Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Cisplatin

Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day.

Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later.

Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day

Definitive Radiochemotherapy

Concurrent Radiochemotherapy: Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later.

Neoadjuvant Radiochemotherapy

Dong Qian, PHD & MD

Ping Wang, PHD & MD

Neoadjuvant chemoradiotherapy(Neo-CRT) plus surgery has been regarded as a standard of care for patients with resectable locally advanced esophageal 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 Ⅲ multicenter 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 resectable locally advanced esophageal cancer.

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.
5. 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 major 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

A Study to Compare Efficacy and Safety of DRT VS CRT Plus Surgery in Patients Who Achieved CCR for Esophageal Cancer

A Phase Ⅲ Trial to Compare Efficacy and Safety of Definitive Chemoradiation VS Neoadjuvant Chemoradiation Plus Surgery in Patients Who Achieved Clinical Complete Response After Neoadjuvant Treatment for Locally Advanced Esophageal Cancer

Compare overall survival of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete response after neoadjuvant radiochemotherapy

Compare progression-free survival of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete response after neoadjuvant radiochemotherapy

grade 3 or 4 toxicity of leukocytes, febrile neutropenia, thrombocytes, hemoglobin, nausea/vomiting, diarrhea, stomatitis, esophagitis, cardiovascular.

In the group of neoadjuvant radiochemotherapy plus surgery, we will compare the pathological diagnosis between specimens of endoscopic biopsy after neoadjuvant treatment and surgically resected.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Sun Yat-sen University

Peking University Cancer Hospital & Institute

Tianjin Medical University Cancer Institute and Hospital

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Rectal Diseases

Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy followed by a clinical complete response, and refused surgery but went on with the watch and wait approach.

Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy followed by a clinical complete response, and received radical resection.

standard TME surgery

Yuan-hong Gao, MD

This was a propensity-score matched observational analysis, comparing the oncological outcome of surgical resection vs watch and wait apporach for rectal cancer patients with a cCR.

Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy followed by a clinical complete response from the year 2010 to 2018 were included. Sequential subjects were identified from a prospective maintained database in the Sun Yat-sen University Cancer Center. Clinical experts on rectal cancer from other 5 regional medical centers in China were also invited to participate, and provided data of cCR patients. Standardized forms for data collection were sanded to researchers in each center. Patients received radical resection will constituted our surgery group. Those refused surgery constituted the observation group who went on with the watch and wait approach. A propensity-score matched observational analysis will be used to compare the oncological outcome of these two groups.

Treatment Strategy for Rectal Cancer Patients With Complete Clinical Response

Watch-and-wait Approach Versus Surgical Resection for Rectal Cancer Patients With Complete Clinical Response After Chemoradiotherapy: a Multi-center Cohort Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Compare Efficacy and Safety of DRT VS CRT Plus Surgery in Patients Who Achieved CCR for Esophageal Cancer	NCT03708042	Stage II Esopha... Stage III Esoph...	Definitive Radi... Neoadjuvant Rad...	18 Years - 70 Years	Tianjin Medical University Cancer Institute and Hospital
Treatment Strategy for Rectal Cancer Patients With Complete Clinical Response	NCT03846726	Rectal Cancer Organ Preservat...	standard TME su...	16 Years - 90 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for clinical complete response