Advertisement

Topics

A Phase II Trial to Compare Efficacy and Safety of CRT VS Neo-CRT in Patients Who Achieved CCR for Esophageal Cancer

2016-11-10 09:38:22 | BioPortfolio

Summary

Neoadjuvant chemoradiotherapy(Neo-CRT) plus surgery has been regarded as a standard of care for patients with resectable locally advanced oesophageal cancer. Many studies suggest that definitive Radiochemotherapy(CRT) has similar efficacy as neoadjuvant chemoradiotherapy plus surgery for esophageal cancers who respond to chemoradiation. Herein, a single center prospective randomized phase II clinical trial will be carried out to compare efficacy and safety of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection in patients who achieved clinical complete response(CCR) after neoadjuvant radiochemotherapy for stage II-III esophageal Cancer.

Description

1. Compare progression-free survival (PFS) and overall survival (OS) of definitive radiochemotherapy versus(VS) neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete response after neoadjuvant treatment;

2. Compare the toxic and side effects of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete remission after neoadjuvant treatment;

3. Compare the relationship and consistency between pathological complete response of endoscopic biopsy specimens after neoadjuvant treatment and pathological complete response of surgical specimens in neoadjuvant radiochemotherapy plus radical resection group;

4. Assess impact of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection on quality of life of patients.

Clinical Complete Response After Neoadjuvant Treatment: Endoscope biopsy pathologic diagnosis indicate pathologic complete response after Neoadjuvant treatment; upper gastrointestinal/chest CT and symptom assessment indicate clinical complete response after Neoadjuvant treatment (Concurrent Radiochemotherapy: Radiotherapy, Intensity Modulation Radiation Therapy(IMRT), 40Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2), 1st/8th/15th/22nd day

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Stage II Esophageal Cancer

Intervention

Definitive Radiochemotherapy, Neoadjuvant Radiochemotherapy

Location

Department of Radiation Oncology, Tianjin Medical University Cancer Hospital
Tianjin
Tianjin
China
300060

Status

Recruiting

Source

Tianjin Medical University Cancer Institute and Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-11-10T09:38:22-0500

Clinical Trials [3499 Associated Clinical Trials listed on BioPortfolio]

Different Radiation Dose With Concurrent Chemotherapy for Thoracic Esophageal Carcinoma

Definitive chemoradiation is the standard treatment for locally advanced esopahgeal cancer. NCCN recommends radiation dose of 50-50.4Gy as the definitive radiation dose for esophageal canc...

RCT on the Combined Modality Treatment of Squamous Cell Carcinoma of the Esophagus

The purpose of the study was to test a null hypothesis that a combined modality treatment of esophageal cancer with neoadjuvant chemotherapy or chemoradiotherapy is equivalent to surgery a...

Detection of Circulating Tumor Tells as The Guidance of the Neoadjuvant Chemotherapy of Esophageal Cancer

Esophageal carcinoma is a common digestive system tumor, with number of deaths ranking No. 4 in malignant tumors. Esophageal squamous cell carcinoma in stage Ⅱ, III is the most common in...

A Trial of Neoadjuvant Chemotherapy for Stage II, III Esophageal Squamous Cell Carcinoma

The purpose of this study is to determine whether docetaxel, cisplatin, and capecitabine (DCX) are effective as the neoadjuvant chemotherapy before esophagectomy in patients with loco-regi...

Different Cycles of Capecitabine Usage in Esophageal Cancer Concurrent Chemoradiotherapy

Definitive chemoradiotherapy with cisplatin with cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer.But in China because of its toxic reaction, most of ...

PubMed Articles [17153 Associated PubMed Articles listed on BioPortfolio]

Consolidation systemic treatment after radiochemotherapy for unresectable stage III non-small cell lung cancer.

The majority of stage III NSCLC patients managed with a combination of radiotherapy and chemotherapy will develop a locoregional or distant relapse. Concomitant radiochemotherapy allows for improved l...

Survival benefits with the addition of adjuvant hysterectomy to radiochemotherapy for treatment of stage I-II adenocarcinoma of the uterine cervix.

To determine the survival benefits of additional adjuvant hysterectomy in the International Federation of Gynecology and Obstetrics (FIGO) stage I-II cervical adenocarcinoma patients treated with radi...

Active surveillance and postponed operation after neoadjuvant radiochemotherapy for oesophageal cancer-findings of the preSANO study.

High-risk endometrial cancer: In each case an adjuvant radiochemotherapy?

Skeletal Muscle Loss during Neoadjuvant Chemotherapy Is an Independent Risk Factor for Postoperative Infectious Complications in Patients with Advanced Esophageal Cancer.

Neoadjuvant therapy followed by surgery has been the standard treatment for advanced esophageal cancer. Severe toxicities may influence body composition, including skeletal muscle mass, and increase p...

Medical and Biotech [MESH] Definitions

Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.

Tumors or cancer of the ESOPHAGUS.

A pathological condition characterized by the presence of a number of ESOPHAGEAL DIVERTICULA in the ESOPHAGUS.

Surgical incision of the lower esophageal sphincter near the CARDIA often used to treat ESOPHAGEAL ACHALASIA.

Component of the NATIONAL INSTITUTES OF HEALTH. Through basic and clinical biomedical research and training, it conducts and supports research with the objective of cancer prevention, early stage identification and elimination. This Institute was established in 1937.

More From BioPortfolio on "A Phase II Trial to Compare Efficacy and Safety of CRT VS Neo-CRT in Patients Who Achieved CCR for Esophageal Cancer"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Cancer
  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...


Searches Linking to this Trial