Colorectal NeoplasmsPhase 3NCT02087475
Perioperative FOLFIRI VS Adjuvant FOLFIRI in Resectable Advanced CRC Failed to Oxaliplatin
A Phase 3 study testing Irinotecan, 5-fluorouracil and Local radiotherapy in people with Colorectal Neoplasms and Effects of Chemotherapy, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Colorectal cancer (CRC) is one of the most leading causes of cancer death in China. Although multiple treatment modalities including surgery, radiotherapy and chemotherapy have been developed, the prognosis of advanced CRC still remains poor. While around 30% of resectable advanced CRC could be cured. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Neoplasms, Effects of Chemotherapy, Surgery
- What is being tested?
- Irinotecan, 5-fluorouracil and Local radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age:18-80
- ECOG score: 0 or 1
- Histological confirmed of Colorectal Adenocarcinoma
- History of exposure to oxaliplatin
- With local recurrent or metastatic focus
- Tumor resectable confirmed by at less 3 hepatobiliary surgeon
- Informed content acquired
Who cannot join
- History of Exposure to Irinotecan
- Received surgery in recently 4 weeks or did not recover from surgery
- Other history of cancer in recent 5 years
- Fluorouracil allergy or dihydropyrimidine dehydrogenase defect
- Women with potential pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The 6th Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
Jian Xiao, MD, +8613711114566, xiao_jian@139.com
Jian Xiao, MD
About this study
Official title: Randomized Open-label Phase III Study Comparing Perioperative FOLFIRI Versus Adjuvant FOLFIRI in Resectable Advanced Colorectal Cancer Failed to Oxaliplatin-containing Treatment
Colorectal cancer (CRC) is one of the most leading causes of cancer death in China. Although multiple treatment modalities including surgery, radiotherapy and chemotherapy have been developed, the prognosis of advanced CRC still remains poor. While around 30% of resectable advanced CRC could be cured. This study is designed to compare perioperative FOLFIRI versus adjuvant FOLFIRI in resectable advanced CRC who exposed to oxaliplatin in open-label, phase III mode.
- Conditions
- Colorectal Neoplasms, Effects of Chemotherapy, Surgery, Metastasis, Local Neoplasm Recurrence
- Being tested
- Irinotecan, 5-fluorouracil, Local radiotherapy, R0 resection
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Neoplasm Recurrence, Local
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
5-fluorouracilDrug
Local radiotherapyRadiation
R0 resectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant therapy arm | Experimental | FOLFIRI * 6 cycles +/- radiotherapy -> surgery -> FOLFIRI * 6 cycles Receives: Drug: Irinotecan; Drug: 5-fluorouracil; Radiation: Local radiotherapy; Procedure: R0 resection |
| Adjuvant therapy arm | Active comparator | Surgery -> FOLFIRI * 12 cycles +/- radiotherapy Receives: Drug: Irinotecan; Drug: 5-fluorouracil; Radiation: Local radiotherapy; Procedure: R0 resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress Free Survival
Measured: 3 years
Secondary outcomes (4)
Overall Survival
Measured: 3 Years
R0 Resection Rate
Measured: 6 Month
Treatment RelatedToxicity
Adverse events grade that greater than 3 is considered secondary endpoint, according to the Common Terminology Criteria for Adverse Events Version 3.0.
Measured: 3 Year
Life Quality
EORTC QoL Questionaires
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startJan 2011
- Primary completionDec 2021 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Lan, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Ping Lan, MD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087475
- Sponsor's protocol ID
- SAH 5010 CRC
- Status last verified
- Jun 2019
- First submitted
- 7 Mar 2014
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open-label Phase III Study Comparing Perioperative FOLFIRI Versus Adjuvant FOLFIRI in Resectable Advanced Colorectal Cancer Failed to Oxaliplatin-containing Treatment
- ClinicalTrials.gov ID
- NCT02087475
- Acronym / sponsor ID
- SAH 5010 CRC
- Conditions
- Colorectal Neoplasms, Effects of Chemotherapy, Surgery, Metastasis, Local Neoplasm Recurrence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Mar 2014 (estimated)
- 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.
Colorectal cancer (CRC) is one of the most leading causes of cancer death in China. Although multiple treatment modalities including surgery, radiotherapy and chemotherapy have been developed, the prognosis of advanced CRC still remains poor. While around 30% of resectable advanced CRC could be cured. This study is designed to compare perioperative FOLFIRI versus adjuvant FOLFIRI in resectable advanced CRC who exposed to oxaliplatin in open-label, phase III mode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant therapy arm | Experimental | Drug: Irinotecan, Drug: 5-fluorouracil, Radiation: Local radiotherapy, Procedure: R0 resectionFOLFIRI * 6 cycles +/- radiotherapy -> surgery -> FOLFIRI * 6 cycles |
| Adjuvant therapy arm | Active comparator | Drug: Irinotecan, Drug: 5-fluorouracil, Radiation: Local radiotherapy, Procedure: R0 resectionSurgery -> FOLFIRI * 12 cycles +/- radiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age:18-80
- ECOG score: 0 or 1
- Histological confirmed of Colorectal Adenocarcinoma
- History of exposure to oxaliplatin
- With local recurrent or metastatic focus
Key exclusion criteria (5 listed)
- History of Exposure to Irinotecan
- Received surgery in recently 4 weeks or did not recover from surgery
- Other history of cancer in recent 5 years
- Fluorouracil allergy or dihydropyrimidine dehydrogenase defect
- Women with potential pregnancy.
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 |
|---|---|---|
| Irinotecan | Drug | Adjuvant therapy arm, Neoadjuvant therapy arm |
| 5-fluorouracil | Drug | Adjuvant therapy arm, Neoadjuvant therapy arm |
| Local radiotherapy | Radiation | Adjuvant therapy arm, Neoadjuvant therapy arm |
| R0 resection | Procedure or surgery | Adjuvant therapy arm, Neoadjuvant therapy arm |
Primary outcome
Progress Free Survival
Time frame: 3 years
4 secondary outcomes
Overall Survival
Time frame: 3 Years
R0 Resection Rate
Time frame: 6 Month
Treatment RelatedToxicity
Time frame: 3 Year
Life Quality
Time frame: 3 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
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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.
Ping Lan, MD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
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 Irinotecan, 5-fluorouracil and Local radiotherapy in people with Colorectal Neoplasms and Effects of Chemotherapy, run by Sixth Affiliated Hospital, Sun Yat-sen 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 7 inclusion and 5 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 5 Jun 2019. 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 Jian Xiao, MD (+8613711114566, xiao_jian@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress Free Survival (time frame: 3 years). 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 5 Jun 2019.