Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Blood and Lymph Conditions

Breast Neoplasms

Lymphedema

Lymphatic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Michael S Gordon, MD

The purpose of this study is to determine the safety and side effects of bevacizumab in subjects with lymphedema who will initially receive bevacizumab alone and then in combination with standard manual lymphatic drainage (MLD) and combined decongestive therapy (CDT). This study will help to determine the dose of bevacizumab to be used in future studies of subjects with lymphedema.

Lymphedema occurs with varying frequency in patients with cancer but approximately 10-15% of all breast cancer patients will develop lymphedema following breast cancer treatment. Lymphedema in breast cancer patients following axillary lymph node dissection is caused by the interruption of the axillary lymphatic system by surgery or radiation therapy, which causes an accumulation of fluid in the subcutaneous tissue of the arm, with decreased distensibility of tissue around the joints and increased weight of the extremity. The primary current therapy employed involves complete decongestive therapy (CDT) which encompasses the use of manual lymphatic drainage (MLD) and compression bandaging (CB) to the affected limb.

The specific contribution of the vascular system to the development of lymphedema is unclear. Vascular permeability is a complex process which is primarily controlled by the interaction of the ligand vascular endothelial growth factor (VEGF). As a result of the understanding of the biology of VEGF and the anecdotal appreciation of women with lymphedema who have noted improvement in their lymphedema while on VEGF inhibitor therapy, it is hypothesized that the reduction in vascular permeability resulting from the use of a VEGF inhibitor either alone or in conjunction with standard decongestive lymphedema therapy may significantly improve the outcome for patients with this post-operative complication.

Bevacizumab is a recombinant humanized monoclonal antibody directed against VEGF. Bevacizumab blocks the development of new blood vessels in cancer and it is approved by the FDA for the treatment of colon cancer in combination with chemotherapy. While bevacizumab has been administered to thousands of patients with cancer, there is only limited information about the use of bevacizumab in subjects without active cancer.

This study will evaluate the safety profile of escalating doses of bevacizumab administered intravenously alone for 4 weeks followed by 4 weeks of therapy in combination with manual lymph drainage (MLD) and compression bandaging (CB) to patients with moderate to severe unilateral upper extremity lymphedema due to prior breast cancer therapy.

Safety Study of Bevacizumab to Treat Women With a History of Breast Cancer and Suffering From Upper Extremity Lymphedema

Phase I Study Evaluating the Safety of Bevacizumab in Women With a History of Breast Cancer Suffering From Moderate to Severe Upper Extremity Lymphedema

Genentech, Inc.

Premiere Oncology of Arizona

Wounds and Injuries

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Pre-operative IMRT with concurrent and sequential Anlotinib

Anlotinib 12mgQD, from D1 of pre-operative IMRT to 1 month after end of IMRT

Anlotinib hydrochloride

Ning-Ning Lu

Ningning Lu, Doctor

Shu-Lian Wang, M.D.

Shu-Lian Wang, M.D

Sheng-Ji Yu, M.D

Ning-Ning Lu, M.D.

To investigate the safety and efficacy of preoperative IMRT and concurrent Anlotinib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To investigate the Quality of life and extremity function post-combination treatment; To study the mechanism of radio-sensitizing effects of Anlotinib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To assess the relationship between the MRI imaging, pathological findings and local control.

Preoperative IMRT With Concurrent Anlotinib for Localised Extremity or Trunk Sarcoma

Preoperative Intensity-modulated Radiotherapy (IMRT) With Concurrent Anlotinib Hydrochloride for Localised Extremity or Trunk Sarcoma

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Evaluate quality of life by QOL questionnaires at different time points

Evaluate quality of life by MSTS forms at different time points

evaluate the tumor remission rate microscopically

Chinese Academy of Medical Sciences

Principle Investigator

Subjects with resectable extremity soft tissue sarcoma received neoadjuvant grid radiation therapy (GRID), followed by standard-of-care conventional radiotherapy (XRT) and tumor resection.

GRID therapy delivers a high dose of radiation to small areas of tumor interleaved with areas that intentionally receive a low dose

GRID therapy

Flora Danquah

Claire Kowalczyk

Theodore K Yanagihara, MD, PhD

Theodore K Yanagihara, MD. PhD

Patients with extremity soft tissue sarcoma (STS) are at high risk of recurrence. Pre-operative radiotherapy is used to increase the safe removal of tumors and improve local control in these patients. Increasing the preoperative radiotherapy dose with standard techniques might lead to normal tissue toxicity and postoperative wound complications.

GRID radiation therapy is a technique that may increases radiation dose with minimal added toxicity. It is hypothesized that GRID radiation dose will improve tumor response without increasing post-operative wound complications. While GRID has been used in many patients, there have been few formal studies to evaluate the safety and efficacy of the technique. In this study, a single priming dose of GRID will be administered to subjects with high-risk extremity soft tissue sarcoma prior to standard radiotherapy and tumor resection to determine the safety and clinical efficacy of the GRID dose. This single-arm pilot study will assess the safety of spatially fractionated grid radiation therapy (GRID) on 20 subjects with resectable extremity soft tissue sarcoma, followed by standard-of-care conventional radiotherapy (XRT) and tumor resection.

GRID Therapy for Extremity Soft Tissue Sarcoma

Safety, Efficacy, and Mechanism of Pre-operative Spatially Fractionated GRID Radiation Therapy in Patients With Extremity Soft Tissue Sarcoma: A Pilot Study

Safety will be quantified as the incidence of Grade 2 or higher post-operative wound complications after GRID, the standard of care XRT, and surgery.

Wound complications will be graded according to The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

CTCAE is a descriptive terminology that can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

The effect of GRID on tumor response will be measured using the tumor specimen of the surgery. The major pathological response (MPR) rate will be defined as the viable residual tumor in 10% or less of the resection specimen.

Safety will be quantified as the incidence of Grade 2 or higher post-operative wound complications after GRID, the standard of care XRT, and surgery.

Wound complications will be graded according to The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

CTCAE is a descriptive terminology that can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

The comparative effect of GRID will be quantified using histopathologic substrates. Comparisons will be made between pre-treatment biopsies, biopsies taken from different dose regions of the tumor specimen following GRID, and samples of the surgically resected tumor. The viable tumor rate will be compared.

UNC Lineberger Comprehensive Cancer Center

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Ichthyosis, X-Linked

Preoperative intensity modulated radiation therapy followed by surgery

Surgery followed by postoperative intensity modulated radiation therapy

50 Gy delivered in 25 fractions 4-6 weeks prior to surgical excision

Preoperative intensity modulated radiation therapy

Surgery followed by 50 Gy delivered in 25 fractions within 6 weeks of surgery for patients with negative margins; for patients with positive margins a boost of 16 Gy in 8 fractions will be added.

Postoperative intensity modulated radiation therapy

Peter Ferguson, MD, FRCSC

Peter Chung, MD

This study is designed to determine if preoperative image guided radiation therapy (IGRT) delivered using intensity modulated radiation therapy (IMRT) followed by surgery results in similar short-term wound healing complications as surgery followed by postoperative IGRT in patients with extremity or truncal soft tissue sarcoma. Half of the patients will receive preoperative radiotherapy, half will receive postoperative radiotherapy.

Perioperative RT in addition to surgery is widely accepted as standard management for soft tissue sarcoma (STS) of the extremity and trunk. However, controversy remains as to whether RT should be delivered preoperatively or postoperatively. While both confer similar rates of local control, preoperative RT leads to a decrease in late tissue morbidities such as fibrosis, limb edema, joint stiffness and fracture as compared to postoperative RT. The reasons for this are likely multifactorial, but are in part related to total dose delivered (50 Gray (GY) preoperatively and 60-66 Gy postoperatively) and, based on a previous National Cancer Institute (Canada) Phase III randomized controlled trial, the much larger volume treated in the postoperative setting compared to that in the preoperative setting. The optimal radiation dose used in the postoperative setting is unknown but has been developed empirically and doses of 60-66 Gy are generally employed.However, investigators in Norway/Sweden and France have found equivalent local control rates for patients with negative surgical margins treated with 50 GY postoperativelyThe main concern with preoperative RT has centered on the risk of an increased rate of delayed wound healing and major wound complications. Although some studies suggest it may be possible to reduce the incidence of acute wound healing complications associated with pre-operative radiation than previously seen in the 2D RT era, this has yet to be tested in the phase III setting. IG-IMRT allows a much higher degree of conformality and accurate delivery of dose to the tumour while sparing surrounding normal tissue. This may allow similar rates of acute wound healing complications for pre- and postoperative RT in the treatment of STS.

Preoperative vs Postoperative IMRT for Extremity/Truncal STS

Phase III Study of Preoperative vs Postoperative Intensity Modulated Radiation Therapy For Truncal/Extremity Soft Tissue Sarcoma

* Secondary operations required for wound treatment (debridement, secondary closure procedures such as rotationplasty, free flaps or skin grafts);
* Readmission to hospital for wound care;
* Invasive procedures required for wound care (drainage of hematoma, seroma or infected wound collection);
* Deep wound packing required at any time (deep packing defined as packing deep to dermis in an area of dehisced wound) to an area of the wound measuring at least 2 cm in length;
* Prolonged dressing changes, including packing of the wound for greater than six weeks from wound breakdown;
* Repeat surgery for revision of a split thickness skin graft or requirement for wet dressings for longer than four weeks. (It is permissible for a patient to protect a totally epithelialized skin graft with a dry dressing without declaring a major wound complication)
* Use of vacuum-assisted closure (VAC)

Acute radiation skin toxicity will be documented according to the Radiotherapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria.

Late radiation morbidity to skin, subcutaneous tissue, bone and joints will be documented according to the RTOG/EORTC Late Radiation Morbidity Scoring Scheme.

Late radiation morbidity to skin, subcutaneous tissue, bone and joints will be documented according to the Common Toxicity Criteria v4.0

Peripheral limb edema will be documented according to the Late Limb Edema Scoring Criteria.

Limb function will be documented according to the Musculoskeletal Tumor Society Rating Scale.

Patient function will be documented according to the patient completed Toronto Extremity Salvage Score (TESS)

Overall patient survival in months during the study period

Patient survival without a local recurrence in months during the study period.

Patient survival without systemic metastases in months during the study period.

Princess Margaret Hospital, Canada

Mount Sinai Hospital, Canada

Apatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Apatinib 500mg QD, used 2 weeks prior to IMRT, concurrent with pre-operative IMRT, and 1 month after end of IMRT

Apatinib Mesylate 500mg QD, begin from 2 weeks prior to IMRT, to 1 month after end of IMRT

Apatinib Mesylate

To investigate the safety and efficacy of preoperative IMRT and concurrent Apatinib for primary truncal or extremity soft tissue sarcoma; To investigate the Quality of life and extremity function post-combination treatment; To study the mechanism of radio-sensitizing effects of Apatinib for primary truncal or extremity soft tissue sarcoma; To assess the relationship between the MRI imaging, pathological findings and local control.

Preoperative IMRT With Concurrent Apatinib for Localised Extremity or Trunk Sarcoma

Preoperative Intensity-modulated Radiotherapy (IMRT) With Concurrent Apatinib Mesylate for Localised Extremity or Trunk Sarcoma

Evaluate the quality of life by patient-reported EORTC-QLQ-C30 questionnaire at different time points

Evaluate the extremity function by MSTS (Musculoskeletal Tumor Rating Scale) and TESS (Toronto Extremity Salvage Score) forms at different time points

Evaluate the tumor remission rate microscopically 2 weeks after operation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety Study of Bevacizumab to Treat Women With a History of Breast Cancer and Suffering From Upper Extremity Lymphedema	NCT00318513	Lymphedema	Bevacizumab	0 Years -	Premiere Oncology of Arizona
Preoperative IMRT With Concurrent Anlotinib for Localised Extremity or Trunk Sarcoma	NCT05167994	Sarcoma,Soft Ti... Extremity Trunk Anlotinib Intensity-modul... Major Wound Com...	Anlotinib hydro...	18 Years -	ChineseAMS
Safety Study of Bevacizumab to Treat Women With a History of Breast Cancer and Suffering From Upper Extremity Lymphedema	NCT00318513	Lymphedema	Bevacizumab	0 Years -	Premiere Oncology of Arizona
GRID Therapy for Extremity Soft Tissue Sarcoma	NCT06073067	Sarcoma	GRID therapy	18 Years -	UNC Lineberger Comprehensive Cancer Center
GRID Therapy for Extremity Soft Tissue Sarcoma	NCT06073067	Sarcoma	GRID therapy	18 Years -	UNC Lineberger Comprehensive Cancer Center
Preoperative vs Postoperative IMRT for Extremity/Truncal STS	NCT02565498	Adult Soft Tiss...	Preoperative in... Postoperative i...	18 Years -	Mount Sinai Hospital, Canada
GRID Therapy for Extremity Soft Tissue Sarcoma	NCT06073067	Sarcoma	GRID therapy	18 Years -	UNC Lineberger Comprehensive Cancer Center
Preoperative IMRT With Concurrent Apatinib for Localised Extremity or Trunk Sarcoma	NCT05235100	Sarcoma,Soft Ti... Extremity Trunk Intensity-modul... Targetd Therapy Major Wound Com...	Apatinib Mesyla...	18 Years -	ChineseAMS
Preoperative IMRT With Concurrent Anlotinib for Localised Extremity or Trunk Sarcoma	NCT05167994	Sarcoma,Soft Ti... Extremity Trunk Anlotinib Intensity-modul... Major Wound Com...	Anlotinib hydro...	18 Years -	ChineseAMS

Spots Global Cancer Trial Database for extremity

Every month we try and update this database with for extremity cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for extremity

Every month we try and update this database with for extremity cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for extremity cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.