Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Nervous System Diseases

Heart and Blood Diseases

Neoplasms

Mouth and Tooth Diseases

Inflammation

Muscle Cramp

Spasm

Aneurysm

Brain Neoplasms

Hemifacial Spasm

Intracranial Aneurysm

Vascular Diseases

Brain Diseases

Central Nervous System Diseases

Intracranial Arterial Diseases

Cerebrovascular Disorders

Mouth Diseases

Stomatognathic Diseases

Neuromuscular Manifestations

Neurologic Manifestations

The acupuncture intervention will start no more than 48 hours after craniotomy and will be given once a day for 6 days (a total of 6 sessions within 8 days). It will be given in addition to conventional treatments. All interventions will be performed by one Korean Medicine doctor with over 5 years of working experience with a college education of 6 years. This doctor will be trained in the study protocol before the start of the trial.

The subjects in the control group will only receive conventional treatment. This involves general management after craniotomy in the department of neurosurgery.

Acupuncture, electroacupuncture, and intradermal acupuncture will be performed at every session.

Sterile disposable stainless steel acupuncture needles (0.25 mm × 30 mm) will be used. Acupuncture needles will be inserted bilaterally at the following acupuncture points: LI4, LI11, PC6, ST36, GB39 and LR3, and GV20. If GV20 is close to the surgical site, this acupoint may be excluded.

An electric stimulator will be connected to the handle of each needle at LI4, LI11, ST36, and LR3 and a current of 5 Hz will be applied.

After the needles are removed, intradermal acupuncture needles with tape (DB130A; 0.25 mm × 1.5mm) will be inserted at the same acupoints (LI4, LI11, PC6, ST36, GB39, and LR3 bilaterally, and GV20) and left in place until the next session.

acupuncture

The subjects in the control group will only receive conventional treatment. This involves general management after craniotomy in the department of neurosurgery and includes stabilizing vital signs, pain control, prevention and treatment of infections, and other IV fluid or drug therapy required based on the condition of the patient.

conventional treatment

Seong-Uk Park, KMD, PhD

The aim of this study is to evaluate the effect of acupuncture on inflammation and immune function after craniotomy. This study will be a single-center, parallel group clinical trial that will be conducted at Kyung Hee University Hospital at Gangdong, Seoul, Korea.

For Study group, The intervention will start no more than 48 hours after craniotomy and will be given once a day for 6 days (a total of 6 sessions within 8 days). Acupuncture, electroacupuncture, and intradermal acupuncture will be performed at every session.

For Control group, The subjects in the control group will only receive conventional treatment.

Effect of Acupuncture on Inflammation and Immune Function After Craniotomy

Turbidimetric immunoassay will be performed for measurement of CRP. A blood sample will be drawn from the brachial vein at a fixed time in the morning before breakfast.

The photometrical capillary method will be performed for measurement of ESR. A blood sample will be drawn from the brachial vein at a fixed time in the morning before breakfast.

Enzyme-linked immunosorbent assay (ELISA) will be performed for measurement A blood sample will be drawn from the brachial vein at a fixed time in the morning before breakfast.

Any fever with a body temperature over 38℃ will be recorded on the case report form.

Use of additional antibiotics will be recorded on the case report form.

Infections such as pneumonia or urinary tract infections will be recorded on the case report form.

Kyunghee University

Kyunghee University Medical Center

KMD, PhD

Ear, Nose, and Throat Diseases

Carcinoma

Oropharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Immune Checkpoint Inhibitors

Docetaxel

Cisplatin

Two cycles toripalimab+docetaxel+cisplatin+capecitabine (TPF) induction chemotherapy followed by reducing radiation dose(60Gy/30Fx) and omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 70% Partial Response(PR) in HPV-related patients.

Two cycles toripalimab+docetaxel+cisplatin+capecitabine (TPF) induction chemotherapy followed by reducing radiation dose(60Gy/30Fx) combined with concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 70% Partial Response(PR) in HPV-urelated patients.

Two cycles toripalimab+docetaxel+cisplatin+capecitabine (TPF) induction chemotherapy followed by concurrent cisplatin chemoradiotherapy with standard radiation dose (70.4Gy/32Fx) when responses to induction chemotherapy are less than 70% Partial Response (PR) regardless of HPV status.

Toxicities reduced treatment

Conventional treatment

Xiaoshen Wang, MD, Ph.D

Ruichen Li, MD

Xiaoshen Wang

More and more studies have shown that the efficacy and prognosis of HPV （Human papillomavirus）-positive oropharyngeal cancer (OPC) patients are better than those of others. However, in the NCCN (National Comprehensive Cancer Network) Oncology Clinical Guidelines for OPC treatment, each group of p16+ is consistent with the corresponding group of p16-, which indicates that the treatment of OPC is basically the same regardless of whether it is related to HPV. Several studies attempted to reduce the toxicities of treatment of HPV related OPC through reduced-dose radiation and showed promising results, and all of the studies have shown that induction chemotherapy is a good way to screen followed treatment. Those who are effective in induction chemotherapy are usually more sensitive to radiation therapy, and reducing the intensity of subsequent treatment will not affect the survival outcome of patients. Immune checkpoint inhibitors (ICIs) have proved to improve outcomes of head and neck cancers. However, In KEYMAT-048, a Phase III controlled trial of relapsed/metastatic head and neck squamous cell carcinoma, ICIs showed an overall survival advantage, but the survival advantage was independent of HPV status. Therefore, patients with HPV-negative OPC still have a good response to ICIs. So we added anti-PD-1 antibody Toripalimab to induction chemotherapy in order to achieve better response rates to receive de-escalation chemoradiotherapy followed regardless of whether it is related to HPV.

PD-1 Inhibitor Based Induction Chemotherapy Followed by De-escalation Protocols in OPSCC

Selective De-escalation of Radiotherapy Density Based on Response to Induction Chemotherapy With PD-1 Inhibitor Toripalimab, Docetaxel, Cisplatin, and Capecitabine in Locally Advanced Oropharyngeal Carcinoma: A Prospective Phase II Trial (DEDICATE-1)

The incidence (percentage) of late toxicity , Grade 3 and 4 adverse reactions in NCI-CTC AE 5.0 and RTOG.

Quality of Life according to EORTC QLQ-C30

The detail number and percentage of adverse events by every systems Assessed by CTCAE v5.0 and RTOG.

Fudan University

Professor

Rare Diseases

Nasopharyngeal Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Nasopharyngeal Neoplasms

Nasopharyngeal Diseases

Patients receive docetaxel(75mg/m2 d1) and cisplatin(25 mg/m2 d1-3) every 3 weeks for 3 cycles as induction chemotherapy, followed by omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR).

Patients receive docetaxel(75mg/m2 d1) and cisplatin(25 mg/m2 d1-3) every 3 weeks for 3 cycles as induction chemotherapy, followed by concurrent cisplatin chemotherapy with standard radiation dose when responses to induction chemotherapy are less than 50% Partial Response(PR).

Drug: docetaxel and cisplatin (Induction chemotherapy) Patients receive docetaxel (75 mg/m2 d1) and cisplatin (25mg/m2 d1-3) every 3 weeks for 3 cycles before IMRT.

Omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR).

Radiation: IMRT Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor.

Drug: docetaxel and cisplatin (Induction chemotherapy) Patients receive docetaxel (75 mg/m2 d1) and cisplatin (25mg/m2 d1-3) every 3 weeks for 3 cycles before IMRT.

Concurrent cisplatin chemoradiotherapy delivered when responses to induction chemotherapy are less than 50% Partial Response(PR).

Radiation: IMRT Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor.

Youqi Yang, MD

Xueguan Lu, MD

Chaosu Hu, MD

The purpose of this study is to explore the efficacy and safety of image guided de-escalation protocols in patients with locoregionally advanced nasopharyngeal carcinoma (NPC). So the investigators studied whether toxicities reducing treatment with omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with locoregionally advanced nasopharyngeal carcinoma.

De-escalation Protocols in Locoregionally Advanced Nasopharyngeal Carcinoma

De-escalation of Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

Chaosu Hu

Principal Investigator

Blood and Lymph Conditions

Hemorrhage

Hemostatic Disorders

Blood Coagulation Disorders

Blood Loss, Surgical

Intraoperative Complications

Hematologic Diseases

Hemorrhagic Disorders

Coagulants

Hemostatics

Thrombin

Treatment of significant blood loss using point-of-care testing of whole blood viscoelasticity (ROTEM) monitoring coagulopathy or hyperfibrinolysis.

Treatment of significant blood loss conventionally, ie. using massive transfusion protocol if necessary, clinical judgement and conventional coagulation tests, such as prothrombin time (as international normalized ratio, INR), activated partial thrombin time (APTT), fibrinogen in plasma (Clauss method).

ROTEM-guided protocol of hemostatic resuscitation

Rotational thromboelastometry

Clinical judgement and conventional coagulation tests

Anne Kuitunen, MD, PhD

Need for perioperative blood transfusion is still high in certain types of oncological abdominal surgery. Allogeneic blood transfusion may be detrimental in cancer patients undergoing a potentially curative resection of malignant tumor, although the detailed mechanism of this effect is still under debate. We plan to evaluate whether a new, rotational thromboelastography-guided algorithm (ROTEM) to guide hemostatic resuscitation intra-operatively decreases the use of allogeneic blood products, the total amount of bleeding, transfusion related side effects, thromboembolic complications and costs. Its effect on each patient's post-operative hemostatic profile is also measured. 60 patients having a potentially curative pancreaticoduodenectomy (or resection of cauda of pancreas), total removal or partial resection of kidney and open radical cystectomy are recruited when an active blood loss of more than 1500 ml is estimated and/or measured and are randomized into two groups: one will be treated conventionally, ie. using massive transfusion protocol (MTP) if necessary, clinical judgement and conventional coagulation tests, the other treated using a ROTEM-based algorithm.

60 patients having a potentially curative abdomino-oncological surgery and reaching an active blood loss of more than 1500 ml are randomized into two groups. One will be treated conventionally, ie. using MTP if necessary, clinical judgement and conventional coagulation tests, the other treated using a ROTEM-based algorithm. Randomization (ratio 1:1 in blocks of 10) between the two groups will be done beforehand. Each paper containing the treatment protocol in question will be put into a closed envelope. The envelopes are numbered from 1 to 60 and are placed in a box in the operative department.

Participants do not know which group he/she is randomized into. They are under general anaesthesia, thus not knowing which protocol is used. When assessing outcomes, two groups are labeled only by number: the assessor does not know which arm is number 1 or 2 until whole data is analyzed.

ROTEM-guided Transfusion Protocol in Attempt to Reduce Blood Transfusions in Major Oncological Surgery

ROTEM-guided Transfusion Protocol Versus Standard Care in Attempt to Reduce Blood Transfusions in Potentially Curative Major Abdominal and Urological Oncological Surgery

Possible signs hypercoagulopathy in thromboelastometry: EXTEM value of more than 72 mm

Red blood cell units transfused per patient during operation or up to 24 hours after beginning of surgery

Number of patients admitted to intensive care or high dependency, if this is considered associating with the surgery

Number of days patient is in hospital immediately after surgery

Any side-effect considered or suspected originating from blood product transfusion

Clinically diagnosed deep vein thrombosis, pulmonary embolism, stroke or other thromboembolic event

Tampere University Hospital

Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by concurrent cisplatin chemoradiotherapy with standard radiation dose (70Gy/35Fx) when responses to induction chemotherapy are less than 50% Partial Response(PR)

Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by reducing radiation dose(60Gy/30Fx) and omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR)

Tingting xu, MD

xueguan Lu, MD

Tingting Xu, MD

Human papillomavirus (HPV)-related oropharyngeal carcinoma are exquisitely radiosensitive. Several studies attempted to reduce the toxicities of treatments through reduced-dose radiation and showed promising results, but all data were collected from non-Chinese areas. Like nasopharyngeal carcinoma, oropharyngeal carcinoma may have different biological behavior and relationship with HPV infection. So the investigators studied whether toxicities reducing treatment with reduced radiation dose and omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with HPV-positive oropharyngeal carcinoma.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Acupuncture on Inflammation and Immune Function After Craniotomy	NCT02761096	Unruptured Cere... Hemifacial Spas... Brain Tumor	acupuncture conventional tr...	18 Years -	Kyunghee University Medical Center
Effect of Acupuncture on Inflammation and Immune Function After Craniotomy	NCT02761096	Unruptured Cere... Hemifacial Spas... Brain Tumor	acupuncture conventional tr...	18 Years -	Kyunghee University Medical Center
PD-1 Inhibitor Based Induction Chemotherapy Followed by De-escalation Protocols in OPSCC	NCT06156891	Oropharyngeal C...	Toxicities redu... Conventional tr...	18 Years - 70 Years	Fudan University
De-escalation Protocols in Locoregionally Advanced Nasopharyngeal Carcinoma	NCT04158518	Nasopharyngeal ...	Toxicities redu... Conventional tr...	18 Years - 70 Years	Fudan University
ROTEM-guided Transfusion Protocol in Attempt to Reduce Blood Transfusions in Major Oncological Surgery	NCT03993977	Blood Loss, Sur... Blood Loss Requ... Coagulation Def...	Rotational thro... Conventional tr...	18 Years -	Tampere University Hospital
De-escalation Protocols in HPV-related Oropharyngeal Carcinoma in Chinese Populations	NCT04012502	Oropharyngeal C... De-escalation	Toxicities redu... conventional tr...	18 Years -	Fudan University

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