Colon CancerNCT05424692
Drug Sensitivity Detection of Micro Tumor (PTC) to Guide Postoperative Adjuvant Treatment Strategy of Colorectal Cancer
A study testing 5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate in people with Colon Cancer and Rectal Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The research objectives is to compare vitro 3D drug sensitivity test results of micro tumor (PTC) with the clinical outcomes of patients, evaluate the consistency between the test results of the technology platform and the clinical prognosis, and explore the decision-making value and guiding significance of this… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer, Rectal Cancer, Chemotherapy Effect
- What is being tested?
- 5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 ~ 75 years old, regardless of gender
- Patients with colorectal cancer diagnosed by histopathology or cytology
- Colorectal cancer patients who need adjuvant therapy after radical surgery and have not received neoadjuvant therapy
- Having at least one assessable tumor focus
- ECoG physical condition score ≤ 2 points
- Voluntarily participate and sign informed consent
Who cannot join
- Patients diagnosed with metastasis
- Patients who cannot obtain tumor samples
- Pregnant and lactating women
- Patients with poor compliance
- Patients with severe cardiovascular and cerebrovascular complications who cannot receive adjuvant treatment
- Patients with other malignant tumors
- Suffering from serious mental and nervous system diseases
- The researchers believe that patients should not be selected for this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Guole Lin, 13801081483, linguole@126.com
Jiaolin Zhou, 13910136704, conniezhjl@yahoo.com
About this study
Official title: Vitro 3D Drug Sensitivity Detection of Micro Tumor (PTC) Combined with Tumor Whole Exon (WES) Sequencing Technology to Guide Postoperative Adjuvant Treatment Strategy and Prognosis of Colorectal Cancer
The research objectives is to compare vitro 3D drug sensitivity test results of micro tumor (PTC) with the clinical outcomes of patients, evaluate the consistency between the test results of the technology platform and the clinical prognosis, and explore the decision-making value and guiding significance of this technology in assisting the precise treatment of colorectal cancer. The completion of this study will provide real-world data support for the clinical application of micro tumor (PTC) in vitro 3D drug sensitivity detection technology, and provide more valuable reference basis for realizing the individualization and accuracy of colorectal cancer treatment and improving the clinical benefit rate.
Read the detailed description
The study is a multi agency prospective cohort study in China. The subjects were patients aged 18 ~ 75 years with colorectal cancer diagnosed by histopathology or cytology. They must be colorectal cancer patients who have at least one assessable tumor focus, need adjuvant therapy after radical surgery, and have not received neoadjuvant therapy， ECoG physical condition score ≤ 2 points. And they must be voluntarily participate in and sign informed consent.
The patients were randomly divided into PTC drug sensitivity test group and control group. The PTC drug sensitivity test group selected the adjuvant chemotherapy scheme according to the 3D drug sensitivity test results of micro tumor (PTC) in vitro. The control group made adjuvant chemotherapy strategy according to clinical experience. All exon (WES) data collection was used to predict postoperative survival in both groups.
The primary endpoint was the non inferiority test, and the 3-year disease-free survival rate was T-C >- Δ
- Conditions
- Colon Cancer, Rectal Cancer, Chemotherapy Effect, PTC, Exon Mutation
- Being tested
- 5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolateDrug
Also called PTC drug sensitivity results
Choose chemotherapeutic drugs（5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate） based on PTC drug sensitivity results.
| Study group | Role | What they receive |
|---|---|---|
| PTC test group | Experimental | The adjuvant chemotherapy scheme was selected according to the 3D drug sensitivity test results of micro tumor (PTC) in vitro Receives: Drug: 5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate |
| control group | No intervention | Making adjuvant chemotherapy strategy based on clinical experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of 3-year disease-free survival rate of patients in both group
Follow-up the survival status of patients, and calculate 3-year disease-free survival rate of patients in both group
Measured: 3 years
Secondary outcomes (9)
The relation between TMB and clinical outcomes
Use tumor whole exon (WES) sequencing to detect the Tumor Mutation Burden (TMB) of patients, and use correlation analysis to detect whether it's risk factor of clinical outcomes.
Measured: 3 years
The relation between MSI and clinical outcomes
Use tumor whole exon (WES) sequencing to detect the Microsatellite Instability (MSI) of patients, and use correlation analysis to detect whether it's risk factor of clinical outcomes.
Measured: 3 years
The relation between dMMR and clinical outcomes
Use tumor whole exon (WES) sequencing to detect the Deficient Mismatch Repair (dMMR) of patients, and use correlation analysis to detect whether it's risk factor of clinical outcomes.
Measured: 3 years
The difference of clinical outcomes of patients in both group
Follow-up the health status and weather tumor recurrence and metastasis of patients, and evaluate whether the test results of extended drug regimen correspond with clinical outcomes
Measured: 3 years
The difference of TTP of patients in both group
Follow-up the results of patients' periodic reviews and calculate Time To Progress (TTP） of patients in both group, and use survival analysis to detect whether the two group has difference in TTP.
Measured: 3 years
The difference of ORR of patients in both group
Follow-up the results of patients' periodic reviews and calculate Objective Response Rate (ORR） of patients in both group, and use survival analysis to detect whether the two group has difference in ORR.
Measured: three years
The difference of DFS of patients in both group
Follow-up the results of patients' periodic reviews and calculate Disease Free Survival (DFS) of patients in both group, and use survival analysis to detect whether the two group has difference in DFS.
Measured: 3 years
The difference of PFS of patients in both group
Follow-up the results of patients' periodic reviews and calculate Progress Free Survival (PFS） of patients in both group, and use survival analysis to detect whether the two group has difference in PFS.
Measured: 3 years
The difference of OS of patients in both group
Follow-up the results of patients' periodic reviews and calculate Overall Survival (OS） of patients in both group, and use survival analysis to detect whether the two group has difference in OS.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Sep 2021
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guole Lin, Study chair, Peking Union Medical College HospitalJiaolin Zhou, Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424692
- Sponsor's protocol ID
- PekingUMCHPTC
- Status last verified
- Sep 2024
- First submitted
- 3 May 2022
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Gramont A, Figer A, Seymour M, Homerin M, Hmissi A, Cassidy J, Boni C, Cortes-Funes H, Cervantes A, Freyer G, Papamichael D, Le Bail N, Louvet C, Hendler D, de Braud F, Wilson C, Morvan F, Bonetti A. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol. 2000 Aug;18(16):2938-47. doi: 10.1200/JCO.2000.18.16.2938.
PubMed 10944126Siegel R, DeSantis C, Virgo K, Stein K, Mariotto A, Smith T, Cooper D, Gansler T, Lerro C, Fedewa S, Lin C, Leach C, Cannady RS, Cho H, Scoppa S, Hachey M, Kirch R, Jemal A, Ward E. Cancer treatment and survivorship statistics, 2012. CA Cancer J Clin. 2012 Jul-Aug;62(4):220-41. doi: 10.3322/caac.21149. Epub 2012 Jun 14.
PubMed 22700443Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Alberts SR. A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol. 2004 Jan 1;22(1):23-30. doi: 10.1200/JCO.2004.09.046. Epub 2003 Dec 9.
PubMed 14665611Yin S, Xi R, Wu A, Wang S, Li Y, Wang C, Tang L, Xia Y, Yang D, Li J, Ye B, Yu Y, Wang J, Zhang H, Ren F, Zhang Y, Shen D, Wang L, Ying X, Li Z, Bu Z, Ji X, Gao X, Jia Y, Jia Z, Li N, Li Z, Ji JF, Xi JJ. Patient-derived tumor-like cell clusters for drug testing in cancer therapy. Sci Transl Med. 2020 Jun 24;12(549):eaaz1723. doi: 10.1126/scitranslmed.aaz1723.
PubMed 32581131Cassidy J, Clarke S, Diaz-Rubio E, Scheithauer W, Figer A, Wong R, Koski S, Lichinitser M, Yang TS, Rivera F, Couture F, Sirzen F, Saltz L. Randomized phase III study of capecitabine plus oxaliplatin compared with fluorouracil/folinic acid plus oxaliplatin as first-line therapy for metastatic colorectal cancer. J Clin Oncol. 2008 Apr 20;26(12):2006-12. doi: 10.1200/JCO.2007.14.9898.
PubMed 18421053Gao H, Korn JM, Ferretti S, Monahan JE, Wang Y, Singh M, Zhang C, Schnell C, Yang G, Zhang Y, Balbin OA, Barbe S, Cai H, Casey F, Chatterjee S, Chiang DY, Chuai S, Cogan SM, Collins SD, Dammassa E, Ebel N, Embry M, Green J, Kauffmann A, Kowal C, Leary RJ, Lehar J, Liang Y, Loo A, Lorenzana E, Robert McDonald E 3rd, McLaughlin ME, Merkin J, Meyer R, Naylor TL, Patawaran M, Reddy A, Roelli C, Ruddy DA, Salangsang F, Santacroce F, Singh AP, Tang Y, Tinetto W, Tobler S, Velazquez R, Venkatesan K, Von Arx F, Wang HQ, Wang Z, Wiesmann M, Wyss D, Xu F, Bitter H, Atadja P, Lees E, Hofmann F, Li E, Keen N, Cozens R, Jensen MR, Pryer NK, Williams JA, Sellers WR. High-throughput screening using patient-derived tumor xenografts to predict clinical trial drug response. Nat Med. 2015 Nov;21(11):1318-25. doi: 10.1038/nm.3954. Epub 2015 Oct 19.
PubMed 26479923Qiu X, Li R, Xie G, Ning N, Wang Z, Zhou J, Liu G, Tang Q, He Z, Yang L, Lu J, Li P, Lin G. In vitro 3D drug sensitivity testing for patient-derived tumor-like cell clusters and whole-exome sequencing to personalize postoperative treatment: A study protocol for a multicenter randomized controlled trial. PLoS One. 2025 Jul 14;20(7):e0326760. doi: 10.1371/journal.pone.0326760. eCollection 2025.
PubMed 40658653
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitro 3D Drug Sensitivity Detection of Micro Tumor (PTC) Combined with Tumor Whole Exon (WES) Sequencing Technology to Guide Postoperative Adjuvant Treatment Strategy and Prognosis of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05424692
- Acronym / sponsor ID
- PekingUMCHPTC
- Conditions
- Colon Cancer, Rectal Cancer, Chemotherapy Effect, PTC, Exon Mutation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 21 Jun 2022 (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 research objectives is to compare vitro 3D drug sensitivity test results of micro tumor (PTC) with the clinical outcomes of patients, evaluate the consistency between the test results of the technology platform and the clinical prognosis, and explore the decision-making value and guiding significance of this technology in assisting the precise treatment of colorectal cancer. The completion of this study will provide real-world data support for the clinical application of micro tumor (PTC) in vitro 3D drug sensitivity detection technology, and provide more valuable reference basis for realizing the individualization and accuracy of colorectal cancer treatment and improving the clinical benefit rate.
Detailed description
The study is a multi agency prospective cohort study in China. The subjects were patients aged 18 ~ 75 years with colorectal cancer diagnosed by histopathology or cytology. They must be colorectal cancer patients who have at least one assessable tumor focus, need adjuvant therapy after radical surgery, and have not received neoadjuvant therapy， ECoG physical condition score ≤ 2 points. And they must be voluntarily participate in and sign informed consent.
The patients were randomly divided into PTC drug sensitivity test group and control group. The PTC drug sensitivity test group selected the adjuvant chemotherapy scheme according to the 3D drug sensitivity test results of micro tumor (PTC) in vitro. The control group made adjuvant chemotherapy strategy according to clinical experience. All exon (WES) data collection was used to predict postoperative survival in both groups.
The primary endpoint was the non inferiority test, and the 3-year disease-free survival rate was T-C >- Δ
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTC test group | Experimental | Drug: 5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolateThe adjuvant chemotherapy scheme was selected according to the 3D drug sensitivity test results of micro tumor (PTC) in vitro |
| control group | No intervention | –Making adjuvant chemotherapy strategy based on clinical experience |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 ~ 75 years old, regardless of gender
- Patients with colorectal cancer diagnosed by histopathology or cytology
- Colorectal cancer patients who need adjuvant therapy after radical surgery and have not received neoadjuvant therapy
- Having at least one assessable tumor focus
- ECoG physical condition score ≤ 2 points
Key exclusion criteria (8 listed)
- Patients diagnosed with metastasis
- Patients who cannot obtain tumor samples
- Pregnant and lactating women
- Patients with poor compliance
- Patients with severe cardiovascular and cerebrovascular complications who cannot receive adjuvant treatment
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 |
|---|---|---|
| 5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolateAlso: PTC drug sensitivity resultsChoose chemotherapeutic drugs（5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate） based on PTC drug sensitivity results. | Drug | PTC test group |
Primary outcome
The difference of 3-year disease-free survival rate of patients in both group
Time frame: 3 years
Follow-up the survival status of patients, and calculate 3-year disease-free survival rate of patients in both group
9 secondary outcomes
The relation between TMB and clinical outcomes
Time frame: 3 years
The relation between MSI and clinical outcomes
Time frame: 3 years
The relation between dMMR and clinical outcomes
Time frame: 3 years
The difference of clinical outcomes of patients in both group
Time frame: 3 years
The difference of TTP of patients in both group
Time frame: 3 years
The difference of ORR of patients in both group
Time frame: three years
The difference of DFS of patients in both group
Time frame: 3 years
The difference of PFS of patients in both group
Time frame: 3 years
The difference of OS of patients in both group
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Background: PubMed 10944126de Gramont A, Figer A, Seymour M, Homerin M, Hmissi A, Cassidy J, Boni C, Cortes-Funes H, Cervantes A, Freyer G, Papamichael D, Le Bail N, Louvet C, Hendler D, de Braud F, Wilson C, Morvan F, Bonetti A. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol. 2000 Aug;18(16):2938-47. doi: 10.1200/JCO.2000.18.16.2938.
- Background: PubMed 22700443Siegel R, DeSantis C, Virgo K, Stein K, Mariotto A, Smith T, Cooper D, Gansler T, Lerro C, Fedewa S, Lin C, Leach C, Cannady RS, Cho H, Scoppa S, Hachey M, Kirch R, Jemal A, Ward E. Cancer treatment and survivorship statistics, 2012. CA Cancer J Clin. 2012 Jul-Aug;62(4):220-41. doi: 10.3322/caac.21149. Epub 2012 Jun 14.
- Background: PubMed 14665611Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Alberts SR. A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol. 2004 Jan 1;22(1):23-30. doi: 10.1200/JCO.2004.09.046. Epub 2003 Dec 9.
- Background: PubMed 32581131Yin S, Xi R, Wu A, Wang S, Li Y, Wang C, Tang L, Xia Y, Yang D, Li J, Ye B, Yu Y, Wang J, Zhang H, Ren F, Zhang Y, Shen D, Wang L, Ying X, Li Z, Bu Z, Ji X, Gao X, Jia Y, Jia Z, Li N, Li Z, Ji JF, Xi JJ. Patient-derived tumor-like cell clusters for drug testing in cancer therapy. Sci Transl Med. 2020 Jun 24;12(549):eaaz1723. doi: 10.1126/scitranslmed.aaz1723.
- Background: PubMed 18421053Cassidy J, Clarke S, Diaz-Rubio E, Scheithauer W, Figer A, Wong R, Koski S, Lichinitser M, Yang TS, Rivera F, Couture F, Sirzen F, Saltz L. Randomized phase III study of capecitabine plus oxaliplatin compared with fluorouracil/folinic acid plus oxaliplatin as first-line therapy for metastatic colorectal cancer. J Clin Oncol. 2008 Apr 20;26(12):2006-12. doi: 10.1200/JCO.2007.14.9898.
- Background: PubMed 26479923Gao H, Korn JM, Ferretti S, Monahan JE, Wang Y, Singh M, Zhang C, Schnell C, Yang G, Zhang Y, Balbin OA, Barbe S, Cai H, Casey F, Chatterjee S, Chiang DY, Chuai S, Cogan SM, Collins SD, Dammassa E, Ebel N, Embry M, Green J, Kauffmann A, Kowal C, Leary RJ, Lehar J, Liang Y, Loo A, Lorenzana E, Robert McDonald E 3rd, McLaughlin ME, Merkin J, Meyer R, Naylor TL, Patawaran M, Reddy A, Roelli C, Ruddy DA, Salangsang F, Santacroce F, Singh AP, Tang Y, Tinetto W, Tobler S, Velazquez R, Venkatesan K, Von Arx F, Wang HQ, Wang Z, Wiesmann M, Wyss D, Xu F, Bitter H, Atadja P, Lees E, Hofmann F, Li E, Keen N, Cozens R, Jensen MR, Pryer NK, Williams JA, Sellers WR. High-throughput screening using patient-derived tumor xenografts to predict clinical trial drug response. Nat Med. 2015 Nov;21(11):1318-25. doi: 10.1038/nm.3954. Epub 2015 Oct 19.
- Derived from this study: PubMed 40658653Qiu X, Li R, Xie G, Ning N, Wang Z, Zhou J, Liu G, Tang Q, He Z, Yang L, Lu J, Li P, Lin G. In vitro 3D drug sensitivity testing for patient-derived tumor-like cell clusters and whole-exome sequencing to personalize postoperative treatment: A study protocol for a multicenter randomized controlled trial. PLoS One. 2025 Jul 14;20(7):e0326760. doi: 10.1371/journal.pone.0326760. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
Guole Lin study chair
Peking Union Medical College Hospital
Jiaolin Zhou study director
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate in people with Colon Cancer and Rectal Cancer, run by Peking Union Medical College Hospital at 1 site in China.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 4 Nov 2024. 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 China. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guole Lin (13801081483, linguole@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of 3-year disease-free survival rate of patients in both group (time frame: 3 years). 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 NCT05424692, which also lists 7 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 4 Nov 2024.