Locally Advanced Rectal CancerPhase 2NCT03702985
Radiation-protection Effect of Amifostine in Locally Advanced Rectal Cancer
A Phase 2 study testing Radiation, Capecitabine and Irinotecan in people with Locally Advanced Rectal Cancer, run by Fudan University at 1 site in China.
Trial summary
The study evaluates the addition of Amifostine to capecitabine and irinotecan in neoadjuvant chemoradiation(CRT) in locally advanced rectal cancer. Half of participants will receive capecitabine and along with neoadjuvant radiotherapy, followed by a cycle of XELIRI, while the others will receive capecitabine and… 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?
- Radiation, Capecitabine and Irinotecan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 28 May 2018to 1 Mar 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathological confirmed adenocarcinoma
- clinical stage T3-4 and/or N+
- the distance from anal verge less than 12 cm
- without distance metastases
- performance status score: 0~1
- UGT1A1*28 6/6 or 6/7
- without previous anti-cancer therapy
- sign the inform consent
Who cannot join
- pregnancy or breast-feeding women
- serious medical illness
- baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
- DPD deficiency
- UGT1A1*28 7/7
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Ji Zhu, MD, leo.zhu@126.com
Zhen Zhang, MD
About this study
Official title: A Phase II Trial of Capecitabine and Irinotecan With or Without Amifostine in Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer
The study evaluates the addition of Amifostine to capecitabine and irinotecan in neoadjuvant chemoradiation(CRT) in locally advanced rectal cancer. Half of participants will receive capecitabine and along with neoadjuvant radiotherapy, followed by a cycle of XELIRI, while the others will receive capecitabine and irinotecan added by amifostine during CRT, followed by a cycle of XELIRI. All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT. Then it will depends which regimens the patient would receive according to his or her pathological results.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- Radiation, Capecitabine, Irinotecan, Amifostine
- Keywords
- Neoadjuvant Chemoradiotherapy, amifostine, irinotecan, capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
Pelvic Radiation: 50Gy/25Fx
CapecitabineDrug
Also called Xeloda
625mg/m2 bid Monday-Friday per week
IrinotecanDrug
80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7)
AmifostineDrug
400mg/m2 per week
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine and Irinotecan without Amifostine | Active comparator | 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: Radiation; Drug: Capecitabine; Drug: Irinotecan |
| Capecitabine and Irinotecan with Amifostine | Experimental | 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) Amifostine: 400mg/m2 per week
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: Radiation; Drug: Capecitabine; Drug: Irinotecan; Drug: Amifostine |
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: during neoadjuvant chemoradiation.
Secondary outcomes (3)
Impact of participants' quality of life during treatment as assessed by EQ-5D questionnaire and EORTC-QLQ-C30 questionnaire
Measured: during neoadjuvant chemoradiation.
pathological response rate
Measured: Surgery scheduled 6-8 weeks after the end of chemoradiation.
the morbidity of late radiation proctitis
Measured: late radiation proctitis is measured 9 months after the end of chemoradiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start28 May 2018
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Mar 2020 (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
- None (open label)
- Enrolment
- 160 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
- NCT03702985
- Sponsor's protocol ID
- FDRT-R007
- Status last verified
- Oct 2018
- First submitted
- 14 Jun 2018
- Last updated
- 23 Jan 2019
- 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 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Capecitabine and Irinotecan With or Without Amifostine in Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT03702985
- Acronym / sponsor ID
- FDRT-R007
- Conditions
- Locally Advanced Rectal Cancer
- Keywords
- Neoadjuvant Chemoradiotherapy, amifostine, irinotecan, capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 28 May 2018 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 11 Oct 2018 (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 Amifostine to capecitabine and irinotecan in neoadjuvant chemoradiation(CRT) in locally advanced rectal cancer. Half of participants will receive capecitabine and along with neoadjuvant radiotherapy, followed by a cycle of XELIRI, while the others will receive capecitabine and irinotecan added by amifostine during CRT, followed by a cycle of XELIRI. All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT. Then it will depends which regimens the patient would receive according to his or her pathological results.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capecitabine and Irinotecan without Amifostine | Active comparator | Radiation: Radiation, Drug: Capecitabine, Drug: IrinotecanConcurrent 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. |
| Capecitabine and Irinotecan with Amifostine | Experimental | Radiation: Radiation, Drug: Capecitabine, Drug: Irinotecan, Drug: AmifostineConcurrent 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) Amifostine: 400mg/m2 per week 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 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- pathological confirmed adenocarcinoma
- clinical stage T3-4 and/or N+
- the distance from anal verge less than 12 cm
- without distance metastases
- performance status score: 0~1
Key exclusion criteria (5 listed)
- pregnancy or breast-feeding women
- serious medical illness
- baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
- DPD deficiency
- UGT1A1*28 7/7
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 |
|---|---|---|
| RadiationPelvic Radiation: 50Gy/25Fx | Radiation | Capecitabine and Irinotecan with Amifostine, Capecitabine and Irinotecan without Amifostine |
| CapecitabineAlso: Xeloda625mg/m2 bid Monday-Friday per week | Drug | Capecitabine and Irinotecan with Amifostine, Capecitabine and Irinotecan without Amifostine |
| Irinotecan80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7) | Drug | Capecitabine and Irinotecan with Amifostine, Capecitabine and Irinotecan without Amifostine |
| Amifostine400mg/m2 per week | Drug | Capecitabine and Irinotecan with Amifostine |
Primary outcome
the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
Time frame: during neoadjuvant chemoradiation.
3 secondary outcomes
Impact of participants' quality of life during treatment as assessed by EQ-5D questionnaire and EORTC-QLQ-C30 questionnaire
Time frame: during neoadjuvant chemoradiation.
pathological response rate
Time frame: Surgery scheduled 6-8 weeks after the end of chemoradiation.
the morbidity of late radiation proctitis
Time frame: late radiation proctitis is measured 9 months after the end of chemoradiation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 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.
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 Radiation, Capecitabine and Irinotecan 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 8 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 23 Jan 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 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: during neoadjuvant chemoradiation.). 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 23 Jan 2019.