Neoplasms

All Conditions

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Cisplatin

Antimetabolites

All patients get IMRT with concurrent cisplatin \& gemcitabine, with the dose of gemcitabine varying according to cohort

45 Gy in 25 daily fractions (1.8 Gy per fraction)

Intensity Modulated Radiation Therapy (IMRT)

Weekly infusion of 40 mg/m2 x 5 weeks (70 mg maximum)

Weekly infusion x 5 weeks at escalating dose levels (50mg/m2, 75mg/m2, 100mg/m2, and 125mg/m2)

Loren Mell, MD

The primary objective of the study is to identify the highest dose of gemcitabine that can be given safely with cisplatin and pelvic intensity modulated radiation therapy (IMRT) in women with locally advanced cervical cancer. The investigators hypothesis is that IMRT will reduce gastrointestinal and hematologic toxicity, permitting escalating doses of gemcitabine to be feasibly delivered in patients with locally advanced cervical cancer.

Many studies have investigated multiagent chemotherapy as a means of intensifying treatment. The results of such trials indicate that gemcitabine has considerable activity against cervical cancer when given with cisplatin/RT, however, it is quite toxic. The predominant toxicities are gastrointestinal and hematologic. Methods to reduce gastrointestinal and hematologic toxicity during chemoradiotherapy could mitigate this toxicity and take advantage of the therapeutic benefits of gemcitabine

IMRT is an advanced radiation therapy delivery technique that reduces the amount of radiation given to normal tissues and may therefore reduce unwanted side effects. IMRT tries to lower the amount of radiation that normal tissues receive, while still delivering the desired amount of radiation to the cancer cells and other areas, such as lymph nodes. IMRT does this by using computers to design the best way to aim radiation at the tumor(s), while still delivering a radiation dose comparable to standard radiation.

Intensity Modulated Radiation Therapy With Cisplatin and Gemcitabine to Treat Locally Advanced Cervical Carcinoma

A Phase I Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin and Escalating Gemcitabine for Locally Advanced Cervical Carcinoma

To determine the maximum tolerated dose (MTD) of weekly gemcitabine that can be administered with concurrent weekly cisplatin and pelvic intensity modulated radiation therapy (IMRT) in women with locally advanced cervical cancer

To quantify acute treatment-related adverse events that occur within 30 days of completing protocol treatment.

To determine the progression-free and overall survival of patients treated with gemcitabine at the MTD in this regimen.

University of California, San Diego

Associate Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Adenocarcinoma

Recurrence

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Androgens

Patients undergo hypofractionated intensity modulated radiotherapy once daily, 5 days a week, for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with intermediate- and high-risk disease may also receive concurrent and adjuvant or long-term androgen deprivation therapy for up to 36 months.

Low risk - 69.6 Gy in 2.4 Gy fractions to prostate

Intermediate risk - delivered in 30 fractions with neoadjuvant and concurrent androgen deprivation therapy: 72 Gy in 2.4 Gy fractions to prostate + 60 Gy in 2 Gy fractions to seminal vesicles +/- 50.4 Gy in 1.68 Gy fractions to lymph nodes

High risk - 30 fractions with neoadjuvant, concurrent, and long term adjuvant androgen deprivation therapy: 72 Gy in 2.4 Gy fractions to prostate + 60 Gy in 2 Gy fractions to seminal vesicles +/- 50.4 Gy at 1.68 Gy fractions to lymph nodes

intensity modulated external beam radiation therapy

Michael G. Chang, MD

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy, such as intensity-modulated radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This clinical trial studies intensity-modulated external beam radiation therapy in treating patients with prostate cancer.

PRIMARY OBJECTIVES:

I. To demonstrate that patients can safely receive IMRT teletherapy using the proposed IMRT fractionation schedule without experiencing a treatment limiting toxicity.

SECONDARY OBJECTIVES:

I. To assess treatment efficacy through the surrogate measures of PSA nadir and biochemical failure-free survival.

OUTLINE: Patients undergo hypofractionated intensity modulated radiotherapy once daily, 5 days a week, for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with intermediate- and high-risk disease may also receive concurrent and adjuvant or long-term androgen deprivation therapy for up to 36 months. After completion of study treatment, patients are followed at 4-6 weeks, every 4 months for 3 years, every 6 months for 2 years, and then annually until year 5.

Intensity-Modulated External Beam Radiation Therapy in Treating Patients With Prostate Cancer

Study of Hypofractionated Intensity Modulated External Beam Therapy for the Treatment of Patients With Adenocarcinoma of the Prostate

Virginia Commonwealth University

Skin and Connective Tissue Diseases

Breast Neoplasms

David Rohde, MD

This is an Aurora Health Care system registry of patients receiving accelerated partial breast irradiation and external beam.

Patient Registry: Partial Breast Irradiation

Patient Registry: A Study of the Use of Accelerated Partial Breast Irradiation to Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities

The primary endpoint of this registry trial is collection and analysis of sufficient data to determine 5 and 10-year local recurrence rates for each PBI type used and for the overall Aurora population. The following endpoints will also be reported and analyzed:

* Disease Free Survival
* Regional Recurrence
* Distant Metastasis
* Combined Recurrence

The secondary endpoint is the collection and analysis of data to evaluate and compare cosmetic outcome (per Harvard Score) and toxicities/complications for each PBI type (per Common Terminology Criteria for Adverse Events (referred to as CTC or CTCAE))

Aurora Health Care

Radiation Oncologist

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

All patients receive IMRT with concurrent cisplatin 40 mg/m2

Patients in Phase III, Arm A receive 4-field box RT with concurrent cisplatin 40 mg/m2

Patients in Phase III, Arm B receive IMRT with concurrent cisplatin 40 mg/m2

45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks

Weekly infusion of 40 mg/m2 (80 mg max) x 5 weeks

The purpose of this study is to find out whether patients with cervical cancer treated with IMRT have less side effects with equal cancer control compared to standard radiation techniques. With standard radiation techniques, normal pelvic organs near the tumor receive radiation dose, which leads to side effects. IMRT is a new radiation technique that can reduce radiation dose to these organs and may reduce side effects.

Compared to conventional RT techniques, the hypothesis is that IMRT will reduce acute hematologic and gastrointestinal toxicity for cervical cancer patients treated with concurrent cisplatin.

Multiple randomized controlled trials have established concurrent cisplatin-based chemoradiotherapy as the standard of care for locally advanced cervical cancer \[3-8\]. The addition of concurrent cisplatin to radiotherapy (RT) increases pelvic control, disease-free survival (DFS) and overall survival; however, 5-year DFS and overall survival are still only approximately 60% and 5-year pelvic failure is approximately 30%. Moreover, acute gastrointestinal (GI) and hematologic toxicity are increased. Approximately 30% of patients will experience acute grade ≥ 3 toxicity, predominantly GI and hematologic. Methods to reduce toxicity during chemoradiotherapy, particularly gastrointestinal and hematologic, could mitigate this toxicity and take advantage of the therapeutic benefits of intensive concurrent chemotherapy.

Intensity modulated radiation therapy (IMRT) is a modern RT technique that differs from conventional techniques in many ways. First, patients undergo computed tomography (CT) simulation so that customized target volumes can be defined 3-dimensionally. IMRT treatment planning involves multiple beam angles and uses computerized inverse treatment planning optimization algorithms to identify dose distributions and intensity patterns that conform dose to the target, reducing radiation dose to surrounding tissues. IMRT delivery is typically accomplished with the use of multileaf collimators, which involve small motorized leaflets (collimators) that move in and out of the beam path, modulating the dose intensity.

Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer

Phase II/III Clinical Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin for Stage I-IVA Cervical Carcinoma

To test whether IMRT will reduce the rate of acute grade ≥ 3 hematologic or clinically significant grade ≥ 2 gastrointestinal toxicity compared to conventional RT techniques for cervical cancer patients treated with concurrent cisplatin

To estimate and compare the probability of acute and late adverse events

To estimate and compare efficacy of cisplatin/IMRT in terms of locoregional failure, disease-specific survival, disease-free survival, and overall survival.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intensity Modulated Radiation Therapy With Cisplatin and Gemcitabine to Treat Locally Advanced Cervical Carcinoma	NCT01554410	Cervical Carcin...	Intensity Modul... Cisplatin Gemcitabine	18 Years -	University of California, San Diego
Intensity-Modulated External Beam Radiation Therapy in Treating Patients With Prostate Cancer	NCT01117935	Adenocarcinoma ... Stage I Prostat... Stage II Prosta... Stage III Prost... Stage IV Prosta...	intensity modul...	18 Years -	Virginia Commonwealth University
Patient Registry: Partial Breast Irradiation	NCT01127971	Breast Cancer		19 Years -	Aurora Health Care
Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer	NCT01554397	Cervical Cancer	Intensity Modul... Cisplatin	18 Years -	University of California, San Diego

Spots Global Cancer Trial Database for external beam