Locally Advanced Rectal CancerPhase 2NCT04394598
A Study of Chinese Herbal Compound Dendrobium Huoshanense Granules in NCRT for Patients With Locally Advanced Rectal Cancer
A Phase 2 study testing Dendrobium Huoshanense Granules, Pelvic Radiation and Capecitabine in people with Locally Advanced Rectal Cancer, run by Fudan University at 1 site in China.
Trial summary
The study evaluates the addition of Chinese Herbal Compound Dendrobium Huoshanense Granules to capecitabine and irinotecan in neoadjuvant chemoradiation(CRT) in locally advanced rectal cancer. Half of participants will receive CRT with Dendrobium Huoshanense Granules, while the others will receive CRT with placebo. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- Dendrobium Huoshanense Granules, Pelvic Radiation and Capecitabine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 1 Dec 2022
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathological confirmed rectum adenocarcinoma
- clinical stage T3-4 and/or N+
- the distance from anal verge less than 10 cm
- without distance metastases
- performance status score: 0~1
- UGT1A1*28 6/6 or 6/7
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- without previous anti-cancer therapy
- able to follow the protocol during the study period
- sign the inform consent
Who cannot join
- Pregnant or breastfeeding women
- Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ
- If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
- Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months
- Organ transplantation requires immunosuppressive therapy
- Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
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- Subject blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; Alanine transaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (ALP) ≤2.5 times the normal upper limit; serum total bilirubin <1.5 times the normal upper limit; serum creatinine <1 times the normal upper limit; serum albumin ≥ 30g / L
- Anyone who is allergic to any research medication
- DPD deficiency
- UGT1A1*28 7/7
Trial locations and contacts
1 site in 1 country.
Zhen Zhang, MD contact
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200023
Zhu Ji, MD, leo.zhu@126.com
Zhen Zhang, MD
About this study
Official title: A Phase II Randomized Study of the Protection Effect of Chinese Herbal Compound Dendrobium Huoshanense Granules in NCRT for Patients With Locally Advanced Rectal Cancer
The study evaluates the addition of Chinese Herbal Compound Dendrobium Huoshanense Granules to capecitabine and irinotecan in neoadjuvant chemoradiation(CRT) in locally advanced rectal cancer. Half of participants will receive CRT with Dendrobium Huoshanense Granules, while the others will receive CRT with placebo. We will evaluate whether Dendrobium Huoshanense Granules can enhance the immune function and alleviate symptoms caused by the tumor and CRT .
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- Dendrobium Huoshanense Granules, Pelvic Radiation, Capecitabine, Irinotecan, Placebo
- Keywords
- Neoadjuvant Chemoradiotherapy, Dendrobium Huoshanense, irinotecan, capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dendrobium Huoshanense GranulesDrug
3g tid per day for 5weeks
Pelvic RadiationRadiation
50Gy/25Fx
CapecitabineDrug
625mg/m2 bid Monday-Friday per week
IrinotecanDrug
80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7)
PlaceboOther
3g tid per day for 5weeks
| Study group | Role | What they receive |
|---|---|---|
| CRT with Dendrobium Huoshanense | Experimental | Dendrobium Huoshanense Granules: 3g tid per day for 5weeks
Concurrent Chemoradiotherapy:
Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7)
Chemotherapy in Interval Between CRT and Surgery:
Capecitabine: 1000mg/m2 bid d1-14; Irinotecan: 200mg/m2 d1
Surgery:
Scheduled 6-8 weeks after the completion of CRT Adjuvant Chemotherapy: depends on patients pathological review. Receives: Drug: Dendrobium Huoshanense Granules; Radiation: Pelvic Radiation; Drug: Capecitabine; Drug: Irinotecan |
| CRT with Placebo | Placebo comparator | Placebo: 3g tid per day for 5weeks
Concurrent Chemoradiotherapy:
Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7)
Chemotherapy in Interval Between CRT and Surgery:
Capecitabine: 1000mg/m2 bid d1-14; Irinotecan: 200mg/m2 d1
Surgery:
Scheduled 6-8 weeks after the completion of CRT Adjuvant Chemotherapy: depends on patients pathological review. Receives: Radiation: Pelvic Radiation; Drug: Capecitabine; Drug: Irinotecan; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
Measured: twice weekly during the neoadjuvant chemotherapy (5 weeks)
Secondary outcomes (4)
Impact of participants' quality of life during treatment as assessed by EQ-5D questionnaire
Measured: once weekly during the neoadjuvant chemotherapy (5 weeks)
Impact of participants' quality of life during treatment as assessed by EORTC-QLQ-C30 questionnaire
Measured: once weekly during the neoadjuvant chemotherapy (5 weeks)
ORR(objective response rate) includes CR(complete rate) and PR(partial rate)
Measured: Surgery scheduled 6-8 weeks after the end of chemoradiation
Number of the concurrent chemotherapy cycles that patients can receive during radiotherapy
Measured: once weekly during neoadjuvant chemoradiation(5 weeks,each cycle is one week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Mar 2020
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Ji, Fudan University
- Investigators
- Zhen Zhang, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394598
- Sponsor's protocol ID
- FDRT-R20
- Status last verified
- May 2020
- First submitted
- 13 May 2020
- Last updated
- 19 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Study of the Protection Effect of Chinese Herbal Compound Dendrobium Huoshanense Granules in NCRT for Patients With Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT04394598
- Acronym / sponsor ID
- FDRT-R20
- Conditions
- Locally Advanced Rectal Cancer
- Keywords
- Neoadjuvant Chemoradiotherapy, Dendrobium Huoshanense, irinotecan, capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluates the addition of Chinese Herbal Compound Dendrobium Huoshanense Granules to capecitabine and irinotecan in neoadjuvant chemoradiation(CRT) in locally advanced rectal cancer. Half of participants will receive CRT with Dendrobium Huoshanense Granules, while the others will receive CRT with placebo. We will evaluate whether Dendrobium Huoshanense Granules can enhance the immune function and alleviate symptoms caused by the tumor and CRT .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT with Dendrobium Huoshanense | Experimental | Drug: Dendrobium Huoshanense Granules, Radiation: Pelvic Radiation, Drug: Capecitabine, Drug: IrinotecanDendrobium Huoshanense Granules: 3g tid per day for 5weeks Concurrent Chemoradiotherapy: Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7) Chemotherapy in Interval Between CRT and Surgery: Capecitabine: 1000mg/m2 bid d1-14; Irinotecan: 200mg/m2 d1 Surgery: Scheduled 6-8 weeks after the completion of CRT Adjuvant Chemotherapy: depends on patients pathological review. |
| CRT with Placebo | Placebo comparator | Radiation: Pelvic Radiation, Drug: Capecitabine, Drug: Irinotecan, Other: PlaceboPlacebo: 3g tid per day for 5weeks Concurrent Chemoradiotherapy: Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7) Chemotherapy in Interval Between CRT and Surgery: Capecitabine: 1000mg/m2 bid d1-14; Irinotecan: 200mg/m2 d1 Surgery: Scheduled 6-8 weeks after the completion of CRT Adjuvant Chemotherapy: depends on patients pathological review. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- pathological confirmed rectum adenocarcinoma
- clinical stage T3-4 and/or N+
- the distance from anal verge less than 10 cm
- without distance metastases
- performance status score: 0~1
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding women
- Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ
- If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
- Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months
- Organ transplantation requires immunosuppressive therapy
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 |
|---|---|---|
| Dendrobium Huoshanense Granules3g tid per day for 5weeks | Drug | CRT with Dendrobium Huoshanense |
| Pelvic Radiation50Gy/25Fx | Radiation | CRT with Dendrobium Huoshanense, CRT with Placebo |
| Capecitabine625mg/m2 bid Monday-Friday per week | Drug | CRT with Dendrobium Huoshanense, CRT with Placebo |
| Irinotecan80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7) | Drug | CRT with Dendrobium Huoshanense, CRT with Placebo |
| Placebo3g tid per day for 5weeks | Other | CRT with Placebo |
Primary outcome
the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
Time frame: twice weekly during the neoadjuvant chemotherapy (5 weeks)
4 secondary outcomes
Impact of participants' quality of life during treatment as assessed by EQ-5D questionnaire
Time frame: once weekly during the neoadjuvant chemotherapy (5 weeks)
Impact of participants' quality of life during treatment as assessed by EORTC-QLQ-C30 questionnaire
Time frame: once weekly during the neoadjuvant chemotherapy (5 weeks)
ORR(objective response rate) includes CR(complete rate) and PR(partial rate)
Time frame: Surgery scheduled 6-8 weeks after the end of chemoradiation
Number of the concurrent chemotherapy cycles that patients can receive during radiotherapy
Time frame: once weekly during neoadjuvant chemoradiation(5 weeks,each cycle is one week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
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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.
Zhen Zhang, MD contact
Zhen Zhang, MD principal investigator
Fudan University
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 Dendrobium Huoshanense Granules, Pelvic Radiation and Capecitabine in people with Locally Advanced Rectal Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 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 19 May 2020. 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. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji Zhu, MD (+86-2164175590 ext. 81607, leo.zhu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0 (time frame: twice weekly during the neoadjuvant chemotherapy (5 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2020.