Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

FDA approved drugs for the study population: Bevacizumab, Xeloda

consolidative radiotherapy plus maintenance chemotherapy

National Comprehensive Cancer Network (NCCN) or European Society for Medical Oncology (ESMO) suggested maintenance chemotherapy regimens: xeloda, bevacizumab

maintenance chemotherapy

Stereotacticbodyradiationtherapy (SBRT) or intensity modulated radiation therapy (IMRT) for metastatic sites (less than 5)

Consolidative Radiotherapy

Tao Zhang, MD,PHD

Tao Zhang, MD, PHD

Zhenyu Lin, MD

This study is a randomized phase II trial of maintenance chemotherapy versus consolidative radiotherapy plus maintenance chemotherapy for patients with unresectable metastatic colorectal cancer (MCRC).

Prior to accrual on the trial, patients with unresectable metastatic colorectal cancer will be treated with palliative chemotherapy. And patients who achieve a partial response or stable disease by imaging criteria will receive maintenance chemotherapy. In our study, these group patients will be randomized to maintenance chemotherapy or consolidative radiotherapy to all sites of disease (followed by maintenance chemotherapy at the medical oncologist's discretion). Choices of palliative and maintenance chemotherapy will be determined by the medical oncologist based on clinical appropriateness.

Radiation: SBRT or IMRT Drug: Maintenance chemotherapy

Consolidative Radiotherapy Plus Maintenance Chemotherapy for Metastatic Colorectal Cancer

Maintenance Chemotherapy Versus Consolidative Radiotherapy Plus Maintenance Chemotherapy for Unresectable Metastatic Colorectal Cancer: A Randomized Phase II Trial

Evaluate the effect of consolidative radiotherapy with or without maintenance chemotherapy versus maintenance chemotherapy alone on progression free survival

To describe the actuarial rate in-field local control and rate of out-of-field disease progression

Acute toxicity was scored according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v3.0 criteria during and up to 3 months after radiotherapy. Late toxicity was graded using the Radiation Therapy Oncology Group (RTOG)/European Organisation for the Research and Treatment of Cancer (EORTC) criteria.

To evaluate overall survival after consolidative radiotherapy followed by maintenance chemotherapy in comparison to maintenance chemotherapy alone.

Wuhan Union Hospital, China

Cancer Center

Symptoms and General Pathology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Disease Progression

Nasopharyngeal Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Gemcitabine

Immune Checkpoint Inhibitors

Cisplatin

Nedaplatin

4-6 Cycles System chemotherapy (Camrelizumab , Gemcitabine and cisplatin or nedaplatin) ; And local consolidative radiotherapy for all metastatic lesion (30-45Gy/3-8F) and Maintenance of Camrelizumab (total 2 years; from first cycles of System chemotherapy to last cycles of miantenance of camrelizumab)

local consolidative radiotherapy for all metastatic lesion (30-45Gy/3-8F)

consolidative radiotherapy

Shaojun Lin, MD

Qiaojuan Guo, PhD

Wei Wu, MD

Jingao Li, MD

Xiaochang Gong, MD

The purpose of this study is to explore the efficacy and tolerance of local consolidative radiotherapy combined with Camrelizumab and chemotherapy in patients with oligometastatic nasopharyngeal carcinoma

This trial was a single-arm, multicenter phase Ⅱ clinical study. Eligible oligometastatic NPC patients were scheduled to evaluate the efficacy and tolerance of local consolidative radiotherapy combined with camrelizumab and chemotherapy in patients with oligometastatic NPC. Progression-free survival (PFS) determined will be the primary outcome measures.

System chemotherapy (Camrelizumab , Gemcitabine and cisplatin or nedaplatin) And local consolidative radiotherapy for all metastatic lesion, and Maintenance of Camrelizumab

Consolidative Radiotherapy Combined With Camrelizumab and Chemotherapy for Oligometastatic Nasopharyngeal Carcinoma

Consolidative Radiotherapy Combined With Camrelizumab and Chemotherapy for Oligometastatic Nasopharyngeal Carcinoma: A Multicenter, Open-Label, Phase II Trial (NPC-CR01)

After completing the treatment plan, we will report our research plan and research results.

The time from the start of treatment to the first observation of disease progression or death from any cause (whichever occurs first)

the proportion of patients achieving the optimal overall remission (complete or partial remission)

the proportion of patients with the best efficacy (CR or PR or SD)

the time from the start of treatment to death from any cause

the time the patient first reaches complete or partial remission to disease progression

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Consolidative Radiotherapy Plus Maintenance Chemotherapy for Metastatic Colorectal Cancer	NCT03142282	Metastatic Colo... Radiotherapy	maintenance che... Consolidative R...	-	Wuhan Union Hospital, China
Consolidative Radiotherapy Combined With Camrelizumab and Chemotherapy for Oligometastatic Nasopharyngeal Carcinoma	NCT05128201	Oligometastatic...	consolidative r...	18 Years - 70 Years	Jiangxi Provincial Cancer Hospital
Consolidative Radiotherapy Combined With Camrelizumab and Chemotherapy for Oligometastatic Nasopharyngeal Carcinoma	NCT05128201	Oligometastatic...	consolidative r...	18 Years - 70 Years	Jiangxi Provincial Cancer Hospital
Consolidative Radiotherapy Combined With Camrelizumab and Chemotherapy for Oligometastatic Nasopharyngeal Carcinoma	NCT05128201	Oligometastatic...	consolidative r...	18 Years - 70 Years	Jiangxi Provincial Cancer Hospital

Spots Global Cancer Trial Database for consolidative radiotherapy