Colon CancerPhase 3ZJCH-CRCC-1NCT06609551
ctDNA-guided Selection of Adjuvant Chemotherapy Regimens for Elderly Colon Cancer Patients After Surgery: A Single-center, Randomized, Controlled Study
A Phase 3 study testing 6-month adjuvant chemotherapy with 5-FU monotherapy and XELOX intensive treatment group in people with Colon Cancer and Colon Cancer (Stage II &Amp;Amp;Amp; III), run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to explore the disease-free survival period of elderly patients with high-risk stage II and stage III colon cancer based on ctDNA detection. The main questions it aims to answer are: Can ctDNA detection effectively guide the assessment of disease-free survival in elderly patients… Read more about this study
- Who is it for?
- Ages 70 to 80 years
- Conditions the study is for
- Colon Cancer, Colon Cancer (Stage II &Amp;Amp;Amp; III)
- What is being tested?
- 6-month adjuvant chemotherapy with 5-FU monotherapy and XELOX intensive treatment group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2024to 31 Dec 2034
- Phase
- Phase 3
- 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 70 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged 70-80, both male and female are eligible;
- Patients with histopathologically confirmed stage II high-risk or stage III colon cancer;
- Patients with an ECOG score of ≤2;
- Patients who are required to undergo tissue genetic testing;
- Subjects who voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up visits.
Who cannot join
- Patients with one or more severe concomitant systemic diseases that, in the investigator\'s opinion, would impair the patient\'s ability to complete the study.
- Patients who have had a history of malignant tumors within 5 years.
- Any unstable systemic disease (including active infection, poorly controlled diabetes, poorly controlled hypertension, unstable angina, congestive heart failure, myocardial infarction within one year, severe arrhythmia requiring medical treatment, liver, kidney, or metabolic diseases).
- Patients suffering from severe mental illnesses.
- Patients who have participated in other clinical trials within 30 days prior to screening.
- Patients who are unable to undergo adjuvant chemotherapy.
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
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Yuping Zhu, M.D., 86-0571-88128011, drzyp@163.com
Yibo Cai, M.D., 86-0571-88128011, caiyiyibo@zju.edu.cn
About this study
The goal of this clinical trial is to explore the disease-free survival period of elderly patients with high-risk stage II and stage III colon cancer based on ctDNA detection. The main questions it aims to answer are:
Can ctDNA detection effectively guide the assessment of disease-free survival in elderly patients with high-risk stage II and stage III colon cancer? What is the correlation between postoperative ctDNA status and patient imaging as well as prognosis in elderly patients?
Read more
Secondary objectives include:
Evaluating the correlation between postoperative ctDNA status and patient imaging, as well as prognosis, in elderly patients.
Analyzing the positive rate of postoperative ctDNA and the ctDNA clearance rate.
Additionally, an exploratory objective of this study is to investigate recurrence models for postoperative patients.
Participants will undergo ctDNA testing to assess their disease status and will be monitored for disease-free survival. Imaging studies will also be conducted to correlate with ctDNA findings. The study aims to gain a deeper understanding of the role of ctDNA in predicting prognosis and monitoring disease recurrence in elderly patients with colon cancer.
Read the detailed description
This study is a prospective, randomized controlled trial designed to explore the disease-free survival period of elderly patients with high-risk stage II and stage III colon cancer based on ctDNA detection.
- Screening Phase Complete the routine pre-enrollment evaluation of subjects, such as medical history, pathological staging, and treatment history. Researchers will assess whether subjects meet the enrollment criteria (see inclusion and exclusion criteria). For subjects who meet the enrollment criteria, the attending physician will inform the subjects and their families, explaining the purpose, advantages, disadvantages, and the entire research process of this clinical trial. They will seek the opinions of the subjects and their families, and obtain signed informed consent from the subjects. Researchers need to collect baseline postoperative tissue samples for detection, which will be used for the customization of personalized probes for subsequent blood tests.
- Adjuvant Therapy/Follow-up Phase Elderly colorectal cancer patients who meet the inclusion and exclusion criteria will undergo ctDNA-MRD testing after surgery. ctDNA-negative patients will be randomly divided into two groups in a 1:1 ratio: 1) Observation and follow-up; 2) 6-month adjuvant chemotherapy with 5-FU monotherapy. Patients who test positive for ctDNA will be randomly assigned in a 1:1 ratio to receive: 1) 6 months of 5-FU monotherapy; 2) XELOX intensive treatment group. The follow-up strategy is the same for all four groups, including but not limited to chest plain or enhanced CT, abdominal/pelvic enhanced CT, and detection of the tumor marker carcinoembryonic antigen (CEA) until disease progression occurs. All patients will undergo peripheral blood ctDNA-MRD testing again half a year after surgery.
- Management Measures for Subjects with Disease Progression If a patient experiences disease progression, efforts should be made to continue tracking and recording the patient\'s subsequent anti-tumor treatment and survival outcomes, including local and/or systemic therapy.
- Being tested
- 6-month adjuvant chemotherapy with 5-FU monotherapy, XELOX intensive treatment group
- Keywords
- ctDNA (circulating tumor DNA), elderly colon cancer patients
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-month adjuvant chemotherapy with 5-FU monotherapyDrug
6 months of adjuvant chemotherapy with 5-FU monotherapy. The follow-up strategy for the four groups of subjects will be the same, including but not limited to chest plain or enhanced CT, abdominal/pelvic enhanced CT, and detection of the tumor marker carcinoembryonic antigen (CEA), until disease progression occurs. All patients will undergo peripheral blood ctDNA-MRD testing again six months after surgery.
XELOX intensive treatment groupDrug
XELOX intensive treatment group. The follow-up strategy for the four groups of subjects will be the same, including but not limited to chest plain or enhanced CT, abdominal/pelvic enhanced CT, and detection of the tumor marker carcinoembryonic antigen (CEA), until disease progression occurs. All patients will undergo peripheral blood ctDNA-MRD testing again six months after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Arm-A | No intervention | Patients with negative ctDNA；Observation and follow-up |
| Arm-B | Experimental | Patients with negative ctDNA;6-month adjuvant chemotherapy with 5-FU monotherapy Receives: Drug: 6-month adjuvant chemotherapy with 5-FU monotherapy |
| Arm-C | Experimental | Patients with positive ctDNA; 6-month adjuvant chemotherapy with 5-FU monotherapy Receives: Drug: 6-month adjuvant chemotherapy with 5-FU monotherapy |
| Arm-D | Experimental | Patients with positive ctDNA; XELOX intensive treatment group Receives: Drug: XELOX intensive treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year DFS (Disease-Free Survival)
Disease-free survival (DFS): the time from the start of treatment to the progression of the disease.
Measured: From enrollment to the end of treatment at 2 years
Secondary outcomes (3)
5-year DFS (Disease-Free Survival)
Disease-free survival (DFS): the time from the start of treatment to the progression of the disease.
Measured: From enrollment to the end of treatment at 5 years
2-year OS (Overall Survival)
Overall Survival (OS) refers to the total survival time from the start of treatment until death directly caused by the disease.
Measured: From enrollment to the end of treatment at 2 years
5-year OS (Overall Survival)
Overall Survival (OS) refers to the total survival time from the start of treatment until death directly caused by the disease.
Measured: From enrollment to the end of treatment at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start3 Jul 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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 Zhejiang Cancer 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Yuping, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609551
- Sponsor's protocol ID
- IRB-2024-380
- Acronym
- ZJCH-CRCC-1
- Status last verified
- Sep 2024
- First submitted
- 22 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Badia-Ramentol J, Linares J, Gomez-Llonin A, Calon A. Minimal Residual Disease, Metastasis and Immunity. Biomolecules. 2021 Jan 20;11(2):130. doi: 10.3390/biom11020130.
PubMed 33498251Dasari A, Morris VK, Allegra CJ, Atreya C, Benson AB 3rd, Boland P, Chung K, Copur MS, Corcoran RB, Deming DA, Dwyer A, Diehn M, Eng C, George TJ, Gollub MJ, Goodwin RA, Hamilton SR, Hechtman JF, Hochster H, Hong TS, Innocenti F, Iqbal A, Jacobs SA, Kennecke HF, Lee JJ, Lieu CH, Lenz HJ, Lindwasser OW, Montagut C, Odisio B, Ou FS, Porter L, Raghav K, Schrag D, Scott AJ, Shi Q, Strickler JH, Venook A, Yaeger R, Yothers G, You YN, Zell JA, Kopetz S. ctDNA applications and integration in colorectal cancer: an NCI Colon and Rectal-Anal Task Forces whitepaper. Nat Rev Clin Oncol. 2020 Dec;17(12):757-770. doi: 10.1038/s41571-020-0392-0. Epub 2020 Jul 6.
PubMed 32632268Ueda Y, Shiraishi N, Kawasaki T, Akagi T, Ninomiya S, Shiroshita H, Etoh T, Inomata M. Short- and long-term outcomes of laparoscopic surgery for colorectal cancer in the elderly aged over 80 years old versus non-elderly: a retrospective cohort study. BMC Geriatr. 2020 Nov 4;20(1):445. doi: 10.1186/s12877-020-01779-2.
PubMed 33148215Argiles G, Tabernero J, Labianca R, Hochhauser D, Salazar R, Iveson T, Laurent-Puig P, Quirke P, Yoshino T, Taieb J, Martinelli E, Arnold D; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Localised colon cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020 Oct;31(10):1291-1305. doi: 10.1016/j.annonc.2020.06.022. Epub 2020 Jul 20. No abstract available.
PubMed 32702383Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
PubMed 31912902Hutchins LF, Unger JM, Crowley JJ, Coltman CA Jr, Albain KS. Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med. 1999 Dec 30;341(27):2061-7. doi: 10.1056/NEJM199912303412706.
PubMed 10615079Kim JH. Chemotherapy for colorectal cancer in the elderly. World J Gastroenterol. 2015 May 7;21(17):5158-66. doi: 10.3748/wjg.v21.i17.5158.
PubMed 25954089Herrera AP, Snipes SA, King DW, Torres-Vigil I, Goldberg DS, Weinberg AD. Disparate inclusion of older adults in clinical trials: priorities and opportunities for policy and practice change. Am J Public Health. 2010 Apr 1;100 Suppl 1(Suppl 1):S105-12. doi: 10.2105/AJPH.2009.162982. Epub 2010 Feb 10.
PubMed 20147682Waldron RP, Donovan IA, Drumm J, Mottram SN, Tedman S. Emergency presentation and mortality from colorectal cancer in the elderly. Br J Surg. 1986 Mar;73(3):214-6. doi: 10.1002/bjs.1800730320.
PubMed 3947921Dekker JW, van den Broek CB, Bastiaannet E, van de Geest LG, Tollenaar RA, Liefers GJ. Importance of the first postoperative year in the prognosis of elderly colorectal cancer patients. Ann Surg Oncol. 2011 Jun;18(6):1533-9. doi: 10.1245/s10434-011-1671-x. Epub 2011 Mar 29.
PubMed 21445672Zheng R, Zhang S, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2016. J Natl Cancer Cent. 2022 Feb 27;2(1):1-9. doi: 10.1016/j.jncc.2022.02.002. eCollection 2022 Mar.
PubMed 39035212Kurniali PC, Hrinczenko B, Al-Janadi A. Management of locally advanced and metastatic colon cancer in elderly patients. World J Gastroenterol. 2014 Feb 28;20(8):1910-22. doi: 10.3748/wjg.v20.i8.1910.
PubMed 24616568Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ctDNA-guided Selection of Adjuvant Chemotherapy Regimens for Elderly Colon Cancer Patients After Surgery: A Single-center, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT06609551
- Acronym / sponsor ID
- ZJCH-CRCC-1 / IRB-2024-380
- Keywords
- ctDNA (circulating tumor DNA), elderly colon cancer patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 24 Sep 2024 (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 goal of this clinical trial is to explore the disease-free survival period of elderly patients with high-risk stage II and stage III colon cancer based on ctDNA detection. The main questions it aims to answer are:
Can ctDNA detection effectively guide the assessment of disease-free survival in elderly patients with high-risk stage II and stage III colon cancer? What is the correlation between postoperative ctDNA status and patient imaging as well as prognosis in elderly patients?
Secondary objectives include:
Evaluating the correlation between postoperative ctDNA status and patient imaging, as well as prognosis, in elderly patients.
Analyzing the positive rate of postoperative ctDNA and the ctDNA clearance rate.
Additionally, an exploratory objective of this study is to investigate recurrence models for postoperative patients.
Participants will undergo ctDNA testing to assess their disease status and will be monitored for disease-free survival. Imaging studies will also be conducted to correlate with ctDNA findings. The study aims to gain a deeper understanding of the role of ctDNA in predicting prognosis and monitoring disease recurrence in elderly patients with colon cancer.
Detailed description
This study is a prospective, randomized controlled trial designed to explore the disease-free survival period of elderly patients with high-risk stage II and stage III colon cancer based on ctDNA detection.
- Screening Phase Complete the routine pre-enrollment evaluation of subjects, such as medical history, pathological staging, and treatment history. Researchers will assess whether subjects meet the enrollment criteria (see inclusion and exclusion criteria). For subjects who meet the enrollment criteria, the attending physician will inform the subjects and their families, explaining the purpose, advantages, disadvantages, and the entire research process of this clinical trial. They will seek the opinions of the subjects and their families, and obtain signed informed consent from the subjects. Researchers need to collect baseline postoperative tissue samples for detection, which will be used for the customization of personalized probes for subsequent blood tests.
- Adjuvant Therapy/Follow-up Phase Elderly colorectal cancer patients who meet the inclusion and exclusion criteria will undergo ctDNA-MRD testing after surgery. ctDNA-negative patients will be randomly divided into two groups in a 1:1 ratio: 1) Observation and follow-up; 2) 6-month adjuvant chemotherapy with 5-FU monotherapy. Patients who test positive for ctDNA will be randomly assigned in a 1:1 ratio to receive: 1) 6 months of 5-FU monotherapy; 2) XELOX intensive treatment group. The follow-up strategy is the same for all four groups, including but not limited to chest plain or enhanced CT, abdominal/pelvic enhanced CT, and detection of the tumor marker carcinoembryonic antigen (CEA) until disease progression occurs. All patients will undergo peripheral blood ctDNA-MRD testing again half a year after surgery.
- Management Measures for Subjects with Disease Progression If a patient experiences disease progression, efforts should be made to continue tracking and recording the patient\'s subsequent anti-tumor treatment and survival outcomes, including local and/or systemic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm-A | No intervention | –Patients with negative ctDNA；Observation and follow-up |
| Arm-B | Experimental | Drug: 6-month adjuvant chemotherapy with 5-FU monotherapyPatients with negative ctDNA;6-month adjuvant chemotherapy with 5-FU monotherapy |
| Arm-C | Experimental | Drug: 6-month adjuvant chemotherapy with 5-FU monotherapyPatients with positive ctDNA; 6-month adjuvant chemotherapy with 5-FU monotherapy |
| Arm-D | Experimental | Drug: XELOX intensive treatment groupPatients with positive ctDNA; XELOX intensive treatment group |
Who may qualify
- Ages
- 70 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients aged 70-80, both male and female are eligible;
- Patients with histopathologically confirmed stage II high-risk or stage III colon cancer;
- Patients with an ECOG score of ≤2;
- Patients who are required to undergo tissue genetic testing;
- Subjects who voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up visits.
Key exclusion criteria (6 listed)
- Patients with one or more severe concomitant systemic diseases that, in the investigator\'s opinion, would impair the patient\'s ability to complete the study.
- Patients who have had a history of malignant tumors within 5 years.
- Any unstable systemic disease (including active infection, poorly controlled diabetes, poorly controlled hypertension, unstable angina, congestive heart failure, myocardial infarction within one year, severe arrhythmia requiring medical treatment, liver, kidney, or metabolic diseases).
- Patients suffering from severe mental illnesses.
- Patients who have participated in other clinical trials within 30 days prior to screening.
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 |
|---|---|---|
| 6-month adjuvant chemotherapy with 5-FU monotherapy6 months of adjuvant chemotherapy with 5-FU monotherapy. The follow-up strategy for the four groups of subjects will be the same, including but not limited to chest plain or enhanced CT, abdominal/pelvic enhanced CT, and detection of the tumor marker carcinoembryonic antigen (CEA), until disease progression occurs. All patients will undergo peripheral blood ctDNA-MRD testing again six months after surgery. | Drug | Arm-B, Arm-C |
| XELOX intensive treatment groupXELOX intensive treatment group. The follow-up strategy for the four groups of subjects will be the same, including but not limited to chest plain or enhanced CT, abdominal/pelvic enhanced CT, and detection of the tumor marker carcinoembryonic antigen (CEA), until disease progression occurs. All patients will undergo peripheral blood ctDNA-MRD testing again six months after surgery. | Drug | Arm-D |
Primary outcome
2-year DFS (Disease-Free Survival)
Time frame: From enrollment to the end of treatment at 2 years
Disease-free survival (DFS): the time from the start of treatment to the progression of the disease.
3 secondary outcomes
5-year DFS (Disease-Free Survival)
Time frame: From enrollment to the end of treatment at 5 years
2-year OS (Overall Survival)
Time frame: From enrollment to the end of treatment at 2 years
5-year OS (Overall Survival)
Time frame: From enrollment to the end of treatment at 5 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 24 Sep 2024.
- Results publication: PubMed 33498251Badia-Ramentol J, Linares J, Gomez-Llonin A, Calon A. Minimal Residual Disease, Metastasis and Immunity. Biomolecules. 2021 Jan 20;11(2):130. doi: 10.3390/biom11020130.
- Results publication: PubMed 32632268Dasari A, Morris VK, Allegra CJ, Atreya C, Benson AB 3rd, Boland P, Chung K, Copur MS, Corcoran RB, Deming DA, Dwyer A, Diehn M, Eng C, George TJ, Gollub MJ, Goodwin RA, Hamilton SR, Hechtman JF, Hochster H, Hong TS, Innocenti F, Iqbal A, Jacobs SA, Kennecke HF, Lee JJ, Lieu CH, Lenz HJ, Lindwasser OW, Montagut C, Odisio B, Ou FS, Porter L, Raghav K, Schrag D, Scott AJ, Shi Q, Strickler JH, Venook A, Yaeger R, Yothers G, You YN, Zell JA, Kopetz S. ctDNA applications and integration in colorectal cancer: an NCI Colon and Rectal-Anal Task Forces whitepaper. Nat Rev Clin Oncol. 2020 Dec;17(12):757-770. doi: 10.1038/s41571-020-0392-0. Epub 2020 Jul 6.
- Results publication: PubMed 33148215Ueda Y, Shiraishi N, Kawasaki T, Akagi T, Ninomiya S, Shiroshita H, Etoh T, Inomata M. Short- and long-term outcomes of laparoscopic surgery for colorectal cancer in the elderly aged over 80 years old versus non-elderly: a retrospective cohort study. BMC Geriatr. 2020 Nov 4;20(1):445. doi: 10.1186/s12877-020-01779-2.
- Results publication: PubMed 32702383Argiles G, Tabernero J, Labianca R, Hochhauser D, Salazar R, Iveson T, Laurent-Puig P, Quirke P, Yoshino T, Taieb J, Martinelli E, Arnold D; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Localised colon cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020 Oct;31(10):1291-1305. doi: 10.1016/j.annonc.2020.06.022. Epub 2020 Jul 20. No abstract available.
- Results publication: PubMed 31912902Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
- Results publication: PubMed 10615079Hutchins LF, Unger JM, Crowley JJ, Coltman CA Jr, Albain KS. Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med. 1999 Dec 30;341(27):2061-7. doi: 10.1056/NEJM199912303412706.
- Results publication: PubMed 25954089Kim JH. Chemotherapy for colorectal cancer in the elderly. World J Gastroenterol. 2015 May 7;21(17):5158-66. doi: 10.3748/wjg.v21.i17.5158.
- Results publication: PubMed 20147682Herrera AP, Snipes SA, King DW, Torres-Vigil I, Goldberg DS, Weinberg AD. Disparate inclusion of older adults in clinical trials: priorities and opportunities for policy and practice change. Am J Public Health. 2010 Apr 1;100 Suppl 1(Suppl 1):S105-12. doi: 10.2105/AJPH.2009.162982. Epub 2010 Feb 10.
- Results publication: PubMed 3947921Waldron RP, Donovan IA, Drumm J, Mottram SN, Tedman S. Emergency presentation and mortality from colorectal cancer in the elderly. Br J Surg. 1986 Mar;73(3):214-6. doi: 10.1002/bjs.1800730320.
- Results publication: PubMed 21445672Dekker JW, van den Broek CB, Bastiaannet E, van de Geest LG, Tollenaar RA, Liefers GJ. Importance of the first postoperative year in the prognosis of elderly colorectal cancer patients. Ann Surg Oncol. 2011 Jun;18(6):1533-9. doi: 10.1245/s10434-011-1671-x. Epub 2011 Mar 29.
- Results publication: PubMed 39035212Zheng R, Zhang S, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2016. J Natl Cancer Cent. 2022 Feb 27;2(1):1-9. doi: 10.1016/j.jncc.2022.02.002. eCollection 2022 Mar.
- Results publication: PubMed 24616568Kurniali PC, Hrinczenko B, Al-Janadi A. Management of locally advanced and metastatic colon cancer in elderly patients. World J Gastroenterol. 2014 Feb 28;20(8):1910-22. doi: 10.3748/wjg.v20.i8.1910.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 6-month adjuvant chemotherapy with 5-FU monotherapy and XELOX intensive treatment group in people with Colon Cancer and Colon Cancer (Stage II &Amp;Amp;Amp; III), run by Zhejiang Cancer 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 5 inclusion and 6 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 24 Sep 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yuping Zhu, M.D. (86-0571-88128011, drzyp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year DFS (Disease-Free Survival) (time frame: From enrollment to the end of treatment at 2 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 NCT06609551, which also lists 13 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 24 Sep 2024.