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Small Cell Lung Carcinoma clinical trials

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NCT ID: NCT01809756 Terminated - Clinical trials for Non Small Cell Lung Cancer

The Effect of Caphosol® on the Development of Esophagitis in (N)SCLC Patients Treated With Concurrent Chemo/Radiotherapy

CARACTER
Start date: February 25, 2014
Phase: N/A
Study type: Interventional

Rationale: In the Netherlands 1770 people are being diagnosed with SCLC (Small Cell Lung Cancer) and 8764 patients are being diagnosed with NSCLC (Non Small Cell Lung Cancer) in 2011. This is approximately 15% and 75% of all new diagnosed lungcancers. Part of them will need a combination of chemo-radiationtherapy. A review of the incidence and severity of esophagitis in (N)SCLC patients receiving a combination of chemotherapy and once daily radiotherapy revealed overall esophagitis rates up to 58% experiencing esophagitis grade 2 and higher. As concurrent radiotherapy is moving to twice daily radiation (30 x 1,5 Gy in 3 weeks or 30-35 x 2 Gy in 3 weeks) it is expected that the incidence of esophagitis will rise, the clinical symptoms are likely to arise earlier and become more severe. Mucositis of the upper tractus digestivus is a serious adverse event leading to pain, problems with swallowing and decreased food intake. It has a negative infect on QoL and can lead to prolonged hospital stay and delayed cancer treatment. Physicians seek improvements in treatment modalities to improve these daily patient toxicities. Caphosol® is an advanced electrolyte solution indicated as an adjunct to standard oral care in treating oral mucositis caused by radiation or high dose chemotherapy. Positive effects of Caphosol® oral rinse 4 times daily in a study with head and neck chemoradiation patients were found on the presence of mucositis and on oral comfort. It's supposed that the pathogenesis of chemo- or radiotherapy induced mucositis is the same for the whole tractus digestivus. The appearance does differ due to differences in cell proliferation. Swallowing Caphosol® after oral rinse could have a positive effect on esophageal mucositis on time of onset, severity and duration. Objective: Adding the use of Caphosol® (rinsing and swallowing four times a day) to the standard of care for esophagitis/mucositis, reduces the incidence, onset, duration and severity of esophagitis in (N)SCLC patients, comparing to the standard of care alone. Study design: A multi-centre, open, randomized prospective phase II study. Study population: 108 patients 18 years or older with histologically proven (N)SCLC (all histological subtypes), treated with concurrent chemo- and radiotherapy are estimated to be included in this study (2:1 ratio inclusion; 72 patients with Caphosol® and 36 patients without Caphosol®; α=0.05, power 80%). Intervention (if applicable): 108 patients eligible for this study will be monitored during their (N)SCLC chemo/radiotherapy treatment. One group of 72 patients will receive Caphosol®, 4 times a day - next to the standard of care. Caphosol® will start at day 1 of treatment and will be continued until 3 weeks after the last radiotherapy (RT).Another group of 36 patients will receive only the current standard of care for esophagitis. The patients will be randomly assigned to one of the groups. Main study parameters/endpoints: The primary objective is to estimate the incidence, onset, duration and severity of esophagitis in (N)SCLC patients undergoing radiation therapy with chemotherapy who receive Caphosol®. Secondary study parameters/outcome of the study (if applicable): 1. To correlate components of esophagitis data with clinical outcomes (pain, dysphagia, analgetic use, oral intake, weight loss, infection, need for hospitalization, QoL) 2. Discontinuation or delay of chemotherapy due to esophagitis. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks are very small. The patient has to fill in a Esophagitis Daily Questionnaire and during regular visits QOL questionaires are performed. Sputumswabs are collected on a weekly basis for determination of the microbiological flora of the mouth. During regular blood control max. 8 ml extra blood is taken for immunologic status research. Caphosol® is a saturated calciumphosphate solution. The daily intake of calcium and phosphor when swallowing Caphosol® 4 times daily is far beyond the Acceptable Daily Intake (ADI)(< 5%). Compared to daily nutrients like milk (270 mg calcium per unit milk (225 ml)) or meat (200 mg phosphor per 100 g meat) the intake of calcium and phosphor due to Caphosol® is negligible and is considered safe.

NCT ID: NCT01803269 Terminated - Clinical trials for Extensive Stage Small Cell Lung Cancer

Topotecan Hydrochloride or Cyclodextrin-Based Polymer-Camptothecin CRLX101 in Treating Patients With Recurrent Small Cell Lung Cancer

Start date: January 16, 2013
Phase: Phase 2
Study type: Interventional

This randomized phase II trial studies how well giving topotecan hydrochloride or cyclodextrin-based polymer-camptothecin CRLX101 works in treating patients with recurrent small cell lung cancer. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cyclodextrin-based polymer-camptothecin CRLX101 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether topotecan hydrochloride is more effective than cyclodextrin-based polymer-camptothecin CRLX101 in treating patients with lung cancer.

NCT ID: NCT01797874 Completed - SCLC Clinical Trials

Pazopanib Maintenance for SCLC

Start date: June 2013
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy of pazopanib maintenance after 1st line CTx for SCLC.

NCT ID: NCT01797159 Completed - Clinical trials for Small-cell Lung Cancer

Hippocampal Prophylactic Cranial Irradiation for Small Cell Lung Cancer

Start date: March 11, 2013
Phase: N/A
Study type: Interventional

The Investigators are looking to compare standard treatment for the management of small cell lung cancer (SCLC) which is prophylactic cranial Irradiation (PCI) (shown to be very good in patient survival) with cranial sparing PCI. Although standard of care PCI is successful in patient survival it also has neurologic side-effects. The Investigators are hoping the cranial sparing PCI has the same positive survival results with the added benefit of lowering neurological side-effects.

NCT ID: NCT01784107 Recruiting - Clinical trials for Small Cell Lung Cancer

A Phase Ib/II Trial of Belotecan and Ifosfamide in Patients With Extensive Disease of Small Cell Lung Cancer

Start date: July 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Phase 1 : To evaluate MTD(Maximal tolerated dose)and DLT(Dose limiting Toxicity) of Belotecan and Ifosfamide. Phase 2 : To analyse efficacy and toxicity of Belotecan and Ifosfamide.

NCT ID: NCT01780675 Completed - Lung Cancer Clinical Trials

Hippocampus Avoidance PCI vs PCI

HA-PCI
Start date: April 2013
Phase: Phase 3
Study type: Interventional

Using Intensity Modulated radiotherapy it is possible to treat the entire brain to standard dosages of whole-brain radiation, while keeping the radiation dose to the hippocampus low. However, a clear relationship between radiation dose and damage to the hippocampal stem cells has not been established yet. This study is initiated to investigate the early and delayed neurotoxicity of PCI and to assess in a randomised design the benefits and risks of sparing the hippocampus in Small Cell Lung Cancer patients who receive PCI.

NCT ID: NCT01770665 Terminated - Clinical trials for Mesothelioma, Small Cell Lung Cancer, NSCLC

Validation of the MiCK Assay

MiCK Assay
Start date: June 2012
Phase: N/A
Study type: Observational [Patient Registry]

Testing Mayo Clinic cancer patients with the results being correlated with prior patient therapy, performance status, and extent of disease.

NCT ID: NCT01752517 Recruiting - Clinical trials for Small Cell Lung Cancer

Vinorelbine and Ifosfamide as Third-line Treatment for Refractory Small Cell Lung Cancer

Start date: December 2012
Phase: N/A
Study type: Observational

Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and etoposide(CE)and second-line therapy with topotecan has been given, patients with ED-SCLC still relapse and 2-year survival is less than 10%. There is no standard treatment recommendation for this group of patients who failed to second-line therapy and had good performance status. Some cytotoxic drugs for the treatment of non-small cell lung cancer, i.e. vinorelbine, paclitaxel, and ifosfamide, were used in refractory or recurrent SCLC patients. Recently, a retrospective study showed the overall response rate was 30%, the median progression free survival (PFS) was 6.5 months, and the median overall survival was 10.4 months in advanced combined SCLC patients treated with first-line regimen of vinorelbine, ifosfamide and cisplatin (NIP). Because of the previous platinum administration and patient's performance status, only vinorelbine and ifosfamide (NI) are combined and used as third-line therapy for refractor or recurrent ED-SCLC in our lung cancer center. And this clinical trial is designed to prospectively investigate the efficacy and safety of NI regimen in refractory or recurrent ED-SCLC patients in our center.

NCT ID: NCT01745445 Recruiting - Clinical trials for Small Cell Lung Cancer

Clinical Randomized Study of Concurrent Chemo-radiotherapy vs Radiotherapy Alone to Local-advanced Small Cell Lung Cancer (SCLC)

SCLC
Start date: January 2012
Phase: Phase 2
Study type: Interventional

This trial aims to evaluate the efficacy and safety between radiotherapy alone and concurrent chemo-radiotherapy after 3-4 cycles of chemotherapy in LS-SCLC.

NCT ID: NCT01737502 Completed - Clinical trials for Stage IV Non-Small Cell Lung Cancer

Sirolimus and Auranofin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer or Small Cell Lung Cancer

Start date: May 14, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies the side effects and best dose of auranofin when given together with sirolimus and to see how well it works in treating patients with lung cancer that has spread or other places in the body and cannot be cured or controlled by treatment or has come back after a period of time during which the cancer could not be detected. Auranofin and sirolimus may stop or slow the growth of lung cancer.