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Prognostic and predictive value of 18F-fluoroazomycin arabinoside-PET/CT in head and neck squamous cell carcinoma

2 Objectives2.1 Primary objective •To evaluate FAZA-PET/CT as a prognostic factor of the loco-regional control rate at 2 years in HNSCC patients receiving chemo-radiotherapy ± nimorazole.•Time to locoregional recurrence is counted from the day of…

Prospective evaluation of the predictive value of a circulating tumor cell (CTC) sensitivity profile to Cisplatin chemotherapy in metastatic breast cancer patients

The aim of this study is to prospectively explore the predictive value of a cDDP-sensitivity profile determined in CTCs of metastatic BC patients previously treated with at least antracycline- and taxane-based chemotherapy.

Multi-arm, Non-randomized, Open-Label Phase IB Study to Evaluate GSK3052230 in Combination with Paclitaxel and Carboplatin, or Docetaxel or as Single Agent in Subjects with Solid Malignancies and Deregulated FGF Pathway Signaling (FGF117360)

Primary: to characterize the safety and tolerability of GSK3052230 in combination with chemotherapy regimens, to determine the MTD and to assess overall response rate in patients with stage IV or recurrent squamous NSCLC with FGFR1 gene…

De-ESCALaTE HPV: Determination of Epidermal growth factor receptor-inhibitor (cetuximab) versus Standard Chemotherapy (cisplatin) early And Late Toxicity Events in Human Papillomavirus-positive oropharyngeal squamous cell carcinoma.

Primary objective: To compare the severe (acute and late) toxicity (Grade 3-5), as assessed by CTCAE Version 4, caused by cetuximab and RT to that caused by cisplatin and RT in patients with HPV+OPSCC.Secondary objectives:- Compare overall number of…

Phase I study evaluating indomethacin in combination with platinum-based chemotherapy

Phase I study to investigate safety of the combination indomethacin and two platinum-based chemotherapy regimens in patients with advanced cancers.

A randomized study with cisplatinum concomitant with standard or adaptive high dose radiotherapy for advanced head and neck cancer.

The most important questions of this phase III trial is:Can adaptive high dose radiotherapy improve loco-regional control without increase of toxicity?

ACNS 0331: a study evaluating limited target volume boost irradiation and reduced dose craniospinal radiotherapy (18.00 Gy) and chemotherapy in children with newly diagnosed standard risk medulloblastoma: a phase III double randomized trial.

The aim of the study is to assess if a dose reduction of craniospinal irradiation in children with a medulloblastoma does not reduce event free survival (EFS) or overall survival (OS). Furthermore it will be assessed if a field reduction (only tumor…

A phase 1b/2 study with the agonistic TRAIL-R1 antibody, mapatumumab, in combination with cisplatin and radiotherapy as a first line therapy in patients with advanced cervical cancer

Primary objective:Phase 1b:-To evaluate the safety and tolerability of escalating doses of mapatumumab in combination with cisplatin and radiotherapy in subjects with locally advanced cervical cancer.Phase 2:-To evaluate the efficacy of mapatumumab…

A phase Ib/II, open-label, multicenter trial with oral cMET inhibitor INC280 alone and in combination with erlotinib versus platinum/pemetrexed in adult patients with EGFR mutated, cMET-amplified, locally advanced/metastatic non-small cell lung cancer (NSCLC) with acquired resistance to prior EGFR tyrosine kinase inhibitor (EGFR TKI)

Primary phase 1: To determine MTD and/or RP2D of INC280 incombination with erlotinibPrimary phase 2: To compare the antitumor activity of INC280 alone, and INC280 in combination with erlotinib, vs platinum with pemetrexed, as measured by Progression…

The Effect of Prehydration on the Pharmacokinetics of Low-dose Cisplatin

To determine if there is a difference in the pharmacokinetics of low-dose cisplatin with and without prehydration.

Phase I/II study of combined treatment with AT-101, cisplatin and radiotherapy in patients with locally advanced head and neck cancer

Primary objective:The main objective of this study is to assess the feasibility, tolerability and the maximum tolerated dose (MTD) of oral AT-101 in combination with concurrent cisplatin-based chemotherapy and radiotherapy (RT) in advanced HNSCC, as…

A randomized phase III study of adjuvant chemotherapy in patients with completely resected Non-Small-Cell Lung Cancer and low risk for recurrence: NVALT-8A

The primary aim of the study is to investigate whether it is possible to select patients by PET in a good prognosis group (i.e. low SUV) who will not benefit from adjuvant chemotherapy.

Phase 1b Multiple Ascending Dose Study of BMS-833923 (XL139) Administered in Combination with Cisplatin and Capecitabine as First-Line Therapy in Patients with Inoperable Metastatic Gastric, Gastroesophageal, or Esophageal Adenocarcinomas

To establish the MaximumTolerated Dose, Dose Limiting Toxicities, and the safety profile of BMS-833923 administered in combination with cisplatin and capecitabine as first-line therapy. To describe preliminary evidence of tumor response as measured…

Open-label, randomised, multi-center study investigating Cetuximab, in combination with concurrent chemo- / radiotherapy in locally advanced non-small cell lung carcinoma

The aim of the study is to assess the feasibility of combined treatment of Cisplatin, Cetuximab and concurrent RT and to get insight in the clinical efficacy (for study schedule, see flow chart 1). The first phase of the study will mainly focus on…

A randomised phase II study of radio-chemotherapy with or without panitumumab (Vectibix®) in irresectable squamous cell carcinoma or adenocarcinoma of the oesophagus (Panoramic)

Primary Objective: Description of the 1-year overall survival after chemo-radiation therapy with or without panitumumab in irresectable carcinoma of the oesophagus. The control arm is used to validate whether the historical cohort used for…

A 2-step phase I study evaluating the safety of (neo-)adjuvant cisplatin-pemetrexed and stereotactic radiotherapy for patients with stage IB non-small-cell lung cancer

Primary goal is studying the safety and feasibility of administering chemotherapy (cisplatin and pemetrexed) after of before treatment with stereotactic radiotherapy by observing and recording toxicity during and after the study.

Allogeneic Stem Cell Transplantation after Reduced Intensity Conditioning for High-risk Relapsed or Refractory CLL

Evaluation of the effect of salvage therapy with R-DHAP followed by reduced-intensity conditioning and allogeneic stem cell transplantation from a sibling or unrelated donor

PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF THE EFFICACY AND SAFETY OF CRIZOTINIB VERSUS PEMETREXED/CISPLATIN OR PEMETREXED/CARBOPLATIN IN PREVIOUSLY UNTREATED PATIENTS WITH NON-SQUAMOUS CARCINOMA OF THE LUNG HARBORING A TRANSLOCATION OR INVERSION EVENT INVOLVING THE ANAPLASTIC;LYMPHOMA KINASE (ALK) GENE LOCUS

To demonstrate that crizotinib (Arm A) is superior to first-line chemotherapy, pemetrexed/cisplatin or pemetrexed/carboplatin (Arm B), in prolonging PFS in patients with advanced non-squamous NSCLC whose tumors harbor a translocation or inversion…

A double-blind, placebo-controlled, randomized, multicenter phase III study evaluating the efficacy and safety of pertuzumab in combination with trastuzumab and chemotherapy in patients with HER2-positive metastatic gastro-esophageal junction and gastric cancer

Pertuzumab is the investigational agent being studied for the treatment of HER2-positive gastric cancer. This study is to compare the overall survival (OS) in patients treated with pertuzumab in addition to trastuzumab (Herceptin®) plus cisplatin…

A Single-Arm, Multicenter, Open-Label, Phase 2 Study of;Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab;(IMC-11F8) in the First-Line Treatment of Patients With;Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

The primary objective of this study is to estimate the best objective response rates (ORR; complete response [CR] + partial response [PR]) associated with gemcitabine-cisplatin plus necitumumab in chemotherapy-naïve patients with Stage IV squamous…