Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Wounds and Injuries

Breast Neoplasms

Fibrosis

Radiation Fibrosis Syndrome

Syndrome

Breast Diseases

Skin Diseases

Radiation Injuries

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Flavonoid

Other Dietary Supplements

Herbal and Botanical

Grape Seed Extract

Proanthocyanidin

Procyanidin

Antioxidants

Protective Agents

Antiprotozoal Agents

Antiparasitic Agents

Anthocyanidin

Grape

IH636 grape seed proanthocyanidin extract

John R. Yarnold, MD, FRCR

RATIONALE: IH636 grape seed extract may lessen hardening of breast tissue caused by radiation therapy and may help patients live more comfortably.

PURPOSE: Randomized phase II trial to study the effectiveness of IH636 grape seed extract in treating hardening of breast tissue in women who have undergone radiation therapy for early breast cancer.

OBJECTIVES:

* Determine the efficacy of IH636 grape seed proanthocyanidin extract for the treatment of radiation-induced fibrosis after high-dose radiotherapy in women with a history of early breast cancer.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to time since prior radiotherapy. Patients are randomized to 1 of 2 arms.

* Arm I: Patients receive oral IH636 grape seed proanthocyanidin extract three times daily for 6 months.
* Arm II: Patients receive an oral placebo three times daily for 6 months. Patients are followed at 6 months.

PROJECTED ACCRUAL: A total of 72 patients (48 for arm I and 24 for arm II) will be accrued for this study.

IH636 Grape Seed Extract in Treating Hardening of Breast Tissue in Women Who Have Undergone Radiation Therapy for Early Breast Cancer

Double-Blind, Placebo-Controlled, Randomized Phase II Trial of IH636 Grape Seed Proanthocyanidin Extract (GSPE) in Patients With Adverse Effects of High Dose Breast Radiotherapy

Royal Marsden NHS Foundation Trust

Digestive System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Infections

Rare Diseases

Esophageal Neoplasms

Carcinoma

Adenocarcinoma

Respiratory Insufficiency

Carcinoma, Squamous Cell

Pulmonary Fibrosis

Pneumonia

Radiation Pneumonitis

Communicable Diseases

Respiratory Tract Infections

Lung Diseases

Respiratory Tract Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Respiration Disorders

Lung Diseases, Interstitial

Lung Injury

Esophageal Cancer

FEV1, FVC and DLCO will be assessed at baseline and one month post induction therapy. Radiation induced lung injury (RILI EORTC grade≥2), CCI, Clavien-Dindo, and pulmonary complications will be monitored. Changes in pulmonary function will be compared with cardiorespiratory symptoms and HR-QL among disease-free survivors.

Esophagectomy

Although recent global trends indicate reduced postoperative mortality after esophagectomy, major morbidity, in particular pulmonary, remains high, with considerable health and economic costs. In a recent modern international collaborative series of 2704 patients from high-volume centers, with an approximate equal mix of open and minimally invasive approaches, respiratory complications were evident in 28% of patients, pneumonia in 15%, and respiratory failure in 7%.1 In other series, respiratory failure is reported in up to 15% of patients and is the most common cause of mortality. Prediction of risk and prevention of respiratory morbidity is therefore of considerable importance, and in this context baseline assessment of respiratory physiology compliments clinical assessment, history and enhanced recovery pathways representing key elements of current patient management.

In this study, which will include all prospective patients with locally advanced esophageal cancer treated at a National Center, pulmonary function will be systematically measured before and after neoadjuvant therapy. The investigators seek to evaluate the incidence of radiation induced lung injury (RILI), as well as subclinical changes in pulmonary physiology that may be linked to postoperative complications, and quality-of-life in survivorship, and to compare cohorts who received radiation therapy or chemotherapy alone, preoperatively.

Neoadjuvant Therapy for Esophageal Cancer and Cardiopulmonary Physiology

Neoadjuvant Therapy for Locally Advanced Esophageal Cancer: Impact on Cardiopulmonary Physiology, Short- and Long-term Morbidity

Changes in FEV1 (forced expiratory volume in one second, litres), both as a raw value, and as percentage of predicted values normalized for ethnicity, sex, age and height according to Global Lung Function Initiative algorithms will be determined.

Changes in FVC (forced vital capacity, litres), both as a raw value, and as percentage of predicted values normalized for ethnicity, sex, age and height according to Global Lung Function Initiative algorithms will be determined.

Changes in DLCO (pulmonary diffusion capacity for carbon monoxide, mmol·min.-1.kPa. -1), both as a raw value, and as percentage of predicted values normalized for ethnicity, sex, age and height according to Global Lung Function Initiative algorithms will be determined.

Incidence of postoperative pulmonary morbidity, defined according to ECCG guidelines, will be compared after neoadjuvant chemotherapy versus chemoradiation.

"Global health" HR-QL scores at one year postoperatively among disease-free patients will be compared between neoadjuvant chemotherapy and chemoradiation cohorts

Disease-free survival will be compared between neoadjuvant chemotherapy and chemoradiation groups using Kaplan-Meier methods, as well as multivariable Cox proportional hazards regression models adjusting for known prognostic factors.

St. James's Hospital, Ireland

Surgical Research Fellow

12 weekly sessions of occupational therapy tailored to patients with RFS secondary to breast cancer treatment. Sessions can include manual therapy, education, and active and passive range-of-motion, etc.

Standard OT

12 weekly sessions of occupational therapy tailored to patients with RFS secondary to breast cancer treatment. Sessions can include use of the PhysioTouch electronic massager in lieu of manual therapy, education, and active and passive range-of-motion, etc.

PhysioTouch

Katie Rogers, MSOTR-CLT

A quarter of a million women will develop breast cancer (BC) in this year alone. Many of these women will have side effects as a result of their breast cancer treatment. Radiation Fibrosis Syndrome (RFS) is a common complication from breast cancer treatment that progressively changes tissue and can cause decreased function, pain, and range of motion. The PhysioTouch is a hand held device that can be used to treat RFS and may improve the treatment of fibrotic tissue. This pilot randomized controlled trial aims to determine the efficacy of using the PhysioTouch in addition to current standard of care for treatment of BC-related RFS.

PhysioTouch for Treatment of Radiation Fibrosis

The PhysioTouch, A Novel Treatment for Radiation Fibrosis Syndrome in Breast Cancer Patients

Self-reported upper extremity function as measured by QuickDash

Self-reported upper extremity pain as measured by the BPI

Degrees of should abduction as measured by OT

Degrees of should flexsion as measured by OT

University of Michigan

Occupational Therapist

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Pirfenidone

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

pirfenidone

Kevin Camphausen, MD

RATIONALE: Pirfenidone may prevent or lessen fibrosis caused by radiation therapy.

PURPOSE: Pilot trial to study the effectiveness of pirfenidone in preventing or lessening fibrosis in patients who have undergone radiation therapy for cancer.

OBJECTIVES:

* Determine the safety and therapeutic efficacy of pirfenidone in cancer patients with radiation-induced fibrosis.

OUTLINE: Patients receive oral pirfenidone 3 times daily. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.

Principal functional abilities are assessed at baseline, every 3 months, and at termination of therapy.

PROJECTED ACCRUAL: A total of 10-25 patients will be accrued for this study within 1 year.

Pirfenidone in Treating Patients With Fibrosis Caused by Radiation Therapy for Cancer

A Pilot Study Of Pirfenidone For The Treatment Of Radiation-Induced Fibrosis

National Cancer Institute (NCI)

Blood and Lymph Conditions

Sarcoma

Lymphedema

Chondrosarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Lymphatic Diseases

Soft Tissue Sarcoma

Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost

Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost

Up to 6 courses of investigator's choice of neoadjuvant, adjuvant, concurrent, or interdigitated chemotherapy

Chemotherapy

Preoperative IGRT (3D-CRT or IMRT): If receiving neoadjuvant or adjuvant chemotherapy or no chemotherapy: 50 Gy (2 Gy once a day, 5 times a week). If receiving concurrent or interdigitated chemotherapy: 44 Gy (2 Gy once a day, 5 times a week). Postoperative radiotherapy boost for patients with positive margins following surgery: 16 Gy (2 Gy once a day, 5 times a week) external beam radiation therapy or 16 Gy at ≤ 80 cGy per hour brachytherapy or 3.4 Gy/fraction in 4 fractions brachytherapy or 10-12.5 Gy in a single fraction intraoperative radiation therapy boost.

Radiation therapy

Resection of the sarcoma with the goal of having negative pathologic margins. Every effort should be made to have limb preservation surgery unless there is documented evidence of tumor progression that would require amputation for an appropriate negative margin resection. All lesions of the extremities should be treated with wide excision.

Surgery

Dian Wang, MD, PhD

Scott Okuno, MD

Burton L. Eisenberg, MD

John M. Kane, MD

David G. Kirsch, MD, PhD

RATIONALE: Image-guided radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a lower dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase II trial is studying the side effects and how well image-guided radiation therapy works in treating patients with primary soft tissue sarcoma of the shoulder, arm, hip, or leg.

OBJECTIVES:

Primary

* To determine the effect of reduced radiation volume using image-guided radiotherapy (IGRT) on lymphedema ≥ grade 2, subcutaneous fibrosis, and joint stiffness at 2 years in patients with primary soft tissue sarcoma of the extremity.

Secondary

* To estimate the rates of other grade 3-5 adverse events as measured by Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0.
* To determine the pattern of first failure, including local failure (in-field, marginal, and outside-field failure), regional failure, distant failure, and death without disease progression.
* To estimate the rates of local failure, local-regional failure, distant failure, distant disease-free survival, disease-free survival, overall survival, and second primary tumor.
* To estimate the rate of wound complications.
* To correlate the degree of late radiation morbidity (defined as any lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years with scores on the clinical measure, Musculoskeletal Tumor Rating Scale (MSTS).

OUTLINE: This is a multicenter study.

* Neoadjuvant radiotherapy: Patients are assigned to 1 of 2 treatment groups (group 1 closed to accrual as of 01/08/10).

  * Group 1 (closed to accrual as of 01/08/10): Patients undergo 3-D conformal radiotherapy (3D-CRT) or intensity-modulated therapy (IMRT) once daily, 5 days a week, for 4½-5 weeks. Patients also receive up to 6 courses of neoadjuvant, adjuvant, concurrent, or interdigitated chemotherapy.
  * Group 2: Patients undergo 3D-CRT or IMRT once daily, 5 days a week, for 5 weeks.
* Surgery: At 4-8 weeks after completion of neoadjuvant radiotherapy, patients undergo surgical resection of the tumor. Patients with positive tumor margins (residual tumor) undergo intraoperative radiotherapy boost or proceed to adjuvant radiotherapy within 2 weeks after surgery.
* Adjuvant radiotherapy: Patients undergo either external-beam radiotherapy (EBRT) once daily for 8 fractions or brachytherapy.

After completion of study treatment, patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg

A Phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity

The rate of patients with late radiation morbidity (≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years from the start of radiotherapy as measured by EORTC(European Organisation for Research and Treatment of Cancer)/RTOG (Radiation Therapy Oncology Group) criteria. Grade refers to the severity of the morbidity. The RTOG/EORTC Late Radiation Morbidity Scoring Schema assigns Grades 1 through 5 with unique clinical descriptions of severity for each morbidity based on this general guideline: Grade 1 Mild , Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to morbidity.

Local failure is defined as the time from registration to date of failure (local progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.

Regional failure is defined as the time from registration to date of failure (regional progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.

Distant failure is defined as the time from registration to date of failure (distant progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.

Distant disease-free survival is defined as the time from registration to date of failure (distant progression or death) or last follow-up. Two year rate and 95% confidence interval were estimated by the Kaplan-Meier method.

Disease-free survival is defined as the time from registration to date of failure (local, regional, or distant progression or death) or last follow-up. Two year rate and 95% confidence interval were estimated by the Kaplan-Meier method.

Overall survival is defined as the time from registration to date of death or last follow-up. Two year survival rate and 95% confidence interval were estimated by the Kaplan-Meier method.

Second primary tumor is defined as the time from registration to date of failure (second primary tumor) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.

Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

Estimate rate of patients with acute wound complications with 95% confidence interval assuming binomial distribution.

Pattern of first failure including local failure (in-field, marginal, and outside-field failure), regional failure, distant failure, and death without disease progression.

The Musculoskeletal Tumor Rating Scale (MSTS) is a measure of physical function across 7 items, completed by the physician (preferably by the Orthopedic Surgeon or Surgical Oncologist) or the physician's designated staff. The 7 items are: pain, range of motion, strength, joint stability, joint deformity, emotional, acceptance, and overall function. Each item is scored from 0-5 (worst possible to best possible condition). The item scores are summed to get the total score which ranges from 0-35.

Late radiation morbidity is defined as ≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

NRG Oncology

Radiation Therapy Oncology Group

Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.

Cohort A - Chemotherapy

Cohort B - No Chemotherapy

Total

Age, Continuous

Sex: Female, Male

All eligible patients who started protocol treatment.

Due to unmet accrual goals for Cohort A, the decision was made to close this cohort and to increase the sample size of Cohort B. Due to the small sample size for Cohort A results were not reported.

Wendy Seiferheld, M.S.

Initially designed to test for a 20% absolute improvement from 37% (fixed rate) to 17% using Fisher's exact test, requiring 41 patients per cohort (51 with 20% ineligibility) with 5% type I error and 90% statistical power. During accrual, the sample size for cohort B was increased to 66 (83 with 20% ineligibility) to test for a 15% improvement with 5% type I error and 85% power.

All eligible patients on Cohort B who started study treatment and had an assessment of toxicity at 2 years. (See limitations and caveats, Cohort A is not included.)

Rate of Late Radiation Morbidity (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis, or Joint Stiffness) at 2 Years From the Start of Radiotherapy as Measured by EORTC/RTOG Criteria

All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)

Local Failure Rate at Two Years

Regional Failure Rate at Two Years

Distant Failure Rate at Two Years

Distant Disease-free Survival Rate at Two Years

Disease-free Survival Rate at Two Years

Overall Survival Rate at Two Years

Second Primary Tumor Rate at Two Years

Late Radiation Morbidity Rate (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis or Joint Stiffness) at 2 Years From the Start of Radiotherapy as Measured by CTCAE v3.0

All eligible patients on cohort B that had surgery and a wound assessment. (See limitations and caveats, Cohort A is not included.)

Percentage of Patients With Wound Complications

Local

Regional

Distant

Dead without disease progression

Alive without disease progression

All eligible patients on Cohort B who started study treatment. All eligible patients on Cohort B. (See limitations and caveats, Cohort A is not included.)

Pattern of First Failure

No Late Radiation Morbitity

Has Late Radiation Toxicity

All eligible patients on Cohort B who had a 2-year MSTS assessment. (See limitations and caveats, Cohort A is not included.)

Mean Musculoskeletal Tumor Rating Scale (MSTS) by Late Radiation Morbidity at Two Years

Percentage of Patients With Other CTCAE, v.3.0 Grade 3-5 Adverse Events

Correlation of Late Radiation Morbidity at 2 Years With the 3 Quality of Life Assessments [Functional Assessment of Cancer Therapy-General (FACTG), Toronto Extremity Salvage Score (TESS), and Sexual Adjustment Questionnaire (SAQ)]

Comparison of TESS and the MSTS Scores at 2 Years Between Cohort B Patients and the Preoperative Radiotherapy Patients in the NCIC CTG Trial [National Cancer Institute of Canada Clinical Trials Group]

Comparison of SAQ Scores at 2 Years for Cohort A Patients With Cohort B Patients

Overall Study

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Dyspnea

Respiratory Tract Neoplasms

Thoracic Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Signs and Symptoms, Respiratory

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasoconstrictor Agents

Losartan

Angiotensin II

Giapreza

Angiotensinogen

Angiotensin II Type 1 Receptor Blockers

Angiotensin Receptor Antagonists

50 mg Losartan tablet taken daily for 24 weeks

50 mg Losartan will be taken daily by subjects for 24 weeks

Marisa Couluris, DO

RATIONALE: Losartan potassium may be effective in treating pulmonary fibrosis caused by radiation therapy in patients with non-small cell lung cancer.

PURPOSE: This clinical trial is studying losartan to see how well it works in treating pulmonary fibrosis caused by radiation therapy in patients with stage I, stage II, or stage III non-small cell lung cancer.

OBJECTIVES:

Primary

* To evaluate the effects of losartan potassium on the disease progression in patients with stage I-III non-small cell lung cancer and radiation-induced pulmonary fibrosis.
* To determine the feasibility of losartan potassium as a possible treatment for radiation-induced pulmonary fibrosis.

Secondary

* The evaluate the effects of losartan potassium on the degree of dyspnea, and lung function (FEV_1 and FVC) in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral losartan potassium once daily for 6 months in the absence of disease progression or unacceptable toxicity.

Patients undergo assessment of pulmonary function (e.g., gas movement, lung capacity, and diffusion of gases) by spirometry and dyspnea by the Visual Analog Scale (VAS) at baseline and at weeks 12 and 24.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
IH636 Grape Seed Extract in Treating Hardening of Breast Tissue in Women Who Have Undergone Radiation Therapy for Early Breast Cancer	NCT00041223	Breast Cancer Radiation Fibro...	IH636 grape see...	18 Years -	National Cancer Institute (NCI)
Neoadjuvant Therapy for Esophageal Cancer and Cardiopulmonary Physiology	NCT03462524	Esophageal Canc... Radiation Pneum... Pulmonary Fibro... Respiratory Fai... Pneumonia Surgery Chemotherapy Ef... Radiation Fibro... Radiation Toxic... Adenocarcinoma Squamous Cell C...	Esophagectomy	18 Years -	St. James's Hospital, Ireland
PhysioTouch for Treatment of Radiation Fibrosis	NCT03496909	Radiation Fibro...	Standard OT PhysioTouch	21 Years - 65 Years	University of Michigan
Pirfenidone in Treating Patients With Fibrosis Caused by Radiation Therapy for Cancer	NCT00020631	Radiation Fibro...	pirfenidone	18 Years -	National Cancer Institute (NCI)
Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg	NCT00589121	Lymphedema Musculoskeletal... Radiation Fibro... Radiation Toxic... Sarcoma	Chemotherapy Radiation thera... Surgery	18 Years -	Radiation Therapy Oncology Group
Losartan in Treating Pulmonary Fibrosis in Patients With Stage I, II, or III Non-Small Cell Lung Cancer	NCT00880386	Dyspnea Lung Cancer Pulmonary Compl... Radiation Fibro...	Losartan	18 Years -	University of South Florida
Prophylactic Inhaled Steroids to Reduce Radiation Pneumonitis Frequency and Severity in Lung Cancer Patients	NCT03803787	Radiation Pneum...	Inhaled budeson...	18 Years - 75 Years	Instituto Nacional de Cancerologia de Mexico
Losartan in Treating Pulmonary Fibrosis in Patients With Stage I, II, or III Non-Small Cell Lung Cancer	NCT00880386	Dyspnea Lung Cancer Pulmonary Compl... Radiation Fibro...	Losartan	18 Years -	University of South Florida
Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury	NCT04485286	Lung Cancer Radiation Fibro... Radiation Induc... Pancreas Cancer	[68Ga]CBP8	18 Years - 80 Years	Massachusetts General Hospital
Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury	NCT04485286	Lung Cancer Radiation Fibro... Radiation Induc... Pancreas Cancer	[68Ga]CBP8	18 Years - 80 Years	Massachusetts General Hospital

Spots Global Cancer Trial Database for radiation fibrosis