Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Neoplasm Metastasis

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Neoplastic Processes

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

All patients on study will be accrued to this arm. Sorafenib (200 mg tablets x 2) will be administered orally twice a day for 12 weeks (full daily dose of 800 mg). Patient visits for safety will be conducted at least every 4 weeks. Sorafenib dose reductions for drug-related toxicity will be applied based on considerable prior clinical experience. Surgery will be performed at the completion of the 13th week, allowing for a one-week "washout" period. Sorafenib will be continued post operatively (around 6 weeks post surgery or when complete wound healing has occurred) until patient progresses or unacceptable toxicity occurs.

Starting dose: 400 mg (2x200mg tablets) BID (total= 800mg/day) taken orally. The dose can be adjusted as per investigator if required due to toxicity (ex. 200mg BID, 200mg QD). Study drug is taken for 12 weeks preoperatively. Patients restart on study drug 6 weeks postoperatively and continue until progression or unacceptable toxicity occurs.

Antonio Finelli, MD,MSc,FRCSC

The purpose of this study is to see if preoperative administration of Sorafenib reduces the size of the primary kidney tumour in patients with metastatic disease undergoing cytoreductive surgery.

The study will also assess the safety of preoperative Sorafenib.

The study drug, Sorafenib, will be given to patients preoperatively for 12 weeks. After a 1 week washout period the patient will then have their nephrectomy (kidney removed). Approximately 6 weeks following their nephrectomy, patients will resume on study drug until disease progression.

This is a single centre, non-randomized, open label one arm pilot study of Sorafenib 400 mg twice daily given for 12 weeks preoperatively in patients with advanced metastatic kidney cancer scheduled for cytoreductive surgery. Patients will be fully staged for disease progression with Brain MRI, CT, whole body Bone Scans, Kidney ultrasound and biopsy. Additionally, patients' cardiac status will be evaluated pre-enrolment with an ECG and MUGA Scan. Once enrolled into the study, patients will have clinic visits on weeks 2, 8 and 12 for monitoring visits with vital signs and adverse event recording plus blood evaluations for hematology and chemistry. Patients will be called on weeks 3,5,6,7,9,10 and 11 to determine any changes in health status. Surgery will occur at week 13, after a one week washout from study drug. Patients will resume on study drug 6 weeks post operatively (or later, if wound is not completely healed). Patients will continue on study drug and will be monitored every 4 weeks until disease progression, as determined by bone imaging and CT.

Pre-operative Administration of Sorafenib in Patients With Metastatic Renal Cell Carcinoma Undergoing Kidney Removal

Pre-operative Administration of Sorafenib in Patients With Metastatic Renal Cell Carcinoma Undergoing Cytoreductive Nephrectomy

Bayer

University Health Network, Toronto

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

The cohort stratified by four factors: preoperative treatment (not received, neoadjuvant chemotherapy, preoperative radiotherapy); surgical approach (laparoscopic, abdominal, vaginal, robotic); hysterectomy types (type A, type B, type C1, type C2), primary treatment (Radical hysterectomy + pelvic lymph node dissectionp; radiochemotherapy)

clinical routine treatments

Chen Chunlin, PhD

Li Wenyuan, PhD

To observe the effects of different treatments on the oncological outcome and complications of early cervical cancer (2018 FIGO stage IA1 with lymphovascular space invasion and IA2-IIA2 cervical cancer). This study prospectively collecting enrolled cervical cancer patients clinical data and outcome from June 2020 to June 2025. (Classification factors: preoperative neoadjuvant treatment , surgical approach, type of hysterectomy, whether to receive radiochemotherapy) . This study is an observational study, and segmented analysis according to different treatment methods.

Objectives: To observe the effects of different treatments on the oncological outcome and complications of early cervical cancer (2018 FIGO stage IA1 with lymphovascular space invasion and IA2-IIA2 cervical cancer).

Study Design: We obtained the demographic, clinical, treatment hospital and complication data of patients with cervical cancer undergoing radical hysterectomy from 2004 to 2015 at 37 hospitals. The patients were assigned into groups. Classification factors: preoperative neoadjuvant treatment (not received, neoadjuvant chemotherapy, preoperative radiotherapy) , surgical approach (abdomincal, laparoscopic, vaginal, robotic surgery), type of hysterectomy (type B, type C1, type C2), primary treatment (radiochemotherapy or surgery).

laparoscopic and abdominal surgery groups. The differences in the survival, complication rates, quality of life, and cost were analyzed using univariate and multivariable logistic regression models.

Effect of Different Treatments on the Prognosis of Early Cervical Cancer: A Multicenter, Prospective, Real-world Study

Overall survival was defined as the period from initial treatment until cervical cancer related death.

Tumor-free survival was defined as the period from initial treatment until the recurrence or the date of last follow-up.

date and localization of 1st recurrence as confirmed histologically

The European O-rganization for Reasearch and Treatment of Cance QLQ-30 Questionnaires to measure quality of life for any kind cancer patient. The Europe Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Cervical Cancer Module is a supplementary questionnaire for evaluating the quality of life of patients with cervical cancer.

Southern Medical University, China

Director of Department of Obstetrics and Gynecology

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Trastuzumab

Pertuzumab

Antineoplastic Agents, Immunological

Preoperative treatment with trastuzumab (8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV) and pertuzumab (840 mg as a loading dose, then 420 mg every 3 weeks, IV) every 3 weeks for 4 doses (total 12 weeks or 3 months of treatment) as assessed by Positron Emission Tomography (PET)

PET will be performed at baseline and on day 15

Positron emission tomography (PET)

8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV

840 mg as a loading dose, then 420 mg every 3 weeks, IV

Roisin Connolly, MBBCh

This research is being done to determine if early changes on a type of imaging procedure called PET (Positron Emission Tomography) can predict which patients are most likely to respond to the combination of trastuzumab and pertuzumab when given prior to surgery.

This study will evaluate for the first time the correlation between early changes in SUV and pCR in men and women with ER-negative, human epidermal growth factor receptor 2 (HER2)-positive breast cancer receiving trastuzumab and pertuzumab (PT) pre-operatively. This has not previously been evaluated in patients receiving anti HER2 therapy alone and as such is novel and potentially practice changing. The results from this phase 2 biomarker study will be used to plan a randomized study using a predefined cut point for SUV decline such that the investigators can further attempt to identify a group of individuals with HER2-positive early breast cancer who do not require cytotoxic chemotherapy in addition to anti-HER2 agents. This non-invasive biomarker approach will be of great interest to breast cancer oncologists and patients by facilitating a personalized approach to managing patients with HER2-positive disease that will undoubtedly spare toxicity and reduce the costs associated with anti-cancer strategies, without compromising efficacy.

Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Breast Cancer

A Phase 2 Clinical Trial Assessing the Correlation of Early Changes in Standardized Uptake Value (SUV) on Positron Emission Tomography (PET) With Pathological Complete Response (pCR) to Pertuzumab and Trastuzumab in Patients With Primary Operable HER2-Positive Breast Cancer

There is no plan to share individual patient data.

SULmax is the maximum SUV corrected for lean body mass. Change in SULmax from baseline to Day 15 on FDG PET in correlation with pathological complete response (pCR) in patients treated with preoperative pertuzumab/trastuzumab. pCR was defined as no viable invasive cancer in breast and axilla by local pathology review. SULmax was measured via spherical volume over the target primary breast cancer tissue.

To correlate PIK3CA mutation status and other genomic alterations (mutations/somatic rearrangements) qualitatively and quantitatively in plasma tumor DNA (ptDNA) with pCR

To correlate PI3K pathway activation (e.g. PTEN low and/or PIK3CA mutation, human epidermal growth factor receptor (HER) 1-4 expression and/or phosphorylation) in tumor samples and pCR

To correlate baseline and change (day 15) in Ki67 with pCR

Translational Breast Cancer Research Consortium

Genentech, Inc.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Preoperative treatment with trastuzumab (8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV) and pertuzumab (840 mg as a loading dose, then 420 mg every 3 weeks, IV) every 3 weeks for 4 doses (total 12 weeks or 3 months of treatment) as assessed by Positron Emission Tomography (PET)

Positron emission tomography (PET): PET will be performed at baseline and on day 15

Trastuzumab: 8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV

Pertuzumab: 840 mg as a loading dose, then 420 mg every 3 weeks, IV

Trastuzumab and Pertuzumab

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

White

Black or African American

Other

Race/Ethnicity, Customized

United States

Region of Enrollment

The ECOG scale measures performance status, with scores ranging from 0-5; 0= fully active, performs without restriction, 1= can ambulate, but restricted in physically strenuous activity, 2= ambulatory and capable of self-care, but unable to work, active for \>50% of waking hours, 3= limited self-care, confined to bed or chair for \>50% of waking hours, 4= completely disabled, totally confined to bed/chair, 5= deceased

Eastern Cooperative Oncology Group (ECOG) Performance Status

Primary breast tumor size in centimeters (cm)

Baseline clinical tumor size

T refers to the extent (size) of the tumor and is based off the staging system used for breast cancer is the American Joint Committee on Cancer (AJCC). Staging is as follows: T1= tumor \<= 2cm in greatest dimension, T2= tumor \>2cm in greatest dimension, T3= tumor \>5cm in greatest dimension, and T4= tumor of any size with direct extension to chest wall (T4a) or skin (T4b). A higher number reflects a more progressive stage.

Clinical tumor T staging

Based from the American Joint Committee on Cancer (AJCC) TNM system, this measures whether participants' cancer has spread to lymph nodes near the breast.

Baseline clinical nodal status

AJCC staging: N0= no regional lymph node (LN) metastasis ("mets"), N1= mets in movable ipsilateral axillary LN; N2= mets in ipsilateral axillary LNs fixed or matted, or in clinically apparent ipsilateral internal mammary LN without of clinically evident axillary LN mets; N3= mets in ipsilateral infraclavicular LN, or in clinically apparent ipsilateral internal mammary LNs and in the presence of clinically evident axillary LN mets; or mets in ipsilateral supraclavicular LN with or without axillary or internal mammary lymph node involvement. A higher number reflects a greater region of mets.

Clinical tumor N staging

Based on AJCC TNM staging (as described above): earliest stage breast cancers are stage 0 (carcinoma in situ). It then ranges from stage I (1) through IV (4), with a higher stage reflecting worse outcome. Stage I= T1N0M0, Stage II= T0N1M0, T1N1M0, T2N0M0, T2N1M0, T3N0M0, Stage III= T0N2M0, T1N2M0, T2N2M0, T3N1M0, T3N2M0, T4N0M0, T4N1M0, T4N2M0, any TN3M0.

Baseline clinical stage

Tumor grade measures how much the cancer cells look like normal cells. Grading is as follows: Grade 1 (well differentiated)= the cells are slower-growing, and look more like normal breast tissue; Grade 2 (moderately differentiated)= the cells are growing at a speed of and look like cells somewhere between grades 1 and 3, Grade 3 (poorly differentiated) = the cells look very different from normal cells and will probably grow and spread faster. A higher grade reflects a worse prognosis.

Tumor Grade

Study treatment was pertuzumab and trastuzumab. If required by care team, participants could receive additional treatment, outside of the protocol, prior to surgery.

Additional neoadjuvant therapy

Type of Surgery

Vered Stearns

no pCR

Data was evaluable in only 83/88 participants.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pre-operative Administration of Sorafenib in Patients With Metastatic Renal Cell Carcinoma Undergoing Kidney Removal	NCT00480389	Renal Cell Carc... Metastatic Dise...	Sorafenib	18 Years -	University Health Network, Toronto
Pre-operative Administration of Sorafenib in Patients With Metastatic Renal Cell Carcinoma Undergoing Kidney Removal	NCT00480389	Renal Cell Carc... Metastatic Dise...	Sorafenib	18 Years -	University Health Network, Toronto
Effect of Different Treatments on the Prognosis of Early Cervical Cancer: A Multicenter, Prospective, Real-world Study	NCT04272190	Cervical Cancer	clinical routin...	18 Years -	Southern Medical University, China
Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Breast Cancer	NCT01937117	Breast Cancer	Positron emissi... Trastuzumab Pertuzumab	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Effect of Different Treatments on the Prognosis of Early Cervical Cancer: A Multicenter, Prospective, Real-world Study	NCT04272190	Cervical Cancer	clinical routin...	18 Years -	Southern Medical University, China

Spots Global Cancer Trial Database for preoperative treatment