| 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
|
Drug: Control arm
neoadjuvant concurrent capecitabine-radiotherapy followed by surgery and postoperative chemotherapy.
|
|
Experimental: Experimental arm
Neoadjuvant FOLFOXIRI x4 cycles, then capecitabine-radiotherapy and postoperative chemotherapy
|
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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 |
|
||||||||
| 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 |
||||||||
| 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. |
|||||||||
| 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:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| 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 |
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