RALOX or CAPOX + Bevacizumab in the First-line Treatment of Advanced CRC(ROCB Study)
NCT ID: NCT03813641
Last Updated: 2019-09-09
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE2
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-01-28
Study Completion Date
2021-12-31
Brief Summary
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Raltitrexed is an inhibitor of thymidylate synthase.As a folate antimetabolite drug, raltitrexed has been used in treatment of colorectal cancer(CRC) since 1998, and also used in malignant mesothelioma.Several phase III studies performed in patients with advanced CRC showed that it is as effective as 5-fluorouracil(5-FU) /leucovorin(LV) with regard to response rates and survival. The combination of raltitrexed with oxaliplatin shows response rates of 41%-54% and median survivals of 14.6-14.8 months, which are comparable to those achieved with 5-FU/LV combination with oxaliplatin. This study discussed the efficacy and safety of raltitrexed-oxaliplatin(RALOX) combined with bevacizumab or capecitabine-oxaliplatin(CAPOX) combined with bevacizumab in first-line treatment of patients with advanced colorectal cancer who could not undergo radical surgery. The main endpoint will be progression free survival (PFS). The secondary endpoints will be overall survival, objective response rate and disease control rate (OS,ORR and DCR).It is expected that raltitrexed may be one of options for the treatment of advanced CRC in the first-line setting.
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Detailed Description
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According to the inclusion and exclusion criteria, the patients will be randomly divided into two groups: the experimental group (group A) will be administered with raltitrexed 3mg/m2 intravenously combined with oxaliplatin and bevacizumab, repeated every 21 days. The control group (group B) will be administered with orally capecitabine (1000mg/m2, d 1-14) combined with oxaliplatin and bevacizumab, repeated every 21 days. After 8 cycles of treatments, if evaluated as complete response(CR),partial response(PR) or stable disease(SD), CRC patients will go into maintenance therapy wtih raltitrexed combined with bevacizumab in group A or capecitabine combined with bevacizumab in group B respectively, ended in disease progression(PD) , symptoms deterioration, unacceptable toxicity, death or withdrawal of consent (whichever occurs first). The radiological efficacy will be evaluated every 6 weeks (2 treatment cycles) and non-PD (PD criteria referring to RECIST 1.1 criteria) patients will continue to be treated until the cancer progression or the patient's intolerable toxicity or death. Toxic side effects and quality of life will be assessed at the same time.
Follow up participants and analyse primary endpoint (PFS) and secondary endpoints (OS,ORR and DCR).The causes of confirmed missing data in the trial should be recorded in detail to determine the mechanism of missing data and choose the suitable missing data handling methods.
Follow up participants and analyse primary endpoint (PFS) and secondary endpoints (OS,ORR and DCR).The causes of confirmed missing data in the trial should be recorded in detail to determine the mechanism of missing data and choose the suitable missing data handling methods.
Conditions
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Colorectal Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Randomized controlled trial
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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RALOX + bevacizumab
Oxaliplatin 130mg/m2, i.v.gtt 2h, d1 Raltitrexed 3mg/m2, i.v.gtt 15min ,d1 Bevacizumab 7.5mg/kg, i.v.gtt, d1 The above schemes are repeated every three weeks. After 8 cycles, such as CR, PR or SD, the regimen is changed to raltitrexed (3mg/m2, intravenous drip for 15 minutes, d1)+bevacizumab (7.5mg/kg, intravenous drip, d1). The regimen is repeated every 3 weeks until the disease progresses.
Group Type
EXPERIMENTAL
Raltitrexed
Intervention Type
DRUG
Experimental: Oxaliplatin + Raltitrexed + Bevacizumab The above schemes are repeated every three weeks. After 8 cycles, such as CR, PR or SD, the regimen is changed to Raltitrexed (3mg/m2, intravenous drip for 15 minutes, d1)+bevacizumab (7.5mg/kg, intravenous drip, d1). The regimen is repeated every 3 weeks until the disease progresses.
CAPOX + bevacizumab
Oxaliplatin 130mg/m2, i.v.gtt 2h, d1 Capecitabine 1000mg/m2, po. ,d1 Bevacizumab 7.5mg/kg, i.v.gtt, d1 The above schemes are repeated every three weeks. After 8 cycles, such as CR, PR or SD, the regimen is changed to Capecitabine (1000mg/m2 po. d1-14)+bevacizumab (7.5mg/kg, intravenous drip, d1). The regimen is repeated every 3 weeks until the disease progresses.
Group Type
ACTIVE_COMPARATOR
Capecitabine
Intervention Type
DRUG
Other: Oxaliplatin + Capecitabine + Bevacizumab The above schemes are repeated every three weeks. After 8 cycles, such as CR, PR or SD, the regimen is changed to Capecitabine (1000mg/m2 po. d1-14)+bevacizumab (7.5mg/kg, intravenous drip, d1). The regimen is repeated every 3 weeks until the disease progresses.
Interventions
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Raltitrexed
Experimental: Oxaliplatin + Raltitrexed + Bevacizumab The above schemes are repeated every three weeks. After 8 cycles, such as CR, PR or SD, the regimen is changed to Raltitrexed (3mg/m2, intravenous drip for 15 minutes, d1)+bevacizumab (7.5mg/kg, intravenous drip, d1). The regimen is repeated every 3 weeks until the disease progresses.
Intervention Type
DRUG
Capecitabine
Other: Oxaliplatin + Capecitabine + Bevacizumab The above schemes are repeated every three weeks. After 8 cycles, such as CR, PR or SD, the regimen is changed to Capecitabine (1000mg/m2 po. d1-14)+bevacizumab (7.5mg/kg, intravenous drip, d1). The regimen is repeated every 3 weeks until the disease progresses.
Intervention Type
DRUG
Other Intervention Names
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Tomudex
Xeloda
Eligibility Criteria
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Inclusion Criteria
* Age 18\~75 years;
* Patients are diagnosed by histopathological and/or cytological examination as local advanced or metastatic colorectal cancer who are unable to undergo radical surgery with no symptom of the primary lesions；
* There are one or more measurable lesions, the longest diameter of which is at least 10 mm by spiral CT scanning (RECIST standard, version 1.1)
* ECOG performance status (ECOG PS) 0\~1;
* Life expectancy not less than 3 month
* Blood routine, liver and kidney function reached the following criteria within 14 days before screening:
Absolute neutrophil count (\> 1.5x109/L); hemoglobin (\> 9.0 g/dl); platelet count (\> 100 x109/L); total bilirubin (\< 1.5 times the normal upper limit (ULN); alanine aminotransferase and glutamic oxaloacetate aminotransferase (\< 2.5 x ULN) in patients with liver metastasis (\< 5 x ULN); alkaline phosphatase （\< 3 x ULN（ in patients with liver metastasis \< 5 x ULN)）; serum creatinine （\< 1.5 x ULN）;
* Adequate blood coagulation function \[International Normalized Ratio (INR) ≤1.5 and Partial Thromboplastin Time (PTT) or activated PTT (aPTT) ≤1.5 x upper limit of normal (ULN)). Participants on full-dose anticoagulation must be in a stable phase of anticoagulant therapy and if taking oral anticoagulation, participants must have an INR ≤3 without clinically significant active bleeding or a high risk of bleeding.
* Agree to provide histological specimens from previous operations for biomarker assessment and specimens remain。
* Signed informed consent to be provided
* Patients are diagnosed by histopathological and/or cytological examination as local advanced or metastatic colorectal cancer who are unable to undergo radical surgery with no symptom of the primary lesions；
* There are one or more measurable lesions, the longest diameter of which is at least 10 mm by spiral CT scanning (RECIST standard, version 1.1)
* ECOG performance status (ECOG PS) 0\~1;
* Life expectancy not less than 3 month
* Blood routine, liver and kidney function reached the following criteria within 14 days before screening:
Absolute neutrophil count (\> 1.5x109/L); hemoglobin (\> 9.0 g/dl); platelet count (\> 100 x109/L); total bilirubin (\< 1.5 times the normal upper limit (ULN); alanine aminotransferase and glutamic oxaloacetate aminotransferase (\< 2.5 x ULN) in patients with liver metastasis (\< 5 x ULN); alkaline phosphatase （\< 3 x ULN（ in patients with liver metastasis \< 5 x ULN)）; serum creatinine （\< 1.5 x ULN）;
* Adequate blood coagulation function \[International Normalized Ratio (INR) ≤1.5 and Partial Thromboplastin Time (PTT) or activated PTT (aPTT) ≤1.5 x upper limit of normal (ULN)). Participants on full-dose anticoagulation must be in a stable phase of anticoagulant therapy and if taking oral anticoagulation, participants must have an INR ≤3 without clinically significant active bleeding or a high risk of bleeding.
* Agree to provide histological specimens from previous operations for biomarker assessment and specimens remain。
* Signed informed consent to be provided
Exclusion Criteria
* Previous treatment with Raltitrexed；
* With a large amount of pleural effusions or ascites requiring puncture drainage；
* Active clinical severe infections include hepatitis；
* One of the following complications: 1) Gastrointestinal obstruction (including paralytic ileus) or gastrointestinal bleeding 2) Symptomatic cardiac disease (including unstable angina, myocardial infarction, and heart failure) 3) Pulmonary fibrosis or interstitial pneumonia 4) Uncontrolled diabetes mellitus 5) Uncontrolled diarrhea (that affects daily activities although adequate therapy )
* Symptomatic brain or meningeal metastasis (unless the patient has been treated for \> 6 months, the imaging results are negative in the 4 weeks before entering the study, and the clinical symptoms associated with the tumor are stable at the time of entering the study);
* Undergoing kidney dialysis；
* History of other malignant tumors within 5 years, except for cured cervical carcinoma in situ or basal cell carcinoma of the skin;
* Drug abuse and medical, psychological or social conditions may interfere with patients' participation in the study or have an impact on the evaluation of the study results；
* Pregnant or lactating females, and males and females reluctant to use contraception
* History of concurrent gastrointestinal perforation or gastrointestinal perforation within 1 year prior to enrollment
* Pulmonary hemorrhage/hemoptysis ≥ Grade 2 (identified as bright red blood of not less 2.5mL) within 1 month before enrollment.
* History of thoracotomy,laparotomy, or intestinal resection within 28 days prior to enrollment;
* Unhealed wound (other than suture wounds due to implantation of a central venous port), traumatic fracture, or gastrointestinal ulcer
* Current cerebrovascular disease or thromboembolism or either within 1 year before enrollment
* Current anticoagulation therapy or requiring anticoagulation agents (\> 325 mg/day of aspirin)
* Bleeding diathesis, coagulopathy, or coagulation factor abnormality (INR ≥1.5 within 14 days before enrollment)
* Uncontrolled hypertension
* Urine dipstick for proteinuria \>+2
* Researchers think those should be excluded
* With a large amount of pleural effusions or ascites requiring puncture drainage；
* Active clinical severe infections include hepatitis；
* One of the following complications: 1) Gastrointestinal obstruction (including paralytic ileus) or gastrointestinal bleeding 2) Symptomatic cardiac disease (including unstable angina, myocardial infarction, and heart failure) 3) Pulmonary fibrosis or interstitial pneumonia 4) Uncontrolled diabetes mellitus 5) Uncontrolled diarrhea (that affects daily activities although adequate therapy )
* Symptomatic brain or meningeal metastasis (unless the patient has been treated for \> 6 months, the imaging results are negative in the 4 weeks before entering the study, and the clinical symptoms associated with the tumor are stable at the time of entering the study);
* Undergoing kidney dialysis；
* History of other malignant tumors within 5 years, except for cured cervical carcinoma in situ or basal cell carcinoma of the skin;
* Drug abuse and medical, psychological or social conditions may interfere with patients' participation in the study or have an impact on the evaluation of the study results；
* Pregnant or lactating females, and males and females reluctant to use contraception
* History of concurrent gastrointestinal perforation or gastrointestinal perforation within 1 year prior to enrollment
* Pulmonary hemorrhage/hemoptysis ≥ Grade 2 (identified as bright red blood of not less 2.5mL) within 1 month before enrollment.
* History of thoracotomy,laparotomy, or intestinal resection within 28 days prior to enrollment;
* Unhealed wound (other than suture wounds due to implantation of a central venous port), traumatic fracture, or gastrointestinal ulcer
* Current cerebrovascular disease or thromboembolism or either within 1 year before enrollment
* Current anticoagulation therapy or requiring anticoagulation agents (\> 325 mg/day of aspirin)
* Bleeding diathesis, coagulopathy, or coagulation factor abnormality (INR ≥1.5 within 14 days before enrollment)
* Uncontrolled hypertension
* Urine dipstick for proteinuria \>+2
* Researchers think those should be excluded
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Shenzhen People's Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Ruilian Xu
Phase Ⅱ Clinical Study of RALOX or CAPOX Combined With Bevacizumab in the First-line Treatment of Advanced Colorectal Cancer
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Ruilian Xu, MD
Role: PRINCIPAL_INVESTIGATOR
Shen Zhen People's Hospital
Locations
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Shenzhen People's Hospital
Shenzhen, Guangdong, China
Site Status
RECRUITING
Countries
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China
Central Contacts
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Facility Contacts
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References
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Kindler HL, Shulman KL. Metastatic colorectal cancer. Curr Treat Options Oncol. 2001 Dec;2(6):459-71. doi: 10.1007/s11864-001-0068-7.
Reference Type
BACKGROUND
Meta-analysis Group In Cancer; Piedbois P, Rougier P, Buyse M, Pignon J, Ryan L, Hansen R, Zee B, Weinerman B, Pater J, Leichman C, Macdonald J, Benedetti J, Lokich J, Fryer J, Brufman G, Isacson R, Laplanche A, Levy E. Efficacy of intravenous continuous infusion of fluorouracil compared with bolus administration in advanced colorectal cancer. J Clin Oncol. 1998 Jan;16(1):301-8. doi: 10.1200/JCO.1998.16.1.301.
Reference Type
BACKGROUND
Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: evidence in terms of response rate. Advanced Colorectal Cancer Meta-Analysis Project. J Clin Oncol. 1992 Jun;10(6):896-903. doi: 10.1200/JCO.1992.10.6.896.
Reference Type
BACKGROUND
Meta-Analysis Group In Cancer; Levy E, Piedbois P, Buyse M, Pignon JP, Rougier P, Ryan L, Hansen R, Zee B, Weinerman B, Pater J, Leichman C, Macdonald J, Benedetti J, Lokich J, Fryer J, Brufman G, Isacson R, Laplanche A, Quinaux E, Thirion P. Toxicity of fluorouracil in patients with advanced colorectal cancer: effect of administration schedule and prognostic factors. J Clin Oncol. 1998 Nov;16(11):3537-41. doi: 10.1200/JCO.1998.16.11.3537.
Reference Type
BACKGROUND
Becker K, Erckenbrecht JF, Haussinger D, Frieling T. Cardiotoxicity of the antiproliferative compound fluorouracil. Drugs. 1999 Apr;57(4):475-84. doi: 10.2165/00003495-199957040-00003.
Reference Type
BACKGROUND
Wacker A, Lersch C, Scherpinski U, Reindl L, Seyfarth M. High incidence of angina pectoris in patients treated with 5-fluorouracil. A planned surveillance study with 102 patients. Oncology. 2003;65(2):108-12. doi: 10.1159/000072334.
Reference Type
BACKGROUND
Rougier P, Van Cutsem E, Bajetta E, Niederle N, Possinger K, Labianca R, Navarro M, Morant R, Bleiberg H, Wils J, Awad L, Herait P, Jacques C. Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer. Lancet. 1998 Oct 31;352(9138):1407-12. doi: 10.1016/S0140-6736(98)03085-2.
Reference Type
BACKGROUND
Cunningham D, Pyrhonen S, James RD, Punt CJ, Hickish TF, Heikkila R, Johannesen TB, Starkhammar H, Topham CA, Awad L, Jacques C, Herait P. Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet. 1998 Oct 31;352(9138):1413-8. doi: 10.1016/S0140-6736(98)02309-5.
Reference Type
BACKGROUND
Seymour MT, Maughan TS, Ledermann JA, Topham C, James R, Gwyther SJ, Smith DB, Shepherd S, Maraveyas A, Ferry DR, Meade AM, Thompson L, Griffiths GO, Parmar MK, Stephens RJ; FOCUS Trial Investigators; National Cancer Research Institute Colorectal Clinical Studies Group. Different strategies of sequential and combination chemotherapy for patients with poor prognosis advanced colorectal cancer (MRC FOCUS): a randomised controlled trial. Lancet. 2007 Jul 14;370(9582):143-152. doi: 10.1016/S0140-6736(07)61087-3.
Reference Type
BACKGROUND
Graeven U, Arnold D, Reinacher-Schick A, Heuer T, Nusch A, Porschen R, Schmiegel W. A randomised phase II study of irinotecan in combination with 5-FU/FA compared with irinotecan alone as second-line treatment of patients with metastatic colorectal carcinoma. Onkologie. 2007 Apr;30(4):169-74. doi: 10.1159/000099636. Epub 2007 Mar 23.
Reference Type
BACKGROUND
Leonard P, Seymour MT, James R, Hochhauser D, Ledermann JA. Phase II study of irinotecan with bolus and high dose infusional 5-FU and folinic acid (modified de Gramont) for first or second line treatment of advanced or metastatic colorectal cancer. Br J Cancer. 2002 Nov 18;87(11):1216-20. doi: 10.1038/sj.bjc.6600641.
Reference Type
BACKGROUND
Rougier P, Lepille D, Bennouna J, Marre A, Ducreux M, Mignot L, Hua A, Mery-Mignard D. Antitumour activity of three second-line treatment combinations in patients with metastatic colorectal cancer after optimal 5-FU regimen failure: a randomised, multicentre phase II study. Ann Oncol. 2002 Oct;13(10):1558-67. doi: 10.1093/annonc/mdf259.
Reference Type
BACKGROUND
Peeters M, Price TJ, Cervantes A, Sobrero AF, Ducreux M, Hotko Y, Andre T, Chan E, Lordick F, Punt CJ, Strickland AH, Wilson G, Ciuleanu TE, Roman L, Van Cutsem E, Tzekova V, Collins S, Oliner KS, Rong A, Gansert J. Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer. J Clin Oncol. 2010 Nov 1;28(31):4706-13. doi: 10.1200/JCO.2009.27.6055. Epub 2010 Oct 4.
Reference Type
BACKGROUND
Fuchs CS, Marshall J, Mitchell E, Wierzbicki R, Ganju V, Jeffery M, Schulz J, Richards D, Soufi-Mahjoubi R, Wang B, Barrueco J. Randomized, controlled trial of irinotecan plus infusional, bolus, or oral fluoropyrimidines in first-line treatment of metastatic colorectal cancer: results from the BICC-C Study. J Clin Oncol. 2007 Oct 20;25(30):4779-86. doi: 10.1200/JCO.2007.11.3357.
Reference Type
BACKGROUND
Tournigand C, Andre T, Achille E, Lledo G, Flesh M, Mery-Mignard D, Quinaux E, Couteau C, Buyse M, Ganem G, Landi B, Colin P, Louvet C, de Gramont A. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol. 2004 Jan 15;22(2):229-37. doi: 10.1200/JCO.2004.05.113. Epub 2003 Dec 2.
Reference Type
BACKGROUND
Jarmula A. Antifolate inhibitors of thymidylate synthase as anticancer drugs. Mini Rev Med Chem. 2010 Nov;10(13):1211-22. doi: 10.2174/13895575110091211.
Reference Type
BACKGROUND
Wilson KS, Malfair Taylor SC. Raltitrexed: optimism and reality. Expert Opin Drug Metab Toxicol. 2009 Nov;5(11):1447-54. doi: 10.1517/17425250903307455.
Reference Type
BACKGROUND
Cunningham D. Mature results from three large controlled studies with raltitrexed ('Tomudex'). Br J Cancer. 1998;77 Suppl 2(Suppl 2):15-21. doi: 10.1038/bjc.1998.421.
Reference Type
BACKGROUND
Cocconi G, Cunningham D, Van Cutsem E, Francois E, Gustavsson B, van Hazel G, Kerr D, Possinger K, Hietschold SM. Open, randomized, multicenter trial of raltitrexed versus fluorouracil plus high-dose leucovorin in patients with advanced colorectal cancer. Tomudex Colorectal Cancer Study Group. J Clin Oncol. 1998 Sep;16(9):2943-52. doi: 10.1200/JCO.1998.16.9.2943.
Reference Type
BACKGROUND
Feliu J, Mel JR, Camps C, Escudero P, Aparicio J, Menendez D, Garcia Giron C, Rodriguez MR, Sanchez JJ, Gonzalez Baron M; Oncopaz Cooperative Group Associated Hospitals. Raltitrexed in the treatment of elderly patients with advanced colorectal cancer: an active and low toxicity regimen. Eur J Cancer. 2002 Jun;38(9):1204-11. doi: 10.1016/s0959-8049(02)00005-9.
Reference Type
BACKGROUND
Cascinu S, Graziano F, Ferrau F, Catalano V, Massacesi C, Santini D, Silva RR, Barni S, Zaniboni A, Battelli N, Siena S, Giordani P, Mari D, Baldelli AM, Antognoli S, Maisano R, Priolo D, Pessi MA, Tonini G, Rota S, Labianca R. Raltitrexed plus oxaliplatin (TOMOX) as first-line chemotherapy for metastatic colorectal cancer. A phase II study of the Italian Group for the Study of Gastrointestinal Tract Carcinomas (GISCAD). Ann Oncol. 2002 May;13(5):716-20. doi: 10.1093/annonc/mdf091.
Reference Type
BACKGROUND
Cortinovis D, Bajetta E, Di Bartolomeo M, Dognini G, Beretta E, Ferrario E, Ricotta R, Buzzoni R. Raltitrexed plus oxaliplatin in the treatment of metastatic colorectal cancer. Tumori. 2004 Mar-Apr;90(2):186-91. doi: 10.1177/030089160409000205.
Reference Type
BACKGROUND
Laudani A, Gebbia V, Leonardi V, Savio G, Borsellino N, Cusimano MP, Calabria C, Stefano R, Agostara B. Activity and toxicity of oxaliplatin plus raltitrexed in 5-fluorouracil refractory metastatic colorectal adeno-carcinoma. Anticancer Res. 2004 Mar-Apr;24(2C):1139-42.
Reference Type
BACKGROUND
Santini D, Massacesi C, D'Angelillo RM, Marcucci F, Campisi C, Vincenzi B, Pilone A, Bianco V, Bonsignori M, Tonini G. Raltitrexed plus weekly oxaliplatin as first-line chemotherapy in metastatic colorectal cancer: a multicenter non-randomized phase ii study. Med Oncol. 2004;21(1):59-66. doi: 10.1385/MO:21:1:59.
Reference Type
BACKGROUND
Martoni A, Mini E, Pinto C, Gentile AL, Nobili S, Dentico P, Marino A, Scicolone S, Angelelli B, Mazzei T. Oxaliplatin plus raltitrexed in the treatment of patients with advanced colorectal cancer: a phase II study. Anticancer Res. 2003 Jan-Feb;23(1B):687-91.
Reference Type
BACKGROUND
Neri B, Doni L, Fulignati C, Perfetto F, Turrini M, Andreoli F, Pantalone D, Pernice LM, Taruffi F, Martini V, Poma A, Valeri A, Bacci G, Sancez L, Moretti R. Raltitrexed plus oxaliplatin as first-line chemotherapy in metastatic colorectal carcinoma: a multicentric phase II trial. Anticancer Drugs. 2002 Aug;13(7):719-24. doi: 10.1097/00001813-200208000-00006.
Reference Type
BACKGROUND
Scheithauer W, Kornek GV, Schuell B, Ulrich-Pur H, Penz M, Raderer M, Lang F, Schneeweiss B, Lenauer A, Depisch D. Second-line treatment with oxaliplatin + raltitrexed in patients with advanced colorectal cancer failing fluoropyrimidine/leucovorin-based chemotherapy. Ann Oncol. 2001 May;12(5):709-14. doi: 10.1023/a:1011194712661.
Reference Type
BACKGROUND
Gravalos C, Salut A, Garcia-Giron C, Garcia-Carbonero R, Leon AI, Sevilla I, Maurel J, Esteban B, Garcia-Rico E, Murias A, Cortes-Funes H. A randomized phase II study to compare oxaliplatin plus 5-fluorouracil and leucovorin (FOLFOX4) versus oxaliplatin plus raltitrexed (TOMOX) as first-line chemotherapy for advanced colorectal cancer. Clin Transl Oncol. 2012 Aug;14(8):606-12. doi: 10.1007/s12094-012-0843-x. Epub 2012 Jul 19.
Reference Type
BACKGROUND
Feliu J, Castanon C, Salud A, Mel JR, Escudero P, Pelegrin A, Lopez-Gomez L, Ruiz M, Gonzalez E, Juarez F, Lizon J, Castro J, Gonzalez-Baron M; Oncopaz Cooperative Group, Spain. Phase II randomised trial of raltitrexed-oxaliplatin vs raltitrexed-irinotecan as first-line treatment in advanced colorectal cancer. Br J Cancer. 2005 Nov 28;93(11):1230-5. doi: 10.1038/sj.bjc.6602860.
Reference Type
BACKGROUND
Cheng K, Chen Y, Li LH, Liu JY. Raltitrexed combined with bevacizumab in heavily pretreated metastatic colorectal cancer. J Cancer Res Ther. 2013 Oct-Dec;9(4):727-9. doi: 10.4103/0973-1482.126470.
Reference Type
BACKGROUND
Ito Y, Osaki Y, Tokudome N, Sugihara T, Takahashi S, Iwase T, Hatake K. Efficacy of S-1 in heavily pretreated patients with metastatic breast cancer: cross-resistance to capecitabine. Breast Cancer. 2009;16(2):126-31. doi: 10.1007/s12282-008-0073-9. Epub 2008 Sep 20.
Reference Type
BACKGROUND
Hoff PM, Pazdur R, Lassere Y, Carter S, Samid D, Polito D, Abbruzzese JL. Phase II study of capecitabine in patients with fluorouracil-resistant metastatic colorectal carcinoma. J Clin Oncol. 2004 Jun 1;22(11):2078-83. doi: 10.1200/JCO.2004.05.072.
Reference Type
BACKGROUND
Sato A, Kurihara M, Horikoshi N, Aiba K, Kikkawa N, Shirouzu K, Mitachi Y, Sakata Y, Wakui A. Phase II study of raltitrexed (Tomudex) in chemotherapy-pretreated patients with advanced colorectal cancer. Tomudex Cooperative Study Group. Anticancer Drugs. 1999 Sep;10(8):741-8. doi: 10.1097/00001813-199909000-00008.
Reference Type
BACKGROUND
Douillard JY, Siena S, Cassidy J, Tabernero J, Burkes R, Barugel M, Humblet Y, Bodoky G, Cunningham D, Jassem J, Rivera F, Kocakova I, Ruff P, Blasinska-Morawiec M, Smakal M, Canon JL, Rother M, Oliner KS, Tian Y, Xu F, Sidhu R. Final results from PRIME: randomized phase III study of panitumumab with FOLFOX4 for first-line treatment of metastatic colorectal cancer. Ann Oncol. 2014 Jul;25(7):1346-1355. doi: 10.1093/annonc/mdu141. Epub 2014 Apr 8.
Reference Type
BACKGROUND
Other Identifiers
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Shenzhen CRC-002
Identifier Type: -
Identifier Source: org_study_id
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