Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

If the 2 dose limiting toxicities are documented at dose level 1, therapy will be de-escalated to Dose level 0 defined below.

Dose level 0: 2.2 Gy X 25 fractions = 55 Gy

Many studies have utilized a sequential boost to deliver a total dose of 55 - 60 Gy to the pelvic sidewall (covering the lower pelvic lymph nodes), including 8-10 Gy that is usually delivered with brachytherapy (1-3). This study treatment plan will escalate the dose to pelvic and para-aortic nodal disease from 60 Gy in 2.4 Gy per fraction to 70Gy in 2.8 Gy per fraction in 3 dose cohorts, using an integrated boost technique utilizing the same number of fractions for all cohorts (25 fractions) while the elective volumes are held constant at 45Gy

Boost radiation

Junzo Chino, MD

The purpose of this study is to determine the maximum tolerated dose of integrated boost radiation therapy when given with concurrent chemotherapy (cisplatin).

Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial)

Concurrent radiation therapy and chemotherapy is the standard of care for node positive cervical cancer. While there are several acceptable means to boost the disease in the low pelvis (i.e. brachytherapy, IMRT, or external beam), there is limited research into boosting gross disease in the pelvis or para-aortic region. This protocol is designed to determine the maximum tolerated dose of treating tumor bearing regions within the abdomen and pelvis, using an integrated boost technique and concurrent chemotherapy.

Local-regional control is defined as local control without any nodal recurrence.

Acute DLT will be defined based on the side effects inherent from radiation therapy for gynecologic cancers, including effects on bowel, bladder, and skin.Since integrated radiation dose escalation is unlikely to substantially affect the hematopoietic system, only non-hematologic, grade 3-4, acute toxicity will be considered the primary dose-limiting toxicity (acute DLT). Dose limiting toxicity will include any of the following during treatment or within 6 weeks of completion: Acute Grade 3-4 enteritis or proctitis, Acute Grade 3-4 bladder toxicity, Acute Grade 4 dermatologic toxicity.

Late DLTs will be defined at grade 3-4 GI or GU toxicity with onset after 6 weeks of treatment.

Duke University

Participants received increasing doses of Radiation at 12.4 Gy X 25 fractions = 60 Gy (N=3)

Dose Level 1

Dose Level 2

Dose Level 3

Boost Radiation: Dose Level 1

Boost Radiation: Dose Level 2

Boost Radiation: Dose Level 3

Boost Radiation Dose Level 0

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

No subjects were reduced to Boost Radiation Level 0

Jennifer Mewshaw, MS RN

Participants received increasing doses of Radiation at 12.4 Gy X 25 fractions = 60 Gy (N=3), 2.6 Gy X 25 fractions = 65 Gy (N=6), or 2.8 Gy x 25 fractions = 70 Gy (N=12).

Treatment Arm

Maximum Tolerated Dose of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin).

Participants received increasing doses of Radiation at 12.4 Gy X 25 fractions = 60 Gy (N=3), 2.6 Gy X 25 fractions = 65 Gy (N=3), or 2.8 Gy x 25 fractions = 70 Gy (N=6).

Combined Treatment Arms

Dose level 1 consists of a total 60Gy given in 2.4 Gy per fraction

Boost Radiation: Dose Level 1 (60 Gy)

Dose level 2 consists of a total 65Gy given in 2.6 Gy per fraction

Boost Radiation: Dose Level 2 (65)

Dose level 3 consists of a total 70Gy given in 2.8 Gy per fraction

Boost Radiation: Dose Level 3 (70Gy)

Time to Local-regional Control With Integrated Boost Radiation Therapy (TTLR)

Dose level 1 consists of a total 65Gy given in 2.6 Gy per fraction

Dose level 1 consists of a total 70Gy given in 2.8 Gy per fraction

Time to Distant Recurrence (TTDR)

Disease Free Survival (DFS)

Overall Survival (OS)

Number of Participants With Acute Dose Limiting Toxicities (DLT)

Number of Participants With Late Dose Limiting Toxicities (DLT)

Overall Study

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Breast Neoplasms

Breast Diseases

Skin Diseases

Acute Graft Versus Host Disease

Budhi S Yadav, MD

In a general radiation oncology practice, breast cancer typically comprises approximately 25% of the total patient caseload.1 Surgery is the primary modality of treatment. Radical mastectomy remained the mainstay of surgical therapy into the 1970s. Breast-conserving surgery followed by radiation therapy to the intact breast is an established standard of care for the majority of women with early stage invasive breast cancer. Recommended techniques for breast-conservation treatment are local excision of the primary tumor, preferably with clear margins, axillary lymph node dissection, and breast irradiation (45 to 50 Gy), usually with a boost (10 to 20 Gy, depending on tumor size and status of the surgical margins).

The aim of this study is to compare the two boost regimen 10Gy/5#/1 week with 16Gy/8#/1.5 weeks in post lumpectomy patients of early stage breast cancer, following whole breast irradiation (WBI).

The study will include 50 patients, (25 in each arm) of early stage post lumpectomy breast cancer patients. Each patient will be treated by WBI followed by tumor bed boost with either electron beam therapy or 3D CRT. The primary end point of the study will be assessment of acute and late radiation toxicities, cosmetic score analysis and local control between two schedules. Secondary end points will be recurrence-free survival.

Patients to be included in this study will be pre-operatively staged according to American Joint Committee on Cancer (AJCC) 7th edition, International Union against cancer ( which uses TNM staging ) as stage I , stage II of breast carcinoma. Fifty patients of histologically proven post lumpectomy cases of carcinoma breast suitable for whole breast radiotherapy will be enrolled in this study. Patients would be evaluated at the Department of Radiotherapy PGIMER, Chandigarh by doing a thorough clinical examination followed by routine investigations which will include hemogram, liver function tests, kidney function tests, chest X-ray. Patients will be treated by standard rectangular tangential field radiotherapy to whole breast. CT based planning will be done for photons boost and electron beam therapy.

Inclusion criteria

1. Unicentric primary breast cancer with invasive ductal histology. 2. Stage T1, T2, N0, N1, M0 Exclusion criteria

1. Tumor histology with invasive or in situ lobular carcinoma or pure ductal carcinoma in situ.
2. Skin involvement.
3. History of prior primary malignancy.
4. History of prior irradiation to chest
5. Patients who received neoadjuvant chemotherapy. Procedure Fifty patients (25 in each arm) scheduled for whole breast radiotherapy after lumpectomy will be included in this study. An informed written consent in prescribed proforma for all patients will be taken for performing planning CT scan.

Prior to radiotherapy planning, breast conserving surgery in the form of lumpectomy will be carried out in the department of surgery under general anaesthesia. Patients will be recruited 2-3 weeks after lumpectomy. A planning CT scan will be made for each patient. The patients will be positioned on a breast board with sternum parallel to the table, and the ipsilateral arm abducted above the head. Before the CT scan skin marks would be placed to enable the patient repositioning during treatment. Radioopaque markers will be placed to locate the whole breast and lumpectomy cavity on CT images.

Patients will be scanned from level of larynx to the level of upper abdomen, including both lungs with a scan thickness and index of 5mm. The CT scan will include the complete left and right lung, both breasts and the heart. Then CT images will be transferred to the treatment planning system.

The gross tumor volume (GTV) will be defined by lumpectomy cavity contoured on each CT slice. The clinical target volume (CTV) will consist of GTV uniformly expanded in three dimensions by 1cm; however the volume will be constrained to lie 5mm within external contour and up against the pectoralis major muscles. The planning target volume (PTV) will be calculated from the CTV using uniform three dimensional expansion of 0.5 cm. The ipsilateral whole breast will be defined to lie within the radioopaque markers and as deep as the anterior chest wall muscles. The cranial extent of heart will include the infundibulum of right ventricle, the right atrium and right auricle but exclude the pulmonary trunk, ascending aorta and superior vena cava. The lowest external contour of heart will be the caudal border of mediastinum. The pericardium should be excluded from the heart volume. Both lungs will be contoured. The contralateral breast will be contoured as the breast parenchyma is visible on CT images.

After contouring the target volumes and organs at risk (OAR), standard whole breast rectangular field plans, 3D-CRT boost and electron boost plans will be generated. Dose prescribed would be 40 Gy/16#/3 weeks for whole breast rectangular plans and a boost of 10 Gy/5#/1week in arm A and 16Gy/8#/1.5weeks in Arm B. Plans will be evaluated both quantitatively (analyzing dose volume histograms) and qualitatively (by visually inspecting isodose curves). Plans will be inspected for conformity and doses delivered to target and organs at risk.

First follow up will be after 1 month of treatment, subsequently every 2 months till 6 months, 3 monthly till 1 year and 4 monthly till 3 years. Patient will be examined clinically for acute effects, cosmetic outcome and LRR. Required investigation will be done if indicated.

Assessment of toxicity will be done as per RTOG scores AND LENT SOMA scale SKIN Grade0 Grade1 Grade2 Grade3 Grade4 Toxicity No change over baseline Follicular, faint or dull erythema/ epilation/dry desquamation/ decreased sweating Tender or bright erythema, patchy moist desquamation/ moderate edema Confluent, moist desquamation other than skin folds, pitting edema Ulceration, hemorrhage, necrosis Subcutaneous \& cutaneous tissue Grade 0 Grade 1 Grade 2 Grade 3 Grade 4 Toxicity None Slight induration (fibrosis) and loss of subcutaneous fat Moderate fibrosis but asymptomatic Slight field contracture \<10% linear reduction Severe induration and loss of subcutaneous tissue Field contracture \>10% linear measurement Necrosis

Pigmentary change :

0 = None

1. = Transitory , slight
2. = Permanent , marked

Breast edema :

0 = None 1 = Asymptomatic 2 = Symptomatic 3 = Secondary dysfunction

Cosmetic assessment will be done using Harvard/NSABP/RTOG Breast Cosmesis Grading Scale

Statistical analysis The principle end point of the study will be an analysis of acute and late radiation toxicities,cosmetic score analysis and local control between two boost arms. Skin, subcutaneous toxicity and cosmetic assessment will be done before treatment and then in regular follow up of the study. Chi-square test will be used to compare radiation toxicity parameters. Descriptive statistics including mean and standard deviation will be obtained for all variables. A student t-test will be used to compare the dosimetric parameters. p values of \<0.05 will be taken as significant. All tests would be performed using SPSS (Statistical Package for the Social Sciences) v.12.0.

Evaluation of Two Boost Radiation Schedules in Post Lumpectomy Early Stage Carcinoma Breast

Acute toxicity will be assessed at at 1 month. Assessment of toxicity will be done as per RTOG scores AND LENT SOMA scale

Pigmentary change scale:

0 = None

1. = Transitory , slight
2. = Permanent , marked

Breast edema:

0 = None 1 = Asymptomatic 2 = Symptomatic 3 = Secondary dysfunction

Cosmetic assessment will be done using Harvard/NSABP/RTOG breast cosmesis grading scale.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial)	NCT01627288	Cancer of the C... Cervical Neopla...	Boost radiation	18 Years -	Duke University
Evaluation of Two Boost Radiation Schedules in Post Lumpectomy Early Stage Carcinoma Breast	NCT02142907	Breast Cancer Adverse Effect ...		20 Years - 75 Years	PGIMER

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