Colorectal NeoplasmsPhase 3LcACECNCT02316535
Low-dose Capecitabine Adjuvant Chemotherapy for Elderly Patients With Stage II/III Colorectal Cancer
A Phase 3 study testing Capecitabine in people with Colorectal Neoplasms, run by West China Hospital at 1 site in China.
Trial summary
Approximately half of colorectal cancer (CRC) patients were first diagnosed after 70 years old. However, compared with younger patients, elderly patients were often undertreated in chemotherapy due to their impaired tolerance. Read more about this study
- Who is it for?
- Ages 70 to 90 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 710 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to May 2018
- Phase
- Phase 3
- 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 70 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- With informed consents
- Histologically identified carcinoma of colon and rectum
- pT3-4NanyM0 or pTanyN+M0(stage II/III)
- age between 70 to 90
- undergone R0 resection
- ECOG ≤2
- Stage II patients with microsatellite stable (MSS) or microsatellite low (MSL)
Who cannot join
- With other types of malignances simultaneously
- Creatinine clearance ≤ 70 ml/min
- Undergone neoadjuvant chemotherapy
- In anticoagulant therapy
- Pregnant or lactating women
- History of antineoplastic drugs
- With other contraindications for chemotherapy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610000
Ziqiang Wang, MD/PhD, +86-18980602028, wzqtrial@gmail.com
Yazhou He, MD, +86-15196636081, yazhou_he@foxmail.com
About this study
Official title: Low-dose Versus Standard-dose Capecitabine Adjuvant Chemotherapy for Chinese Elderly Patients With Stage II/III Colorectal Cancer: A Randomized, Phase 3 Non-inferiority Study
Approximately half of colorectal cancer (CRC) patients were first diagnosed after 70 years old. However, compared with younger patients, elderly patients were often undertreated in chemotherapy due to their impaired tolerance. Recently, there have been great controversy on adjuvant chemotherapy strategy for stage II/III CRC patients. As an oral fluoropyrimidine, capecitabine has been demonstrated to be equivalent to i.v. 5-Fu/leucovorin regimen in stage III CRC patients. In light of fewer adverse effects and better flexibility, capecitabine was regarded as an ideal alternative for elderly CRC patients, but the optimal dosage for stage II/III elderly CRC patients still remains inconclusive. Our trial expected to prospectively randomized 710 postoperative stage II/III elderly CRC patients (between 70 and 90 years of age) to adjuvant mono-chemotherapy with a standard dose of capecitabine (2500 mg/m2/day) or a reduced dose (2000 mg/m2/day). This is a non-inferiority phase 3 trial with a primary endpoint of 3-year disease free survival (DFS), and other outcomes include 3-year overall survival(OS), completion rate, toxic and adverse effects and quality of life(Qol). By this trial, we aimed to achieve more precise evidence on the individualized adjuvant chemotherapy strategy for stage II/III elderly CRC patients.
Read the detailed description
An estimated 1,200,000 newly diagnosed colorectal cancer(CRC) cases arose worldwide every year, and CRC has become the third most common malignances in China. Especially in urban areas of China, rapid growth of CRC patients has considerably increased the burden of disease. It is well believed that multi-discipline treatment(MDT) including surgery, chemoradiotherapy and target therapy based on individualized characteristics will benefit CRC patients significantly.
Generally, stage II (T3-4N0M0) and stage III (TanyN1-2M0) colorectal carcinoma can be resected by surgery. In 1990s, National Institutes of Health (NIH) suggested that adjuvant chemotherapy should be applied to stage II/III CRC patients to improve their outcomes. As for stage II CRC, results from the QUASA study indicated that adjuvant chemotherapy could improve 5-year overall survival by 3% to 4% for stage II CRC patients. Currently, most of the global guidelines such as National Comprehensive Cancer Network (NCCN) guidelines still recommended adjuvant chemotherapy for stage II/III CRC patients.
In western countries, approximately 50% of the CRC patients were firstly diagnosed after 70 years old. It was reported that in 1980s, the median age of CRC diagnosis in China was 50. However, in 2005 it had reached 58 years old and has kept increasing in recent years. Limited by age-related organ function decline and comorbid conditions, elderly people shows impaired physical and mental tolerance for chemotherapy. Generally for stage II/III CRC patients, both elderly and younger patients shares common principles of chemotherapy, while a large-scale retrospective analysis based on the ACCENT database showed that among all the CRC cases included, patients with the age ≥ 70 only accounted for 17.1%, much lower than normal. Similarly, Shrag and colleagues reported in their investigation that the proportion of patients ≥75 years old undergoing chemotherapy was substantially lower than patients ≤ 75 years old. These evidence implied that elderly CRC patients held much lower acceptance and completion rate of chemotherapy. With respect to outcomes, a pooled analysis including 3351 CRC cases with adjuvant chemotherapy reported no significant difference on both efficacy and adverse effects among groups of various age, indicating elderly patients could achieve the same benefits from adjuvant chemotherapy. Thus, it is essential to improve the acceptance and completion rate by modifying chemotherapy regimen for elderly CRC patients to achieve better prognosis. There was no random controlled trial focusing on the adjuvant chemotherapy for stage II/III elderly CRC patients.
Results of MOSAIC trial showed that adding oxaliplatin to 5-Fu/ leucovorin could significantly improve 5-year survival of stage II/III colon cancer patients, which made the oxaliplatin-based combine chemotherapy (Folfox, Xelox) be recommended by the latest guidelines. In the subgroup analysis of that trial, however, there was no significant improvement detected in stage II patients. Recent analysis from ACCENT database in 2013 indicated that elderly stage II/III CRC patients (≥ 70 yr) acquired no significant benefits from adding oxaliplatin to fluoropyrimidine-based chemotherapy, which suggested monochemotherapy might be a better option for elderly CRC patients.
Capecitabine ( Xeloda®) is the unique oral prodrug of 5-Fu recommended by global guidelines and especially International Society of Geriatric Oncology (SIOG), and it has been verified by clinical trials that in view of efficacy and safety, capecitabine monochemotherapy was equivalent to i.v. 5-Fu/ leucovorin adjuvant chemotherapy. With efficacy retained, a large group of patients prefer capecitabine due to oral administration which can remarkably enhance flexibility and compliance. These advantages make capecitabine a potential ideal choice for elderly patients. According to the NCCN guideline, the standard dosage of capecitabine was 1250mg/m2 .bid. It was well-established that different characteristics such as ethnicity, age and sex could alter the metabolism and change individual tolerance for drugs; hence, there are still controversies on the optimal dose of capecitabine in different populations. The X-Act trial provided a result that among elderly patients (≥ 70 yr) undergoing standard-dose capecitabine adjuvant chemotherapy(1250mg/m2 .bid), 51% of the patients required dose reduction to complete the whole treatment cycle, implying that the recommended 1250mg/m2 .bid. might be an overdose for elderly patients given the fact that only elderly patients with relatively better health (≤ 75 yr, ECOG≤1) were eventually included in X-ACT trial. Chang and colleagues have verified feasibility of a tailored-dose strategy with a starting dose at 1000 mg/m2 .bid in a single-arm study. The European Society for Medical Oncology (ESMO) has also recommended an option of 80% standard dosage (i.e. 1000 mg/m2 .bid) for elderly II/III CRC patients. However, no prospective trial has been conducted yet to confirm this reduced-dose strategy.
Based on current evidence and controversy above, we designed this non-inferiority, phase 3 clinical trial to explore the optimal dosage of capecitabine monochemotherapy for stage II/III elderly CRC patients. Following the results of sample size estimation, 710 postoperative (pT3-4NanyM0 or pTanyN+M0) elderly patients between 70 to 90 years of age were anticipated to be included and randomly divided into two groups (A and B). Patients in group A would receive the standard dose regimen (1,250 mg/m2 twice daily on days 1-14, and repeated on day 22); accordingly the patients in group B would receive the reduced dose regimen (1,000 mg/m2 twice daily on days 1-14, and repeated on day 22). The primary endpoint was 3-year disease free survival (DFS), other outcomes included 3-year overall survival (OS), completion rate, toxic and adverse effects and quality of life (Qol).
- Conditions
- Colorectal Neoplasms
- Being tested
- Capecitabine
- Keywords
- colorectal cancer, stage II/III, elderly, adjuvant chemotherapy, capecitabine, non-inferiority
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda
adjuvant chemotherapy;
| Study group | Role | What they receive |
|---|---|---|
| standard-dose | Active comparator | capecitabine, oral administration, 1,250 mg/m2 twice daily on days 1-14, and repeated on day 22; 8 circles in total. Receives: Drug: Capecitabine |
| reduced-dose | Experimental | capecitabine, oral administration, 1,000 mg/m2 twice daily on days 1-14, and repeated on day 22; 8 circles in total. Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
Measured: 3 years
Secondary outcomes (4)
overall survival
Measured: 3 years
toxic and adverse effects
Measured: 30 weeks
completion rate
Measured: 24 weeks
quality of life
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 posted15 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by West China 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
- None (open label)
- Enrolment
- 710 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziqiang Wang,MD, West China Hospital
- Investigators
- Ziqiang Wang, MD/PhD, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316535
- Sponsor's protocol ID
- LcACEC-201474
- Acronym
- LcACEC
- Status last verified
- Sep 2016
- First submitted
- 9 Dec 2014
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
PubMed 21296855Benson AB 3rd, Schrag D, Somerfield MR, Cohen AM, Figueredo AT, Flynn PJ, Krzyzanowska MK, Maroun J, McAllister P, Van Cutsem E, Brouwers M, Charette M, Haller DG. American Society of Clinical Oncology recommendations on adjuvant chemotherapy for stage II colon cancer. J Clin Oncol. 2004 Aug 15;22(16):3408-19. doi: 10.1200/JCO.2004.05.063. Epub 2004 Jun 15.
PubMed 15199089Quasar Collaborative Group; Gray R, Barnwell J, McConkey C, Hills RK, Williams NS, Kerr DJ. Adjuvant chemotherapy versus observation in patients with colorectal cancer: a randomised study. Lancet. 2007 Dec 15;370(9604):2020-9. doi: 10.1016/S0140-6736(07)61866-2.
PubMed 18083404Folprecht G, Cunningham D, Ross P, Glimelius B, Di Costanzo F, Wils J, Scheithauer W, Rougier P, Aranda E, Hecker H, Kohne CH. Efficacy of 5-fluorouracil-based chemotherapy in elderly patients with metastatic colorectal cancer: a pooled analysis of clinical trials. Ann Oncol. 2004 Sep;15(9):1330-8. doi: 10.1093/annonc/mdh344.
PubMed 15319237McCleary NJ, Meyerhardt JA, Green E, Yothers G, de Gramont A, Van Cutsem E, O'Connell M, Twelves CJ, Saltz LB, Haller DG, Sargent DJ. Impact of age on the efficacy of newer adjuvant therapies in patients with stage II/III colon cancer: findings from the ACCENT database. J Clin Oncol. 2013 Jul 10;31(20):2600-6. doi: 10.1200/JCO.2013.49.6638. Epub 2013 Jun 3.
PubMed 23733765Schrag D, Cramer LD, Bach PB, Begg CB. Age and adjuvant chemotherapy use after surgery for stage III colon cancer. J Natl Cancer Inst. 2001 Jun 6;93(11):850-7. doi: 10.1093/jnci/93.11.850.
PubMed 11390534Sargent DJ, Goldberg RM, Jacobson SD, Macdonald JS, Labianca R, Haller DG, Shepherd LE, Seitz JF, Francini G. A pooled analysis of adjuvant chemotherapy for resected colon cancer in elderly patients. N Engl J Med. 2001 Oct 11;345(15):1091-7. doi: 10.1056/NEJMoa010957.
PubMed 11596588Andre T, Boni C, Navarro M, Tabernero J, Hickish T, Topham C, Bonetti A, Clingan P, Bridgewater J, Rivera F, de Gramont A. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol. 2009 Jul 1;27(19):3109-16. doi: 10.1200/JCO.2008.20.6771. Epub 2009 May 18.
PubMed 19451431Papamichael D, Audisio R, Horiot JC, Glimelius B, Sastre J, Mitry E, Van Cutsem E, Gosney M, Kohne CH, Aapro M; SIOG. Treatment of the elderly colorectal cancer patient: SIOG expert recommendations. Ann Oncol. 2009 Jan;20(1):5-16. doi: 10.1093/annonc/mdn532. Epub 2008 Oct 15.
PubMed 18922882Van Cutsem E, Hoff PM, Harper P, Bukowski RM, Cunningham D, Dufour P, Graeven U, Lokich J, Madajewicz S, Maroun JA, Marshall JL, Mitchell EP, Perez-Manga G, Rougier P, Schmiegel W, Schoelmerich J, Sobrero A, Schilsky RL. Oral capecitabine vs intravenous 5-fluorouracil and leucovorin: integrated efficacy data and novel analyses from two large, randomised, phase III trials. Br J Cancer. 2004 Mar 22;90(6):1190-7. doi: 10.1038/sj.bjc.6601676.
PubMed 15026800Hofheinz RD, Wenz F, Post S, Matzdorff A, Laechelt S, Hartmann JT, Muller L, Link H, Moehler M, Kettner E, Fritz E, Hieber U, Lindemann HW, Grunewald M, Kremers S, Constantin C, Hipp M, Hartung G, Gencer D, Kienle P, Burkholder I, Hochhaus A. Chemoradiotherapy with capecitabine versus fluorouracil for locally advanced rectal cancer: a randomised, multicentre, non-inferiority, phase 3 trial. Lancet Oncol. 2012 Jun;13(6):579-88. doi: 10.1016/S1470-2045(12)70116-X. Epub 2012 Apr 13.
PubMed 22503032Twelves C, Wong A, Nowacki MP, Abt M, Burris H 3rd, Carrato A, Cassidy J, Cervantes A, Fagerberg J, Georgoulias V, Husseini F, Jodrell D, Koralewski P, Kroning H, Maroun J, Marschner N, McKendrick J, Pawlicki M, Rosso R, Schuller J, Seitz JF, Stabuc B, Tujakowski J, Van Hazel G, Zaluski J, Scheithauer W. Capecitabine as adjuvant treatment for stage III colon cancer. N Engl J Med. 2005 Jun 30;352(26):2696-704. doi: 10.1056/NEJMoa043116.
PubMed 15987918Chang HJ, Lee KW, Kim JH, Bang SM, Kim YJ, Kim DW, Kang SB, Lee JS. Adjuvant capecitabine chemotherapy using a tailored-dose strategy in elderly patients with colon cancer. Ann Oncol. 2012 Apr;23(4):911-8. doi: 10.1093/annonc/mdr329. Epub 2011 Aug 4.
PubMed 21821549He Y, Liu P, Zhang Y, Deng X, Meng W, Wei M, Yang T, Wang Z, Qiu M. Low-dose capecitabine adjuvant chemotherapy in elderly stage II/III colorectal cancer patients (LC-ACEC): study protocol for a randomized controlled trial. Trials. 2015 May 29;16:238. doi: 10.1186/s13063-015-0753-7.
PubMed 26021722
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Versus Standard-dose Capecitabine Adjuvant Chemotherapy for Chinese Elderly Patients With Stage II/III Colorectal Cancer: A Randomized, Phase 3 Non-inferiority Study
- ClinicalTrials.gov ID
- NCT02316535
- Acronym / sponsor ID
- LcACEC / LcACEC-201474
- Conditions
- Colorectal Neoplasms
- Keywords
- colorectal cancer, stage II/III, elderly, adjuvant chemotherapy, capecitabine, non-inferiority
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 710 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 15 Dec 2014 (estimated)
- 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.
Approximately half of colorectal cancer (CRC) patients were first diagnosed after 70 years old. However, compared with younger patients, elderly patients were often undertreated in chemotherapy due to their impaired tolerance. Recently, there have been great controversy on adjuvant chemotherapy strategy for stage II/III CRC patients. As an oral fluoropyrimidine, capecitabine has been demonstrated to be equivalent to i.v. 5-Fu/leucovorin regimen in stage III CRC patients. In light of fewer adverse effects and better flexibility, capecitabine was regarded as an ideal alternative for elderly CRC patients, but the optimal dosage for stage II/III elderly CRC patients still remains inconclusive. Our trial expected to prospectively randomized 710 postoperative stage II/III elderly CRC patients (between 70 and 90 years of age) to adjuvant mono-chemotherapy with a standard dose of capecitabine (2500 mg/m2/day) or a reduced dose (2000 mg/m2/day). This is a non-inferiority phase 3 trial with a primary endpoint of 3-year disease free survival (DFS), and other outcomes include 3-year overall survival(OS), completion rate, toxic and adverse effects and quality of life(Qol). By this trial, we aimed to achieve more precise evidence on the individualized adjuvant chemotherapy strategy for stage II/III elderly CRC patients.
Detailed description
An estimated 1,200,000 newly diagnosed colorectal cancer(CRC) cases arose worldwide every year, and CRC has become the third most common malignances in China. Especially in urban areas of China, rapid growth of CRC patients has considerably increased the burden of disease. It is well believed that multi-discipline treatment(MDT) including surgery, chemoradiotherapy and target therapy based on individualized characteristics will benefit CRC patients significantly.
Generally, stage II (T3-4N0M0) and stage III (TanyN1-2M0) colorectal carcinoma can be resected by surgery. In 1990s, National Institutes of Health (NIH) suggested that adjuvant chemotherapy should be applied to stage II/III CRC patients to improve their outcomes. As for stage II CRC, results from the QUASA study indicated that adjuvant chemotherapy could improve 5-year overall survival by 3% to 4% for stage II CRC patients. Currently, most of the global guidelines such as National Comprehensive Cancer Network (NCCN) guidelines still recommended adjuvant chemotherapy for stage II/III CRC patients.
In western countries, approximately 50% of the CRC patients were firstly diagnosed after 70 years old. It was reported that in 1980s, the median age of CRC diagnosis in China was 50. However, in 2005 it had reached 58 years old and has kept increasing in recent years. Limited by age-related organ function decline and comorbid conditions, elderly people shows impaired physical and mental tolerance for chemotherapy. Generally for stage II/III CRC patients, both elderly and younger patients shares common principles of chemotherapy, while a large-scale retrospective analysis based on the ACCENT database showed that among all the CRC cases included, patients with the age ≥ 70 only accounted for 17.1%, much lower than normal. Similarly, Shrag and colleagues reported in their investigation that the proportion of patients ≥75 years old undergoing chemotherapy was substantially lower than patients ≤ 75 years old. These evidence implied that elderly CRC patients held much lower acceptance and completion rate of chemotherapy. With respect to outcomes, a pooled analysis including 3351 CRC cases with adjuvant chemotherapy reported no significant difference on both efficacy and adverse effects among groups of various age, indicating elderly patients could achieve the same benefits from adjuvant chemotherapy. Thus, it is essential to improve the acceptance and completion rate by modifying chemotherapy regimen for elderly CRC patients to achieve better prognosis. There was no random controlled trial focusing on the adjuvant chemotherapy for stage II/III elderly CRC patients.
Results of MOSAIC trial showed that adding oxaliplatin to 5-Fu/ leucovorin could significantly improve 5-year survival of stage II/III colon cancer patients, which made the oxaliplatin-based combine chemotherapy (Folfox, Xelox) be recommended by the latest guidelines. In the subgroup analysis of that trial, however, there was no significant improvement detected in stage II patients. Recent analysis from ACCENT database in 2013 indicated that elderly stage II/III CRC patients (≥ 70 yr) acquired no significant benefits from adding oxaliplatin to fluoropyrimidine-based chemotherapy, which suggested monochemotherapy might be a better option for elderly CRC patients.
Capecitabine ( Xeloda®) is the unique oral prodrug of 5-Fu recommended by global guidelines and especially International Society of Geriatric Oncology (SIOG), and it has been verified by clinical trials that in view of efficacy and safety, capecitabine monochemotherapy was equivalent to i.v. 5-Fu/ leucovorin adjuvant chemotherapy. With efficacy retained, a large group of patients prefer capecitabine due to oral administration which can remarkably enhance flexibility and compliance. These advantages make capecitabine a potential ideal choice for elderly patients. According to the NCCN guideline, the standard dosage of capecitabine was 1250mg/m2 .bid. It was well-established that different characteristics such as ethnicity, age and sex could alter the metabolism and change individual tolerance for drugs; hence, there are still controversies on the optimal dose of capecitabine in different populations. The X-Act trial provided a result that among elderly patients (≥ 70 yr) undergoing standard-dose capecitabine adjuvant chemotherapy(1250mg/m2 .bid), 51% of the patients required dose reduction to complete the whole treatment cycle, implying that the recommended 1250mg/m2 .bid. might be an overdose for elderly patients given the fact that only elderly patients with relatively better health (≤ 75 yr, ECOG≤1) were eventually included in X-ACT trial. Chang and colleagues have verified feasibility of a tailored-dose strategy with a starting dose at 1000 mg/m2 .bid in a single-arm study. The European Society for Medical Oncology (ESMO) has also recommended an option of 80% standard dosage (i.e. 1000 mg/m2 .bid) for elderly II/III CRC patients. However, no prospective trial has been conducted yet to confirm this reduced-dose strategy.
Based on current evidence and controversy above, we designed this non-inferiority, phase 3 clinical trial to explore the optimal dosage of capecitabine monochemotherapy for stage II/III elderly CRC patients. Following the results of sample size estimation, 710 postoperative (pT3-4NanyM0 or pTanyN+M0) elderly patients between 70 to 90 years of age were anticipated to be included and randomly divided into two groups (A and B). Patients in group A would receive the standard dose regimen (1,250 mg/m2 twice daily on days 1-14, and repeated on day 22); accordingly the patients in group B would receive the reduced dose regimen (1,000 mg/m2 twice daily on days 1-14, and repeated on day 22). The primary endpoint was 3-year disease free survival (DFS), other outcomes included 3-year overall survival (OS), completion rate, toxic and adverse effects and quality of life (Qol).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard-dose | Active comparator | Drug: Capecitabinecapecitabine, oral administration, 1,250 mg/m2 twice daily on days 1-14, and repeated on day 22; 8 circles in total. |
| reduced-dose | Experimental | Drug: Capecitabinecapecitabine, oral administration, 1,000 mg/m2 twice daily on days 1-14, and repeated on day 22; 8 circles in total. |
Who may qualify
- Ages
- 70 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- With informed consents
- Histologically identified carcinoma of colon and rectum
- pT3-4NanyM0 or pTanyN+M0(stage II/III)
- age between 70 to 90
- undergone R0 resection
Key exclusion criteria (7 listed)
- With other types of malignances simultaneously
- Creatinine clearance ≤ 70 ml/min
- Undergone neoadjuvant chemotherapy
- In anticoagulant therapy
- Pregnant or lactating women
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 |
|---|---|---|
| CapecitabineAlso: Xelodaadjuvant chemotherapy; | Drug | reduced-dose, standard-dose |
Primary outcome
disease free survival
Time frame: 3 years
4 secondary outcomes
overall survival
Time frame: 3 years
toxic and adverse effects
Time frame: 30 weeks
completion rate
Time frame: 24 weeks
quality of life
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Background: PubMed 21296855Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
- Background: PubMed 15199089Benson AB 3rd, Schrag D, Somerfield MR, Cohen AM, Figueredo AT, Flynn PJ, Krzyzanowska MK, Maroun J, McAllister P, Van Cutsem E, Brouwers M, Charette M, Haller DG. American Society of Clinical Oncology recommendations on adjuvant chemotherapy for stage II colon cancer. J Clin Oncol. 2004 Aug 15;22(16):3408-19. doi: 10.1200/JCO.2004.05.063. Epub 2004 Jun 15.
- Background: PubMed 18083404Quasar Collaborative Group; Gray R, Barnwell J, McConkey C, Hills RK, Williams NS, Kerr DJ. Adjuvant chemotherapy versus observation in patients with colorectal cancer: a randomised study. Lancet. 2007 Dec 15;370(9604):2020-9. doi: 10.1016/S0140-6736(07)61866-2.
- Background: PubMed 15319237Folprecht G, Cunningham D, Ross P, Glimelius B, Di Costanzo F, Wils J, Scheithauer W, Rougier P, Aranda E, Hecker H, Kohne CH. Efficacy of 5-fluorouracil-based chemotherapy in elderly patients with metastatic colorectal cancer: a pooled analysis of clinical trials. Ann Oncol. 2004 Sep;15(9):1330-8. doi: 10.1093/annonc/mdh344.
- Background: PubMed 23733765McCleary NJ, Meyerhardt JA, Green E, Yothers G, de Gramont A, Van Cutsem E, O'Connell M, Twelves CJ, Saltz LB, Haller DG, Sargent DJ. Impact of age on the efficacy of newer adjuvant therapies in patients with stage II/III colon cancer: findings from the ACCENT database. J Clin Oncol. 2013 Jul 10;31(20):2600-6. doi: 10.1200/JCO.2013.49.6638. Epub 2013 Jun 3.
- Background: PubMed 11390534Schrag D, Cramer LD, Bach PB, Begg CB. Age and adjuvant chemotherapy use after surgery for stage III colon cancer. J Natl Cancer Inst. 2001 Jun 6;93(11):850-7. doi: 10.1093/jnci/93.11.850.
- Background: PubMed 11596588Sargent DJ, Goldberg RM, Jacobson SD, Macdonald JS, Labianca R, Haller DG, Shepherd LE, Seitz JF, Francini G. A pooled analysis of adjuvant chemotherapy for resected colon cancer in elderly patients. N Engl J Med. 2001 Oct 11;345(15):1091-7. doi: 10.1056/NEJMoa010957.
- Background: PubMed 19451431Andre T, Boni C, Navarro M, Tabernero J, Hickish T, Topham C, Bonetti A, Clingan P, Bridgewater J, Rivera F, de Gramont A. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol. 2009 Jul 1;27(19):3109-16. doi: 10.1200/JCO.2008.20.6771. Epub 2009 May 18.
- Background: PubMed 18922882Papamichael D, Audisio R, Horiot JC, Glimelius B, Sastre J, Mitry E, Van Cutsem E, Gosney M, Kohne CH, Aapro M; SIOG. Treatment of the elderly colorectal cancer patient: SIOG expert recommendations. Ann Oncol. 2009 Jan;20(1):5-16. doi: 10.1093/annonc/mdn532. Epub 2008 Oct 15.
- Background: PubMed 15026800Van Cutsem E, Hoff PM, Harper P, Bukowski RM, Cunningham D, Dufour P, Graeven U, Lokich J, Madajewicz S, Maroun JA, Marshall JL, Mitchell EP, Perez-Manga G, Rougier P, Schmiegel W, Schoelmerich J, Sobrero A, Schilsky RL. Oral capecitabine vs intravenous 5-fluorouracil and leucovorin: integrated efficacy data and novel analyses from two large, randomised, phase III trials. Br J Cancer. 2004 Mar 22;90(6):1190-7. doi: 10.1038/sj.bjc.6601676.
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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.
Ziqiang Wang, MD/PhD principal investigator
West China Hospital
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 Capecitabine in people with Colorectal Neoplasms, run by West China 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 7 inclusion and 7 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 13 Sep 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yazhou He, MD (+8615196636081, yazhou_he@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease free survival (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 NCT02316535, which also lists 14 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 13 Sep 2016.