Colon CancerPhase 3HATCHEDNCT03716518
Herbal Treatment to Improve Chemotherapy Delivery
A Phase 3 study testing Tonifying Spleen and Kidney Sequential Regimen in people with Colon Cancer, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 12 sites in China.
Trial summary
This study is designed to:(1) determine the efficacy of Traditional Chinese Medicine (TCM) 'Tonifying Spleen and Kidney Sequential Regimen' (TSKSR) in improving the completion rate of 8-cycle CapeOX chemotherapy in patients with stage II (high-risk)\& III colon cancer;(2) evaluate the efficacy of the TCM-TSKSR on… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Tonifying Spleen and Kidney Sequential Regimen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 12 sitesChina
- Study dates
- 12 Dec 2018to 31 May 2021
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with pathological diagnosis of colon cancer; no residual tumor at the resection margin.
- tumor-node-metastasis(TNM)Stage II (high-risk)or III colon cancer according to 8th edition of American Joint Committee on Cancer(AJCC)Staging Manual. High-risk stage II disease is characterized by at least one of the following:
- T4 tumor,
- inadequately sampled nodes (<12 lymph nodes),
- clinical presentation with bowel obstruction or perforation,
- poorly differentiated histology ,exclusive of those cancers that are High degree of microsatellite instability(MSI-H),
Show all 14Show fewer
- lymphovascular invasion,perineural invasion(PNI).
- Underwent radical surgery no more than six weeks ago and plan to start chemotherapy.
- Have not been enrolled in other therapeutic clinical trials within the near 30 days.
- Age between 18 to 75 years; All genders; Eastern Cooperative Oncology Group - performance status(ECOG-PS)from 0 to 2; Women who are pregnant, lactating or of reproductive age are not eligible, while those of reproductive age using secure contraceptives are eligible.
- No history of previous malignancy other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 5 years.
- Laboratory testing: blood routine examination: WBC≥3.5×109/L，NEUT≥1.5×109/L,PLT≥100×109/L,HGB≥90g/L;biochemical tests:TBIL≤1.5×ULN,AST(SGOT),ALT(SGPT)≤2.5×ULN,Scr≤1.5×ULN;CEA after surgery was normal.
- Consented.
- Agree not to be enrolled in other interventional studies during the research.
Who cannot join
- Patients not suitable for chemotherapy of CapeOX ,which will be determined by the investigator or the attending physician.
- Clinically relevant cardiovascular and/or cerebrovascular disease,active hepatitis,severe abnormalities in liver/ renal function tests.
- Known allergy to any of the components of study drug.
- Those who cannot take the study drug orally because of bowel obstruction and/or require for peripheral vein nutrition.
- Malabsorption or diseases that affect the absorption.
- Unstable situations or situations that may endanger the safety of patients and their compliance, such as severe mental illness,schizophrenia.
- Colostomy
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Beijing Chao Yang Hospital
Beijing, Beijing Municipality, 100020
Minzhe Li, M.D.
- Recruiting
Civil Aviation General Hospital
Beijing, Beijing Municipality, 100025
Jianping Cheng
- Recruiting
Oncology Department of Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100091
Yun Xu, M.D., 86 10 62835355, xyxiao78@163.com
Yufei Yang, M.D., 86 10 62835355, yyfwdbwyy@126.com
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Aiwen Wu, M.D., 13911577190
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Wei Wang
- Recruiting
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangdong, Guangzhou, 510120
Jin Wan, M.D.
- Recruiting
Jiangsu Province Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, 210029
Peng Shu, M.D.
- Recruiting
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Tianshu Liu, M.D.
- Recruiting
Tianjin Union Medical Center
Tianjin, Tianjin Municipality, 300121
Huaqing Wang, M.D.
- Recruiting
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan, 450000
Yang Cao
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Shundong Cang, M.D., 13592675836
- Recruiting
Zhengzhou Hospital of Traditional Chinese Medicine
Zhengzhou, Henan, 450007
Baozhu Zeng, 13838520891
About this study
Official title: Effect of TCM-TSKSR on Completion Rates of Chemotherapy in Patients With Stage II & III Colon Cancer: A Randomized Placebo-Controlled Clinical Trial
This study is designed to:(1) determine the efficacy of Traditional Chinese Medicine (TCM) 'Tonifying Spleen and Kidney Sequential Regimen' (TSKSR) in improving the completion rate of 8-cycle CapeOX chemotherapy in patients with stage II (high-risk)\& III colon cancer;(2) evaluate the efficacy of the TCM-TSKSR on adverse events of CapeOX chemotherapy and it's impact on patients' quality of life (QoL).A randomized,double-blinded,placebo-controlled clinical trial including seven centers will be conducted in Mainland China.The study will enroll patients with stage II (high-risk)\& III colon cancer who have completed radical surgery and are going to receive CapeOX chemotherapy.All participants will receive chemotherapy as prescribed by their treating physicians and be randomly assigned to either concurrent use of TCM-TSKSR or placebo.
Read the detailed description
CapeOX chemotherapy is a combination therapy of Oxaliplatin 130mg/m^2 IV on 1st day and Capecitabine 1000mg/m^2 PO twice daily from 1th day to 14th day,21 days for each course of treatment.Adverse effects of chemotherapy,such as myelosuppression and gastrointestinal reactions,may lead to dose reductions,treatment delays or even discontinuation among cancer patients. According to IDEA study,the completion rate of 8-cycle CapeOX chemotherapy in colorectal cancer patients is 64%,which means that nearly 4 in 10 patients could not complete adjuvant chemotherapy as planned,which may negatively impact patients' survival outcomes.Some prior studies have shown that TCM can improve patients' symptom control and QoL during adjuvant chemotherapy,which may further improve the completion of adjuvant chemotherapy. However,there is a lack of definitive evidence to evaluate the effects of TCM in stage II(high-risk)\& III colon cancer patients who receive adjuvant chemotherapy after radical surgery.The study will be conducted between 2018 and 2021.Four hundred participants will be enrolled and randomly assigned to either the experimental group or the control group.
- Conditions
- Colon Cancer
- Being tested
- Tonifying Spleen and Kidney Sequential Regimen, Placebo of 'Tonifying Spleen and Kidney Sequential Regimen
- Keywords
- Colon Cancer, Traditional Chinese Medicine, Adverse Effect of Chemotherapy, Chemotherapy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tonifying Spleen and Kidney Sequential RegimenDrug
Also called TSKSR
TSKSR will be given to the participants as follows:Liu-jun-an-wei Granule,1 pack each time,twice a day,PO,from 0 to 6th day of chemotherapy and Qi-tu-er-zhi Granule,1 pack each time,twice a day,PO,from 7th to 20th day of chemotherapy.
Placebo of 'Tonifying Spleen and Kidney Sequential RegimenDrug
Also called Placebo of TSKSR
Placebo of TCM-TSKSR will be given to the participants as follows:placebo of Liu-jun-an-wei Granule,1 pack each time,twice a day,PO,from 0 to 6th day of chemotherapy and placebo of Qi-tu-er-zhi Granule,1 pack each time,twice a day,from 7th to 20th day of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| TCM group | Experimental | Tonifying Spleen and Kidney Sequential Regimen(TSKSR) will be prescribed to the participants in each course of chemotherapy. Receives: Drug: Tonifying Spleen and Kidney Sequential Regimen |
| Placebo group | Placebo comparator | Placebo of Tonifying Spleen and Kidney Sequential Regimen(TSKSR)similar in color,smell and texture with TSKSR will be prescribed to participants in each course of chemotherapy. Receives: Drug: Placebo of 'Tonifying Spleen and Kidney Sequential Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion Rate of 8-cycle Adjuvant Chemotherapy
Completion Rate of 8-cycle Adjuvant Chemotherapy=number of participants completing 8-cycle adjuvant chemotherapy/number of participants randomized to each group*100%
Measured: 6months
Secondary outcomes (17)
Completion Rate of Adjuvant Chemotherapy of Each Participant
Completion Rate of Adjuvant Chemotherapy of Each Participant=number of the last courses of chemotherapy/8*100%
Measured: 6months
Completion Rate of 4-cycle Adjuvant Chemotherapy
Completion Rate of 4-cycle Adjuvant Chemotherapy=number of participants completing 4-cycle adjuvant chemotherapy/number of participants randomized to each group*100%
Measured: 3months
Time to Treatment Failure,TTF
TTF is the period from randomization to the earliest day of an event such as withdrawal from protocol treatment for any reasons, patients refusal and loss to follow-up.
Measured: 6months
Relative Dose Intensity (RDI) of Adjuvant Chemotherapy
Relative dose intensity (RDI) (%) = (actual dose/ initial dose of adjuvant chemotherapy) × 100%
Measured: 6months
Proportion of Modifications of Time
Proportion of Modifications of Time=number of participants delaying chemotherapy /number of participants randomized to each group*100%.Delay is defined as ≥7days because of adverse event,such as weakness, myelosuppression, gastrointestinal reactions and other toxicity,except for administrative issues related to hospitalization.
Measured: 6months
Time of Dose Reductions of Adjuvant Chemotherapy for the First Time
It is the period from randomization to when a chemo-induced grade 3-4 granulocytopenia and/or a chemo-induced grade 2 thrombocytopenia is observed in participants for the first time,in which case,the dose of both Oxaliplatin and Capecitabine will be reduced by 25% of planned dosage.
Measured: 6months
Time of Dose Reductions of Adjuvant Chemotherapy for the Second Time
It is the period from randomization to when a chemo-induced grade 3-4 granulocytopenia and/or a chemo-induced grade 2 thrombocytopenia is observed in participants for the second time,in which case,the dose of both Oxaliplatin and Capecitabine will be reduced by 50% of planned dosage.
Measured: 6months
Proportion of Salvage Treatment
Proportion of Salvage Treatment=Number of participants receiving salvage treatment/Number of participants randomized to each group*100%.
Measured: 6months
Incidence of a Chemo-induced Grade 3-4 Nausea/Vomiting
Measured: 6 months
Incidence of a Chemo-induced Grade 2 Diarrhea
Measured: 6 months
Changes of Participants' ESAS Score
Edmonton Symptom Assessment Scale(ESAS) score will be used to evaluate the change of participants' QoL during adjuvant chemotherapy.ESAS has 9 items designed to assess the severity of commonly reported symptoms experienced by cancer patients,including pain, fatigue, drowsiness, nausea, dyspnea, depression, anxiety, well-being, and loss of appetite.Each items ranges from 0 to 10.
Measured: 6 months
Changes of Participants' FACT-C Score
Functional Assessment of Cancer Therapy-Colorectal (FACT-C) score will be used to evaluate the change of participants' QoL during adjuvant chemotherapy.The FACT-C consists of 36 items,in four domains of well-being (physical,emotional,social,and functional),on a scale of 0 to 4.
Measured: 6months
Changes of TCM Symptoms Score
Based on a prior expert consensus,11 TCM symptoms were considered to be the most common symptoms during CapeOX chemotherapy,including vomiting, numbness, diarrhea, constipation, sensation of chill, nocturia, forgetfulness, spontaneous sweating, night sweats, dry mouth and canker sores, each of which ranges from 0 to 10.
Measured: 6months
Changes of Spleen Deficiency Scale Score
Based on prior researches,the investigator designed Spleen Deficiency Scale,which includes 8 items involving appetite,abdominal distension and so on.Each question ranges from 1 to 5.
Measured: 6months
Changes of Kidney Deficiency Scale Score
Based on prior researches,the investigator designed Kidney Deficiency Scale, which includes 8 items involving soreness of waist, tinnitus, and so on. Each question ranged from 1 to 5.
Measured: 6months
Incidence of AEs
Adverse effects(AEs) includes abnormal results of blood/urine/stool routine examination, liver/renal function test and electrocardiograms.
Measured: 6months
Incidence of SAEs
Serious Adverse effects(SAEs) includes abnormal results of blood/urine/stool routine examination, liver/renal function test and electrocardiograms.
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start12 Dec 2018
- Primary completion31 May 2021 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing University of Chinese Medicine, Peking University Third Hospital, Beijing Chao Yang Hospital, Jiangsu Province Hospital of Traditional Chinese Medicine, Shanghai Zhongshan Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Tianjin Union Medical Center, Henan Provincial People's Hospital, Zhengzhou Hospital of Traditional Chinese Medicine, Peking University Cancer Hospital & Institute, Chongqing University Cancer Hospital, Civil Aviation General Hospital
- Responsible party
- Sponsor
- Investigators
- Yufei Yang, M.D., Principal investigator, Xi-Yuan Hospital, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716518
- Sponsor's protocol ID
- 2017YFC1700604
- Acronym
- HATCHED
- Status last verified
- Nov 2020
- First submitted
- 14 Oct 2018
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang T, Fei YT, Xu Y, Sun LY, He B, Yan SH, Tang M, Yan YZ, Mao J, Yang YF. Effect of Jianpi Bushen Sequential Formula on Adjuvant Chemotherapy of Colon Cancer: Study Protocol for a Randomized Controlled Trial. Chin J Integr Med. 2021 Dec;27(12):891-895. doi: 10.1007/s11655-021-3448-9. Epub 2021 Aug 25.
PubMed 34432206
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of TCM-TSKSR on Completion Rates of Chemotherapy in Patients With Stage II & III Colon Cancer: A Randomized Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03716518
- Acronym / sponsor ID
- HATCHED / 2017YFC1700604
- Conditions
- Colon Cancer
- Keywords
- Colon Cancer, Traditional Chinese Medicine, Adverse Effect of Chemotherapy, Chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Beijing University of Chinese Medicine, Peking University Third Hospital, Beijing Chao Yang Hospital, Jiangsu Province Hospital of Traditional Chinese Medicine, Shanghai Zhongshan Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Tianjin Union Medical Center, Henan Provincial People's Hospital, Zhengzhou Hospital of Traditional Chinese Medicine, Peking University Cancer Hospital & Institute, Chongqing University Cancer Hospital, Civil Aviation General Hospital
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 23 Oct 2018 (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 study is designed to:(1) determine the efficacy of Traditional Chinese Medicine (TCM) 'Tonifying Spleen and Kidney Sequential Regimen' (TSKSR) in improving the completion rate of 8-cycle CapeOX chemotherapy in patients with stage II (high-risk)\& III colon cancer;(2) evaluate the efficacy of the TCM-TSKSR on adverse events of CapeOX chemotherapy and it's impact on patients' quality of life (QoL).A randomized,double-blinded,placebo-controlled clinical trial including seven centers will be conducted in Mainland China.The study will enroll patients with stage II (high-risk)\& III colon cancer who have completed radical surgery and are going to receive CapeOX chemotherapy.All participants will receive chemotherapy as prescribed by their treating physicians and be randomly assigned to either concurrent use of TCM-TSKSR or placebo.
Detailed description
CapeOX chemotherapy is a combination therapy of Oxaliplatin 130mg/m^2 IV on 1st day and Capecitabine 1000mg/m^2 PO twice daily from 1th day to 14th day,21 days for each course of treatment.Adverse effects of chemotherapy,such as myelosuppression and gastrointestinal reactions,may lead to dose reductions,treatment delays or even discontinuation among cancer patients. According to IDEA study,the completion rate of 8-cycle CapeOX chemotherapy in colorectal cancer patients is 64%,which means that nearly 4 in 10 patients could not complete adjuvant chemotherapy as planned,which may negatively impact patients' survival outcomes.Some prior studies have shown that TCM can improve patients' symptom control and QoL during adjuvant chemotherapy,which may further improve the completion of adjuvant chemotherapy. However,there is a lack of definitive evidence to evaluate the effects of TCM in stage II(high-risk)\& III colon cancer patients who receive adjuvant chemotherapy after radical surgery.The study will be conducted between 2018 and 2021.Four hundred participants will be enrolled and randomly assigned to either the experimental group or the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCM group | Experimental | Drug: Tonifying Spleen and Kidney Sequential RegimenTonifying Spleen and Kidney Sequential Regimen(TSKSR) will be prescribed to the participants in each course of chemotherapy. |
| Placebo group | Placebo comparator | Drug: Placebo of 'Tonifying Spleen and Kidney Sequential RegimenPlacebo of Tonifying Spleen and Kidney Sequential Regimen(TSKSR)similar in color,smell and texture with TSKSR will be prescribed to participants in each course of chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient with pathological diagnosis of colon cancer; no residual tumor at the resection margin.
- tumor-node-metastasis(TNM)Stage II (high-risk)or III colon cancer according to 8th edition of American Joint Committee on Cancer(AJCC)Staging Manual. High-risk stage II disease is characterized by at least one of the following:
- Underwent radical surgery no more than six weeks ago and plan to start chemotherapy.
- Have not been enrolled in other therapeutic clinical trials within the near 30 days.
- Age between 18 to 75 years; All genders; Eastern Cooperative Oncology Group - performance status(ECOG-PS)from 0 to 2; Women who are pregnant, lactating or of reproductive age are not eligible, while those of reproductive age using secure contraceptives are eligible.
Key exclusion criteria (7 listed)
- Patients not suitable for chemotherapy of CapeOX ,which will be determined by the investigator or the attending physician.
- Clinically relevant cardiovascular and/or cerebrovascular disease,active hepatitis,severe abnormalities in liver/ renal function tests.
- Known allergy to any of the components of study drug.
- Those who cannot take the study drug orally because of bowel obstruction and/or require for peripheral vein nutrition.
- Malabsorption or diseases that affect the absorption.
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 |
|---|---|---|
| Tonifying Spleen and Kidney Sequential RegimenAlso: TSKSRTSKSR will be given to the participants as follows:Liu-jun-an-wei Granule,1 pack each time,twice a day,PO,from 0 to 6th day of chemotherapy and Qi-tu-er-zhi Granule,1 pack each time,twice a day,PO,from 7th to 20th day of chemotherapy. | Drug | TCM group |
| Placebo of 'Tonifying Spleen and Kidney Sequential RegimenAlso: Placebo of TSKSRPlacebo of TCM-TSKSR will be given to the participants as follows:placebo of Liu-jun-an-wei Granule,1 pack each time,twice a day,PO,from 0 to 6th day of chemotherapy and placebo of Qi-tu-er-zhi Granule,1 pack each time,twice a day,from 7th to 20th day of chemotherapy. | Drug | Placebo group |
Primary outcome
Completion Rate of 8-cycle Adjuvant Chemotherapy
Time frame: 6months
Completion Rate of 8-cycle Adjuvant Chemotherapy=number of participants completing 8-cycle adjuvant chemotherapy/number of participants randomized to each group*100%
17 secondary outcomes
Completion Rate of Adjuvant Chemotherapy of Each Participant
Time frame: 6months
Completion Rate of 4-cycle Adjuvant Chemotherapy
Time frame: 3months
Time to Treatment Failure,TTF
Time frame: 6months
Relative Dose Intensity (RDI) of Adjuvant Chemotherapy
Time frame: 6months
Proportion of Modifications of Time
Time frame: 6months
Time of Dose Reductions of Adjuvant Chemotherapy for the First Time
Time frame: 6months
Time of Dose Reductions of Adjuvant Chemotherapy for the Second Time
Time frame: 6months
Proportion of Salvage Treatment
Time frame: 6months
Incidence of a Chemo-induced Grade 3-4 Nausea/Vomiting
Time frame: 6 months
Incidence of a Chemo-induced Grade 2 Diarrhea
Time frame: 6 months
Changes of Participants' ESAS Score
Time frame: 6 months
Changes of Participants' FACT-C Score
Time frame: 6months
Changes of TCM Symptoms Score
Time frame: 6months
Changes of Spleen Deficiency Scale Score
Time frame: 6months
Changes of Kidney Deficiency Scale Score
Time frame: 6months
Incidence of AEs
Time frame: 6months
Incidence of SAEs
Time frame: 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Derived from this study: PubMed 34432206Zhang T, Fei YT, Xu Y, Sun LY, He B, Yan SH, Tang M, Yan YZ, Mao J, Yang YF. Effect of Jianpi Bushen Sequential Formula on Adjuvant Chemotherapy of Colon Cancer: Study Protocol for a Randomized Controlled Trial. Chin J Integr Med. 2021 Dec;27(12):891-895. doi: 10.1007/s11655-021-3448-9. Epub 2021 Aug 25.
- 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.
Yufei Yang, M.D. principal investigator
Xi-Yuan Hospital, China Academy of Chinese Medical Sciences
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tonifying Spleen and Kidney Sequential Regimen in people with Colon Cancer, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 12 sites 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 14 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 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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. Some participants in this study may receive a placebo. 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 Yufei Yang, M.D. (8613701366913, yyfwdbwyy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion Rate of 8-cycle Adjuvant Chemotherapy (time frame: 6months). 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 NCT03716518, which also lists 1 linked publication.
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 Jan 2021.