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

2014-08-27 03:39:31 | BioPortfolio


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.



- Determine the maximum tolerated dose of adjuvant celecoxib administered with radiotherapy in patients with resected stage II or III soft tissue sarcoma of the extremity.

OUTLINE: This is a dose-escalation study of celecoxib.

Beginning within 10 weeks of the most recent resection, patients undergo standard radiotherapy once daily, 5 days a week, in weeks 1-7. Patients also receive oral celecoxib twice daily in weeks 1-7 in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of celecoxib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. A maximum of 6 patients are treated at the MTD.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Study Design

Primary Purpose: Treatment


Childhood Malignant Fibrous Histiocytoma of Bone


celecoxib, adjuvant therapy, radiation therapy


University of Miami Sylvester Comprehensive Cancer Center - Miami
United States




University of Miami Sylvester Comprehensive Cancer Center

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:39:31-0400

Clinical Trials [5573 Associated Clinical Trials listed on BioPortfolio]

Adjuvant Pembrolizumab After Radiation Therapy for Lung-Intact Malignant Pleural Mesothelioma

The goal of this clinical research study is to assess the safety of pembrolizumab (also called MK-3475) after radiation therapy (with or without surgery and/or chemotherapy) in patients wi...

Cisplatin, CPT-11 and Celecoxib With Radiation Therapy and Surgery for Operable Esophageal Cancer

This is a study for patients with resectable, locally advanced esophageal cancer. There is evidence to suggest that celecoxib in combination with cisplatin and irinotecan (CPT-11) may work...

A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors

The primary objectives of this study are to evaluate whether the administration of AdV-tk to malignant brain tumors followed by anti-herpetic prodrug in combination with radiation therapy ...

CPT-11/Cisplatin and Celecoxib With Radiation Therapy for Patients With Unresectable Non-Small Cell Lung Cancer (NSCLC)

Primary Objectives: - To determine the feasibility, activity, and toxicity of a novel regimen using a concurrent irinotecan (CPT-11)/cisplatin and celecoxib combination for patien...

Ifosfamide and Doxorubicin, Radiation Therapy, and/or Surgery in Treating Young Patients With Localized Soft Tissue Sarcoma

RATIONALE: Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from di...

PubMed Articles [17481 Associated PubMed Articles listed on BioPortfolio]

Radiation Therapy as Sole Management for Solitary Fibrous Tumors (SFT): A Retrospective Study From the Global SFT Initiative in Collaboration With the Sarcoma Patients EuroNet.

Solitary fibrous tumors (SFTs) are extremely rare mesenchymal malignancies. Given the lack of large prospective studies on radiation therapy (RT) with definitive and/or palliative intent in SFT patien...

Objective assessment of flap volume changes and aesthetic results after adjuvant radiation therapy in patients undergoing immediate autologous breast reconstruction.

The use of immediate breast reconstruction and adjuvant radiation therapy is increasing in breast cancer patients. This study aimed to analyze the aesthetic outcome and changes in flap volume in patie...

Risk of cardiac disease after adjuvant radiation therapy among breast cancer survivors.

Adjuvant radiation therapy (RT) for breast cancer is associated with heart disease, although the impact of patient-specific factors on the interaction between cardiac risk and RT is not well-studied i...

The opportunities of computer simulation training in radiation therapy.

The use of computer simulation is arguably more widespread in other industries than in medicine. However, it has filtered into mainstream use in radiation therapy via a commercial product born from co...

Assessment of radiation resistance and therapeutic targeting of cancer stem cells: A Raman spectroscopic study of Glioblastoma.

Radiation is the standard therapy used for treating Glioblastoma (GBM), a grade IV brain cancer. Glioma Stem-like Cells (GSCs), an integral part of GBM enforces resistance to radiation therapy of GBM....

Medical and Biotech [MESH] Definitions

Drug therapy given to augment or stimulate some other form of treatment such as surgery or radiation therapy. Adjuvant chemotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.

A therapeutic approach, involving chemotherapy, radiation therapy, or surgery, after initial regimens have failed to lead to improvement in a patient's condition. Salvage therapy is most often used for neoplastic diseases.

Organs which might be damaged during exposure to a toxin or to some form of therapy. It most frequently refers to healthy organs located in the radiation field during radiation therapy.

Radiotherapy given to augment some other form of treatment such as surgery or chemotherapy. Adjuvant radiotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

More From BioPortfolio on "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"

Quick Search


Relevant Topic

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...

Searches Linking to this Trial