Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Pre-operative concurrent chemoradiation therapy

Paclitaxel 90mg/m2 + Cisplatin 40mg/m2 on D1 \& 8 q 3weeks, Pre-OP \& post-op : 2cycles (total 4 cycles)

chemotherapy

Paclitaxel 50mg/m2 + Cisplatin 20mg/m2 on D1 \& 8 q 3weeks, Pre-OP \& post-op : 2cycles (total 4 cycles)

Concurrent chemoradiation therapy

Preoperative Thoracic radiation: 180cGy/fx, total: 4500cGy, 25fx

Heung Tae Kim, M.D.

Jae-Ill Zoo, M.D.

Jong Mog Lee, M.D.

Moon Soo Kim, M.D.

Hyun-Sung Lee, M.D.

Jin Soo Lee, M.D.

Ji-Youn Han, M.D.

Kwan Ho Cho, M.D.

Hong Ryull Pyo, M.D.

Bin Hwangbo, M.D.

Hee Seok Lee, M.D.

Hyae Young Kim, M.D.

Geon Kook Lee, M.D.

Moon Woo Seong, M.D.

Kyeong-Man Hong, M.D.

Byung-Ho Nam, Ph.D.

Tak Yun, M.D.

It is suggested that a bimodal or trimodal approach combining neoadjuvant chemotherapy with or without radiotherapy followed by surgery provides a potentially superior method of enhancing resectability and improving locoregional control and survival compared to radiotherapy alone followed by surgery. Unsolved questions are the identification of the best induction strategy, the impact of surgery on long-term survival, and the contribution of radiation therapy in this setting. Thus, the investigators conduct a phase II trial to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with biopsy proven N2 stage IIIA NSCLC to address optimal induction strategy.

Preoperative Therapy Arm 1. (preoperative chemotherapy) Paclitaxel (90 mg/m2)on day 1 and 8 Cisplatin (40 mg/m2)on day 1 and 8. q 3 weeks, 2 cycles

Arm 2. (preoperative chemoradiotherapy) Paclitaxel (50 mg/m2)on day 1, 8, 15, 22 \& 29 Cisplatin (20 mg/m2)on day 1, 8, 15, 22 \& 29. Thoracic radiation therapy (TRT) 1.8 Gy daily, five times per week (45 Gy target dose in 5 weeks).

Postoperative Consolidation Chemotherapy:

Paclitaxel (90 mg/m2) on day 1 and 8. Cisplatin (40 mg/m2) on day 1 and 8. q 3weeks, 2 cycles

Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in N2 Positive IIIA Non Small Cell Lung Cancer (NSCLC)

A Randomized Phase II Study Preoperative Chemotherapy Versus Preoperative Concurrent Chemoradiotherapy for Patients With Biopsy-Proven N2 Stage IIIA Non-Small Cell Lung Cancer

National Cancer Center, Korea

Heung Tae Kim

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Surgical debulking of bulky or multiple lymph node followed by CCRT

1. Radiation: Extended field-external beam radiation therapy (EF-EBRT) + brachytherapy + lymph node boost.
2. Chemotherapy: Cisplatin 40mg/m2, every week, 4 to 6 cycles.
3. Radiation and chemotherapy are administered concurrently.

CCRT

1. Open/minimally invasive method.
2. Surgical debulking of bulky or multiple lymph nodes.
3. Postoperative imaging evaluation to determine whether the lymph node has been successfully removed.

Surgical debulking of bulky or multiple lymph nodes

1. Radiation: EBRT/EF-EBRT + brachytherapy + lymph node boost.
2. Chemotherapy: Cisplatin 40mg/m2, every week, 4 to 6 cycles.
3. Radiation and chemotherapy are administered concurrently.

Ju-Won Roh

Ha Kyun Chang

Chae Hyeong LEE

Myung-Chul Lim

Yogn Jung Song

Dae Gy Hong

Chi Heum Cho

Gwang-Beom LEE

Jae-Weon Kim

Sang Wun Kim

Joong Sup Choi

Dae-Youn KIM

Jae Hoon KIM

Chel Hun Choi

Keun-Ho LEE

This study is a prospective, multicenter and randomized clinical trial (DEBULK trial) to determine the therapeutic effect of surgical debulking of bulky or multiple lymph nodes before concurrent chemoradiation therapy (CCRT) in cervical cancer stage IIICr.

Bulky or multiple lymph nodes metastasis in cervical cancer shows poor prognosis and can also diminish the effect of radiotherapy or concurrent chemoradiation therapy (CCRT). However, it is difficult to increase the dose of radiation and chemotherapy considering their side effects. Therefore, the objective of this study is to determine the therapeutic effect of surgical debulking of bulky or multiple lymph nodes before concurrent chemoradiation therapy (CCRT) compared to CCRT only, in cervical cancer stage IIICr. This study is a phase III, multicenter and randomized clinical trial (DEBULK trial).

* Concurrent chemoradiation therapy (CCRT)
* Surgical debulking of bulky or multiple lymph node followed by CCRT

Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr

Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr: A Phase III, Randomized Controlled Clinical Trial

To determine the accuracy of LN metastasis in imaging study

Gachon University Gil Medical Center

Seoul St. Mary's Hospital

Korea University Ansan Hospital

Samsung Medical Center

Gangnam Severance Hospital

Asan Medical Center

Ewha Womans University

Hanyang University

DongGuk University

Seoul National University Hospital

Severance Hospital

Keimyung University Dongsan Medical Center

Kyungpook National University Chilgok Hospital

Pusan National University Yangsan Hospital

Korean Gynecologic Oncology Group

CHA University

Study Principal Investigator

Radical hysterectomy followed by tailored adjuvant therapy

Primary concurrent chemoradiation therapy

Piver-Rutledge type III hysterectomy New classification type C2 hysterectomy Open, vaginal, laparoscopic assisted, laparoscopic, robotic radical hysterectomy are all allowed

Radical hysterectomy

After radical hysterectomy, intermediate risk group according to GOG protocol 92 criteria will receive adjuvant radiation therapy. High risk group will receive adjuvant chemoradiation therapy with weekly cisplatin (40mg/m2, IV for 6 cycles). Extended filed radiation therapy is allowed in case of common iliac lymph node or para-aortic lymph node metastasis. Intracavitary brachytherapy and nodal or parametrial boost is not allowed.

Tailored adjuvant therapy

Patient will receive primary radiation therapy including external pelvic irradiation, intracavitary brachytherapy, and parametrial or nodal boost. Extended filed radiation therapy is allowed in case of common iliac lymph node enlargement. Patients will receive concurrent weekly cisplatin (cisplatin 40mg/m2 for 6 cycles) during external radiation therapy.

Primary chemoradiation therapy

Joo-Hyun Nam, M.D., Ph.D.

To compare 5-year overall survival between patients who undergo radical hysterectomy followed by tailored adjuvant therapy and patients who receive primary chemoradiation therapy in FIGO stage IB2 and IIA2 cervical cancer

Radical Hysterectomy Followed by Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)

A Randomized Controlled Trial Comparing Radical Hysterectomy Plus Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)

Treatment related toxicity will be evaluated using CTCAE v3.0.

Professor

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Central Nervous System Stimulants

Psychotropic Drugs

Anti-Infective Agents

Cardiotonic Agents

Curcumin

Modafinil

Bupropion

Minocycline

Antidepressive Agents

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Neurotransmitter Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Anti-Bacterial Agents

Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.

Initial Dose 150 mg once a day (50 mg and 100 mg oral tablets) for 10 weeks.

Armodafinil

Initial Dose 100 mg two times a day (200 mg) for 10 weeks.

Initial Dose 4 gm stick pack once a day (4 gm) for 10 weeks.

Telephone Questionnaire

Zhongxing Liao, MD

The goal of this clinical research study is to compare armodafinil, bupropion, curcumin, and minocycline when given alone or in combination to learn which is better for controlling symptoms, such as the side effects of chemoradiation, when given to treat lung cancer.

The Study Drugs:

It is not known which study drug or combination of study drugs is better at reducing side effects patients may experience during chemoradiation therapy. For this reason, researchers have chosen 4 study drugs that may help to reduce side effects. The study drugs will be tested alone and in combination with each other.

Armodafinil is designed to prevent excessive sleepiness.

Bupropion is an antidepressant with anti-inflammatory properties that may help reduce multiple symptoms.

Curcumin is the active ingredient in the spice, turmeric. It may interfere with the production of cytokines (which cause inflammation), which may reduce multiple symptoms.

Minocycline is an antibiotic. Minocycline has been shown to interrupt cytokine production, which may help to reduce multiple symptoms.

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the roll of dice) to join 1 of 16 groups. You may be assigned to receive no study drugs, 1 study drug, or a combination of 2, 3, or all 4 of the study drugs.

During this study, you may receive 1 or more placebos. A placebo looks like the study drug(s) but has no active ingredients. There is a chance that you will be in a group that does not receive any study drugs at all. However, all patients are under standard care by their treating doctors.

Neither you nor the study staff you will see in the clinic will know if you are receiving the study drugs and/or the placebo(s). However, if needed for your safety, the study staff will be able to find out which study drug you are receiving.

Study Drug Administration:

You will take the study drugs/placebos every day for 10 weeks. You will take either single or combined study drug(s) or placebos by mouth everyday as instructed by the study doctor.

You will be given pamphlets with more information about how to take the study drugs/placebos.

You will be given a daily diary to write down when you take the study drugs/placebo. You should bring your study drug/placebo blister packs/sticks to the clinic to every study visit. You should also bring your diary to every visit.

Completing the Symptom Questionnaire:

Throughout the study, you will be asked to complete the symptom questionnaire. You will be asked about symptoms from therapy you may be experiencing and how they may be interfering with your daily activities. The study staff will either meet you during your regular clinic visit or call you at your home at a time that is convenient for you. In the clinic, you will complete the questionnaire by paper and pen, or by entering your answers into an electronic tablet computer. On the phone, study staff will ask you the questions and record your answers on paper or enter them into a computer. The symptom questionnaire will take up to 5 minutes to complete.

* During Weeks 1-10, you will complete the symptom questionnaire 2 times a week.
* During Weeks 11-16, you will complete the symptom questionnaire 1 time a week.

Study Visits:

Before you begin chemoradiation:

* You will complete 4 questionnaires about pain and other symptoms, your mood, and your quality of life. Completing all 4 of the questionnaires will take about 15 minutes.
* You will have a blood coagulation test, called a PT-INR, to make sure your blood clots normally.
* If you are a woman who is able to become pregnant, you will have a urine pregnancy test. The study staff will give you the pregnancy test kit at your scheduled visit, and will review and record the results of the test before your study prescriptions are filled by the pharmacy.

After 4 weeks of chemoradiation:

* You will complete 1 questionnaire about your quality of life. This questionnaire will take about 2-3 minutes to complete.
* You will have a blood coagulation test, called a PT-INR, to make sure your blood clots normally.

During the last week of chemoradiation (about Week 7):

-You will complete 3 questionnaires about your symptoms, mood, and quality of life. These questionnaires will take about 10 minutes total to complete.

After about Week 7, the study staff will call you 2 times a week to check on you until week 10. This phone call should last only a few minutes. If you have experienced several side effects from chemoradiation, this phone call make take longer.

About Week 12 (at a routine clinical visit):

* You will complete 3 questionnaires about your symptoms, mood, and quality of life.
* If you were smoking at the beginning of the study, you will complete a questionnaire that asks if you stopped smoking any time during the study. This will take a few minutes.
* You will have a blood coagulation test, called a PT-INR, to make sure your blood clots normally.
* You will be asked to complete another questionnaire that asks about your satisfaction with the study drug(s). This will take a few minutes.

Length of Study:

You will be on study for about 16 weeks. You will take the study drug(s) for 10 weeks and complete the symptom survey until 16 weeks. You will be taken off study if you experience intolerable side effects.

This is an investigational study. Armodafinil is FDA approved and commercially available for the treatment of excessive sleepiness. Bupropion is FDA approved and commercially available for the treatment of depression. Minocycline is FDA approved and commercially available for the treatment of bacterial infection. Curcumin is not FDA approved. At this time, curcumin is only being used in research. The different possible combinations of these drugs being used in this study is investigational.

Up to 32 patients will take part in this study. All will be enrolled at MD Anderson.

Reducing Symptom Burden - Non Small Cell Lung Cancer (NSCLC)

A Study of Reducing the Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in N2 Positive IIIA Non Small Cell Lung Cancer (NSCLC)	NCT00452803	Lung Cancer	chemotherapy Concurrent chem... Concurrent chem...	18 Years -	National Cancer Center, Korea
Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr	NCT05421650	Cervical Cancer	CCRT Surgical debulk... CCRT	20 Years - 70 Years	CHA University
Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr	NCT05421650	Cervical Cancer	CCRT Surgical debulk... CCRT	20 Years - 70 Years	CHA University
Radical Hysterectomy Followed by Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)	NCT01680523	Cervical Cancer	Radical hystere... Tailored adjuva... Primary chemora...	20 Years - 75 Years	Asan Medical Center
Reducing Symptom Burden - Non Small Cell Lung Cancer (NSCLC)	NCT01048983	Non Small Cell ...	Armodafinil Bupropion Minocycline Curcumin Telephone Quest...	18 Years - 65 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for concurrent chemoradiation therapy