Locally Advanced Colorectal CancerPhase 2NCT06596343
Evaluating the Benefits of Personalized Traditional Chinese Medicine in Postoperative Treatment for Locally Advanced Colorectal Cancer
A Phase 2 study testing Adjuvant Chemotherapy Combined with Traditional Chinese Medicine (TCM) Supportive Therapy in people with Locally Advanced Colorectal Cancer and Postoperative Adjuvant Therapy, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
This study aims to explore the role of Traditional Chinese Medicine (TCM) based on syndrome differentiation in reducing chemotherapy side effects, lowering the risk of metastasis and recurrence, and improving survival rates in postoperative colorectal cancer patients through a prospective, single-arm interventional… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Colorectal Cancer, Postoperative Adjuvant Therapy
- What is being tested?
- Adjuvant Chemotherapy Combined with Traditional Chinese Medicine (TCM) Supportive Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Oct 2024to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age between 18 and 75 years. 2. Diagnosed with colorectal cancer at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, and underwent standard radical colorectal cancer surgery. Postoperative pathological staging is stage III (AJCC 8th edition: T4, any N+, M0, or any T, N2, M0), indicating the need for chemotherapy according to the CSCO 2023 colorectal cancer guidelines.
- 3. Willing to receive Traditional Chinese Medicine (TCM) treatment. 4. Voluntarily agree to participate in the study and sign the informed consent form. If the subject is unable to read or sign the consent due to incapacity, the informed consent must be obtained from a legal guardian. If the subject cannot read the consent (e.g., illiterate subjects), a witness must observe and sign the consent process.
- 5. Expected survival of ≥12 months. 6. ECOG performance status score of 0-1. 7. No prior anti-cancer, immunotherapy, or radiation treatment. 8. Laboratory tests meeting the following criteria:
- White blood cell count ≥3.5 × 10^9/L, absolute neutrophil count ≥1.8 × 10^9/L, platelet count ≥100 × 10^9/L, hemoglobin ≥100 g/L.
- INR ≤1.5 and APTT ≤1.5 times the upper limit of normal (ULN) or PTT ≤1.5 times ULN.
- Total bilirubin ≤1.25 times ULN; ALT and AST ≤3 times ULN; serum albumin ≥28 g/L.
- 24-hour creatinine clearance rate ≥50 mL/min or serum creatinine ≤1.5 times ULN.
Who cannot join
- 1. Colorectal cancer patients with distant metastasis as indicated by preoperative evaluation.
- 2. Postoperative pathological results indicate that chemotherapy is not required according to the CSCO 2023 colorectal cancer guidelines.
- 3. Patients who have received neoadjuvant chemoradiotherapy before surgery. 4. Patients with severe heart, liver, kidney damage, or bone marrow dysfunction.
- 5. Pregnant or breastfeeding women. 6. Patients with known allergies to Traditional Chinese Medicine components. 7. Patients who refuse chemotherapy or TCM treatment. 8. Patients with a history of mental illness or cognitive impairment.
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
Sir Run Run Shaw Hospital, Zhejiang University
Hangzhou, China, 310016
Zhangfa Song, +86 13867421652, songzhangfa@zju.edu.cn
About this study
Official title: Study on the Value of Traditional Chinese Medicine Precision Treatment Based on Syndrome Differentiation in Postoperative Adjuvant Therapy for Locally Advanced Colorectal Cancer
This study aims to explore the role of Traditional Chinese Medicine (TCM) based on syndrome differentiation in reducing chemotherapy side effects, lowering the risk of metastasis and recurrence, and improving survival rates in postoperative colorectal cancer patients through a prospective, single-arm interventional clinical trial.
Read the detailed description
Colorectal cancer is the third leading cause of cancer-related deaths worldwide, with 1.9 million new cases and nearly 935,000 deaths reported in 2020. In China, colorectal cancer ranks third in new cases for both men and women, while it ranks fifth in cancer-related deaths among men and second among women. It has become a global public health issue and a major threat to people's health. Surgical resection is the primary treatment for colon cancer and can potentially cure the tumor. More than 50% of colon cancer patients are diagnosed at locally advanced stages (stage II and III). Even after curative surgery, about 50% of these patients experience tumor recurrence due to undetectable micrometastases that persist post-surgery. Most of these patients require adjuvant chemotherapy to eliminate micrometastases and improve cure rates. Postoperative adjuvant chemotherapy can eradicate hidden micrometastases and prolong survival in colorectal cancer patients. Large clinical trials have shown that adjuvant chemotherapy reduces the recurrence rate by 41% and overall mortality by 33%. Thus, surgery combined with postoperative adjuvant chemotherapy is the standard treatment approach to cure colon cancer.
However, about 25% of stage III colorectal cancer patients still relapse despite adjuvant chemotherapy, indicating that not all patients benefit from it. Additionally, postoperative adjuvant chemotherapy can cause numerous side effects. The IDEA study reported that grade 3 or higher chemotherapy-related toxicities occurred in 20% of patients receiving 3 months of adjuvant chemotherapy and 36.9% of patients receiving 6 months. These side effects include mucositis, vomiting, diarrhea, febrile neutropenia, fatigue, hair loss, hand-foot syndrome (pain, redness, and peeling of the skin on the palms and soles), neurotoxicity, and cardiotoxicity. The incidence and severity of these side effects vary depending on the specific drugs and administration methods, and some side effects, such as oxaliplatin-induced peripheral neuropathy, can persist long-term, significantly affecting patients' quality of life.
Thus, both healthcare providers and patients are seeking additional therapies to reduce toxicity and improve the efficacy of standard treatment. In real-world practice, many colorectal cancer patients have received Traditional Chinese Medicine (TCM) as part of their postoperative care, and TCM plays a significant role in colorectal cancer prevention and treatment.
In TCM, colorectal cancer is classified under conditions such as "zang du" (organ toxin), "chang ji" (intestinal accumulation), and "ji ju" (mass accumulation), primarily caused by irregular diet, emotional imbalance, and deficiency of vital energy (qi). Although the disease originates in the intestines, it is closely related to the spleen, stomach, liver, and kidneys. Early-stage disease is dominated by damp-heat and toxin stagnation, while later stages are characterized by a deficiency of vital energy with excess pathogenic factors, typically involving spleen and kidney yang deficiency, qi and blood deficiency, or liver and kidney yin deficiency. A deficiency in vital energy and yin-yang imbalance are key factors in the development of colorectal cancer. Damp-heat accumulation in the intestines leads to stagnation of qi, toxin formation, and eventual mass formation, which is a core mechanism of disease development.
This study aims to investigate the role of adding TCM during and after surgery and chemotherapy to enhance the clinical efficacy of adjuvant chemotherapy, reduce the occurrence of adverse effects, prevent metastasis and recurrence, and ultimately improve survival rates.
- Being tested
- Adjuvant Chemotherapy Combined with Traditional Chinese Medicine (TCM) Supportive Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant Chemotherapy Combined with Traditional Chinese Medicine (TCM) Supportive TherapyDrug
- Chemotherapy Regimen:
- Postoperative adjuvant chemotherapy: A dual-drug concurrent regimen will be used, with each cycle lasting 21 days. On day 1 of each cycle, oxaliplatin will be administered intravenously at a dose of 130 mg/m². From day 1 to day 14 of each cycle, capecitabine will be taken orally at a dose of 1000 mg/m², twice daily. The treatment duration will follow the CSCO 2023 guidelines for colorectal cancer, with chemotherapy lasting for 6 months.
- TCM Treatment:
- TCM treatment will be based on syndrome differentiation ("Zheng") and guided by the Guidelines for TCM Diagnosis and Treatment of Malignant Tumors.
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant Chemotherapy Combined with Traditional Chinese Medicine (TCM) Supportive Therapy | Experimental | Patients will sign an informed consent form after surgery but before starting chemotherapy, and those enrolled will receive a combination of chemotherapy and Traditional Chinese Medicine (TCM) supportive therapy.
1. Chemotherapy Regimen:
* Postoperative adjuvant chemotherapy: A dual-drug concurrent regimen will be used, with each cycle lasting 21 days. On day 1 of each cycle, oxaliplatin will be administered intravenously at a dose of 130 mg/m². From day 1 to day 14 of each cycle, capecitabine will be taken orally at a dose of 1000 mg/m², twice daily. The treatment duration will follow the CSCO 2023 guidelines for colorectal cancer, with chemotherapy lasting for 6 months.
2. TCM Treatment:
* TCM treatment will be based on syndrome differentiation ("Zheng") and guided by the Guidelines for TCM Diagnosis and Treatment of Malignant Tumors. Receives: Drug: Adjuvant Chemotherapy Combined with Traditional Chinese Medicine (TCM) Supportive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of grade III/IV adverse events
According to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, adverse events (AEs) are graded on a scale from 1 to 5 based on severity:
- Grade I: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; no intervention required.
- Grade II: Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADLs).
- Grade III: Severe; medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self-care ADLs.
- Grade IV: Life-threatening consequences; urgent intervention required.
- Grade V: Death related to adverse event.
Measured: From the beginning of the first chemotherapy to three months after the end of the course of chemotherapy
Secondary outcomes (5)
3-year Disease-Free Survival
3-year Disease-Free Survival (DFS) refers to the percentage of patients who remain free from any signs or symptoms of cancer recurrence or progression for three years after treatment.
Measured: 3 years post-treatment
3-year Overall Survival
3-year Overall Survival (OS) refers to the percentage of patients who are still alive three years after the start of treatment, regardless of whether the cancer has recurred or progressed.
Measured: 3 years post-treatment
Completion rate of adjuvant chemotherapy
The completion rate of adjuvant chemotherapy is defined as the percentage of patients who successfully complete the full chemotherapy regimen within 6 months post-surgery, in accordance with the CSCO 2023 guidelines for colorectal cancer
Measured: From the beginning of the first chemotherapy to the end of the course of chemotherapy, up to 6 months.
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30
The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) is a widely used tool for assessing the quality of life of cancer patients in clinical trials. Each subscale of the EORTC QLQ-C30 is scored on a range from 0 to 100. Score Interpretation: Higher Scores:
For functional scales (e.g., physical, role, emotional, cognitive, social functioning): Higher scores indicate a better quality of life. For symptom scales (e.g., fatigue, pain, nausea/vomiting): Higher scores indicate worse symptoms or problems.
The global health status/QoL scale: Higher scores indicate a better overall quality of life.
Measured: From the beginning of the first chemotherapy to three months after the end of the course of chemotherapy
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer Module （EORTC QLQ-CR29）
The EORTC QLQ-CR29 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer Module) is a supplementary tool to the EORTC QLQ-C30, specifically designed to assess the quality of life in patients with colorectal cancer. Similar to the EORTC QLQ-C30, each item or subscale in the EORTC QLQ-CR29 is scored on a scale of 0 to 100.
Score Interpretation: Higher Scores: For functional scales (e.g., body image, sexual functioning): Higher scores reflect better functioning and, thus, a better quality of life. For symptom scales (e.g., bowel symptoms, urinary symptoms, blood/mucus in stool): Higher scores indicate worse symptoms, reflecting a worse outcome.
Measured: From the beginning of the first chemotherapy to three months after the end of the course of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhangfa Song, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596343
- Sponsor's protocol ID
- TCM-1
- Status last verified
- Sep 2024
- First submitted
- 8 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grothey A, Sobrero AF, Shields AF, Yoshino T, Paul J, Taieb J, Souglakos J, Shi Q, Kerr R, Labianca R, Meyerhardt JA, Vernerey D, Yamanaka T, Boukovinas I, Meyers JP, Renfro LA, Niedzwiecki D, Watanabe T, Torri V, Saunders M, Sargent DJ, Andre T, Iveson T. Duration of Adjuvant Chemotherapy for Stage III Colon Cancer. N Engl J Med. 2018 Mar 29;378(13):1177-1188. doi: 10.1056/NEJMoa1713709.
PubMed 29590544Taghizadeh H, Prager GW. Personalized Adjuvant Treatment of Colon Cancer. Visc Med. 2020 Oct;36(5):397-406. doi: 10.1159/000508175. Epub 2020 Jun 29.
PubMed 33178737Sauer S, Reed DR, Ihnat M, Hurst RE, Warshawsky D, Barkan D. Innovative Approaches in the Battle Against Cancer Recurrence: Novel Strategies to Combat Dormant Disseminated Tumor Cells. Front Oncol. 2021 Apr 27;11:659963. doi: 10.3389/fonc.2021.659963. eCollection 2021.
PubMed 33987095Nelson H, Petrelli N, Carlin A, Couture J, Fleshman J, Guillem J, Miedema B, Ota D, Sargent D; National Cancer Institute Expert Panel. Guidelines 2000 for colon and rectal cancer surgery. J Natl Cancer Inst. 2001 Apr 18;93(8):583-96. doi: 10.1093/jnci/93.8.583.
PubMed 11309435Siegel RL, Wagle NS, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2023. CA Cancer J Clin. 2023 May-Jun;73(3):233-254. doi: 10.3322/caac.21772. Epub 2023 Mar 1.
PubMed 36856579
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Value of Traditional Chinese Medicine Precision Treatment Based on Syndrome Differentiation in Postoperative Adjuvant Therapy for Locally Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06596343
- Acronym / sponsor ID
- TCM-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 19 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.
This study aims to explore the role of Traditional Chinese Medicine (TCM) based on syndrome differentiation in reducing chemotherapy side effects, lowering the risk of metastasis and recurrence, and improving survival rates in postoperative colorectal cancer patients through a prospective, single-arm interventional clinical trial.
Detailed description
Colorectal cancer is the third leading cause of cancer-related deaths worldwide, with 1.9 million new cases and nearly 935,000 deaths reported in 2020. In China, colorectal cancer ranks third in new cases for both men and women, while it ranks fifth in cancer-related deaths among men and second among women. It has become a global public health issue and a major threat to people's health. Surgical resection is the primary treatment for colon cancer and can potentially cure the tumor. More than 50% of colon cancer patients are diagnosed at locally advanced stages (stage II and III). Even after curative surgery, about 50% of these patients experience tumor recurrence due to undetectable micrometastases that persist post-surgery. Most of these patients require adjuvant chemotherapy to eliminate micrometastases and improve cure rates. Postoperative adjuvant chemotherapy can eradicate hidden micrometastases and prolong survival in colorectal cancer patients. Large clinical trials have shown that adjuvant chemotherapy reduces the recurrence rate by 41% and overall mortality by 33%. Thus, surgery combined with postoperative adjuvant chemotherapy is the standard treatment approach to cure colon cancer.
However, about 25% of stage III colorectal cancer patients still relapse despite adjuvant chemotherapy, indicating that not all patients benefit from it. Additionally, postoperative adjuvant chemotherapy can cause numerous side effects. The IDEA study reported that grade 3 or higher chemotherapy-related toxicities occurred in 20% of patients receiving 3 months of adjuvant chemotherapy and 36.9% of patients receiving 6 months. These side effects include mucositis, vomiting, diarrhea, febrile neutropenia, fatigue, hair loss, hand-foot syndrome (pain, redness, and peeling of the skin on the palms and soles), neurotoxicity, and cardiotoxicity. The incidence and severity of these side effects vary depending on the specific drugs and administration methods, and some side effects, such as oxaliplatin-induced peripheral neuropathy, can persist long-term, significantly affecting patients' quality of life.
Thus, both healthcare providers and patients are seeking additional therapies to reduce toxicity and improve the efficacy of standard treatment. In real-world practice, many colorectal cancer patients have received Traditional Chinese Medicine (TCM) as part of their postoperative care, and TCM plays a significant role in colorectal cancer prevention and treatment.
In TCM, colorectal cancer is classified under conditions such as "zang du" (organ toxin), "chang ji" (intestinal accumulation), and "ji ju" (mass accumulation), primarily caused by irregular diet, emotional imbalance, and deficiency of vital energy (qi). Although the disease originates in the intestines, it is closely related to the spleen, stomach, liver, and kidneys. Early-stage disease is dominated by damp-heat and toxin stagnation, while later stages are characterized by a deficiency of vital energy with excess pathogenic factors, typically involving spleen and kidney yang deficiency, qi and blood deficiency, or liver and kidney yin deficiency. A deficiency in vital energy and yin-yang imbalance are key factors in the development of colorectal cancer. Damp-heat accumulation in the intestines leads to stagnation of qi, toxin formation, and eventual mass formation, which is a core mechanism of disease development.
This study aims to investigate the role of adding TCM during and after surgery and chemotherapy to enhance the clinical efficacy of adjuvant chemotherapy, reduce the occurrence of adverse effects, prevent metastasis and recurrence, and ultimately improve survival rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adjuvant Chemotherapy Combined with Traditional Chinese Medicine (TCM) Supportive Therapy | Experimental | Drug: Adjuvant Chemotherapy Combined with Traditional Chinese Medicine (TCM) Supportive TherapyPatients will sign an informed consent form after surgery but before starting chemotherapy, and those enrolled will receive a combination of chemotherapy and Traditional Chinese Medicine (TCM) supportive therapy. 1. Chemotherapy Regimen: * Postoperative adjuvant chemotherapy: A dual-drug concurrent regimen will be used, with each cycle lasting 21 days. On day 1 of each cycle, oxaliplatin will be administered intravenously at a dose of 130 mg/m². From day 1 to day 14 of each cycle, capecitabine will be taken orally at a dose of 1000 mg/m², twice daily. The treatment duration will follow the CSCO 2023 guidelines for colorectal cancer, with chemotherapy lasting for 6 months. 2. TCM Treatment: * TCM treatment will be based on syndrome differentiation ("Zheng") and guided by the Guidelines for TCM Diagnosis and Treatment of Malignant Tumors. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Age between 18 and 75 years. 2. Diagnosed with colorectal cancer at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, and underwent standard radical colorectal cancer surgery. Postoperative pathological staging is stage III (AJCC 8th edition: T4, any N+, M0, or any T, N2, M0), indicating the need for chemotherapy according to the CSCO 2023 colorectal cancer guidelines.
- 3. Willing to receive Traditional Chinese Medicine (TCM) treatment. 4. Voluntarily agree to participate in the study and sign the informed consent form. If the subject is unable to read or sign the consent due to incapacity, the informed consent must be obtained from a legal guardian. If the subject cannot read the consent (e.g., illiterate subjects), a witness must observe and sign the consent process.
- 5. Expected survival of ≥12 months. 6. ECOG performance status score of 0-1. 7. No prior anti-cancer, immunotherapy, or radiation treatment. 8. Laboratory tests meeting the following criteria:
- White blood cell count ≥3.5 × 10^9/L, absolute neutrophil count ≥1.8 × 10^9/L, platelet count ≥100 × 10^9/L, hemoglobin ≥100 g/L.
- INR ≤1.5 and APTT ≤1.5 times the upper limit of normal (ULN) or PTT ≤1.5 times ULN.
Key exclusion criteria (4 listed)
- 1. Colorectal cancer patients with distant metastasis as indicated by preoperative evaluation.
- 2. Postoperative pathological results indicate that chemotherapy is not required according to the CSCO 2023 colorectal cancer guidelines.
- 3. Patients who have received neoadjuvant chemoradiotherapy before surgery. 4. Patients with severe heart, liver, kidney damage, or bone marrow dysfunction.
- 5. Pregnant or breastfeeding women. 6. Patients with known allergies to Traditional Chinese Medicine components. 7. Patients who refuse chemotherapy or TCM treatment. 8. Patients with a history of mental illness or cognitive impairment.
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 |
|---|---|---|
| Adjuvant Chemotherapy Combined with Traditional Chinese Medicine (TCM) Supportive Therapy1. Chemotherapy Regimen: * Postoperative adjuvant chemotherapy: A dual-drug concurrent regimen will be used, with each cycle lasting 21 days. On day 1 of each cycle, oxaliplatin will be administered intravenously at a dose of 130 mg/m². From day 1 to day 14 of each cycle, capecitabine will be taken orally at a dose of 1000 mg/m², twice daily. The treatment duration will follow the CSCO 2023 guidelines for colorectal cancer, with chemotherapy lasting for 6 months. 2. TCM Treatment: * TCM treatment will be based on syndrome differentiation ("Zheng") and guided by the Guidelines for TCM Diagnosis and Treatment of Malignant Tumors. | Drug | Adjuvant Chemotherapy Combined with Traditional Chinese Medicine (TCM) Supportive Therapy |
Primary outcome
The incidence of grade III/IV adverse events
Time frame: From the beginning of the first chemotherapy to three months after the end of the course of chemotherapy
According to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, adverse events (AEs) are graded on a scale from 1 to 5 based on severity: * Grade I: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; no intervention required. * Grade II: Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADLs). * Grade III: Severe; medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self-care ADLs. * Grade IV: Life-threatening consequences; urgent intervention required. * Grade V: Death related to adverse event.
5 secondary outcomes
3-year Disease-Free Survival
Time frame: 3 years post-treatment
3-year Overall Survival
Time frame: 3 years post-treatment
Completion rate of adjuvant chemotherapy
Time frame: From the beginning of the first chemotherapy to the end of the course of chemotherapy, up to 6 months.
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30
Time frame: From the beginning of the first chemotherapy to three months after the end of the course of chemotherapy
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer Module （EORTC QLQ-CR29）
Time frame: From the beginning of the first chemotherapy to three months after the end of the course of chemotherapy
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 19 Sep 2024.
- Results publication: PubMed 29590544Grothey A, Sobrero AF, Shields AF, Yoshino T, Paul J, Taieb J, Souglakos J, Shi Q, Kerr R, Labianca R, Meyerhardt JA, Vernerey D, Yamanaka T, Boukovinas I, Meyers JP, Renfro LA, Niedzwiecki D, Watanabe T, Torri V, Saunders M, Sargent DJ, Andre T, Iveson T. Duration of Adjuvant Chemotherapy for Stage III Colon Cancer. N Engl J Med. 2018 Mar 29;378(13):1177-1188. doi: 10.1056/NEJMoa1713709.
- Results publication: PubMed 33178737Taghizadeh H, Prager GW. Personalized Adjuvant Treatment of Colon Cancer. Visc Med. 2020 Oct;36(5):397-406. doi: 10.1159/000508175. Epub 2020 Jun 29.
- Results publication: PubMed 33987095Sauer S, Reed DR, Ihnat M, Hurst RE, Warshawsky D, Barkan D. Innovative Approaches in the Battle Against Cancer Recurrence: Novel Strategies to Combat Dormant Disseminated Tumor Cells. Front Oncol. 2021 Apr 27;11:659963. doi: 10.3389/fonc.2021.659963. eCollection 2021.
- Results publication: PubMed 11309435Nelson H, Petrelli N, Carlin A, Couture J, Fleshman J, Guillem J, Miedema B, Ota D, Sargent D; National Cancer Institute Expert Panel. Guidelines 2000 for colon and rectal cancer surgery. J Natl Cancer Inst. 2001 Apr 18;93(8):583-96. doi: 10.1093/jnci/93.8.583.
- Results publication: PubMed 36856579Siegel RL, Wagle NS, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2023. CA Cancer J Clin. 2023 May-Jun;73(3):233-254. doi: 10.3322/caac.21772. Epub 2023 Mar 1.
- Individual participant dataSharing planned: No
Related trials for Locally Advanced Colorectal Cancer
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Not yet recruitingObservational study
Multidimensional Study Designed to Develop a Methodological Framework Based on MRI Data to Predict Pathological Complete Response (pCR) in Patients With Locally Advanced Rectal Cancer After Neoadjuvant Treatment
Rectal Cancer, Chemoradiotherapy
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
RecruitingPhase 1
Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer
Locally Advanced Rectal Carcinoma, Rectal Adenocarcinoma
RecruitingPhase 2
Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors
Rectal Adenocarcinoma, Clinical Stage: Stage II (T3-4, N-)
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 2 study testing Adjuvant Chemotherapy Combined with Traditional Chinese Medicine (TCM) Supportive Therapy in people with Locally Advanced Colorectal Cancer and Postoperative Adjuvant Therapy, run by Sir Run Run Shaw 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 4 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: opening soon, as of the sponsor's last update on 19 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Zhangfa Song (+86 13867421652, songzhangfa@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of grade III/IV adverse events (time frame: From the beginning of the first chemotherapy to three months after the end of the course of chemotherapy). 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 NCT06596343, which also lists 5 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 19 Sep 2024.