Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Oxaliplatin

Antimetabolites

Standard chemoradiotherapy (Capecitabine 825mg/m2 combined with radiotherapy )

induction chemotherapy (Capecitabine 2000mg/m2 +oxaliplatine 130mg/m2) + 2 cycles of chemoradiotherapy (Capecitabine 2000mg/m2 +oxaliplatine 100mg/m2 combined with radiotherapy) + gap chemotherapy (Capecitabine 2000mg/m2 + oxaliplatine 130mg/m2)

All rectal cancer patients in this group will receive induction, gap chemotherapy (capecitabine combined with oxaliplatin) alone with chemoradiotherapy (capecitabine combine with oxaliplatin) before surgery.

Induction chemotherapy, Chemoradiotherapy and gap chemotherapy (Capecitabine combine with oxaliplatin)

All rectal patients in this group will receive standard radiotherapy and surgical resection.

standard chemoradiotherapy

Zhen-Hai Lu, Prof.

Although neoadjuvant chemoradiotherapy has significantly reduced the risk of local recurrence in locally advanced rectal cancer, systemic failure remains a predominant issue probably due to the insufficient control of systemic micro-metastasis in the neoadjuvant treatment. Induction chemotherapy is one of the most studied strategies. However, the efficacy of induction chemotherapy prior to neoadjuvant chemotherapy remains controversial. In our previous study, induction chemotherapy, gap chemotherapy combined with neoadjuvant chemoradiotherapy can improve response rate of rectal cancer patients, but the results have not been confirmed in clinical trial. Whether this new kind of treatment can optimize neoadjuvant therapy for locally advanced rectal cancer or not is still a big problem in clinical practice. This study will focus on how to optimize neoadjuvant chemotherapy.

Randomized Controlled Study on Optimize Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer

Sun Yat-sen University

Pofessor

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

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

Chaosu Hu

Chaosu Hu, M.D

Up to now, IMRT has largely improved the local control of locally advanced nasopharyngeal carcinoma (NPC), leaves the distant metastasis as the main treatment failure modality of patients with bulky lymph nodes (especially N3 stage). Although concurrent chemoradiotherapy (CCRT) continues to stand as the standard treatment of these patients, the role of adjuvant chemotherapy remains controversial due to its relatively severe toxicities and inferior compliance. However, our retrospective study of 2D-RT and IMRT era had proved adjuvant chemotherapy played key role in N3 NPC patients in terms of reducing distant metastasis and improving overall survival. Maintenance chemotherapy of gemicitabine single drug is promising with adequate efficacy and moderate toxicities. So we aim to conduct "A Phase III Randomized Trial of Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage" to evaluate the effectiveness and compliance of gemicitabine as maintenance chemotherapy in N3 nasopharyngeal carcinoma.

We aim to conduct "A Phase III Randomized Trial of Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage" to evaluate the effectiveness and compliance of gemicitabine as maintenance chemotherapy in N3 nasopharyngeal carcinoma.

Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage

A Phase III Randomized Trial of Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage

Fudan University

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Randomized Controlled Study on Optimize Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer	NCT02031939	Advanced Rectal...	Induction chemo... standard chemor...	18 Years - 75 Years	Sun Yat-sen University
Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage	NCT03403829	Nasopharyngeal ...	Gemcitabine standard chemor...	18 Years - 60 Years	Fudan University
Randomized Controlled Study on Optimize Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer	NCT02031939	Advanced Rectal...	Induction chemo... standard chemor...	18 Years - 75 Years	Sun Yat-sen University
Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage	NCT03403829	Nasopharyngeal ...	Gemcitabine standard chemor...	18 Years - 60 Years	Fudan University

Spots Global Cancer Trial Database for standard chemoradiotherapy