Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

A percutaneous (utlrasound-guided) radiofrequency ablation (RFA) of the tumor will be performed by the radiologist under general anesthesia. Immediately after, excision of the tumor with appropriate margin will be accomplished.

Normal excision of the tumor according to the protocol

After tumor ablation and excision of the tumor, the pathologist performed a macroscopic study of the specimen,measuring the distance between the tumor and the margin in order to indicate if extensions are mandatory. Secondly and delayed, margins will be evaluated microscopically by H\&E stain. Furthermore, the tumoral viability in the ablation zone will be evaluated by NADH-diaphorase, COX and tunnel.

Radiofrequency ablation

Amparo Garcia-Tejedor, MDPhD

Background/Main objective: Radiofrequency ablation (RFA) is a minimally invasive procedure widespread accepted in the treatment of different tumors, especially in the liver but its benefit is not yet well-known in breast cancer.

Our main objective is to evaluate the usefulness of RFA in \< 2cm malignant breast tumors to reduce the proportion of positive margins.

Methodology: The investigator propose a single-center, single-blind, phase I and II randomized controlled trial. Phase I:Security of the cool-tip cluster electrode assessing the potential adverse effects in three stages: initial,intermediate and final. Phase II: Randomized clinical trial, 2 parallel groups with 37 patients in each one.

Experimental group: percutaneous RFA previous to conventional lumpectomy. Control group: conventional surgery with lumpectomy. The number of positive margins in both groups, and the need of extending margin resection will be assessed intraoperatively. Inclusion criteria: women \>40 years, infiltrating ductal breast carcinoma by biopsy. The tumor must be unique, visible by ultrasound, smaller than 2cm and located \> 1 cm from the chest wall and the skin. Patients will be followed up for a period of two years to assess cosmetic result, short -term and long -term complications and recurrences.

Expected results: The "cool-tip" (cluster) ablation method reduces by at least 30% the risk of intraoperative extensions for positive margins during lumpectomy compared to conventional surgery in breast tumors with a diameter \< 2 cm.

Therefore this procedure may reduce the risk of second surgeries and the removed volume of tissue.Consequently the final cosmetic result should be improved.

Main objectives of the project:

* To evaluate the usefulness of radiofrequency ablation (RFA) to achieve a lower percentage of positive margins.
* To validate clinically the efficacy and safety of the method in breast tumors smaller than \< 2 cm.

Specific objectives of the project:

1. To demonstrate that , after RFA, clear margins are increased in the intraoperative pathological analysis compared to conventional surgery.

   1. To quantify the number of positive margins requiring intraoperative extension in each patient, comparing the ratio in both groups.
   2. To quantify the percentage of patients requiring intraoperative extension compared in both groups.
2. To demonstrate a reduction in the volume of breast tissue removed after RFA compared to conventional surgery.

   1. Comparing in both groups the anteroposterior, transverse and craniocaudal diameters of the excised specimen, measured in cm, and to calculate the volume.
   2. Tumor weight in grams (including extensions) will be measured to compare the weights in both groups.
3. To evaluate the differences in cosmetic outcome after RFA versus conventional surgery.

   a. An international scale will be used and the scores will be compared. There will be two independent assessments, one for the physician and another for the patient.
4. To demonstrate the effectiveness of the RFA by cluster "cool-tip" electrode in the experimental group.

   1. RFA is considered as complete when no viable tumor tissue is evidenced by oxidation-reduction reaction mediated by NADH-diaphorase after surgical resection. Mitochondrial dysfunction will be also evaluated by semiquantitative and quantitative method using the enzyme cytochrome c oxidase or Complex IV (COX) and tunel. Any residual viable tumor tissue will be considered as incomplete RFA.
   2. Risk factors for incomplete ablations will be analyzed, especially tumor vascularization.
5. To demonstrate the safety of RFA by cluster "cool-tip" electrode in breast cancer tumors a. To quantify all side effects that may occur after the RFA and / or surgery and to correlate the complication rate in each group with severity.

Radiofrequency Ablation in Breast Cancer

Impact of Radiofrequency Ablation on Surgical Margins in Early Stage of Malignant Breast Tumors

The pathologist performed a macroscopic study of the specimen, measuring the distance between the tumor and the margin in order to indicate if extensions are mandatory.

Adverse effects and cosmetic result will be evaluated 15 days after the procedure

Tumoral viability in the ablation zone will be evaluated by NADH-diaphorase, COX and tunel

Hospital Universitari de Bellvitge

MD PhD

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

Cola

In the FOBT kit, individuals will receive a card that asks them to complete and return their FOBT kit within 30 days.

In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will be mailed a voucher that can be exchanged for $5 at PVAMC.

In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will be mailed a voucher that can be exchanged for $10 at PVAMC.

In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will be mailed a voucher that can be exchanged for $20 at PVAMC.

In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will have a 1 in 10 chance of being mailed a voucher that can be exchanged for $50 at PVAMC.

In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will be entered into a raffle in which 1 randomly chosen patient (out of about 100 patients) will be mailed a check in the amount of $500.

Patients who are prescribed an FOBT kit in one of the PVAMC Primary Care clinics (i.e., Module B or C) will be randomly assigned by day to one of 4 study arms. All FOBT kits will include a card with a description of the arm that the patient has been randomized to.

Stage 1

Patients who are prescribed an FOBT kit in one of the PVAMC Primary Care clinics (i.e., Module B or C) will be randomly assigned by day to one of 4 study arms. All FOBT kits will include a card with a description of the arm that the patient has been randomized to. The exact dollar amounts for the Voucher-Based Incentive, Lottery-Based Incentive, and Raffle-Based Incentive arms will be based on the results of Stage 1.

Stage 2

Jeffrey T Kullgren, MD, MS, MPH

Steven C Marcus, PhD

This is a 4-arm cluster randomized controlled trial to evaluate whether patient financial incentives directly integrated into primary care can improve fecal occult blood test (FOBT) completion rates. We will recruit primary care patients at the Philadelphia Veterans Affairs Medical Center (PVAMC) in 2 stages. In stage 1, we hypothesize that, compared to usual care, $5, $10, $20 incentives will each lead to a statistically significant increase in the rate of FOBT completion. We also hypothesize that there will be a direct dose-response relationship between the incentive amount and rates of FOBT completion. In stage 2, we hypothesize that a lottery-based incentive and a raffle-based incentive will both lead to a statistically significant increase in the rate of FOBT completion compared to a fixed payment incentive with an equivalent dollar per patient value.

Improving Fecal Occult Blood Test Completion Rates Among Veterans

There are 2 secondary outcomes. First, we will compare time to FOBT kit return by arm. Second, we will compare 30 day FOBT completion rates among previously non-adherent patients (i.e., individuals who had failed to complete a prescribed FOBT kit in the year prior to the start of the study) by arm.

VA Pittsburgh Healthcare System

Corporal Michael J. Crescenz VA Medical Center

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Carcinoma

Adenocarcinoma

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Quality of Life

For patients with clinical stage I disease, removal of the uterus and both tubes and ovaries are considered current standard treatment in Australia.

Total Abdominal Hysterectomy

The technique of total laparoscopic hysterectomy (TLH), utilising the McCartney tube, has been developed by Anthony J. McCartney over the last 10 years. It allows the completion of the hysterectomy entirely laparoscopically, without the need for additional vaginal surgery.

Total Laparoscopic Hysterectomy

Andreas Obermair

The primary objective of this study is to assess disease-free survival at 4.5 years postoperatively for women with apparent Stage 1 endometrial cancer, comparing patients who are randomised to receive Total Laparoscopic Hysterectomy (TLH) and patients who are randomised to receive Total Abdominal Hysterectomy (TAH).

This phase III international, multicenter, open-label, randomized clinical trial is an equivalence study with the hypothesis is that Total Laparoscopic Hysterectomy (TLH) is associated with equivalent disease-free survival when compared to the standard treatment of Total Abdominal Hysterectomy (TAH) for women with apparent Stage I endometrial cancer.

The secondary hypotheses are:

* TLH is associated with equivalent or improved Quality of Life (QoL) at 6 months;
* TLH is associated with reduced treatment-related morbidity;
* TLH is associated with shorter hospital stay;
* TLH is associated with less analgesic consumption;
* TLH is cost effective;
* TLH is associated with improved pelvic floor function.

Laparoscopic Approach to Cancer of the Endometrium

LACE - Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tyco Healthcare Group

Gynetech

Queensland Government - Smart Health Research Grant

National Health and Medical Research Council, Australia

Cancer Council Queensland

Cancer Council New South Wales

Cancer Council Victoria

Cancer Council Western Australia

Cancer Australia

Queensland Centre for Gynaecological Cancer

Single cohort to receive Accelerated Partial Breast Irradiation (APBI) 27Gy in 5 fractions

Patients will be treated with 3-D conformal, external beam, partial breast RT to deliver 27 Gy in 5 daily fractions using 3-5 beams on a linear accelerator. The target PTV will be the CT-visible seroma plus a 1cm margin to form the CTV (minus 5mm from skin and excluding chest wall) and a further 7mm to form the PTV. Real time review will ensure compliance with target and normal tissues dose constraints in this multi-institutional study. Any (or no) systemic therapy is permitted.

APBI 27Gy in 5 fractions

Petra Grendarova, MD

Mark Lesiuk, BSc

Mark Lesiuk, BScRT MRTT

This study will test the safety of partial breast RT using 27Gy in 5 daily fractions which is expected to be equally tolerated as standard whole breast irradiation (WBI) based on radiobiologic modeling of the fibrosis response of normal tissues but be more convenient and less costly than 3-6 weeks of standard WBI. 274 women will be treated. Rates of fibrosis and cosmesis at 2 years will be compared to data already collected using standard WBI in the Canadian RAPID trial.

Background: Previously, accelerated partial breast irradiation (APBI) using 3D conformal external beam techniques to deliver 38.5Gy in 10, twice daily, fractions caused worse fibrosis and cosmetic deterioration than standard whole breast irradiation (WBI) following breast conserving surgery (BCS) for women with early breast cancer. Over the decade since the original APBI technique was designed, long-term outcomes of various breast RT fractionation regimens have become available and suggest that normal tissue fibrosis and cosmesis varies with the radiobiological constant: α/β=2 rather than α/β=3.4 as previously estimated. Radiobiologic modeling using α/β=2, indicates that a dose of 27Gy in 5 daily treatments should result in comparable late effects as 42.5Gy in 16, or 50Gy in 25 fractions. This clinical trial will validate the safety of a short, convenient and less costly APBI using 27Gy in 5 daily fractions.

Objective: To determine the cosmetic and normal tissue outcomes of APBI using 3D-conformal RT with 27Gy in 5 fractions over 1 week.

Methods: A single-arm, phase II, non-inferiority, prospective study will be conducted. 274 women with newly diagnosed, invasive or in-situ ductal carcinoma treated with BCS and sentinel lymph node biopsy (or axillary dissection) who are candidates for WBI alone, will be treated. Subjects will be age 50 years and older, with tumors less than 3cm diameter, with negative margins and nodes and with excellent or good baseline cosmetic outcome following BCS. Patients with extensive ductal carcinoma in-situ, BRCA mutations, Grade 3 cancers with lymphatic or vascular invasion, or lobular carcinoma will be excluded. These selection criteria are similar to the Canadian RAPID trial. In the first phase of the study, 150 patients will be recruited and interim analyses will be conducted to rule out unacceptable toxicity at 2 years.

Study endpoints: The primary endpoint will be the proportion of women who retain an Excellent or Good cosmetic score at 2 years using the EORTC Cosmetic Rating System and clinical photographs taken prior to, and at 1 and 2 years after RT. Secondary endpoints will include rates and grades of breast fibrosis, induration, telangiectasia, breast pain, ipsilateral breast tumor recurrence, overall and breast cancer-specific survival and subsequent mastectomy rates.

Sample size, statistical analyses: In the RAPID trial, 88% of patients with Excellent or Good cosmesis prior to RT had Excellent or Good scores at 3 years. Only patients with Excellent/Good cosmesis at baseline will be included in the current study. The proportion of women with Excellent/Good cosmesis at 1 and 2 years will be calculated. Using 80% power, a non-inferiority margin of 0.08 and a one-sided binomial test for non-inferiority and a significance level of 0.05, will require a sample size of 249 women with evaluable 2-yr cosmesis. 274 patients will be recruited to allow for a 10% drop-out rate. To ensure safety, a first interim analysis with Grade 2 or higher breast fibrosis as the primary endpoint, will be conducted when 50 patients have completed their 1-year assessment and repeated when 50 patients have completed their 2-year follow up. If the rate of Grade 2 or higher fibrosis exceeds 5% at either time point, trial accrual will be suspended.

Feasibility: Over 600 women eligible for this protocol receive RT in Alberta each year. If 30% accept study participation, accrual will be complete in \<2 years.

APBI: 27Gy in 5 Fractions for Early Breast Cancer

Accelerated Partial Breast Irradiation Using Five Daily Fractions: A Single Arm, Phase II, Prospective Cohort Study to Examine Cosmetic Outcomes and Toxicity (The ACCEL Trial)

At least one peer-review publication will be prepared by the investigators following the conclusion of the study. In addition, an abstract to report interim results following the 1-year, interim cosmetic evaluation may be submitted to the annual Canadian Association of Radiation Oncology and/or San Antonio Breast Cancer Symposium scientific meetings.

Authorship will include the named investigators involved in the development of the grant proposal plus additional authors proportional to subject accrual, participation in the cosmetic photograph review panels and/or other contributions to study analysis or success.

Global cosmetic score assessed by trained observers and patients themselves using the European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer rating system for cosmetic assessment; rate of deterioration from Excellent/Good to Fair Poor. This will be augmented by assessment of clinical photographs prior to and at 1 and 2 years after radiation therapy (RT).

Radiation Therapy Oncology Group (RTOG) Late Radiation Morbidity Scoring Scheme, rate of Grade 2+ subcutaneous fibrosis

Patient reported average and worst pain in the treated breast over the week prior to assessment

Any new invasive or in situ breast cancer within the ipsilateral breast

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiofrequency Ablation in Breast Cancer	NCT02281812	Breast Cancer	Radiofrequency ...	40 Years -	Hospital Universitari de Bellvitge
Improving Fecal Occult Blood Test Completion Rates Among Veterans	NCT01516489	Colorectal Canc...	Stage 1 Stage 2	-	Corporal Michael J. Crescenz VA Medical Center
Laparoscopic Approach to Cancer of the Endometrium	NCT00096408	Endometrial Can...	Total Abdominal... Total Laparosco...	18 Years -	Queensland Centre for Gynaecological Cancer
Improving Fecal Occult Blood Test Completion Rates Among Veterans	NCT01516489	Colorectal Canc...	Stage 1 Stage 2	-	Corporal Michael J. Crescenz VA Medical Center
Laparoscopic Approach to Cancer of the Endometrium	NCT00096408	Endometrial Can...	Total Abdominal... Total Laparosco...	18 Years -	Queensland Centre for Gynaecological Cancer
APBI: 27Gy in 5 Fractions for Early Breast Cancer	NCT02681107	Breast Cancer	APBI 27Gy in 5 ...	50 Years -	AHS Cancer Control Alberta
Laparoscopic Approach to Cancer of the Endometrium	NCT00096408	Endometrial Can...	Total Abdominal... Total Laparosco...	18 Years -	Queensland Centre for Gynaecological Cancer

Spots Global Cancer Trial Database for stage 1

Every month we try and update this database with for stage 1 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 stage 1

Every month we try and update this database with for stage 1 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 stage 1 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.