Locally Advanced Rectal CancerPhase 3NCT05079438
Dendrobium Huoshanense Suppository in Rectal Cancer
A Phase 3 study testing Dendrobium Huoshanense Suppository in people with Locally Advanced Rectal Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
To evaluates the role of Dendrobium Huoshanense Suppository for radiation proctitis in locally advanced rectal cancer treated by capecitabine and irinotecan based neoadjuvant chemoradiation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- Dendrobium Huoshanense Suppository
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2021to 31 Aug 2024
- 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
- 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
- without previous anti-cancer therapy
- able to follow the protocol during the study period
- sign the inform consen
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
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ji Zhu
Hangzhou, Zhejiang, 310022
JI Zhu, MD, 571-88128142 ext. +86, leo.zhu@126.com
About this study
Official title: A Multicenter Randomized Controlled Stage III Clinical Study of Dendrobium Huoshanense Suppository in Locally Advanced Rectal Cancer Patients Treated by Neoadjuvant Chemoradiotherapy
To evaluates the role of Dendrobium Huoshanense Suppository for radiation proctitis in locally advanced rectal cancer treated by capecitabine and irinotecan based neoadjuvant chemoradiation.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- Dendrobium Huoshanense Suppository
- 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 SuppositoryDrug
1.7g rectal administration per day for 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| CRT with Dendrobium huoshanense Suppository | Experimental | Dendrobium huoshanense Suppository: 1.7g rectal administration per day for 5 weeks
Concurrent Chemoradiotherapy:
Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1*28 and *6: 6/6+GG) or 65mg/m2 (UGT1A1*28 and *6 ：6/7+GG or 6/6+GA) or 50mg/m2 （UGT1A1*28 and *6 ：7/7+GG or 6/6+AA or 6/7+GA）. Receives: Drug: Dendrobium Huoshanense Suppository |
| CRT with Placebo | No intervention | Placebo: 1.7g rectal administration per day for 5 weeks Concurrent Chemoradiotherapy: Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1*28 and *6: 6/6+GG) or 65mg/m2 (UGT1A1*28 and *6 ：6/7+GG or 6/6+GA) or 50mg/m2 （UGT1A1*28 and *6 ：7/7+GG or 6/6+AA or 6/7+GA）. |
What is being measured
The primary outcome is the main question the study is designed to answer.
≥Grade 2 proctitis
Measured: During chemoradiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start7 Sep 2021
- Primary completion30 Jul 2023 (estimated)
- Study completion31 Aug 2024 (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 Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhuji, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079438
- Sponsor's protocol ID
- CARTOnG-2103
- Status last verified
- Oct 2021
- First submitted
- 1 Oct 2021
- Last updated
- 15 Oct 2021
- 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 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Stage III Clinical Study of Dendrobium Huoshanense Suppository in Locally Advanced Rectal Cancer Patients Treated by Neoadjuvant Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT05079438
- Acronym / sponsor ID
- CARTOnG-2103
- Conditions
- Locally Advanced Rectal Cancer
- Keywords
- Neoadjuvant Chemoradiotherapy, Dendrobium Huoshanense, irinotecan, capecitabine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 15 Oct 2021 (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.
To evaluates the role of Dendrobium Huoshanense Suppository for radiation proctitis in locally advanced rectal cancer treated by capecitabine and irinotecan based neoadjuvant chemoradiation.
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 Suppository | Experimental | Drug: Dendrobium Huoshanense SuppositoryDendrobium huoshanense Suppository: 1.7g rectal administration per day for 5 weeks Concurrent Chemoradiotherapy: Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1*28 and *6: 6/6+GG) or 65mg/m2 (UGT1A1*28 and *6 ：6/7+GG or 6/6+GA) or 50mg/m2 （UGT1A1*28 and *6 ：7/7+GG or 6/6+AA or 6/7+GA）. |
| CRT with Placebo | No intervention | –Placebo: 1.7g rectal administration per day for 5 weeks Concurrent Chemoradiotherapy: Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1*28 and *6: 6/6+GG) or 65mg/m2 (UGT1A1*28 and *6 ：6/7+GG or 6/6+GA) or 50mg/m2 （UGT1A1*28 and *6 ：7/7+GG or 6/6+AA or 6/7+GA）. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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 (8 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 Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
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 Suppository1.7g rectal administration per day for 5 weeks | Drug | CRT with Dendrobium huoshanense Suppository |
Primary outcome
≥Grade 2 proctitis
Time frame: During chemoradiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
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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.
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 Dendrobium Huoshanense Suppository in people with Locally Advanced Rectal Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 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 15 Oct 2021. 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 Ji Zhu, MD (571-88128142 ext. +86, leo.zhu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
≥Grade 2 proctitis (time frame: During chemoradiotherapy). 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 15 Oct 2021.