Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Conducted prior to administration of sunitinib therapy

Tumor biopsy

Nephrectomy 2-4 weeks after last dose of Sunitinib

Nephrectomy

Biomarker evaluation of blood prior to treatment, after 4 weeks of Sunitinib administration, and every three months for a year after surgery.

Biomarker evaluation of tissue prior to 4 week administration of Sunitinib

Biomarkers

Fairooz Kabbinavar, M.D.

This study is designed to explore the molecular modulatory effect of Sunitinib when given in a neoadjuvant setting prior to radical or partial nephrectomy. The study will evaluate aforementioned outcomes in 30 patients at a dose of 50mg/day for 4 weeks followed by surgery 2-4 weeks following the last dose.

Study of Sunitinib in Subjects With High Risk Renal Cell Carcinoma

Phase II, Open Label, Single Center Study of Sunitinib in Subjects With High Risk Renal Cell Carcinoma

Toxicities will be graded using the NCI Common Toxicity Criteria, version 3.0

Pfizer

Jonsson Comprehensive Cancer Center

Fairooz Kabbinavar, MD / Principal Investigator

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

Fluorouracil

Cola

Patients with T4 colon cancer receive laparoscopic surgery only.

Patients with T4 colon cancer receive neoadjuvantive chemotherapy and laparoscopic surgery.

4 cycles of XELOX or FOLFOX neoadjuvant chemotherapy before surgery

XELOX or FOLFOX chemotherapy

Jiong Wu, MD,PhD

Wei Jin, MD,PhD

Xinxiang Li, MD,PhD

Primary Outcome Measures: Disease free survival

Secondary Outcome Measures:

Overall survival

Adverse events (Mortality, morbidity)

The proportion of completion of Laparoscopic Surgery

Estimated Enrollment: Oct, 2016

Study Start Date: Oct, 2016

Estimated Study Completion Date: Oct, 2019

Estimated Primary Completion Date: Oct, 2021

Groups/Cohorts

1. Laparoscopic surgery for T4 colon cancers
2. Neoadjuvantive chemotherapy + Laparoscopic surgery for T4 colon cancers

Investigators' previous studies indicated that laparoscopic surgery is feasible in T4 colon cancers with comparable clinical and oncologic outcomes. Laparoscopy may be considered as an alternative approach for T4 colon cancers with the advantage of faster recovery. The survival outcome of T4 colon cancers still dismays clinicians and patients. Preoperative chemotherapy is an attractive concept for locally advanced colon cancer. Optimal systemic therapy at the earliest possible opportunity may be more effective at eradicating distant metastases than the same treatment given after the delay and immunological stress of surgery. Besides, the shrinkage of primary tumor before surgery may reduce the risk of incomplete surgical excision and the risk of shedding of tumor cells during surgery. The aim of the present study is to compare the short-and long-term survival outcomes between laparoscopic surgery alone and laparoscopic surgery with 4 cycles of neoadjuvant chemotherapy for T4 colon cancer as well as the mortality and the morbidity.

The number of patients, which needs to get power of 80%, is 1960. The average numbers of patients needs to reach approximately 200, and that of surgical centers needs to reach 10.

Arrangements in the preoperative, intraoperative and postoperative period will be in complete accordance with the usual care of the center.

The baseline demographics and conditions as well as the perioperative items and the postoperative occurrences will be recorded through a prior designed e-questionnaire.

Globally,the disease free survival rate (chemotherapy and surgery), mortality (chemotherapy and surgery), the morbidity (chemotherapy and surgery) and the proportion of completion of laparoscopic surgery of the two surgical strategies will be analized and compared.

Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer

Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer: A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group Clinical Trial

calculated from the date of surgery to the date of recurrence

calculated from the date of diagnosis to the date of death from any cause

Number of participants with treatment-related adverse events assessed by CTCAE v4.0

The number of completion of laparoscopic surgery/the number of participants

Shanghai Jiao Tong University School of Medicine

Zhejiang University

Tongji University

Fudan University

Professor

Rectal Neoplasms

Rectal Diseases

Capecitabine

Cetuximab

Antimetabolites

Antineoplastic Agents, Immunological

825 mg/m2 bid (on each therapy day of first 4 therapy weeks)

Josef Thaler, MD

Joerg Tschmelitsch, MD

Alexander de Vries, MD

* feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma
* collection of response rate (T-downstaging, pathological complete remission), correlation of responsiveness with EGFR-status

Preoperative Chemoradiation With Capecitabine and Cetuximab

Preoperative Chemoradiation With Capecitabine and Cetuximab Within a Multidisciplinary Therapeutic Approach in Patients With Operable T3-T4 Rectal Cancer: a Phase II Study

Hoffmann-La Roche

Merck Gesellschaft mbH, Austria

Austrian Breast & Colorectal Cancer Study Group

Laparoscopic surgery for T4 colon cancers

Conventional open surgery for T4 colon cancers

Laparoscopic surgery

Qingguo Li, MD,PhD

The purpose of this study is to compare the short- and long-term survival of laparoscopic surgery and conventional open surgery for T4 colon cancer.

The investigators previous study indicated that laparoscopic surgery is feasible in T4 colon cancers with comparable clinical and oncologic outcomes. Laparoscopy can be considered as an alternative approach for T4 colon cancers with the advantage of faster recovery. However, the clinical value of laparoscopic surgery for T4 colon cancer was only validated in some retrospective study and some prospective study in single institute with small sample of patients. The aim of the present study is to compare the short-and long-term survival outcomes of laparoscopic surgery and conventional open surgery for T4 colon cancer as well as the mortality and the morbidity.

The number of patients needed to get a 80% power is 1960. The average number of patients/surgical center is approximately 200 in each of 10 surgical centers.

The preoperative, intraoperative and postoperative period will be in complete accordance with the usual care of the center.

The baseline demographics and conditions as well as the perioperative items and the postoperative occurrences will be recorded through a prior designed e-questionnaire.

Systematically analyze and compare the disease free survival rate, the mortality, the morbidity, and the proportion of completion of laparoscopic surgery of the two surgical strategies (laparoscopy VS conventional open surgery).

Laparoscopic Surgery for T4 Tumor of the Colon Cancer

Laparoscopic Surgery for T4 Tumor of the Colon Cancer: A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group Clinical Trial

LI XIN-XIANG

Symptoms and General Pathology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Carcinoma, Squamous Cell

Neoplasm Metastasis

Recurrence

Head and Neck Neoplasms

Mouth Neoplasms

Squamous Cell Carcinoma of Head and Neck

Oropharyngeal Neoplasms

Neoplasms, Squamous Cell

Neoplastic Processes

Disease Attributes

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Mouth Diseases

Oral Cancer

Lip and Oral Cavity Cancer

Pembrolizumab

Cisplatin

Immunomodulating Agents

Immune Checkpoint Inhibitors

Intensity-modulated radiation therapy to 70 Gy in 33-35 fractions over 6.5 weeks plus concurrent cisplatin 100 mg/m2 every 3 weeks for 3 cycles (7 weeks)

Intensity-modulated radiation therapy to 70 Gy in 33-35 fractions over 6.5 weeks plus concurrent and adjuvant pembrolizumab 200 mg IV infusion every 3 weeks x 20 cycles

Pembrolizumab 200 mg IV infusion every 3 weeks x 20 cycles

Radiation therapy

Loren Mell, MD

Gerald Henderson

Alysha Zeoli

Ricklie Julian, MD

Khushbu Singh, MBBS, CCRP

Jennifer Pope, CCRP

Melissa Young, MD, PhD

Elisa Lemerond

Jimmy Caudell, MD

Melissa Butler

Douglas Adkins, MD

Aubrey Hamilton

Sarah Wilson

Trisha Wise-Draper, MD, PhD

Kathy Taylor

Mike Gibson, MD

The purpose of this study is to compare any good or bad effects of using pembrolizumab (an experimental drug) and radiation therapy (RT), compared to using cisplatin chemotherapy and radiation therapy (RT) in the treatment of patients with head and neck squamous cell carcinoma (HNSCC).

This study is a prospective, multi-institutional, open-label, randomized phase II trial that will evaluate the efficacy of concurrent and adjuvant pembrolizumab with radiation therapy (RT) versus RT plus cisplatin in intermediate/high-riskp16-positive locoregionally advanced head and neck squamous cell carcinoma (HNSCC). The primary endpoint is progression-free survival (PFS).

Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer

Phase II Randomized Trial of Radiotherapy With Concurrent and Adjuvant Pembrolizumab (Keytruda®) Versus Concurrent Chemotherapy in Patients With Advanced/Intermediate-Risk p16+ Head and Neck Squamous Cell Carcinoma (KEYCHAIN)

compare the outcomes with RT/pembrolizumab in patients with tumors as a function of PD-L1 expression.

time from randomization to progression/relapse or death from any cause.

time from randomization to death from any cause

Toxicities due to therapy occurring within 3 months of therapy completion based on CTCAE criteria using questionnaires

Toxicity due to therapy occurring greater than 3 months after completion of therapy based on CTCAE criteria using questionnaires

Local and regional and distant recurrence of cancer and causes of death from competing events

Merck Sharp & Dohme LLC

Director, Division of Clinical and Translational Research/ Department of Radiation Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Sunitinib in Subjects With High Risk Renal Cell Carcinoma	NCT01070186	Renal Cell Carc...	Sunitinib Tumor biopsy Nephrectomy Biomarkers	18 Years -	Jonsson Comprehensive Cancer Center
Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer	NCT02777437	Colonic Neoplas...	XELOX or FOLFOX...	18 Years - 75 Years	Fudan University
Preoperative Chemoradiation With Capecitabine and Cetuximab	NCT00297128	Rectal Cancer	Capecitabine Cetuximab	18 Years - 80 Years	Austrian Breast & Colorectal Cancer Study Group
Laparoscopic Surgery for T4 Tumor of the Colon Cancer	NCT02852915	Colonic Neoplas...	Laparoscopic su...	18 Years - 75 Years	Fudan University
Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer	NCT03383094	Head and Neck S... Cancer Cancer of Head ... Cancer, Advance... Cancer, Metasta... Tumor Tumor Recurrenc... Tumor Neck Tumor Metastasi... Oral Cancer Oropharyngeal C... Oropharynx Canc... Oropharynx Canc... Oropharynx Canc... Oropharynx Canc...	Pembrolizumab Radiation thera... Cisplatin	18 Years -	University of California, San Diego
Preoperative Chemoradiation With Capecitabine and Cetuximab	NCT00297128	Rectal Cancer	Capecitabine Cetuximab	18 Years - 80 Years	Austrian Breast & Colorectal Cancer Study Group

Spots Global Cancer Trial Database for t4

Every month we try and update this database with for t4 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 t4

Every month we try and update this database with for t4 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 t4 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.