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A Phase 3, Randomized, Placebo-controlled, Multicenter, Double-blind Study to Evaluate the Safety and Efficacy of Telotristat Etiprate (LX1606) in Patients with Carcinoid Syndrome

Primary Study Objective: To evaluate the effect of telotristat etiprate versus placebo over the double-blind portion of the study on the incidence of treatment-emergent adverse events (TEAEs)

A prospective, multicenter, randomised, open-label, active controlled, 2 parallel groups, phase 3 study to compare the efficay and safety of masitinib to sunitinib in patients with gastrointestinal stromal tumor after progression with imitinib

The objective is to compare the efficacy and safety of masitinib 12 mg/kg/day to sinutinib 50 mg/day

A prospective, multicenter, randomized, open-label, active-controlled, phase III study to compare efficacy and safety of masitinib to imatinib at 400 or 600 mg in treatment of patients with gastro-intestinal stromal tumour in first line medical treatment

Safety and efficacy objectives:The objective is to compare the safety and efficacy of masitinib at 6 of 7.5 mg/kg/day to imatinib at 400 or 600 mg, in patients with gastro-intestinal stromal tumour in first line medical treatment.

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Capecitabine and Cisplatin With or Without Ramucirumab as First-line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (RAINFALL)

The primary objective of this study is to compare PFS of ramucirumab in combination with capecitabine (or 5-fluorouracil [5-FU]) and cisplatin versus placebo in combination with capecitabine (or 5-FU) and cisplatin as first-line treatment in…

Perioperative selective decontamination of the digestive tract (SDD) in elective colorectal cancer patients: a multicenter randomized clinical trial

The primary objective of this randomized clinical trial is to evaluate if perioperative SDD can reduce anastomotic leakage rate and other infectious complications while thereby simultaneously improving long-term oncological outcome. Secondary…

A Randomized, Double-Blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine

The primary objective of this study is to compare overall survival (OS) in patients with metastatic colorectal carcinoma (CRC) when treated with FOLFIRI in combination with placebo versus FOLFIRI in combination with ramucirumab DP.Secondary…

The influence of micrometastases on prognosis and survival in stage I-II colon cancerpatients: the EnRoute+ study

The purpose of the study is to delineate the upstaging percentage of pN0 patients by detection of micrometastases (pN0micro+) and evaluate the benefits from adjuvant chemotherapy on disease recurrence in pN0micro+ CC patients.

A randomized, double-blind, placebo-controlled phase III study of regorafenib plus BSC versus placebo plus BSC in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy

To evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapies.The primary efficacy endpoint of this study is * Overall survivalThe secondary efficacy endpoints of this…

A Randomized, Multicenter, Open-label, Phase 3 Study to Compare the Efficacy and Safety of Panitumumab and Cetuximab in Subjects with Previously Treated, Wild-type KRAS, Metastatic Colorectal Cancer

The purpose of this clinical research study is to compare the effect of panitumumab to cetuximab (Erbitux®) in treating metastatic colorectal cancer in patients whose tumor contains the wild-type (unchanged) KRAS gene and who have previously been…

Prevention of radiation-induced parotid gland dysfunction by parotid-gland stem-cell sparing intensity-modulated radiotherapy (SCS-IMRT)

To investigate whether stem cell sparing radiotherapy results in a lower risk of dry-mouth syndrome than current standard treatment technique.

A phase III randomized study evaluating surgery of residual disease in patients with metastatic gastro-intestinal stromal tumor responding to Imatinib mesylate.

The primary objective of this study is to evaluate whether surgery of residual disease in patients iwth advanced GIST responding to Imatinib improves the progression free survival.The secondary objective is to correlate the pharmacokinetics of…

EXPAND (Erbitux in combination with Xeloda and cisplatine in advanced esophago-gastric cancer);Open-label, randomized, controlled, multicenter phase III study investigating cetuximab in combination with capecitabine (Xeloda, X) and cisplatin (P) versus XP alone as first-line treatment for subjects with advanced gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction.

To demonstrate superiority of XP chemotherapy regimen plus cetuximab versus XP alone asfirst-line treatment for advanced gastric cancer in terms of PFS. To assess cetuximab + XP versus XP alone with respect to: OS; overall response; QoL; safety.

A Randomized, Multicenter Phase 3 Study to Compare the Efficacy of Panitumumab in Combination with Chemotherapy to the Efficacy of Chemotherapy Alone in Patients with Previously Treated Metastatic Colorectal Cancer

The primary objective is to evaluate the treatment effect of P*mAb plus FOLFIRI on overall survival (OS) and progression-free survival (PFS) compared to FOLFIRI alone as second line therapy for metastatic colorectal cancer.

A double-blind, randomised, placebo controlled Phase III study of
nintedanib plus best supportive care (BSC) versus placebo plus BSC in
patients with colorectal cancer refractory to standard therapies.

The objective of this Phase III study is to evaluate the efficacy and safety of nintedanib in patients with mCRC after failure of previous treatment with standard chemotherapy and biological agents.

A Randomized Trial of Dose Escalation in definitive Chemoradiotherapy for patients with Oesophageal cancer *ART DECO*

To improve the local tumor control rate by escalating the radiation dose in definitive chemoradiotherapy for patients with locally irresectable or medically inoperable carcinoma of the esophagus or gastric junction without distant metastases (stage…

A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter, Double-blind Study to Evaluate the Efficacy and Safety of Telotristat Etiprate (LX1606) in Patients with Carcinoid Syndrome Not Adequately Controlled by Somatostatin Analog (SSA) Therapy

The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the change from baseline in the number of daily bowel movements (BMs) averaged over the 12-week…

A multicenter randomized phase III trial of neo-adjuvant chemotherapy followed by surgery and chemotherapy or by surgery and chemoradiotherapy in resectable gastric cancer (CRITICS-study: ChemoRadiotherapy after Induction chemoTherapy In Cancer of the Stomach).

This study investigates whether chemoradiotherapy (45 Gy in 5 weeks with daily cisplatin and capecitabine) after preoperative chemotherapy (3x ECC (epirubicin, cisplatin, capecitabine)) and adequate (D1+) surgery leads to improved survival in…

Second and third look laparoscopy in pT4 colon cancer patients for early detection of peritoneal metastases; the COLOPEC 2 randomized multicentre trial.

The primary aim of this study is to determine the added value of third look DLS to detect PM at a clinically occult stage following a negative second look DLS.

A Phase 3 Randomized Clinical Trial of Nivolumab alone, Nivolumab in
Combination with Ipilimumab, or an Investigator's Choice Chemotherapy in
Participants with Microsatellite Instability High (MSI-H) or Mismatch
Repair Deficient (dMMR) Metastatic Colorectal Cancer

This study has been transitioned to CTIS with ID 2023-503956-29-00 check the CTIS register for the current data. Primary Objective:All lines1) To compare the BICR-assessed PFS of participants with centrally confirmed dMMR/MSI-H mCRC and randomized…

HERBERT II: external beam radiation therapy followed by high-dose rate endorectal brachytherapy (HDRBT) in elderly early rectal cancer patients not undergoing surgery: A randomized multicenter phase III study

To assess the added value of a brachytherapy boost after external beam radiotherapy in elderly, frail patients with rectal cancer.