Colorectal CancerNCT04752930
ctDNA as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer
A study testing ctDNA monitoring and Imageology in people with Colorectal Cancer and Peritoneal Metastases, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
This is a prospective, open-label, randomized controlled clinical trial, by monitoring the serum ctDNA mutational profile using NGS, aiming to elucidate the correlation between the postoperative ctDNA status and the assisted diagnosis, early intervention and prognosis for colorectal cancer peritoneal metastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Peritoneal Metastases
- What is being tested?
- ctDNA monitoring and Imageology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 24 Aug 2020to 24 Aug 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be a man or woman of at 18-75;
- Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-21；
- Patients with primary colorectal cancer proven by pathology；
- Patients with high risk factors for peritoneal metastasis (simultaneous peritoneal metastasis, ovarian metastasis, PT4, CT4, tumor perforation, tumor-complete intestinal obstruction, mucinous adenocarcinoma/signet ring cell carcinoma of PT3, positive surgical margin, and tumor rupture and hemorrhage);
- 6-12 months after colorectal cancer radical surgery, patients who have two consecutive positive ctDNA tests within one month;
- Patients who have finished standard adjuvant therapy after surgery; (Choose 5-FU or 5-FU analog-based chemotherapy regimen, and the perioperative chemotherapy should not exceed 6 months)；
- Patients who are negative of recurrence or metastasis in conventional oncology examination (serology, endoscopy, imaging) ;
- Written informed consent must be obtained from patients and ability for patients to comply with the requirements of the study.
Who cannot join
- Patients who were diagnosed with other malignant tumors within 2 years before diagnosis of colorectal cancer;
- ASA class Ⅳ to Ⅴ;
- Patients who have other existence of distant metastasis outside the abdomen;
- Patients with serious mental illness;
- Patients with severe cardiovascular disease, uncontrollable infections, or other uncontrollable co-diseases;
- Patients who cannot be followed up as scheduled;
- Patients who participated in other clinical studies within 3 months prior to the trial;
- Pregnant or nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
About this study
Official title: Circulating Tumor DNA (ctDNA) as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer: A Prospective, Open-label, Randomized Controlled Study
This is a prospective, open-label, randomized controlled clinical trial, by monitoring the serum ctDNA mutational profile using NGS, aiming to elucidate the correlation between the postoperative ctDNA status and the assisted diagnosis, early intervention and prognosis for colorectal cancer peritoneal metastases.
- Conditions
- Colorectal Cancer, Peritoneal Metastases
- Being tested
- ctDNA monitoring, Imageology
- Keywords
- ctDNA
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ctDNA monitoringDiagnostic test
Patients who undergoing radical surgery for colorectal cancer for 6~12 months and with 2 consecutive positive ctDNA testing results within 1 month will be enrolled, and diagnostic laparoscopy will be performed immediately after enrollment. Patients with positive peritoneal metastasis (PCI score <20) will be treated with CRS+HIPEC. Tumor markers, endoscopic and imaging examinations, and ctDNA monitoring will be performed every 3 months in patients with negative peritoneal metastasis. Laparoscopy will be performed when imaging suggested peritoneal metastasis (oligometastases). Re-diagnostic laparoscopy will be performed 24 months after radical surgery when there is no radiographic evidence of recurrence or metastasis. Follow-up time will up to 36 months after colorectal cancer surgery.
ImageologyDiagnostic test
Patients who undergoing radical surgery for colorectal cancer for 6~12 months and with 2 consecutive positive ctDNA testing results within 1 month will be enrolled. and there will be no need to conduct endoscopic exploration immediately after enrollment. Tumor markers, endoscopic and imaging examinations, and ctDNA monitoring will be performed every 3 months until imaging suggested peritoneal metastasis (oligometastases). Patients with positive peritoneal metastasis (PCI score <20) will be treated with CRS+HIPEC. Re-diagnostic laparoscopy will be performed 24 months after radical surgery when there is no radiographic evidence of recurrence or metastasis. Follow-up time will up to 36 months after colorectal cancer surgery.
| Study group | Role | What they receive |
|---|---|---|
| ctDNA monitoring | Experimental | ctDNA monitoring will be performed at protocol-specified intervals and requirement Receives: Diagnostic Test: ctDNA monitoring |
| Imageology (SOC) | Active comparator | Imaging examination will be performed at protocol-specified intervals and requirement Receives: Diagnostic Test: Imageology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritoneal Metastasis Free Survival (PMFS)
The survival rate without peritoneal metastasis (oligometastatic) at 24 months after radical resection of colorectal cancer.
Measured: Through study completion, up to 3 years
Secondary outcomes (9)
Detection Rate (DR)
DR of ctDNA monitoring for predicting peritoneal metastasis with abdominal exploration as the reference.
DR of imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.
DR of combination of ctDNA monitoring and imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.
Will be compared in both arms.
Measured: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
Positive Percent Agreement (PPA)
PPA of ctDNA monitoring for predicting peritoneal metastasis with abdominal exploration as the reference.
PPA of imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.
PPA of combination of ctDNA monitoring and imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.
Will be compared in both arms.
Measured: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
Negative Percent Agreement (NPA)
NPA of ctDNA monitoring for predicting peritoneal metastasis with abdominal exploration as the reference.
NPA of imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.
NPA of combination of ctDNA monitoring and imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.
Will be compared in both arms.
Measured: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
The time of peritoneal metastasis diagnosed after radical surgery
Will be compared in both arms.
Measured: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
Peritoneal Cancer Index (PCI) Score
This scale measures the extent of peritoneal cancer throughout the peritoneal cavity.
The range of this scale is from 0 to 39.
0 = no disease within the peritoneal cavity
0-9 = minimal disease
10-29 = moderate disease
30-39 = extensive disease
Lower values are considered a better outcome for the patient.
Will be compared in both arms.
Measured: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
Completeness of Cytoreduction (CC) Score
The degree to which the disease was able to be excised during the procedure.
This scale ranges from CC0-CC3.
CC0 = all disease has been cleared, with no visible peritoneal carcinomatosis after CRS
CC1 = microscopic disease remains (Nodules persisting < 2.5 mm after CRS)
CC2 = macroscopic disease remains (Nodules persisting between 2.5 mm and 2.5 cm)
CC3 = Substantial Macroscopic disease remains (Nodules persisting > 2.5 cm)
Lower values are considered a better outcome, with CC0/1 classed as favourable and CC2/3 indicating an incomplete clearance of disease.
Will be compared in both arms.
Measured: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
The ctDNA clearance rate before and after CRS+HIPEC treatment
Will be compared in both arms.
Measured: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
The rate of Disease Free Survival (DFS) at 3 years after radical resection of colorectal cancer
Whether the patient is still alive and free of disease or not.
Will be compared in both arms.
Measured: Through study completion, up to 3 years
The Overall Survival (OS) at 3 years after radical resection of colorectal cancer
Whether the patient is still alive or not.
Will be compared in both arms.
Measured: Through study completion, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start24 Aug 2020
- Primary completion24 Sep 2023 (estimated)
- Study completion24 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752930
- Sponsor's protocol ID
- SixthSunYetSen-ctDNA
- Status last verified
- Jan 2021
- First submitted
- 26 Jan 2021
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Franko J, Shi Q, Goldman CD, Pockaj BA, Nelson GD, Goldberg RM, Pitot HC, Grothey A, Alberts SR, Sargent DJ. Treatment of colorectal peritoneal carcinomatosis with systemic chemotherapy: a pooled analysis of north central cancer treatment group phase III trials N9741 and N9841. J Clin Oncol. 2012 Jan 20;30(3):263-7. doi: 10.1200/JCO.2011.37.1039. Epub 2011 Dec 12.
PubMed 22162570Yonemura Y, Bandou E, Kawamura T, Endou Y, Sasaki T. Quantitative prognostic indicators of peritoneal dissemination of gastric cancer. Eur J Surg Oncol. 2006 Aug;32(6):602-6. doi: 10.1016/j.ejso.2006.03.003. Epub 2006 Apr 17.
PubMed 16617004Elias D, Lefevre JH, Chevalier J, Brouquet A, Marchal F, Classe JM, Ferron G, Guilloit JM, Meeus P, Goere D, Bonastre J. Complete cytoreductive surgery plus intraperitoneal chemohyperthermia with oxaliplatin for peritoneal carcinomatosis of colorectal origin. J Clin Oncol. 2009 Feb 10;27(5):681-5. doi: 10.1200/JCO.2008.19.7160. Epub 2008 Dec 22.
PubMed 19103728Baratti D, Kusamura S, Deraco M. The Fifth International Workshop on Peritoneal Surface Malignancy (Milan, Italy, December 4-6, 2006): methodology of disease-specific consensus. J Surg Oncol. 2008 Sep 15;98(4):258-62. doi: 10.1002/jso.21056.
PubMed 18726888Esquivel J, Chua TC, Stojadinovic A, Melero JT, Levine EA, Gutman M, Howard R, Piso P, Nissan A, Gomez-Portilla A, Gonzalez-Bayon L, Gonzalez-Moreno S, Shen P, Stewart JH, Sugarbaker PH, Barone RM, Hoefer R, Morris DL, Sardi A, Sticca RP. Accuracy and clinical relevance of computed tomography scan interpretation of peritoneal cancer index in colorectal cancer peritoneal carcinomatosis: a multi-institutional study. J Surg Oncol. 2010 Nov 1;102(6):565-70. doi: 10.1002/jso.21601.
PubMed 20976729Dromain C, Leboulleux S, Auperin A, Goere D, Malka D, Lumbroso J, Schumberger M, Sigal R, Elias D. Staging of peritoneal carcinomatosis: enhanced CT vs. PET/CT. Abdom Imaging. 2008 Jan-Feb;33(1):87-93. doi: 10.1007/s00261-007-9211-7.
PubMed 17632751Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094.
PubMed 24553385Abbosh C, Birkbak NJ, Wilson GA, Jamal-Hanjani M, Constantin T, Salari R, Le Quesne J, Moore DA, Veeriah S, Rosenthal R, Marafioti T, Kirkizlar E, Watkins TBK, McGranahan N, Ward S, Martinson L, Riley J, Fraioli F, Al Bakir M, Gronroos E, Zambrana F, Endozo R, Bi WL, Fennessy FM, Sponer N, Johnson D, Laycock J, Shafi S, Czyzewska-Khan J, Rowan A, Chambers T, Matthews N, Turajlic S, Hiley C, Lee SM, Forster MD, Ahmad T, Falzon M, Borg E, Lawrence D, Hayward M, Kolvekar S, Panagiotopoulos N, Janes SM, Thakrar R, Ahmed A, Blackhall F, Summers Y, Hafez D, Naik A, Ganguly A, Kareht S, Shah R, Joseph L, Marie Quinn A, Crosbie PA, Naidu B, Middleton G, Langman G, Trotter S, Nicolson M, Remmen H, Kerr K, Chetty M, Gomersall L, Fennell DA, Nakas A, Rathinam S, Anand G, Khan S, Russell P, Ezhil V, Ismail B, Irvin-Sellers M, Prakash V, Lester JF, Kornaszewska M, Attanoos R, Adams H, Davies H, Oukrif D, Akarca AU, Hartley JA, Lowe HL, Lock S, Iles N, Bell H, Ngai Y, Elgar G, Szallasi Z, Schwarz RF, Herrero J, Stewart A, Quezada SA, Peggs KS, Van Loo P, Dive C, Lin CJ, Rabinowitz M, Aerts HJWL, Hackshaw A, Shaw JA, Zimmermann BG; TRACERx consortium; PEACE consortium; Swanton C. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017 Apr 26;545(7655):446-451. doi: 10.1038/nature22364.
PubMed 28445469Tie J, Wang Y, Tomasetti C, Li L, Springer S, Kinde I, Silliman N, Tacey M, Wong HL, Christie M, Kosmider S, Skinner I, Wong R, Steel M, Tran B, Desai J, Jones I, Haydon A, Hayes T, Price TJ, Strausberg RL, Diaz LA Jr, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Sci Transl Med. 2016 Jul 6;8(346):346ra92. doi: 10.1126/scitranslmed.aaf6219.
PubMed 27384348Saluja H, Karapetis CS, Pedersen SK, Young GP, Symonds EL. The Use of Circulating Tumor DNA for Prognosis of Gastrointestinal Cancers. Front Oncol. 2018 Jul 24;8:275. doi: 10.3389/fonc.2018.00275. eCollection 2018.
PubMed 30087854Ossandon MR, Agrawal L, Bernhard EJ, Conley BA, Dey SM, Divi RL, Guan P, Lively TG, McKee TC, Sorg BS, Tricoli JV. Circulating Tumor DNA Assays in Clinical Cancer Research. J Natl Cancer Inst. 2018 Sep 1;110(9):929-934. doi: 10.1093/jnci/djy105.
PubMed 29931312Yang QM, Bando E, Kawamura T, Tsukiyama G, Nemoto M, Yonemura Y, Furukawa H. The diagnostic value of PET-CT for peritoneal dissemination of abdominal malignancies. Gan To Kagaku Ryoho. 2006 Nov;33(12):1817-21.
PubMed 17212117Yonemura Y, Elnemr A, Endou Y, Hirano M, Mizumoto A, Takao N, Ichinose M, Miura M, Li Y. Multidisciplinary therapy for treatment of patients with peritoneal carcinomatosis from gastric cancer. World J Gastrointest Oncol. 2010 Feb 15;2(2):85-97. doi: 10.4251/wjgo.v2.i2.85.
PubMed 21160926Satoh Y, Ichikawa T, Motosugi U, Kimura K, Sou H, Sano K, Araki T. Diagnosis of peritoneal dissemination: comparison of 18F-FDG PET/CT, diffusion-weighted MRI, and contrast-enhanced MDCT. AJR Am J Roentgenol. 2011 Feb;196(2):447-53. doi: 10.2214/AJR.10.4687.
PubMed 21257899Brucher BL, Piso P, Verwaal V, Esquivel J, Derraco M, Yonemura Y, Gonzalez-Moreno S, Pelz J, Konigsrainer A, Strohlein M, Levine EA, Morris D, Bartlett D, Glehen O, Garofalo A, Nissan A. Peritoneal carcinomatosis: cytoreductive surgery and HIPEC--overview and basics. Cancer Invest. 2012 Mar;30(3):209-24. doi: 10.3109/07357907.2012.654871.
PubMed 22360361
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA (ctDNA) as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer: A Prospective, Open-label, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04752930
- Acronym / sponsor ID
- SixthSunYetSen-ctDNA
- Conditions
- Colorectal Cancer, Peritoneal Metastases
- Keywords
- ctDNA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 24 Sep 2023 (estimated)
- Study completion
- 24 Aug 2025 (estimated)
- First posted
- 12 Feb 2021 (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.
This is a prospective, open-label, randomized controlled clinical trial, by monitoring the serum ctDNA mutational profile using NGS, aiming to elucidate the correlation between the postoperative ctDNA status and the assisted diagnosis, early intervention and prognosis for colorectal cancer peritoneal metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ctDNA monitoring | Experimental | Diagnostic Test: ctDNA monitoringctDNA monitoring will be performed at protocol-specified intervals and requirement |
| Imageology (SOC) | Active comparator | Diagnostic Test: ImageologyImaging examination will be performed at protocol-specified intervals and requirement |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must be a man or woman of at 18-75;
- Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-21；
- Patients with primary colorectal cancer proven by pathology；
- Patients with high risk factors for peritoneal metastasis (simultaneous peritoneal metastasis, ovarian metastasis, PT4, CT4, tumor perforation, tumor-complete intestinal obstruction, mucinous adenocarcinoma/signet ring cell carcinoma of PT3, positive surgical margin, and tumor rupture and hemorrhage);
- 6-12 months after colorectal cancer radical surgery, patients who have two consecutive positive ctDNA tests within one month;
Key exclusion criteria (8 listed)
- Patients who were diagnosed with other malignant tumors within 2 years before diagnosis of colorectal cancer;
- ASA class Ⅳ to Ⅴ;
- Patients who have other existence of distant metastasis outside the abdomen;
- Patients with serious mental illness;
- Patients with severe cardiovascular disease, uncontrollable infections, or other uncontrollable co-diseases;
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 |
|---|---|---|
| ctDNA monitoringPatients who undergoing radical surgery for colorectal cancer for 6~12 months and with 2 consecutive positive ctDNA testing results within 1 month will be enrolled, and diagnostic laparoscopy will be performed immediately after enrollment. Patients with positive peritoneal metastasis (PCI score <20) will be treated with CRS+HIPEC. Tumor markers, endoscopic and imaging examinations, and ctDNA monitoring will be performed every 3 months in patients with negative peritoneal metastasis. Laparoscopy will be performed when imaging suggested peritoneal metastasis (oligometastases). Re-diagnostic laparoscopy will be performed 24 months after radical surgery when there is no radiographic evidence of recurrence or metastasis. Follow-up time will up to 36 months after colorectal cancer surgery. | Diagnostic test | ctDNA monitoring |
| ImageologyPatients who undergoing radical surgery for colorectal cancer for 6~12 months and with 2 consecutive positive ctDNA testing results within 1 month will be enrolled. and there will be no need to conduct endoscopic exploration immediately after enrollment. Tumor markers, endoscopic and imaging examinations, and ctDNA monitoring will be performed every 3 months until imaging suggested peritoneal metastasis (oligometastases). Patients with positive peritoneal metastasis (PCI score <20) will be treated with CRS+HIPEC. Re-diagnostic laparoscopy will be performed 24 months after radical surgery when there is no radiographic evidence of recurrence or metastasis. Follow-up time will up to 36 months after colorectal cancer surgery. | Diagnostic test | Imageology (SOC) |
Primary outcome
Peritoneal Metastasis Free Survival (PMFS)
Time frame: Through study completion, up to 3 years
The survival rate without peritoneal metastasis (oligometastatic) at 24 months after radical resection of colorectal cancer.
9 secondary outcomes
Detection Rate (DR)
Time frame: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
Positive Percent Agreement (PPA)
Time frame: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
Negative Percent Agreement (NPA)
Time frame: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
The time of peritoneal metastasis diagnosed after radical surgery
Time frame: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
Peritoneal Cancer Index (PCI) Score
Time frame: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
Completeness of Cytoreduction (CC) Score
Time frame: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
The ctDNA clearance rate before and after CRS+HIPEC treatment
Time frame: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
The rate of Disease Free Survival (DFS) at 3 years after radical resection of colorectal cancer
Time frame: Through study completion, up to 3 years
The Overall Survival (OS) at 3 years after radical resection of colorectal cancer
Time frame: Through study completion, up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Background: PubMed 22162570Franko J, Shi Q, Goldman CD, Pockaj BA, Nelson GD, Goldberg RM, Pitot HC, Grothey A, Alberts SR, Sargent DJ. Treatment of colorectal peritoneal carcinomatosis with systemic chemotherapy: a pooled analysis of north central cancer treatment group phase III trials N9741 and N9841. J Clin Oncol. 2012 Jan 20;30(3):263-7. doi: 10.1200/JCO.2011.37.1039. Epub 2011 Dec 12.
- Background: PubMed 16617004Yonemura Y, Bandou E, Kawamura T, Endou Y, Sasaki T. Quantitative prognostic indicators of peritoneal dissemination of gastric cancer. Eur J Surg Oncol. 2006 Aug;32(6):602-6. doi: 10.1016/j.ejso.2006.03.003. Epub 2006 Apr 17.
- Background: PubMed 19103728Elias D, Lefevre JH, Chevalier J, Brouquet A, Marchal F, Classe JM, Ferron G, Guilloit JM, Meeus P, Goere D, Bonastre J. Complete cytoreductive surgery plus intraperitoneal chemohyperthermia with oxaliplatin for peritoneal carcinomatosis of colorectal origin. J Clin Oncol. 2009 Feb 10;27(5):681-5. doi: 10.1200/JCO.2008.19.7160. Epub 2008 Dec 22.
- Background: PubMed 18726888Baratti D, Kusamura S, Deraco M. The Fifth International Workshop on Peritoneal Surface Malignancy (Milan, Italy, December 4-6, 2006): methodology of disease-specific consensus. J Surg Oncol. 2008 Sep 15;98(4):258-62. doi: 10.1002/jso.21056.
- Background: PubMed 20976729Esquivel J, Chua TC, Stojadinovic A, Melero JT, Levine EA, Gutman M, Howard R, Piso P, Nissan A, Gomez-Portilla A, Gonzalez-Bayon L, Gonzalez-Moreno S, Shen P, Stewart JH, Sugarbaker PH, Barone RM, Hoefer R, Morris DL, Sardi A, Sticca RP. Accuracy and clinical relevance of computed tomography scan interpretation of peritoneal cancer index in colorectal cancer peritoneal carcinomatosis: a multi-institutional study. J Surg Oncol. 2010 Nov 1;102(6):565-70. doi: 10.1002/jso.21601.
- Background: PubMed 17632751Dromain C, Leboulleux S, Auperin A, Goere D, Malka D, Lumbroso J, Schumberger M, Sigal R, Elias D. Staging of peritoneal carcinomatosis: enhanced CT vs. PET/CT. Abdom Imaging. 2008 Jan-Feb;33(1):87-93. doi: 10.1007/s00261-007-9211-7.
- Background: PubMed 24553385Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094.
- Background: PubMed 28445469Abbosh C, Birkbak NJ, Wilson GA, Jamal-Hanjani M, Constantin T, Salari R, Le Quesne J, Moore DA, Veeriah S, Rosenthal R, Marafioti T, Kirkizlar E, Watkins TBK, McGranahan N, Ward S, Martinson L, Riley J, Fraioli F, Al Bakir M, Gronroos E, Zambrana F, Endozo R, Bi WL, Fennessy FM, Sponer N, Johnson D, Laycock J, Shafi S, Czyzewska-Khan J, Rowan A, Chambers T, Matthews N, Turajlic S, Hiley C, Lee SM, Forster MD, Ahmad T, Falzon M, Borg E, Lawrence D, Hayward M, Kolvekar S, Panagiotopoulos N, Janes SM, Thakrar R, Ahmed A, Blackhall F, Summers Y, Hafez D, Naik A, Ganguly A, Kareht S, Shah R, Joseph L, Marie Quinn A, Crosbie PA, Naidu B, Middleton G, Langman G, Trotter S, Nicolson M, Remmen H, Kerr K, Chetty M, Gomersall L, Fennell DA, Nakas A, Rathinam S, Anand G, Khan S, Russell P, Ezhil V, Ismail B, Irvin-Sellers M, Prakash V, Lester JF, Kornaszewska M, Attanoos R, Adams H, Davies H, Oukrif D, Akarca AU, Hartley JA, Lowe HL, Lock S, Iles N, Bell H, Ngai Y, Elgar G, Szallasi Z, Schwarz RF, Herrero J, Stewart A, Quezada SA, Peggs KS, Van Loo P, Dive C, Lin CJ, Rabinowitz M, Aerts HJWL, Hackshaw A, Shaw JA, Zimmermann BG; TRACERx consortium; PEACE consortium; Swanton C. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017 Apr 26;545(7655):446-451. doi: 10.1038/nature22364.
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- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ctDNA monitoring and Imageology in people with Colorectal Cancer and Peritoneal Metastases, run by Sixth Affiliated Hospital, Sun Yat-sen University 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 8 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: status not confirmed, as of the sponsor's last update on 12 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Wang, MD, PhD (13926424886, wang89@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peritoneal Metastasis Free Survival (PMFS) (time frame: Through study completion, up to 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 NCT04752930, which also lists 18 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 12 Feb 2021.