Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

The choice of SACT is determined by the treating clinician and will be supplied from hospital commercial stock, and prepared and administered according to institutional guidelines.

SACT followed by radical RT (conventional or SABR) to the primary and SABR to the metastatic sites.

The choice of SACT is determined by the treating clinician and will be supplied from hospital commercial stock, and prepared and administered according to institutional guidelines.

Radical radiotherapy (conventional or SABR) to primary and SABR to the metastases

Radical Radiotherapy (Conventional RT and SABR)

There is no intervention in the control group, patients will receive SACT. The choice of SACT is determined by the treating clinician and will be supplied from hospital commercial stock, and prepared and administered according to institutional guidelines.

Non-investigational SACT

Ka Man Mak

Crispin Dr Hiley

Ruth Dr Eakin

Qamar Dr Ghafoor

Charles Dr Comins

Alex Dr Martin

Stephen Dr Harrow

Veni Dr Erzhil

Kevin Dr Frank

Thiagarajan Dr Sridhar

Shahreen Dr Ahmad

John Dr Conibear

Merina Dr Ahmed

Corinne Dr Faivre-Finn

Clive Dr Peedell

Phillip Dr Atherton

Karen Dr Foweraker

Matthew Dr Hatton

Andrew Dr Bates

Anthony Pope

Fiona McDonald

The trial will assess the addition of stereotactic ablative radiotherapy (SABR) to standard anti-cancer therapy (SACT) in patients with oligometastatic non-small cell lung cancer. Patients will be randomised to receive either standard treatment alone (SACT) or standard treatment with conventional radiotherapy (RT) and SABR.

SARON is a confirmatory phase III study examining the efficacy and safety of stereotactic ablative radiotherapy (SABR) and conventional radiotherapy (RT) alongside standard chemotherapy in patients with oligometastatic non-small cell lung cancer.

Current treatment for this group of patients is systemic anti-cancer therapy. The choice of SACT is determined by the treating clinician and will be supplied from hospital commercial stock, and prepared and administered according to institutional guidelines. There is sufficient evidence regarding the safety of SABR, its effect on local control and a possible impact on overall survival. This trial will further examine overall survival, progression free survival and local control, as well as toxicity, feasibility, patient reported outcomes and health resource use.

There will be a feasibility analysis performed after 50 patients have been randomised. This will assess the practicality of achieving recruitment targets, logistics of delivering the experimental treatment and the potential for contamination (as patients may seek SABR outside of the trial if randomised to the non SABR arm). There will also be a parallel thoracic SABR safety and feasibility study after recruitment and treatment of 20 patients with thoracic metastases.

This is a multicentre randomised phase III study based on patients with oligometastatic NSCLC.

Trial arms:

Control Arm: systemic anti-cancer therapy alone (SACT) Experimental Arm: SACT plus radical RT to primary and SABR and/or SRS to metastases

Stereotactic Ablative Radiotherapy for Oligometastatic Non-small Cell Lung Cancer

Stereotactic Ablative Radiotherapy for Oligometastatic Non-small Cell Lung Cancer. A Randomised Phase III Trial

The trial will investigate the impact of the addition of radical conventional and stereotactic radiotherapy to standard systemic therapy on overall survival

The trial will investigate the impact of the addition of radical conventional and stereotactic radiotherapy to standard systemic therapy on progression free survival

Safety analyses will be performed on all patients who received at least one dose of chemotherapy or fraction of SRT post-randomisation. Radiotherapy-related toxicity and early and late toxicity will be investigated. Adverse events will be compared between the two groups, as well as dose delays, reductions and compliance to chemotherapy and radiotherapy.

The trial will investigate the impact of the addition of radical conventional and stereotactic radiotherapy to standard systemic therapy on local tumour control

The health related quality of life for each treatment arm will be assessed.

Cancer Research UK

University College, London

Blood and Lymph Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Analgesics

Aldesleukin

Interleukin-2

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Analgesics, Non-Narcotic

One cycle of treatment : D1 : 2.5 MUI/m2 (subcutaneous); D2 to D5 : 5 MUI / m2 (subcutaneous)

1 cycle of treatment each month during 12 months

proleukin

Guy Leverger, M.D.

Tabassome Simon, M.D., Ph.D.

Anne Auvrignon, M.D.

The purpose of this study is to evaluate the interest of maintenance treatment with interleukin-2 by randomizing the patients being not allogeneic transplanted in complete remission after induction and consolidation chemotherapy concerning the event free survival.

We designed an open randomized study to evaluate the interest of maintenance treatment with interleukin-2 by randomizing the patients being not allogeneic transplanted in complete remission after induction and consolidation chemotherapy concerning the event free survival. A total of 580 patients will be accrued over 7 years. Treatment consists in subcutaneous application of interleukin-2 in treating patients with complete remission by a monthly regimen of 5 days during 1 year after having received a chemotherapy consisting of 1 induction and 3 consolidation treatments.

Treating Patients With Childhood Acute Myeloid Leukemia With Interleukin-2

Multicenter Protocol in Treating Patients With Childhood Acute Myeloid Leukemia. Randomized Study of Maintenance Treatment With Interleukin-2

Chiron Corporation

Assistance Publique - Hôpitaux de Paris

Therese Ngoue

Digestive System Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Tislelizumab

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Long-course chemoradiation plus PD-1 inhibition (Tislelizumab 200mg, 3 times, 3-week interval) starting on Day 8 of radiation therapy. TME surgery is scheduled in 8\~12 weeks after completion of radiation.

Long-course chemoradiation plus PD-1 inhibition (Tislelizumab 200mg, 3 times, 3-week interval) starting on Day 15 after completion of radiation therapy. TME surgery is scheduled in 8\~12 weeks after completion of radiation.

Long-course chemoradiation plus PD-1 inhibition with no PD-1 inhibition. TME surgery is scheduled in 6\~12 weeks after completion of radiation.

Tislelizumab is added to long-course chemoradiation (CRT) of LARC patients, with CRT+concurrent Tislelizumab for Arm 1, CRT+sequential Tislelizumab for Arm 2, and CRT only for Arm 3

Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)

Zhongtao Zhang, M.D.

Kai Pang, M.D.

Yingchi Yang, M.D.

Hongwei Yao, M.D.

Danyang Zhu, M.D.

Yi Xiao, M.D.

Guole Lin, M.D.

Jiaolin Zhou, M.D.

Yingchao Wu, M.D.

Xin Wang, M.D.

Shuang Cao, M.D.

Yingjiang Ye, M.D.

Zhidong Gao, M.D.

Zhongtao Zhang

This is a phase II/III, multi-center, open-label, 3-arm, randomized controlled trial assessing the efficacy and safety of neoadjuvant long-course chemoradiation combined with Tislelizumab (PD-1 inhibitor) and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1: chemoradiation+concurrent PD-1 inhibitor; Experiment group 2: chemoradiation+sequential PD-1 inhibitor) with a control group (chemoradiation only).

This phase II, multi-center, open-label, 3-arm, randomized trial aims to recruit patients aged 18-75 years, diagnosed histologically as rectal adenocarcinoma, without metastasis (by CT), staged II/III (by MRI, T4b excluded), with distal margin within 10cm to anal verge. All patients should have no history of immune diseases, nor history of immunotherapy or radiotherapy. Sample size was thoroughly calculated to be 186. Eligible participants will be randomly assigned to Experiment Arm 1 (50.4Gy radiation, capecitabine, and anti-PD1 starting at Day 8 of radiation), Experiment Arm 2 (50.4Gy radiation, capecitabine, and anti-PD1 starting 2 weeks after completion of radiation), and Control Arm (50.4Gy radiation, capecitabine) in a 1:1:1 ratio. Randomization is stratified by different centers, with a block size of 6. For both experiment arms, Tislelizumab (anti-PD1) is scheduled to be administered at 200mg each time for 3 times, with 3-week intervals. The primary endpoint is pCR rate, and secondary endpoints include sphincter-preserving rate, adverse event rates, and DFS and OS rate at 2, 3 and 5 years post-operation. Data will be analyzed with an intention-to-treat or modified intention-to-treat approach.

Neoadjuvant Long-course Chemoradiation Plus PD-1 Blockade for Mid-low Locally Advanced Rectal Cancer

Efficacy and Safety of Neoadjuvant Long-course Chemoradiation Plus Tislelizumab in Mid-low Locally Advanced Rectal Cancer: a Phase II, Multi-center, Open-label, Randomized Controlled Trial (POLARSTAR Trial)

Export of individual patient data is a sensitive issue according to current Chinese laws

median length (in months) of overall survival period

median length (in months) of disease free survival period

proportion of patients with preserved anal sphincter

nearly pathological complete response rate

adverse event rate that is deemed to be associated with PD-1 inhibition

adverse event (above Grade 3) rate that is deemed to be associated with PD-1 inhibition

adverse event rate that is deemed to be associated with all treatments

adverse event (above Grade 3) rate that is deemed to be associated with all treatments

incidence rate of surgical complications within 30 days after surgery

incidence rate of Grade 3+ surgical complications within 30 days after surgery

quality of life score during the 5 years after surgery, multiple timepoint assessment

Beijing Chao Yang Hospital

Xuanwu Hospital, Beijing

Beijing Hospital

Peking Union Medical College Hospital

Peking University First Hospital

Peking University People's Hospital

Peking University Cancer Hospital & Institute

BeiGene

Beijing Friendship Hospital

Director

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Acupuncture protocol 1：participants will receive treatment (acupuncture protocol 1, real acupuncture) twice a week; each treatment session can be separated by an interval of 2-4 days, with a maximum of 32 treatment sessions during 16 weeks. Each treatment session lasts for 30 minutes.

Acupuncture protocol 2：participants will receive treatment (acupuncture protocol 2, sham acupuncture) twice a week; each treatment session can be separated by an interval of 2-4 days, with a maximum of 32 treatment sessions during 16 weeks. Each treatment session lasts for 30 minutes. All participants will receive treatment twice a week; each treatment session can be separated by an interval of 2-4 days, with a maximum of 32 treatment sessions during 16 weeks. Each treatment session lasts for 30 minutes.

Disposable, single-use, sterilized needles made of stainless steel, 0.25 x 30 mm and 0.30 x 40/50mm (Wuxi Jiajian Medical Instrument. 251226 Wuxi, China) will be inserted to a depth of 15-35 mm in some acupoints. After getting the needle sensation (de qi), some acupoints will receive electrical stimulation and the others will receive manual stimulation. All participants will receive treatment twice a week; each treatment session can be separated by an interval of 2-4 days, with a maximum of 32 treatment sessions during 16 weeks. Each treatment session lasts for 30 minutes.

acupuncture protocol 1

Disposable, single-use, sterilized needles (0.20 x 20mm) made of stainless steel will be inserted to a depth of \<5 mm at non-acupoints without evoking the needle sensation (Deqi). Electrodes will be attached to the needles and the stimulator will be turned on at an intensity of zero (no active current) in order to mimic EA in the acupuncture protocol 1 group. No manual stimulation of the needles will be performed.

Acupuncture protocol 2

Dongmei Huang, doctor

Low-frequency electroacupuncture (EA) can decrease serum 17-hydroxyprogesterone (17-OHP), androstenedione (A) and testosterone (T)of young women with polycystic ovary syndrome in the Human chorionic gonadotrophin (HCG) stimulation test ，also，we hypothesize that EA is more efficiency in improving ovulation rate and menstrual cycle than sham acupuncture.

First, patients will be recruited according to the inclusion criteria and exclusion criteria.

Second, baseline measurements (including menstrual frequency,human chorionic gonadotropin (HCG) stimulation test,physical examination,trans-abdomen ultrasound of the uterus and ovaries, serum levels of sex hormone steroids) will be taken.

Third, each patient will receive 32 sessions of acupuncture in 16 weeks, twice a week.

Last, the above baseline measurements will be taken again as soon as the treatment is finished and menstrual frequency will be recorded during the 12 weeks of follow-up after the treatment.

Effect of Low-frequency Electroacupuncture (EA) on Polycystic Ovary Syndrome

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Human chorionic gonadotrophin (HCG) stimulation test: Both at baseline and in one week after the treatment, the patients will receive an intramuscular injection of 5000 IU HCG, and 24 h and 48 h later, serum 17-hydroxyprogesterone (17-OHP), androstenedione (A) and testosterone (T) of the patients will be detected.

Serum levels of sex hormone steroids including blood follicle-stimulating hormone (FSH), luteinizing hormone (LH), estrogen, progesterone, prolactin and total testosterone will be evaluated at baseline and 16 weeks. Oral glucose tolerance test (OGTT) and insulin releasing test will be performed at baseline and 16 weeks. Serum levels of leptin, adiponectin, resistin, adrenal cortical hormone and beta endorphin will be examined at baseline and 16 weeks later.

The uterine dimensions, endometrial thickness and echo type, other uterine abnormalities, presence and size of leiomyoma, uterine artery blood flow parameters (pulsation index, resistance index, Shrinkage value / Diastolic value) will be obtained through trans-abdomen ultrasound at baseline and 16 weeks. The ovarian size in three dimensions, the size of the largest ovarian follicle/cyst and size of every follicle with a mean diameter greater than 10 mm, and total antral follicle (small follicles with mean diameter \< 10 mm) count of each ovary; ovarian artery blood flow parameters will be observed through trans-abdomen ultrasound at baseline and 16 weeks later.

Physical examination including vital signs, height, weight, hip and waist measurements, BMI and assessment of hirsutism by Ferriman-Gallwey score and acne standard acne lesion counts will be performed at baseline and 16 weeks.

Adverse events happened during 16-week treatment period and 12-week follow-up will be recorded and classified. Unless otherwise formal requirements, each report about the detail and summary of adverse event to data safety supervision and the commission will be reported by double blind way.

The menstruation characteristics including menstrual cycle, duration and amount of the past 4 months and during the treatment period will be recorded. Menstrual frequency was calculated by dividing the number of menstrual bleeding by 4.

serum levels of AD, NE,5-HT and GABA between two groups both at baseline and after the treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stereotactic Ablative Radiotherapy for Oligometastatic Non-small Cell Lung Cancer	NCT02417662	Non-small Cell ...	Radical Radioth... Non-investigati...	18 Years -	University College, London
Treating Patients With Childhood Acute Myeloid Leukemia With Interleukin-2	NCT00149162	Leukemia	proleukin	- 18 Years	Assistance Publique - Hôpitaux de Paris
Neoadjuvant Long-course Chemoradiation Plus PD-1 Blockade for Mid-low Locally Advanced Rectal Cancer	NCT05245474	Locally Advance...	Long-course che...	18 Years - 75 Years	Beijing Friendship Hospital
Effect of Low-frequency Electroacupuncture (EA) on Polycystic Ovary Syndrome	NCT01812161	Polycystic Ovar...	acupuncture pro... Acupuncture pro...	18 Years - 28 Years	Huazhong University of Science and Technology
Effect of Low-frequency Electroacupuncture (EA) on Polycystic Ovary Syndrome	NCT01812161	Polycystic Ovar...	acupuncture pro... Acupuncture pro...	18 Years - 28 Years	Huazhong University of Science and Technology

Spots Global Cancer Trial Database for controlled

Every month we try and update this database with for controlled cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for controlled

Every month we try and update this database with for controlled cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for controlled cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.