Metastatic Colorectal CarcinomaPhase 4CRC - PTXNCT06115174
Clinical Study Evaluating the Anticancer Effect of Pentoxiphylline in Patients With Metastatic Colorectal Cancer
A Phase 4 study testing Pentoxifylline, FOLFOX and XELOX in people with Metastatic Colorectal Carcinoma, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this work is to assess the antitumor effect of Pentoxiphylline in patients with metastatic colorectal cancer receiving stomatal chemotherapy ± targeted therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Metastatic Colorectal Carcinoma
- What is being tested?
- Pentoxifylline, FOLFOX and XELOX
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 Aug 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with histologically and/or radiologically confirmed diagnosis of metastatic colorectal carcinoma.
- Both genders.
- Age ≥ 18 years old, and ≤ 75 years old.
- Performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG).
- Patients with adequate hematologic parameters (white blood cell count
- ≥3000/mm3, granulocytes ≥1500/mm3, platelets ≥100,000/mm3, hemoglobin ≥ 8 gm/l).
- Patients with adequate renal functions (serum creatinine ≤1.5 mg/dL).
- Patients with adequate hepatic functions (bilirubin ≤1.5 mg/dL or albumin ≥3 g/dL).
Who cannot join
- Patients with active liver diseases (chronic viral hepatitis, autoimmune hepatitis, alcoholic hepatitis, Wilson's disease, hemochromatosis, or cirrhosis).
- Patients with brain metastasis.
- Patients with active infection.
- Patients on chronic use of corticosteroids.
- Patients receiving blood thinning agents(aspirin, clopidogrel, warfarin)
- Patients with other malignancy (synchronous, or metachronous)
Show all 12Show fewer
- Prior exposure to neurotoxic drugs (oxaliplatin, cisplatin, vincristine, paclitaxel, or docetaxel, INH) for at least 6 months prior the study treatment.
- Evidence of pre-existing peripheral neuropathy resulting from another reason (diabetes, brain tumor, brain trauma, HCV, thyroid disorder).
- Patients with diabetes and other conditions that predispose to neuropathy as hypothyroidism, autoimmune diseases, hepatitis C.
- History of known allergy to oxaliplatin or other platinum agents.
- Patients with moderate and severe renal impairment (CrCl <50 ml/min) or serum creatinine >1.5 mg/dl.
- Pregnant and breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this work is to assess the antitumor effect of Pentoxiphylline in patients with metastatic colorectal cancer receiving stomatal chemotherapy ± targeted therapy.
Read the detailed description
Colorectal cancer (CRC) ranks as the third most common cancer globally and second in terms of mortality. Although CRC incidence rates are higher in high-income compared with low-to-middle-income countries (LMICs), mortality is higher in LMICs. And although more than 90% of CRC cases are diagnosed in individuals over age 55, CRC incidence is rising in younger populations. For example, Egypt, Saudi Arabia, the Philippines, and Iran have CRC incidence rates in individuals under age 40 of 38%, 21%, 17%, and 15%-35%, respectively. This is compared with only 2%-8% of new cases in the U.S. and the European Union in individuals in this age bracket. Along with the high incidence rate of CRC in individuals under age 40 in Egypt, CRC is diagnosed at more advanced stages in these younger Egyptians. CRC survival is highly dependent upon the stage of disease at diagnosis and typically ranges from a 90% 5-year survival rate for cancers detected at the localized stage to 14% for individuals diagnosed with distant metastatic cancer.
Apoptosis may occur via two major interconnected pathways: the extrinsic or death receptor-mediated pathway, which is activated by the binding of specific ligands (such as FasL, TNF-α and TRAIL) to the receptors of cell surfaces; and the intrinsic or mitochondrial-mediated pathway, which is regulated through proteins of the Bcl-2 family and triggered either by the loss of growth factor signals or in response to genotoxic stress. Therefore the replication of cells with DNA damage is generally avoided because harmful genomic alterations typically induce the activation of apoptosis. It has been widely accepted that alterations in the physiologic response to DNA damage can facilitate the accumulation of oncogenic mutations; this accumulation may eventually lead to the development of neoplasia.
Angiogenesis is a complex process by which new blood vessels are formed from endothelial precursor. It is a critical step in cancer progression and is considered one of the hallmarks of cancer. This process is mediated through a group of ligands and receptors that work in tight regulation. A group of glycoproteins, including the VEGFs (VEGF-A, VEGF-B, VEGF-C, and VEGF-D) and the placental growth factor (PIGF), act as effectors of angiogenesis. These factors interact with three VEGF receptors (VEGFR- 1, VEGFR-2, and VEGFR-3) and two neuropilin co-receptors (NRP1 and NRP2). The VEGF-A gene consists of eight exons with splice variants forming different isoforms, namely, VEGFA121, VEGFA165, VEGFA189, and VEGFA209; VEGFA165 is the most biologically active of these isoforms [14]. The VEGFRs are tyrosine kinase receptors that are primarily located in the vascular endothelial cells. The binding of VEGF-A to VEGFR-2 is believed to be the most important activator of angiogenesis.
Pentoxifylline (PTX) is a methylxanthine derivative that is commercially available in the name of Trental. It is currently used for management of peripheral vascular diseases. Its postulated mechanism of action is thought to be mediated through reducing blood viscosity and enhancing RBCs flexibility. However, it has been shown that PTX also may potentially be used in the anticancer therapy.
The studies demonstrated the potential effects of pentoxifylline on angiogenesis inhibition. It can affect the release and function of some predominantly proangiogenic vascular endothelial growth factors. Specifically, the release of the VEGF family of pro-angiogenesis factors (notably VEGF-A and VEGF-C) [16]. Furthermore, the mechanism by which pentoxifylline inhibits angiogenesis may be through the inhibition of activation of STAT3 which contributes to tumor cell survival by regulating the expression of metastatic genes, MMPs, serine protease uPA and potent angiogenic genes.
In addition, PTX has also the ability to induce apoptosis and potentiate the apoptotic effects of chemotherapy in several cancer types, one major mechanism is through activation of the caspase-dependent apoptosis that is accompanied by a decrease in kappa B-alpha- phosphorylation and up-regulation of the pro-apoptotic genes Bax, Bad, Bak, and caspases- 3,
-8, and -9.
- Conditions
- Metastatic Colorectal Carcinoma
- Being tested
- Pentoxifylline, FOLFOX, XELOX, Monoclonal antibodies (target therapy)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentoxifyllineDrug
Pentoxifylline (PTX) is a methylxanthine derivative that is commercially available in the name of Trental. It is currently used for management of peripheral vascular diseases. Its postulated mechanism of action is thought to be mediated through reducing blood viscosity and enhancing RBCs flexibility. However, it has been shown that PTX also may potentially be used in the anticancer therapy [15].
The studies demonstrated the potential effects of pentoxifylline on angiogenesis inhibition. It can affect the release and function of some predominantly proangiogenic vascular endothelial growth factors. Specifically, the release of the VEGF family of pro-angiogenesis factors (notably VEGF-A and VEGF-C) [16]. Furthermore, the mechanism by which pentoxifylline inhibits angiogenesis may be through the inhibition of activation of STAT3 which contributes to tumor cell survival by regulating the expression of metastatic genes, MMPs, serine protease uPA and potent angiogenic genes [17].
FOLFOXRadiation
(leucovorin, fluorouracil, oxaliplatin)
XELOXRadiation
(oxaliplatin + capecitabine)
Monoclonal antibodies (target therapy)Drug
target therapy (Bevacizumab).
| Study group | Role | What they receive |
|---|---|---|
| People not recieving the drug | Other | (Control group; n=22) which will receive FOLFOX (leucovorin, fluorouracil, oxaliplatin) or XELOX (oxaliplatin + capecitabine) ± target therapy (Bevacizumab). Receives: Radiation: FOLFOX; Radiation: XELOX; Drug: Monoclonal antibodies (target therapy) |
| People recieving the drug | Active comparator | (Pentoxiphylline group; n=22) which will receive the same FOLFOX (leucovorin, fluorouracil, oxaliplatin) or XELOX regimen (oxaliplatin + capecitabine) ± target therapy (Bevacizumab) in addition to Pentoxiphylline 400 mg twice daily. Receives: Drug: Pentoxifylline; Radiation: FOLFOX; Radiation: XELOX; Drug: Monoclonal antibodies (target therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of RECIST between the two groups.
Difference in response rate (RECIST) between the control and drug groups.
Measured: one year
Change in the serum concentration of the measured biological markers.
Measured: one year
Difference in progression free survival 'PFS' between the two groups
Measured: One year.
Difference in overall survival 'OS' between the two groups.
Measured: One year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Feb 2024
- Primary completion1 Jun 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The design of this study is a randomized, controlled parallel clinical trial which will be conducted on 44 patients with metastatic colorectal cancer. The duration of the study will be one year to determine progression free survival (PFS) and the overall survival (OS). Patients will be recruited from Medical Oncology Department, Oncology Centre, Mansoura University, Mansoura, Egypt. The patients will be randomized using sealed envelope method into the following two groups: Group I (Control group; n=22) which will receive FOLFOX (leucovorin, fluorouracil, oxaliplatin) or XELOX (oxaliplatin + capecitabine) ± target therapy (Bevacizumab). Group II: (Pentoxiphylline group; n=22) which will receive the same FOLFOX or XELOX regimen ± target therapy (Bevacizumab) in addition to Pentoxiphylline 400 mg twice daily.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Abu Eleneen Darwiesh Ibrahim, Tanta University
- Investigators
- Tarek Mohammed, Professor, Study chair, Tanta UniversityDalia Refaat, Assistant Professor, Study chair, Tanta UniversitySherif Refaat, Lecturer, Study chair, Oncology Centre - Faculty of Medicine - Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115174
- Sponsor's protocol ID
- Pentoxiphylline in CRC
- Acronym
- CRC - PTX
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Ferlay J, Colombet M, Soerjomataram I, Dyba T, Randi G, Bettio M, Gavin A, Visser O, Bray F. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries and 25 major cancers in 2018. Eur J Cancer. 2018 Nov;103:356-387. doi: 10.1016/j.ejca.2018.07.005. Epub 2018 Aug 9.
PubMed 30100160Arnold M, Sierra MS, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global patterns and trends in colorectal cancer incidence and mortality. Gut. 2017 Apr;66(4):683-691. doi: 10.1136/gutjnl-2015-310912. Epub 2016 Jan 27.
PubMed 26818619Schreuders EH, Ruco A, Rabeneck L, Schoen RE, Sung JJ, Young GP, Kuipers EJ. Colorectal cancer screening: a global overview of existing programmes. Gut. 2015 Oct;64(10):1637-49. doi: 10.1136/gutjnl-2014-309086. Epub 2015 Jun 3.
PubMed 26041752Sankaranarayanan R. Screening for cancer in low- and middle-income countries. Ann Glob Health. 2014 Sep-Oct;80(5):412-7. doi: 10.1016/j.aogh.2014.09.014.
PubMed 25512156Haggar FA, Boushey RP. Colorectal cancer epidemiology: incidence, mortality, survival, and risk factors. Clin Colon Rectal Surg. 2009 Nov;22(4):191-7. doi: 10.1055/s-0029-1242458.
PubMed 21037809Marley AR, Nan H. Epidemiology of colorectal cancer. Int J Mol Epidemiol Genet. 2016 Sep 30;7(3):105-114. eCollection 2016.
PubMed 27766137Vuik FE, Nieuwenburg SA, Bardou M, Lansdorp-Vogelaar I, Dinis-Ribeiro M, Bento MJ, Zadnik V, Pellise M, Esteban L, Kaminski MF, Suchanek S, Ngo O, Majek O, Leja M, Kuipers EJ, Spaander MC. Increasing incidence of colorectal cancer in young adults in Europe over the last 25 years. Gut. 2019 Oct;68(10):1820-1826. doi: 10.1136/gutjnl-2018-317592. Epub 2019 May 16.
PubMed 31097539Abou-Zeid AA, Khafagy W, Marzouk DM, Alaa A, Mostafa I, Ela MA. Colorectal cancer in Egypt. Dis Colon Rectum. 2002 Sep;45(9):1255-60. doi: 10.1007/s10350-004-6401-z.
PubMed 12352245Gado A, Ebeid B, Abdelmohsen A, et al. Colorectal cancer in Egypt is commoner in young people: Is this cause for alarm? Alexandria J Med. 2014; 50:197-201.
Metwally IH, Shetiwy M, Elalfy AF, et al. Epidemiology and survival of colon cancer among Egyptians: A retrospective study. J Coloproctol. 2018;38:24-29.
American Cancer Society: Treatment of Colon Cancer, by Stage. 2020. Available at https://www.cancer.org/cancer/colon-rectal-cancer/ treating/by-stage- colon.html.
Alcaide J, Funez R, Rueda A, Perez-Ruiz E, Pereda T, Rodrigo I, Covenas R, Munoz M, Redondo M. The role and prognostic value of apoptosis in colorectal carcinoma. BMC Clin Pathol. 2013 Oct 10;13(1):24. doi: 10.1186/1472-6890-13-24.
PubMed 24106912Mousa L, Salem ME, Mikhail S. Biomarkers of Angiogenesis in Colorectal Cancer. Biomark Cancer. 2015 Oct 27;7(Suppl 1):13-9. doi: 10.4137/BIC.S25250. eCollection 2015.
PubMed 26543385Meirovitz A, Baider L, Peretz T, Stephanos S, Barak V. Effect of pentoxifylline on colon cancer patients treated with chemotherapy (Part I). Tumour Biol. 2021;43(1):341-349. doi: 10.3233/TUB-211533.
PubMed 34957976
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Anticancer Effect of Pentoxiphylline in Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06115174
- Acronym / sponsor ID
- CRC - PTX / Pentoxiphylline in CRC
- Conditions
- Metastatic Colorectal Carcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this work is to assess the antitumor effect of Pentoxiphylline in patients with metastatic colorectal cancer receiving stomatal chemotherapy ± targeted therapy.
Detailed description
Colorectal cancer (CRC) ranks as the third most common cancer globally and second in terms of mortality. Although CRC incidence rates are higher in high-income compared with low-to-middle-income countries (LMICs), mortality is higher in LMICs. And although more than 90% of CRC cases are diagnosed in individuals over age 55, CRC incidence is rising in younger populations. For example, Egypt, Saudi Arabia, the Philippines, and Iran have CRC incidence rates in individuals under age 40 of 38%, 21%, 17%, and 15%-35%, respectively. This is compared with only 2%-8% of new cases in the U.S. and the European Union in individuals in this age bracket. Along with the high incidence rate of CRC in individuals under age 40 in Egypt, CRC is diagnosed at more advanced stages in these younger Egyptians. CRC survival is highly dependent upon the stage of disease at diagnosis and typically ranges from a 90% 5-year survival rate for cancers detected at the localized stage to 14% for individuals diagnosed with distant metastatic cancer.
Apoptosis may occur via two major interconnected pathways: the extrinsic or death receptor-mediated pathway, which is activated by the binding of specific ligands (such as FasL, TNF-α and TRAIL) to the receptors of cell surfaces; and the intrinsic or mitochondrial-mediated pathway, which is regulated through proteins of the Bcl-2 family and triggered either by the loss of growth factor signals or in response to genotoxic stress. Therefore the replication of cells with DNA damage is generally avoided because harmful genomic alterations typically induce the activation of apoptosis. It has been widely accepted that alterations in the physiologic response to DNA damage can facilitate the accumulation of oncogenic mutations; this accumulation may eventually lead to the development of neoplasia.
Angiogenesis is a complex process by which new blood vessels are formed from endothelial precursor. It is a critical step in cancer progression and is considered one of the hallmarks of cancer. This process is mediated through a group of ligands and receptors that work in tight regulation. A group of glycoproteins, including the VEGFs (VEGF-A, VEGF-B, VEGF-C, and VEGF-D) and the placental growth factor (PIGF), act as effectors of angiogenesis. These factors interact with three VEGF receptors (VEGFR- 1, VEGFR-2, and VEGFR-3) and two neuropilin co-receptors (NRP1 and NRP2). The VEGF-A gene consists of eight exons with splice variants forming different isoforms, namely, VEGFA121, VEGFA165, VEGFA189, and VEGFA209; VEGFA165 is the most biologically active of these isoforms [14]. The VEGFRs are tyrosine kinase receptors that are primarily located in the vascular endothelial cells. The binding of VEGF-A to VEGFR-2 is believed to be the most important activator of angiogenesis.
Pentoxifylline (PTX) is a methylxanthine derivative that is commercially available in the name of Trental. It is currently used for management of peripheral vascular diseases. Its postulated mechanism of action is thought to be mediated through reducing blood viscosity and enhancing RBCs flexibility. However, it has been shown that PTX also may potentially be used in the anticancer therapy.
The studies demonstrated the potential effects of pentoxifylline on angiogenesis inhibition. It can affect the release and function of some predominantly proangiogenic vascular endothelial growth factors. Specifically, the release of the VEGF family of pro-angiogenesis factors (notably VEGF-A and VEGF-C) [16]. Furthermore, the mechanism by which pentoxifylline inhibits angiogenesis may be through the inhibition of activation of STAT3 which contributes to tumor cell survival by regulating the expression of metastatic genes, MMPs, serine protease uPA and potent angiogenic genes.
In addition, PTX has also the ability to induce apoptosis and potentiate the apoptotic effects of chemotherapy in several cancer types, one major mechanism is through activation of the caspase-dependent apoptosis that is accompanied by a decrease in kappa B-alpha- phosphorylation and up-regulation of the pro-apoptotic genes Bax, Bad, Bak, and caspases- 3,
-8, and -9.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The design of this study is a randomized, controlled parallel clinical trial which will be conducted on 44 patients with metastatic colorectal cancer. The duration of the study will be one year to determine progression free survival (PFS) and the overall survival (OS). Patients will be recruited from Medical Oncology Department, Oncology Centre, Mansoura University, Mansoura, Egypt. The patients will be randomized using sealed envelope method into the following two groups: Group I (Control group; n=22) which will receive FOLFOX (leucovorin, fluorouracil, oxaliplatin) or XELOX (oxaliplatin + capecitabine) ± target therapy (Bevacizumab). Group II: (Pentoxiphylline group; n=22) which will receive the same FOLFOX or XELOX regimen ± target therapy (Bevacizumab) in addition to Pentoxiphylline 400 mg twice daily.
| Arm | Type | Receives |
|---|---|---|
| People not recieving the drug | Other | Radiation: FOLFOX, Radiation: XELOX, Drug: Monoclonal antibodies (target therapy)(Control group; n=22) which will receive FOLFOX (leucovorin, fluorouracil, oxaliplatin) or XELOX (oxaliplatin + capecitabine) ± target therapy (Bevacizumab). |
| People recieving the drug | Active comparator | Drug: Pentoxifylline, Radiation: FOLFOX, Radiation: XELOX, Drug: Monoclonal antibodies (target therapy)(Pentoxiphylline group; n=22) which will receive the same FOLFOX (leucovorin, fluorouracil, oxaliplatin) or XELOX regimen (oxaliplatin + capecitabine) ± target therapy (Bevacizumab) in addition to Pentoxiphylline 400 mg twice daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with histologically and/or radiologically confirmed diagnosis of metastatic colorectal carcinoma.
- Both genders.
- Age ≥ 18 years old, and ≤ 75 years old.
- Performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG).
- Patients with adequate hematologic parameters (white blood cell count
Key exclusion criteria (12 listed)
- Patients with active liver diseases (chronic viral hepatitis, autoimmune hepatitis, alcoholic hepatitis, Wilson's disease, hemochromatosis, or cirrhosis).
- Patients with brain metastasis.
- Patients with active infection.
- Patients on chronic use of corticosteroids.
- Patients receiving blood thinning agents(aspirin, clopidogrel, warfarin)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PentoxifyllinePentoxifylline (PTX) is a methylxanthine derivative that is commercially available in the name of Trental. It is currently used for management of peripheral vascular diseases. Its postulated mechanism of action is thought to be mediated through reducing blood viscosity and enhancing RBCs flexibility. However, it has been shown that PTX also may potentially be used in the anticancer therapy [15]. The studies demonstrated the potential effects of pentoxifylline on angiogenesis inhibition. It can affect the release and function of some predominantly proangiogenic vascular endothelial growth factors. Specifically, the release of the VEGF family of pro-angiogenesis factors (notably VEGF-A and VEGF-C) [16]. Furthermore, the mechanism by which pentoxifylline inhibits angiogenesis may be through the inhibition of activation of STAT3 which contributes to tumor cell survival by regulating the expression of metastatic genes, MMPs, serine protease uPA and potent angiogenic genes [17]. | Drug | People recieving the drug |
| FOLFOX(leucovorin, fluorouracil, oxaliplatin) | Radiation | People not recieving the drug, People recieving the drug |
| XELOX(oxaliplatin + capecitabine) | Radiation | People not recieving the drug, People recieving the drug |
| Monoclonal antibodies (target therapy)target therapy (Bevacizumab). | Drug | People not recieving the drug, People recieving the drug |
Primary outcome
Comparison of RECIST between the two groups.
Time frame: one year
Difference in response rate (RECIST) between the control and drug groups.
Change in the serum concentration of the measured biological markers.
Time frame: one year
Difference in progression free survival 'PFS' between the two groups
Time frame: One year.
Difference in overall survival 'OS' between the two groups.
Time frame: One year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 30100160Ferlay J, Colombet M, Soerjomataram I, Dyba T, Randi G, Bettio M, Gavin A, Visser O, Bray F. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries and 25 major cancers in 2018. Eur J Cancer. 2018 Nov;103:356-387. doi: 10.1016/j.ejca.2018.07.005. Epub 2018 Aug 9.
- Background: PubMed 26818619Arnold M, Sierra MS, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global patterns and trends in colorectal cancer incidence and mortality. Gut. 2017 Apr;66(4):683-691. doi: 10.1136/gutjnl-2015-310912. Epub 2016 Jan 27.
- Background: PubMed 26041752Schreuders EH, Ruco A, Rabeneck L, Schoen RE, Sung JJ, Young GP, Kuipers EJ. Colorectal cancer screening: a global overview of existing programmes. Gut. 2015 Oct;64(10):1637-49. doi: 10.1136/gutjnl-2014-309086. Epub 2015 Jun 3.
- Background: PubMed 25512156Sankaranarayanan R. Screening for cancer in low- and middle-income countries. Ann Glob Health. 2014 Sep-Oct;80(5):412-7. doi: 10.1016/j.aogh.2014.09.014.
- Background: PubMed 21037809Haggar FA, Boushey RP. Colorectal cancer epidemiology: incidence, mortality, survival, and risk factors. Clin Colon Rectal Surg. 2009 Nov;22(4):191-7. doi: 10.1055/s-0029-1242458.
- Background: PubMed 27766137Marley AR, Nan H. Epidemiology of colorectal cancer. Int J Mol Epidemiol Genet. 2016 Sep 30;7(3):105-114. eCollection 2016.
- Background: PubMed 31097539Vuik FE, Nieuwenburg SA, Bardou M, Lansdorp-Vogelaar I, Dinis-Ribeiro M, Bento MJ, Zadnik V, Pellise M, Esteban L, Kaminski MF, Suchanek S, Ngo O, Majek O, Leja M, Kuipers EJ, Spaander MC. Increasing incidence of colorectal cancer in young adults in Europe over the last 25 years. Gut. 2019 Oct;68(10):1820-1826. doi: 10.1136/gutjnl-2018-317592. Epub 2019 May 16.
- Background: PubMed 12352245Abou-Zeid AA, Khafagy W, Marzouk DM, Alaa A, Mostafa I, Ela MA. Colorectal cancer in Egypt. Dis Colon Rectum. 2002 Sep;45(9):1255-60. doi: 10.1007/s10350-004-6401-z.
- BackgroundGado A, Ebeid B, Abdelmohsen A, et al. Colorectal cancer in Egypt is commoner in young people: Is this cause for alarm? Alexandria J Med. 2014; 50:197-201.
- BackgroundMetwally IH, Shetiwy M, Elalfy AF, et al. Epidemiology and survival of colon cancer among Egyptians: A retrospective study. J Coloproctol. 2018;38:24-29.
- BackgroundAmerican Cancer Society: Treatment of Colon Cancer, by Stage. 2020. Available at https://www.cancer.org/cancer/colon-rectal-cancer/ treating/by-stage- colon.html.
- Individual participant dataSharing planned: Yes
Related trials for Metastatic Colorectal Carcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek Mohammed, Professor study chair
Tanta University
Dalia Refaat, Assistant Professor study chair
Tanta University
Sherif Refaat, Lecturer study chair
Oncology Centre - Faculty of Medicine - Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pentoxifylline, FOLFOX and XELOX in people with Metastatic Colorectal Carcinoma, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of RECIST between the two groups. (time frame: one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06115174, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.