Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Infections

Rare Diseases

Pancreatic Neoplasms

Virus Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Capecitabine

Immunomodulating Agents

Oncolytic virus d1 ;Camrelizumab 200mg, d2+AG(Gemcitabine d2/9+Capecitabine d2-d15),q3w；up to 4 cycles;

Oncolytic virus，Camrelizumab ，AG（Gemcitabine +Capecitabine ）

Oncolytic virus Plus Anti-PD1 and Chemotherapy

Zhong Wu, MD

The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Oncolytic virus Plus Anti-PD1 and Chemotherapy as Preoperative therapy for Patients with Borderline Resectable and Locally Advanced Pancreatic Cancer

Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With BRPC/LAPC

Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With Borderline Resectable and Locally Advanced Pancreatic Cancer

Defined by treatment-related adverse events as assessed by CTCAE v4.0

defined as complete resection without any macroscopic or microscopic evidence of lesion at the lateral and deep tissue margins

The incidence of CR (complete remission) and PR (partial remission)

Sichuan University

Professor

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Rectal Diseases

Micronutrients

Hematinics

Vitamins

Oxaliplatin

Bevacizumab

Leucovorin

Fluorouracil

Levoleucovorin

Raltitrexed

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Enzyme Inhibitors

Antidotes

Protective Agents

Trace Elements

Folinic Acid

Folate

Vitamin B9

Preoperative radiation therapy and combination chemotherapy plus bevacizumab

Radiation therapy will be administered at the total dose of 45 Gy, given with five weekly fractions over a period of 5 weeks. The daily fraction dose will be 1.8 Gy

Radiation therapy

100 mg/m2 on day 1 every 2 weeks for 3 cycles (for patients with resectable organ metastases (M1), an additional 2 cycles of chemotherapy will be given after radiation therapy)

2.5 mg/m2 on day 1 every 2 weeks for 3 cycles (for patients with resectable organ metastases (M1) , an additional 2 cycles of chemotherapy will be given after radiation therapy)

250 mg/m2 on day 2 every 2 weeks for 3 cycles (for patients with resectable organ metastases (M1), an additional 2 cycles of chemotherapy will be given after radiation therapy)

levofolinic acid

800 mg/m2 on day 2 every 2 weeks for 3 cycles (for patients with resectable organ metastases (M1), an additional 2 cycles of chemotherapy will be given after radiation therapy)

5-fluorouracil

will be given by intravenous infusion at the dose of 5 mg/kg concurrent with chemotherapy and radiotherapy every 2 weeks for 4 cycles from -14 days to start chemo-radiotherapy (classical schedule) or 4 days before the concurrent administration of chemotherapy and radiation therapy for 2 cycles if the number of TRG1 was not reached in the first stage (statistical design) with the classical schedule (for patients with resectable organ metastases (M1), one additional administration of bevacizumab will be given after radiation therapy)

Antonio Avallone, M.D.

The purpose of this study is to evaluate the use of chemotherapy, radiation therapy and bevacizumab before surgery in patients with locally advanced rectal cancer (LARC).

To determine the pathological complete response (pCR-TRG1) rate in patients treated with 2 different schedule of bevacizumab plus primary chemotherapy and radiotherapy of the pelvic region when optimal surgery is applied.

Bevacizumab will be given by intravenous infusion at the dose of 5 mg/kg concurrent with chemotherapy and radiotherapy every 2 weeks for 4 cycles from -14 days to start chemo-radiotherapy (classical schedule) or 4 days before the concurrent administration of chemotherapy and radiation therapy for 2 cycles if the number of TRG1 was not reached in the first stage with the classical schedule Simon's methods will be used to calculate sample size.Setting a and b errors as 0.05 and 0.20, respectively, and defining as minimum activity of interest (p0) a TRG1 rate=30%. In order to demonstrate a TRG1 rate ≥50% (p1), at least 6 TRG1 on the first 15 patients, and at least 19 TRG1 on a total of 46 patients should be reported in the first and second stage, respectively.

Bevacizumab With Pelvic Radiotherapy And Primary Chemotherapy in Patients With Poor-Risk Rectal Cancer

Bevacizumab With Pelvic Radiotherapy And Primary Chemotherapy in Patients With Poor-Risk Rectal Cancer: the BRANCH Trial

Complete tumor regression rate (TRG1) was the ratio of patients with TRG1, graded at surgical resection, and total patients included in the study, expressed in percentage.

Tumor regression grade (TRG) was misured according to the Mandard Scale. Briefly,TRG1 was a complete tumor regression (regardless of the presence of acellular mucine lakes), and TRG2 was a nearly complete tumor regression with extensive fibrosis; TRG3 presented with clear evidence of residual cancer cells but with predominant fibrosis;TRG4 was a residual of cancer cells outgrowing fibrosis; TRG5 was the absence of regressive changes.

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Sphincter preservation in patients with tumor \< 5 cm from anal verge in 8 weeks after chemoradiation therapy

PFS was calculated from the date of the initial treatment until tumor progression or relapse, death for any cause or last follow up.

Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

OS was calculated from the date of initial treatment to the date of death for any cause or last follow up.

Clinical response was assessed before surgery with the same imaging modalities that were used for the inclusion in the study.

Clinical response rate was the ratio between complete and partial response, evaluated by RECIST CRITERIA, and total of patients evaluated, expressed in percentage of patients.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Number of patients with metastatic lymphnodes at pathology exam after surgery.

National Cancer Institute, Naples

Preoperative radiation therapy and combination chemotherapy plus bevacizumab

Patients received three biweekly cycles of OXATOM/FUFA during RT. Bevacizumab was given 2 weeks before the start of chemoradiotherapy, and on the same day of chemotherapy for 3 cycles (concomitant-schedule A)

Concomitant - Schedule A

Preoperative radiation therapy and combination chemotherapy plus bevacizumab

Patients received three biweekly cycles of OXATOM/FUFA during RT. Bevacizumab was given 4 days prior to the first and second cycle of chemotherapy (sequential-schedule B).

Sequential - Schedule B

Total

Age, Continuous

Sex: Female, Male

Italian

Race/Ethnicity, Customized

Italy

Region of Enrollment

Distance of mesorectal Fascia (MRF) < 5 mm

Dr. Antonio Avallone

Percentage of Patients With Complete Tumor Regression Rate (TRG1)

Number of Participants With Adverse Events

Number of Patients With Sphincter Preservation

PFS for the schedule A was not calculated because the number of TRG1 (2 out of 16 patients) was statistically inconsistent with the hypothesis of activity (30%) to be tested and, consequently, the accrual was early terminated.

Progression Free Survival (PFS)

OS for the schedule A was not calculated because the number of TRG1 (2 out of 16 patients) was statistically inconsistent with the hypothesis of activity (30%) to be tested and, consequently, the accrual was early terminated.

Overall Survival (OS)

Clinical Response Rate

Patients With Metastatic Lymphnodes at Pathology Exam After Surgery

Overall Study

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Treatment with pazopanib 800 mg qd for 21 days followed by resection of the tumor after a 7-14 days break

pazopanib

Peter Hohenberger, MD

The purpose of this study is to examine if a short-term treatment with pazopanib, an oral drug inhibiting the growth of blood vessel, can reduce the metabolism of soft-tissue sarcomas and thus facilitate their resection when given prior to surgery. Moreover, the study assesses the prognostic and predictive value of several new biomarkers (endothelial progenitor cells, soluble vascular epithelial growth factor),

Study of Preoperative Therapy With Pazopanib (Votrient®) to Treat High-risk Soft Tissue Sarcoma

A Phase II Window-of-opportunity Study of Preoperative Therapy With Pazopanib (Votrient®) in High-risk Soft Tissue Sarcoma

Metabolic response rate is defined as the proportion of patients achieving a metabolic response, i.e. a 50% reduction of the mean standardized uptake value (SUVmean) in the post-treatment compared to the pre-treatment FDG-PET-CT

Absolute values of all parameters of FDG kinetics will be used for discriminant analysis evaluation.

Adverse events are graded according to NCI Common Terminology Criteria for Adverse Events v4.0 (NCI CTCAE v4)

Adapted Choi Criteria as defined ín Stacchiotti S, Collini P, Messina A, Morosi C, Barisella M, Bertulli R, et al. High-grade soft-tissue sarcomas: tumor response assessment--pilot study to assess the correlation between radiologic and pathologic response by using RECIST and Choi criteria. Radiology 2009;251(2):447-56.

ADC values as defined by Dudeck O, Zeile M, Pink D, Pech M, Tunn PU, Reichardt P, et al. Diffusion-weighted magnetic resonance imaging allows monitoring of anticancer treatment effects in patients with soft-tissue sarcomas. J Magn Reson Imaging 2008;27(5):1109-13.

Universitätsmedizin Mannheim

Klinikum Frankfurt Höchst

German Cancer Research Center

GlaxoSmithKline

University Hospital Heidelberg

Heidelberg University

Head, Division of Surgical Oncology and Thoracic Surgery

Adenocarcinoma

Series of physical and quality of life assessments administered to participants, taking about 20 minutes to complete. Participants instructed to perform resistance/strengthening exercises for 30 minutes two times each week. Exercise instructional booklet given to all participants describing all exercises. Participants to walk 20-30 minutes at least 3 times a week. Nutrition program discussed with participants. Participants receive phone calls from study staff every 2 weeks for 6 weeks to check for adherence, and if they are having any side effects from the exercise.

Series of physical and quality of life assessments administered to participants, taking about 20 minutes to complete.

Questionnaires

Participants instructed to perform resistance/strengthening exercises for 30 minutes two times each week. Participants to walk 20-30 minutes at least 3 times a week. Participants issued a set of 3 resistance exercise bands with which the exercises can be performed.

Exercise

Within 7 days after being enrolled on study, participant meets with a dietitian to discuss nutrition.

Nutrition Counseling

Participants receive phone calls from study staff every 2 weeks for 6 weeks to check for adherence, and if they are having any side effects from the exercise.

Phone Calls

Exercise instructional booklet given to all participants describing all exercises.

Booklet

Matthew H. Katz, MD

The goal of this research study is to learn if it is possible to start a home-based exercise and nutrition program for patients with pancreatic cancer or who may have pancreatic cancer before surgery (pre-operative rehabilitation, also known as prehabilitation).

Study Procedures:

If you are found to be eligible to take part in this study, you will be asked to complete additional questionnaires about your physical activity and quality of life. It will take about 20 minutes to complete all of the questionnaires in this study. Your strength and walking speed will also be checked using a hand-held grip test, having you stand from a sitting position five times, and a 6 minute walking test.

The exercise regimen will then be discussed with you. It will include a resistance/ strengthening program and a walking program.

You will receive a booklet and an instructional video describing all of the exercises, a set of resistance tubes and accessories you need to perform all exercises, and a pedometer to count your daily steps. Also, a specialist in rehabilitation along with other study staff will teach you the stretching and strengthening exercises. An MD Anderson rehabilitation doctor will oversee all of this.

Resistance/Strengthening Program:

You will be instructed to perform resistance/strengthening exercises for 30 minutes at least two times each week.

The exercises used in this study are designed to strengthen your muscles. Strengthening certain muscle groups will help with upper body control and balance, which the study staff believes may help with mobility before and after surgery. Also, strengthening the shoulder, back, and leg muscles are important for activities such as getting into and out of bed, which is important after surgeries such as pancreas surgery.

You will be instructed to perform any 8 (out of 19) strengthening exercises for a total of 30 minutes. You will be issued a set of 3 resistance exercise tubes with which the exercises can be performed. The strengthening exercises consist of seated and standing weight-bearing exercises. You will perform 3 sets of 8-12 repetitions each of each exercise. When you are able to perform 3 sets of 12 repetitions of an exercise, you will move up to the next level of resistance (different color tube).

Before the strengthening exercises, you will do a series of 4 standing warm-up exercises that will help with balance.

You will record the date, resistance (color of resistance tube used), number of repetitions and sets, and how hard a session of resistance exercises felt for you. You will also record the total time spent on the strengthening program after each exercise session

You will be encouraged to complete an additional 5 minutes of stretching following the exercises. You will be provided with a handout demonstrating upper body, back, and leg stretches to help prevent soreness.

Walking Program:

The walking program will consist of walking briskly for 20-30 minutes at least 3 times each week. If you are unable to tolerate walking at a brisk speed, you will be instructed to walk at a slower pace. You will be given a pedometer and will be instructed to record the number of steps taken each day in addition to the total time spent during each walking session.

Nutrition:

Within 7 days after being enrolled on this study, you will meet with a dietitian to discuss your nutrition. You will be then be provided with recommendations for calorie, protein, and fluid intake, tools for tracking intake (such as a diet log), as well as goals for weight depending on your treatment/recovery. You will also be instructed to eat a high protein snack/meal/shake within 1 hour after each strengthening session.

Phone Calls:

You will be called every 2 weeks and asked if you are following the exercise and nutrition programs and if you are having any side effects from the exercise (such as pain or difficulty breathing). You will also be asked which resistance band you are using. Each phone call will take about 10-15 minutes.

Length of Study:

You will use the exercise programs during your entire pre-operative period, including during the time you are on other treatments before surgery. In addition, you will continue the exercise program and evaluations for up to 4 months after you have had surgery. If you have a side effect or the disease gets worse, the study staff will decide if continuing the exercise program is in your best interest.

This is an investigational study.

Up to 70 participants will be enrolled on this study. All will take part at MD Anderson.

Preoperative Rehabilitation During Neoadjuvant Therapy for Pancreatic Cancer

Preoperative Rehabilitation During Neoadjuvant Therapy for Pancreatic Cancer: A Pilot Study

Feasibility established if \> 60% of patients are adherent. Prehabilitation program deemed feasible if 60% or more of participants complete at least 60% of the weekly 150-minute combined walking and strengthening exercises during the 6-week preoperative period.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With BRPC/LAPC	NCT06346808	Pancreatic Canc...	Oncolytic virus...	18 Years - 75 Years	Sichuan University
Bevacizumab With Pelvic Radiotherapy And Primary Chemotherapy in Patients With Poor-Risk Rectal Cancer	NCT01481545	Rectal Cancer	Radiation thera... Oxaliplatin Raltitrexed levofolinic aci... 5-fluorouracil Bevacizumab	18 Years -	National Cancer Institute, Naples
Study of Preoperative Therapy With Pazopanib (Votrient®) to Treat High-risk Soft Tissue Sarcoma	NCT01543802	Sarcoma, Soft-t...	pazopanib	18 Years -	Heidelberg University
Preoperative Rehabilitation During Neoadjuvant Therapy for Pancreatic Cancer	NCT02295956	Pancreatic Canc...	Questionnaires Exercise Nutrition Couns... Phone Calls Booklet	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for preoperative therapy