort A) * Tumor \> 5 cm in maximal diameter and grade 1 or 2 (low grade) (cohort B) * Locally recurrent disease allowed provided there has been no prior radiotherapy to the primary tumor * No histologically confirmed rhabdomyosarcoma, extraosseous Ewing's primitive neuroectodermal tumors, osteosarcoma or chondrosarcoma, Kaposi's sarcoma, angiosarcoma, desmoid tumors, or dermatofibrosarcoma protuberans * No overt evidence of lung metastases (CT scan evidence of small incidental lesions without histologic diagnosis allowed) * No evidence of other metastases * No sarcoma of the head, neck, intra-abdominal, or retroperitoneal region * Performance status - Zubrod 0-1 * At least 2 years * Absolute neutrophil count ? 1,500/mm\^3 * Platelet count ? 120,000/mm\^3 * Hemoglobin ? 8.0 g/dL (cohort A) * No known hypercoagulable disorders, such as the following: * APC resistance (factor V Leiden) * Protein S deficiency * Protein C deficiency * Antithrombin III deficiency * Hyperhomocystinemia * Dysplasminogenemia * High plasminogen activator inhibitor * Dysfibrinogenemia * Antiphospholipid syndrome * Th…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Treatment Delivery With Compliance Defined as Receiving at Least 95% of the Pre-operative Protocol Dose of RT, All 3 Cycles of MAID (if Applicable), and Receive Thalidomide on 75% of the Days During Radiation

Timeframe: Duration of treatment (which can continue up to approximately 15 months).

Trial details

NCT IDNCT00089544

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2011-09-27

Results submitted2013-03-13

View on ClinicalTrials.gov More Recurrent Adult Soft Tissue Sarcoma trials