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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001688-22 | EudraCT Number |
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Difficulties surrounding recruiting patients
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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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Main outcome: Assess the impact of cancer-related survival at 2 years in patients with unresectable metastatic colorectal cancer treated with chemotherapy alone versus surgery followed by chemotherapy. To assess overall survival. To evaluate postoperative morbidity and mortality in patients treated with resection of the primary tumor. Assess complications and meed for surgery in patients treated with systemic chemotherapy only during the course of the disease. Identify and describe the complications related to chemotherapy and toxicity in the short and medium term systemic treatment. Assessing the quality of life questionnaire QLQ-C30 and QLQ-CR29. To study prognostic survival factors.
Method: multicenter randomized clinical trail (22 hospitals). Two parallel group in which to evaluate two therapeutic strategies for colorectal cancer metastasis unresectable stage IV: chemotherapy alone versus primary tumor resection plus chemotherapy.
Subjects: patients with unresectable nonmetastatic colorectal cancer. Hypothesis:Surgical resection of the primary tumor in stage IV colorectal patients with unresectable synchronous metastases increases by 14% overall survival compared to patients receiving systemic treatment with chemotherapy without resection of the primary tumor (survival of 34% vs 20%).
Intervention: Arm B (control): chemotherapy alone, regimen according to each center. Arm A (experimental): surgery (complete tumoral resection; R0) followed by chemotherapy, regimen according to each center. Statistical Analysis: A power analysis showed that to assure a significance level of 0,05 and a beta error 0.20. 168 patients are necessary in each arm. It has been estimated a loss rate of up to 10%.
Differences between groups will be analyzed by t, U, X2, exact test and survival will be assessed according to Kaplan and Meier method. Evaluation of safety of the trial will be made in the middle of the study statistically
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| colonic resection | Experimental | Arm A (experimental): surgery (complete tumoral resection; R0) followed by chemotherapy, regimen according to each center. |
|
| Chemotherapy | Active Comparator | Arm B (control): chemotherapy alone, regimen according to each center |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonic resection | Procedure | Colonic cancer resection, R0 No surgical intervention on metastasis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the impact of overall survival in patients with unresectable metastatic colorectal cancer treated with chemotherapy alone vs surgery followed by chemotherapy. | The percentage of patients who are still alive for follow-up at 2 years after randomization. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative morbidity and mortality. | Postoperative complications were classified according to the Dindo-Clavien classification. Mortality within 30 days after surgery | 30 days postoperatively |
| Complications in patients treated with systemic chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastiano Biondo, Sponsor | Hospital Universitari de Bellvitge | Study Chair |
| Javier Vaqué | Hospital Universitario La Fe | Principal Investigator |
| Juan García Armengol | Hospital General Universitario de Valencia | Principal Investigator |
| Laura Mora | Corporacion Parc Tauli | Principal Investigator |
| Ignasi Camps Ausàs | Hospital Universitari Gemans Tiras i Pujol | Principal Investigator |
| Miguel Pera Román | Hospital Univesitari del Mar | Principal Investigator |
| Eduardo Targarona Soler | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Principal Investigator |
| Lorenzo Viso Pons | Hospital de Sant Joan Despí Moisès Broggi | Principal Investigator |
| José Manuel Ramírez Rodríguez | Hospital Clínico Univeristario "Lozano Blesa" |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Araba | Vitoria-Gasteiz | Araba | Spain | |||
| Hospital Universitari Germans Trias i Pujol |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38412408 | Derived | Rahbari NN, Biondo S, Frago R, Feisst M, Kreisler E, Rossion I, Serrano M, Jager D, Lehmann M, Sommer F, Dignass A, Bolling C, Vogel I, Bork U, Buchler MW, Folprecht G, Kieser M, Lordick F, Weitz J; SYNCHRONOUS and CCRe-IV Trial Groups. Primary Tumor Resection Before Systemic Therapy in Patients With Colon Cancer and Unresectable Metastases: Combined Results of the SYNCHRONOUS and CCRe-IV Trials. J Clin Oncol. 2024 May 1;42(13):1531-1541. doi: 10.1200/JCO.23.01540. Epub 2024 Feb 27. | |
| 28497402 |
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| Chemotherapy- scheme | Drug | Chemotherapy, specified in each center with or without biological drugs |
|
|
The toxicity will be evaluated and documented according to the CTCAE version 4.0. |
| up to 2 years |
| Questionnaire Quality of life CR29 | Specific questionnaire for colon cancer | up to 2 years |
| Study of possible survival factors | Identify factors that may influence patient survival before applying any treatment (demographics, clinicals and analitycal factors, tumor characteristics; ...) | up to 2 years |
| David Julià Bergkvist | Hospital Universitari de Girona DrJosep Trueta | Principal Investigator |
| Teresa García Martínez | Complejo Hospitalario Universitario de Vigo | Principal Investigator |
| Mario Álvarez Gallego | Hospital Univerisitario La Paz | Principal Investigator |
| José María Enríquez Navascués | Hospital Donostia | Principal Investigator |
| Fernando de la Portilla de Juan | Hospitales Universitarios Virgen del Rocío | Principal Investigator |
| Miguel Angel Ciga | Complejo Hospitalario de Navarra | Principal Investigator |
| Eloy Espín Basany | hospital Universitari de la Vall D'Hebron | Principal Investigator |
| Manuel Ferrer Márquez | Complejo Hospitalario Torrecárdenas | Principal Investigator |
| Jesús Abrisqueta Carrión | Hospital Universitario Virgen de la Arrixaca | Principal Investigator |
| José Errasti Alustiza | Hospital Universitario Araba | Principal Investigator |
| Alberto Parajó Calvo | Complejo Hospitalario Universitario de Orense | Principal Investigator |
| Carlos Moreno Sanz | Complejo Hospitalario La Mancha Centro | Principal Investigator |
| Alejando Espí Macías | Hospital Clínico Universitario de Valencia | Principal Investigator |
| Ricard Frago Montanuy | Hospital Universitari de Bellvitge | Principal Investigator |
| Badalona |
| Barcelona |
| Spain |
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08709 | Spain |
| Corporació Sanitària Parc Taulí | Sabadell | Barcelona | Spain |
| Hospital Moisès Broggi | Sant Joan Despí | Barcelona | Spain |
| Complejo Hospitalario La Mancha Centro | Alcázar de San Juan | Ciudad Real | Spain |
| Complejo Hospitalario de Navarra | Pamplona | Navarre | Spain |
| Complejo Hospitalario Universitario de Vigo | Vigo | Pontevedra | Spain |
| Complejo Hospitalario Torrecárdenas | Almería | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain |
| Hospital del Mar | Barcelona | Spain |
| Hospital Univesitari Vall d'Hebron | Barcelona | Spain |
| Hospital Universitario Donostia | Donostia / San Sebastian | Spain |
| Hospital Universitari de Girona DrJosep Trueta | Girona | Spain |
| Hospital Univerisitario La Paz | Madrid | Spain |
| Hospital Clínico Universitario Virgen de la Arrixaca | Murcia | Spain |
| Complejo Hospitalario Universitario de Orense | Ourense | Spain |
| Hospital Universitario Virgen del Rocío | Seville | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | Spain |
| Hospital General de Valencia | Valencia | Spain |
| Hospital Universitari i Politècnic la Fe | Valencia | Spain |
| Hospital Clínico Univeristario "Lozano Blesa" | Zaragoza | Spain |
| Derived |
| Biondo S, Frago R, Kreisler E, Espin-Basany E; Spanish CR4 Group. Impact of resection versus no resection of the primary tumor on survival in patients with colorectal cancer and synchronous unresectable metastases: protocol for a randomized multicenter study (CR4). Int J Colorectal Dis. 2017 Jul;32(7):1085-1090. doi: 10.1007/s00384-017-2827-3. Epub 2017 May 11. |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C410216 | Folfox protocol |
| C480833 | IFL protocol |
| C509829 | FOLFOXIRI protocol |
| D000068258 | Bevacizumab |
| D000077544 | Panitumumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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