Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Unresectable mCRC patients who respond to chemotherapy will receive surgical resection of primary tumor.

Unresectable mCRC patients who were respond to chemotherapy will continue with chemotherapy.

Surgical resection of primary tumor of mCRC patients who were respond to first line chemotherapy'

Surgical resection of primary tumor

Gong Chen, Prof.

Rong-Xin Zhang, M.D.

Yu-Hong Li, M.D.

Ling-Hneg Kong, M.D.

Zhi-qiang Wang, PhD.

Xiao-Jun Wu, M.D.

Zhi-Zhong Pan, M.D.

Yan-Hong Deng, M.D.

Hui Wang, M.D.

Meng Qiu, M.D.

Zhi-zhong Pan, Prof.

De-Sen Wan, Prof.

There is still no perfect treatment suggestion for patients with asymptomatic colorectal cancer with unresectable metastatic disease. Whether patients can benefit from palliative resection of primary tumor or not is still waiting for answer. The investigators hypothesis that asymptomatic metastatic colorectal cancer patients who respond to chemotherapy will benefit from primary tumor resection.

Effectiveness Study of Resection of Primary Tumor in Stage IV Colorectal Cancer Patients

Palliative Resection of Asymptomatic Primary Tumor Following Effective Induction Chemotherapy in Colorectal Cancer Patients With Unresectable Distant Metastasis: a Multi-center, Prospective, Randomized Controlled Study

Sun Yat-sen University

Sun Yat-Sen University Cancer Center

Rare Diseases

Neuroblastoma

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

Dermatologic Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Infective Agents

Tretinoin

Irinotecan

Etoposide

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Topotecan

Cisplatin

Sirolimus

Etoposide phosphate

Isotretinoin

Temsirolimus

MTOR Inhibitors

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Topoisomerase I Inhibitors

Keratolytic Agents

Protein Kinase Inhibitors

Fixed doses of IV temsirolimus concomitantly with two courses of fixed dosages of irinotecan, 2 days off, repeated daily 5 times.If initial dosages are not tolerable, subsequent patients will be given a reduced dosage of temsirolimus with irinotecan.If this dosage combination is not tolerable,irinotecan dosage will be decreased.If this dosage combination is not tolerable.Further enrollment to initial six week treatment will be terminated.Second course of irinotecan will begin on day 22, response will be determined after six weeks. Resection of primary tumor will be attempted after initial therapy.Following initial treatment children will undergo alternating courses of induction chemotherapy with cyclophosphamide,doxorubicin,etoposide,topotecan, and cisplatin.First cohort of 17 patients will receive Block 2 with temsirolimus for all three courses, weekly 2 times.If this is not tolerated subsequent patients will receive Block 2 chemotherapy with reduced dosages of temsirolimus.

Surgical Resection of Primary Tumor

PBSC

Radiation Therapy

13-cis-retinoic acid

Wayne L Furman, MD

A Phase II study of temsirolimus in combination with standard chemotherapy (irinotecan; cyclophosphamide, doxorubicin and etoposide (CAE); cisplatin and etoposide (HiPE) and topotecan (TPT) followed by and additional six courses of induction chemotherapy and then intensification with autologous hematopoietic stem cell transplantation. The first five courses of induction chemotherapy will also evaluate the feasibility of combining weekly temsirolimus with these standard chemotherapy combinations. This will be followed by 16 months of oral maintenance therapy with eight months of 13-cis-retinoic acid and then eight months of oral topotecan.

All children will receive fixed doses of intravenous temsirolimus (50 mg/m2 weekly 6 times ) concomitantly with two courses of fixed dosages of irinotecan (20 mg/m2 intravenously daily 5 times ,2 days off, repeated daily 5 times .If these initial dosages are not tolerable then subsequent patients will be given a reduced dosage of temsirolimus (25 mg/m2 weekly 6 times) with 20 mg/m2 of irinotecan.If this dosage combination is not tolerable, the irinotecan dosage will be decreased to 15 mg/m2 .If this dosage combination is not tolerable then further enrollment to the initial six week treatment will be terminated.The second course of irinotecan will begin on day 22 and response will be determined after six weeks (two courses). Resection of primary tumor will be attempted after this initial therapy, whenever possible.

Following initial treatment children will undergo alternating courses of induction chemotherapy with cyclophosphamide, doxorubicin, etoposide, topotecan, and cisplatin (Block 2). The first cohort of 17 patients will receive Block 2 with temsirolimus (50mg/m2) for all three courses, weekly 2 times. If this is not tolerated subsequent patients will receive Block 2 chemotherapy with reduced dosages of temsirolimus (25mg/m2).

Neuroblastoma Protocol 2008: Therapy for Children With Advanced Stage High Risk Neuroblastoma

The objective was to measure the efficacy and feasability of Temsirolimus and Irinotecan as measured by the objective response rate and toxicity rate.

St. Jude Children's Research Hospital

Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.

Temsirolimus With Irinotecan

Age, Continuous

Sex: Female, Male

NB2008 was closed because of the publication of a new standard of care for treating high-risk neuroblastoma.At the time of closure, NB2008 had enrolled only 4 patients, which was an insufficient number of patients to answer the primary objective.

Wayne L. Furman

The population consisted of patients eligible for enrollment onto the NB2008 protocol.

Complete Response Plus Partial Response

Overall Study

Head and Neck Neoplasms

Nivolumab

Immunomodulating Agents

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

* Neoadjuvant dose with Nivolumab 3mg/kg after randomization within 2 weeks before surgery
* Surgical resection of primary tumor including neck dissection according to standard of care
* 6-7 weeks risk-adapted adjuvant radio(-chemo)therapy 56-66 Gy (chemotherapy Cisplatin 100 mg/m2 on days 1, 22, 43, or Cisplatin once weekly (40mg/m2) for high risk patients only), start within 6 weeks post-surgery

Arm Ia:

• Adjuvant administration of Nivolumab 3mg/kg i.v. d1 every 2 weeks within 6 weeks after end of radiotherapy until progression or up to 6 months

Arm Ib:

• Adjuvant administration of Nivolumab 3mg/kg i.v. d1 every 2 weeks and Ipilimumab 1mg/kg i.v. d1 every 6 weeks within 6 weeks after end of radiotherapy until progression or up to 6 months

* Surgical resection of primary tumor including neck dissection according to standard of care
* 6-7 weeks risk-adapted adjuvant radio(-chemo)therapy 56-66 Gy (chemotherapy Cisplatin 100 mg/m2 on days 1, 22, 43 or Cisplatin once weekly (40mg/m2) in high risk patients), start within 6 weeks post-surgery
* Standard follow-up

Surgical resection of primary tumor including neck dissection according to standard of care

Risk-adapted adjuvant radio(-chemo)therapy 56-66 Gy (chemotherapy Cisplatin 100 mg/m2 on days 1, 22, 43, or Cisplatin once weekly (40mg/m2) for high risk patients only)

Adjuvant radio(-chemo)therapy

Neoadjuvant dose with Nivolumab 3mg/kg after randomization within 2 weeks before surgery

Neoadjuvant Nivolumab

Administration of Nivolumab 3mg/kg i.v. d1 every 2 weeks within 6 weeks after end of radiotherapy until progression or up to 6 months

Adjuvant Nivolumab

Administration of Nivolumab 3mg/kg i.v. d1 every 2 weeks and Ipilimumab 1mg/kg i.v. d1 every 6 weeks within 6 weeks after end of radiotherapy until progression or up to 6 months

Adjuvant Nivolumab and Ipilimumab

PD Dr. med. Chia-Jung Busch

Multicenter randomized controlled phase III study of nivolumab alone or in combination with ipilimumab as immunotherapy vs standard follow-up in surgical resectable HNSCC after adjuvant therapy

Surgically treated locally advanced head and neck squamous cell carcinoma often requires postoperative chemoradiation with high risk of acute and late toxicity. DFS after 2 years is approximately 70%. Combining anti-PD-1 and anti-CTLA4 as a maintenance therapy may improve DFS due to anti-tumor effects of immunotherapy by enhancing cross-presentation of tumor antigens.

Arm Ia and Arm Ib are summarized in one Arm, due to central ethics committee, as they both include neoadjuvant and adjuvant treatment compared to Arm II

Study of Nivolumab Alone or in Combination With Ipilimumab as Immunotherapy vs Standard Follow-up in Surgical Resectable HNSCC After Adjuvant Therapy

Multicenter Randomized Controlled Phase III Study of Nivolumab Alone or in Combination With Ipilimumab as Immunotherapy vs Standard Follow-up in Surgical Resectable HNSCC After Adjuvant Therapy

disease free survival (DFS) at 3 years of nivolumab alone or in combination with ipilimumab as adjuvant immunotherapy after adjuvant radio(chemo)therapy in locally advanced resected HNSCC

Disease assessment (CT/ MRI) and Panendoscopy and FFPE in case of suspicion or recurrence

Follow Up- Visits after end of treatment every 3 months until month 36 after randomization, afterwards every 6 months

We compare disease free survival, defined as time from randomization to date of first observed either histologically proven recurrence (local, locoregional or distant), or death from any cause whatever occurs first, of arm Ia to arm II and of arm Ib to arm II

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effectiveness Study of Resection of Primary Tumor in Stage IV Colorectal Cancer Patients	NCT02149784	Colorectal Canc...	Surgical resect...	18 Years - 75 Years	Sun Yat-sen University
Neuroblastoma Protocol 2008: Therapy for Children With Advanced Stage High Risk Neuroblastoma	NCT00808899	Neuroblastoma	Temsirolimus Irinotecan Surgical Resect... Cyclophosphamid... Doxorubicin Etoposide Cisplatin Topotecan PBSC Radiation Thera... 13-cis-retinoic...	- 18 Years	St. Jude Children's Research Hospital
Study of Nivolumab Alone or in Combination With Ipilimumab as Immunotherapy vs Standard Follow-up in Surgical Resectable HNSCC After Adjuvant Therapy	NCT03700905	Head and Neck C...	Surgical resect... Adjuvant radio(... Neoadjuvant Niv... Adjuvant Nivolu... Adjuvant Nivolu...	18 Years -	Universitätsklinikum Hamburg-Eppendorf

Spots Global Cancer Trial Database for surgical resection of primary tumor