Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rectal Cancer | Drug: Control arm Drug: Experimental arm | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 72 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Study of Neoadjuvant Chemoradiotherapy With or Without Intensification With the FOLFOXIRI Chemo-regimen for High-risk Locally Advanced Rectal Cancer |
Actual Study Start Date : | September 10, 2019 |
Estimated Primary Completion Date : | March 31, 2022 |
Estimated Study Completion Date : | March 31, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Control arm
neoadjuvant concurrent capecitabine-radiotherapy followed by surgery and postoperative chemotherapy
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Drug: Control arm
neoadjuvant concurrent capecitabine-radiotherapy followed by surgery and postoperative chemotherapy.
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Experimental: Experimental arm
Neoadjuvant FOLFOXIRI x4 cycles, then capecitabine-radiotherapy and postoperative chemotherapy
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Drug: Experimental arm
Neoadjuvant FOLFOXIRI x4 cycles, then capecitabine-radiotherapy and postoperative chemotherapy.
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Brigette MA, MD | 35052118 | brigette@clo.cuhk.edu.hk | |
Contact: Jane Koh, RN | 35051142 | jane@clo.cuhk.edu.hk |
Hong Kong | |
The Chinese University of Hong Kong | Recruiting |
Hong Kong, Hong Kong | |
Contact: Brigette Ma, MD 3505 2118 brigette@clo.cuhk.edu.hk | |
Contact: Jane Koh, RN 35051142 jane@clo.cuhk.edu.hk |
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 19, 2019 | ||||||||
First Posted Date ICMJE | June 25, 2019 | ||||||||
Last Update Posted Date | October 22, 2020 | ||||||||
Actual Study Start Date ICMJE | September 10, 2019 | ||||||||
Estimated Primary Completion Date | March 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Rate of pathologic complete response [ Time Frame: 2 years ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | FOLFOXIRI With or Without Intensification for Rectal Cancer | ||||||||
Official Title ICMJE | A Randomized Study of Neoadjuvant Chemoradiotherapy With or Without Intensification With the FOLFOXIRI Chemo-regimen for High-risk Locally Advanced Rectal Cancer | ||||||||
Brief Summary | Pathologic complete response rate | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Rectal Cancer | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
72 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | March 31, 2023 | ||||||||
Estimated Primary Completion Date | March 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Hong Kong | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03997435 | ||||||||
Other Study ID Numbers ICMJE | COL026 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | CCTU, Chinese University of Hong Kong | ||||||||
Study Sponsor ICMJE | CCTU | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Chinese University of Hong Kong | ||||||||
Verification Date | October 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |