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S-1 versus capecitabine in the first line treatment of metastatic colorectal cancer patients, the SALTO randomised phase III study of the Dutch Colorectal Cancer Group. A safety evaluation of oral fluoropyrimidines.

The primary objective is to determine the incidence of HFS in first line treatment with S-1 compared to capecitabine in patients with metastatic colorectal cancer. Secondary objectives include a comparison of efficacy.

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

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…

Diagnostic value of novel MR imaging techniques for the primary staging and restaging of rectal cancer

The primary objectives are to determine the diagnostic performance of gadofosveset-enhanced T1-weighted MR imaging for the discrimination between pN0 and pN+ patients for both primary staging and restaging after chemoradiotherapy and to determine…

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, open-label, multi-center phase III study to evaluate the efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).

To compare progression free survival (PFS) of nilotinib and imatinib when used as initial therapy of unresectable and/or metastatic GIST in patients either who have not received prior therapy with TKIs or who have recurrent GIST after stopping…

A randomized, open-label, multi-center study to evaluate the efficacy of nilotinib versus best supportive care with or without a tyrosine kinase inhibitor (investigator's choice) in adult patients with gastrointestinal stromal tumors resistant to both imatinib and sunitinib.

Primary* To evaluate whether the efficacy of nilotinib is superior to the control arm (as measured by progression free survivalSecondary* To compare the response rate, and time to response, duration of response, and time to tumor progression of…

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.

An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU 285 vs Regorafenib in Patients with Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)

Primary Objective:* The primary objective is to demonstrate the efficacy of avapritinib based on progression-free survival (PFS) determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST),…

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…

A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA) /Irinotecan (FOLFIRI)/Cetuximab with a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients with BRAF V600E mutant Metastatic Colorectal Cancer

Safety Lead-inIn patients with BRAF V600E mutant (BRAFV600E) metastatic colorectal cancer (mCRC):Primary: • Assess the safety/tolerability of the combination of encorafenib + binimetinib + cetuximabSecondary:• Assess the activity of encorafenib +…

An open-label, randomised, phase III Study cOmparing trifLuridine/tipiracil (S 95005) in combination with bevacizumab to capecitabine in combination with bevacizumab in firST-line treatment of patients with metastatIC colorectal cancer who are not candidatE for intensive therapy

To demonstrate the superiority of S 95005 + bevacizumab over capecitabine + bevacizumab in terms of Progression-free survival (PFS) based on Investigator assessment in first-line treatment of patients with unresectable metastatic colorectal cancer…

A prospective, randomised, controlled, open-label, multicentre phase III study to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).

This study has been transitioned to CTIS with ID 2023-510444-21-00 check the CTIS register for the current data. The primary objective is to demonstrate the efficacy of Peptide Receptor Radionuclide Therapy with 177Lu-edotreotide to prolong…

Treatment strategies in colorectal cancer patients with initially unresectable liver-only metastases. CAIRO5 a randomized phase 3 study of the Dutch Colorectal Cancer Group (DCCG)

To determine the median progression-free survival (PFS) and R0/1 secondary resection rate upon induction systemic treatment in colorectal cancer patients with initially unresectable liver-only metastases, stratified by RAS and BRAF tumor mutation…

A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination with Chemotherapy with or without Tislelizumab in Subjects with HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma (GEA)

This study has been transitioned to CTIS with ID 2023-510319-20-00 check the CTIS register for the current data. Primary objective:- To compare the efficacy of zanidatamab in combination with chemotherapy or in combination with chemotherapy and…

A Randomized, Phase 3 Study of Eryaspase in Combination with Chemotherapy versus Chemotherapy Alone as Second-Line Treatment in Patients with Pancreatic Adenocarcinoma

Primary Objective:To determine whether the addition of eryaspase to chemotherapy improves overall survival (OS) in second-line treatment of pancreatic adenocarcinoma compared to chemotherapy alone.Secondary Objectives:• To compare progression-free…

A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination with Cisplatin+5-Fluorouracil versus Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects with Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma;

Primary objectives:(1) Evaluate Progression Free Survival (PFS) per RECIST 1.1 as assessed by blinded central radiologists' review in subjects with PD-L1 Combined Positive Score (CPS) *1. (2) Evaluate overall survival (OS).Secondary Objectives(…

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.

Adjuvant chemotherapy for prevention of recurrence in patients with detectable ctDNA after surgery in high-risk rectal cancer.

This study has been transitioned to CTIS with ID 2024-517700-12-00 check the CTIS register for the current data. To improve disease-free survival in patients with high-risk rectal cancer by treating these patients with adjuvant chemotherapy in case…

Hepatic arterial infusion PUMP chemotherapy combined with systemic therapy versus systemic therapy alone as Induction Therapy for initially unresectable colorectal liver metastases: a randomised controlled trial

The main objective of this trial is to investigate whether HAIP with concomitant systemic therapy prolongs overall survival in chemo-naive patients with initially unresectable synchronous colorectal liver metastases as compared with systemic therapy…