Rectal Cancer Clinical Trial
— CAIRO4Official title:
The Role of Surgery of the Primary Tumour With Few or Absent Symptoms in Patients With Synchronous Unresectable Metastases of Colorectal Cancer, a Randomized Phase III Study. A Study of the Dutch Colorectal Cancer Group (DCCG)
NCT number | NCT01606098 |
Other study ID # | CAIRO4 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | July 2012 |
Est. completion date | December 2022 |
Verified date | September 2023 |
Source | Dutch Colorectal Cancer Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The clinical benefit of resection of the primary tumour in patients with synchronous unresectable metastases is not known. In the literature studies usually describe retrospective selected patients with synchronous metastases treated with or without resection of the primary tumour. All these studies are biased in patient selection and there are no prospective randomized studies on this topic. In patients with few or absent symptoms of the primary tumour, arguments both in favour and against initial resection have been presented, and therefore a randomized trial is warranted. Although recent publications suggest that resection of the primary tumour in synchronous metastasized colon cancer patients might not be necessary, this appears to be based on feasibility and not on clinical outcome. Several studies comparing large groups of patients with or without resection of the primary tumour suggest an improved survival when the primary tumour is resected. A potential benefit of resection of the primary tumour is to prevent complications of the primary tumour during chemotherapy treatment or during later stages of the disease. A recent analysis of the CAIRO and CAIRO2 data showed that metastatic colon cancer patients who had a resection of the primary tumour prior to study entry, had an improved survival compared to patients without a resection of the primary tumour. However, these patients were selected after the primary tumour was resected and therefore these results are not corrected for surgical morbidity and mortality. The investigators here propose a randomized trial in order to demonstrate that resection of the primary tumour does improve overall survival.
Status | Completed |
Enrollment | 206 |
Est. completion date | December 2022 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histological proof of colorectal cancer - Resectable primary tumour in situ with unresectable distant metastases - No indication for neo-adjuvant (chemo)radiation - No severe signs or symptoms related to the primary tumour (i.e. severe bleeding, obstruction, severe abdominal pain) that require immediate surgery or other symptomatic treatment (e.g. stenting) - No prior systemic treatment for advanced disease - Age = 18 years - WHO performance status 0-2 - Laboratory values obtained = 4 weeks prior to randomization: Adequate bone marrow function (Hb = 6.0 mmol/L, absolute neutrophil count = 1.5 x 109/L, platelets = 100 x 109/L), renal function (serum creatinine = 1.5x ULN and creatinine clearance, Cockroft formula, = 30 ml/min), liver function (serum bilirubin = 2 x ULN, serum transaminases = 3 x ULN without presence of liver metastases or = 5x ULN with presence of liver metastases) - Expected adequacy of follow-up - Written informed consent - CT scan abdomen and CT thorax/X-thorax performed = 4 weeks prior to randomization Exclusion Criteria: - Pregnancy, lactation - Unresectable primary tumour (i.e. neurovascular encasement, substantial ingrowth in pancreatic head), or any condition preventing the safety or feasibility of resection of the primary tumour, i.e. massive ascites or extensive peritoneal disease - Requirement of neoadjuvant (chmo)radiation therapy - Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin - Any medical condition that prevents the safe administration of systemic treatment - Previous intolerance of fluoropyrimidines, known dihydropyrimidine dehydrogenase (DPD) deficiency - Planned radical resection of all metastatic disease - Uncontrolled hypertension, i.e. values consistently > 150/100 mmHg - Use of = 3 antihypertensive drugs - Significant cardiovascular disease < 1 yr before randomization (symptomatic congestive heart failure, myocardial infarction, unstable angina pectoris, serious uncontrolled cardiac arrhythmia, cerebro vascular event) - Chronic active infection - Concurrent treatment with any other anti-cancer therapy as described per protocol |
Country | Name | City | State |
---|---|---|---|
Denmark | University Hospital Aalborg | Aalborg | |
Denmark | Rigshospitalet | Copenhagen | |
Denmark | Herlev Hospital | Herlev | |
Denmark | Regionshospital Herning | Herning | |
Denmark | Roskilde hospital | Roskilde | |
Netherlands | Medisch Centrum Alkmaar | Alkmaar | |
Netherlands | Ziekenhuisgroep Twente | Almelo | |
Netherlands | Flevoziekenhuis | Almere | |
Netherlands | Ziekenhuis Amstelland | Amstelveen | |
Netherlands | Academic Medical Centre | Amsterdam | |
Netherlands | OLVG | Amsterdam | |
Netherlands | VUMC | Amsterdam | |
Netherlands | Gelre Ziekenhuis | Apeldoorn | |
Netherlands | Wilhelmina Ziekenhuis | Assen | |
Netherlands | Rode Kruis Ziekenhuis | Beverwijk | |
Netherlands | Amphia Ziekenhuis | Breda | |
Netherlands | Jeroen Bosch | Den Bosch | |
Netherlands | MC Haaglanden en Bronovo Nebo | Den Haag | |
Netherlands | Slingeland Ziekenhuis | Doetinchem | |
Netherlands | Albert Schweitzer Ziekenhuis | Dordrecht | |
Netherlands | Catharina Ziekenhuis | Eindhoven | |
Netherlands | Maxima Medisch Centrum | Eindhoven | |
Netherlands | St Annaziekenhuis | Geldrop | |
Netherlands | Groene Hart Ziekenhuis | Gouda | |
Netherlands | Martini Ziekenhuis | Groningen | |
Netherlands | UMCG | Groningen | |
Netherlands | Spaarne Gasthuis | Haarlem | |
Netherlands | St Jansdal | Harderwijk | |
Netherlands | Elkerliek Ziekenhuis | Helmond | |
Netherlands | Spaarne Gasthuis | Hoofddorp | |
Netherlands | St Antonius Ziekenhuis | Nieuwegein | |
Netherlands | Radboudumc | Nijmegen | |
Netherlands | Waterland Ziekenhuis | Purmerend | |
Netherlands | Laurentius Ziekenhuis | Roermond | |
Netherlands | Erasmus MC | Rotterdam | |
Netherlands | Fransicus Gastuis & Vlietland | Rotterdam | |
Netherlands | Maasstad Ziekenhuis | Rotterdam | |
Netherlands | Antonius Ziekenhuis | Sneek | |
Netherlands | Ziekenhuis Rivierenland | Tiel | |
Netherlands | Elisabeth-Tweesteden | Tilburg | |
Netherlands | Bernhoven Ziekenhuis | Uden | |
Netherlands | University Medical Centre Utrecht | Utrecht | |
Netherlands | Bernhoven Ziekenhuis | Veghel | |
Netherlands | VieCuri Medisch Centrum | Venlo | |
Netherlands | Zaans Medisch Centrum | Zaandam | |
Netherlands | Isala Klinieken | Zwolle |
Lead Sponsor | Collaborator |
---|---|
Dutch Colorectal Cancer Group | Hoffmann-La Roche |
Denmark, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | Overall survival of the intent-to-treat population | Time from randomisation until death, assessed up to 5 years | |
Secondary | Progression-free survival | Time from randomisation until first progression or death whichever comes first, asessed up to 5 years | ||
Secondary | Response to chemotherapy | Response rate according to RECIST 1.1 | Fist-line chemotherapy, assessed until progression | |
Secondary | Systemic therapy related toxicity | Adverse events grade 3-4 according to NCI-CTC 4.0 | Every 3 weeks during first-line treatment | |
Secondary | Surgery related morbidity and mortality | 30 days | ||
Secondary | Quality of life | EORTC QLQ-C30 and CR38 | Every 6 months from randomisation until first progression | |
Secondary | Interval between randomization and initiation of systemic treatment | Number of days between randomization and initiation of systemic treatment | ||
Secondary | Cost-benefit analyses | Until end of first-line systemic treatment | ||
Secondary | Patients requiring resection of the primary tumour in the non-resection arm | Number of patients requiring resection of the primary tumour in the non-resection arm | Time from randomisation until death, assessed up to 5 years | |
Secondary | Overall survival in patients in whom treatment according to protocol was initiated | Having received at least one cycle of systemic treatment in arm A and surgery in arm B | Time form randomisation until death, assessed up to 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06380101 -
Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)
|
N/A | |
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Recruiting |
NCT04323722 -
Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04088955 -
A Digimed Oncology PharmacoTherapy Registry
|
||
Active, not recruiting |
NCT01347697 -
Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer
|
N/A | |
Recruiting |
NCT04495088 -
Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer
|
Phase 3 | |
Withdrawn |
NCT03007771 -
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
|
Phase 1 | |
Terminated |
NCT01347645 -
Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT03520088 -
PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS
|
N/A | |
Recruiting |
NCT05556473 -
F-Tryptophan PET/CT in Human Cancers
|
Phase 1 | |
Recruiting |
NCT04749381 -
The Role of TCM on ERAS of Rectal Cancer Patients
|
Phase 2 | |
Enrolling by invitation |
NCT05028192 -
Mitochondria Preservation by Exercise Training: a Targeted Therapy for Cancer and Chemotherapy-induced Cachexia
|
||
Recruiting |
NCT03283540 -
Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence
|
||
Completed |
NCT04534309 -
Behavioral Weight Loss Program for Cancer Survivors in Maryland
|
N/A | |
Recruiting |
NCT05914766 -
An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
|
N/A | |
Recruiting |
NCT04852653 -
A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer
|
||
Recruiting |
NCT03190941 -
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients
|
Phase 1/Phase 2 | |
Completed |
NCT02810652 -
Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection
|
N/A | |
Terminated |
NCT02933944 -
Exploratory Study of TG02-treatment as Monotherapy or in Combination With Pembrolizumab to Assess Safety and Immune Activation in Patients With Locally Advanced Primary and Recurrent Oncogenic RAS Exon 2 Mutant Colorectal Cancer
|
Phase 1 |