Celecoxib and Radiation Therapy in Treating Patients With Stage II or Stage III Soft Tissue Sarco… (NCT00450736) | Clinical Trial Compass
CompletedPhase 1
Celecoxib and Radiation Therapy in Treating Patients With Stage II or Stage III Soft Tissue Sarcoma of the Arm, Hand, Leg, or Foot That Has Been Removed by Surgery
United States3 participantsStarted 2004-03
Plain-language summary
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving celecoxib together with radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when given together with radiation therapy in treating patients with stage II or stage III soft tissue sarcoma of the arm, hand, leg, or foot that has been removed by surgery.
Who can participate
Age range
18 Years – 120 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.
DISEASE CHARACTERISTICS:
* Histologically confirmed soft tissue sarcoma of the extremity, including the following disease types:
* Liposarcoma
* Leiomyosarcoma
* Synovial cell sarcoma
* Malignant fibrous histiocytoma
* Spindle cell sarcoma
* Fibrosarcoma
* Chondrosarcoma
* Angiosarcoma
* Hemangiopericytoma
* Neurofibrosarcoma
* The following disease types are excluded:
* Kaposi's sarcoma
* Rhabdomyosarcoma
* Dermatofibrosarcoma
* Epithelioid cell sarcoma
* Ewing's sarcoma
* Osteosarcoma
* Intermediate- or high-grade tumor ≥ 5.0 cm in 1 dimension (stage II or III disease)
* Locally resected disease
* One prior wide local excision of the sarcoma in the same location of the extremity within the past 6 months allowed
* Prior neoadjuvant chemotherapy (of ≤ 3 courses), followed by a limb-sparing surgical resection of sarcoma found to have \< 90% pathological tumor necrosis allowed
* Prior resection of an extremity mass that is subsequently found to be a sarcoma meeting study criteria, followed by ≤ 3 courses of chemotherapy (independent of the percentage of pathological tumor necrosis) allowed
* No evidence of nodal or distant metastases
PATIENT CHARACTERISTICS:
* Karnofsky performance status 70-100%
* WBC ≥ 3,000/mm³
* Absolute granulocyte count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 1.5 mg/dL
* SGPT and SGOT ≤ 2.5 times upper limit of normal (ULN)
* Creatinine ≤ 1.5 times ULN
* Calcium ≤ 1.3 times ULN
* No prior malign…
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.