Rectal NeoplasmsPhase 2NCT03484221
Totally Neoadjuvant FOLFOXIRI + Short-course Radiation + XELOX in Patients With Locally Advanced Rectal Cancer
A Phase 2 study testing FOLFOXIRI, Short-Course Radiation Therapy(5Gy*5) and XELOX in people with Rectal Neoplasms and Drug Therapy, run by China Medical University, China at 1 site in China.
Trial summary
To evaluate the efficacy and safety of totally neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) followed by short-course radiation therapy and XELOX chemotherapy in the patients with locally advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Neoplasms, Drug Therapy, Radiation
- What is being tested?
- FOLFOXIRI, Short-Course Radiation Therapy(5Gy*5) and XELOX
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 1 Apr 2022
- 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
- Age: 18-75 years old
- Primary and pathological diagnosis of rectal adenocarcinoma
- Radiographic evaluation of initial resectable rectal cancer
- T staging was determined by MRI as T3N+ or T4Nx
- Distal border of the tumor must be located < 12 cm from the anal verge
- ECOG status: 0～1
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- Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
- Neutrophil count≥1.5×10^9/L Platelet count≥90×10^9/L Hemoglobin≥90g/L Total bilirubin (TBI) ≤ 1.5 ULN Alanine aminotransferase (ALT)≤2.5 ULN Aspartate aminotransferase (AST)≤2.5 ULN Alkaline phosphatase (ALP)≤2.5 ULN
- Signed informed consent; able to comply with study and/or follow- up procedures
Who cannot join
- Previous treatment with oxaliplatin, irinotecan or fluorouracil
- Hypersensitivity to fluorouracil, oxaliplatin or irinotecan.
- Clear indication of involvement of the pelvic side walls by imaging
- With distant metastasis
- A history of malignant rectal cancer (i. e. sarcoma, lymphoma, carcinoid, squamous cell carcinoma) or synchronous colon cancer
- Cardiovascular disease that would preclude study treatment or follow-up; New York Heart Association class III or IV heart disease; active ischemic heart disease; myocardial infarction within the past 6 months; symptomatic arrhythmia uncontrolled hypertension. Unexplained syncope occurred within 3 months
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- Digestive system diseases that would preclude study treatment or follow-up within the past 6 months
- Gastric ulcers or duodenal ulcers for the treatment of resistance;
- 3 or 4 grade gastrointestinal bleeding / bleeding;
- Gastrointestinal perforation / fistula;
- Abdominal abscess;
- Infectious or inflammatory bowel disease
- HIV infection and/or active hepatitis B virus infection
- Pregnant or lactating women. Fertile patients must use effective contraception
- Any serious acute or chronic disease that can not be involved in the study or to influence the interpretation of the results of the study
- Other intervention clinical trials were combined at the same time.
- Nerve or mental abnormality affecting cognitive ability
- Other malignancy except effectively treated squamous cell or basal cell skin cancer,
- Other situations that the researchers think should be excluded
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China Medical University
Shenyang
Yuanhe Wang
About this study
Official title: Totally Neoadjuvant FOLFOXIRI Chemotherapy Followed by Short-course Radiation and XELOX Chemotherapy in Patients With Locally Advanced Rectal Cancer：an Open-label, Single-arm, Multicenter Phase II Study.
To evaluate the efficacy and safety of totally neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) followed by short-course radiation therapy and XELOX chemotherapy in the patients with locally advanced rectal cancer.
Read the detailed description
Neoadjuvant chemoradiation therapy with double cytotoxic agents is the standard treatment for the patients with locally advanced rectal cancer. Conventional treatment reduced the local recurrence but did not prolong the long-term survival. Furthermore, the patients with pathological complete response (pCR) did not benefit from double cytotoxic chemotherapy. Therefore, we chose triple cytotoxic agents FOLFOXIRI as the neoadjuvant chemotherapy. We will evaluate the efficacy and safety of totally neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) followed by short-course radiation and XELOX chemotherapy in the patients with locally advanced rectal cancer to achieve more pCR and longer survival.
In this prospective study, 30 patients with locally advanced rectal cancer will be recruited. Firstly, 4 cycles of neoadjuvant FOLFOXIRI chemotherapy were administered. Subsequently, a short-course radiation therapy (5Gy*5) will be performed. After that, 4 cycles of XELOX chemotherapy will be administered followed by TME surgery. PET-CT examination will be performed before and after the 4 cycles of neoadjuvant FOLFOXIRI chemotherapy to assess the SUVmax changes. In addition, the dynamic changes of ctDNA in peripheral blood will be monitored at the PET-CT examination. In the course of treatment, safety evaluation will be carried out according to the standard of adverse reaction classification (CTCAE) 4.0.
- Conditions
- Rectal Neoplasms, Drug Therapy, Radiation
- Being tested
- FOLFOXIRI, Short-Course Radiation Therapy(5Gy*5), XELOX
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOXIRIDrug
Also called Irinotecan, Oxaliplatin, 5-Fluorouracil
IRINOTECAN 150 mg/m^2 IV over 1-h, day 1 + OXALIPLATIN 85 mg/m^2 IV over 2-h, day 1 + L-LEUCOVORIN 200 mg/m^2 IV over 2-h, day 1 + 5-FLUOROURACIL 2800 mg/m^2 IV 48-h continuous infusion, starting on day 1 administered every two weeks for 4 cycles (2 months).
Short-Course Radiation Therapy(5Gy*5)Radiation
Patients received a short-course radiation therapy(5Gy*5) after 4 cycles of FOLFOXIRI.
XELOXDrug
Also called Capecitabine, Oxaliplatin
OXALIPLATIN 130 mg/m^2 IV over 2-h, day 1 Capecitabine 1000 mg/m^2 twice daily days 1-14 every 3 weeks for 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| FOLFOXIRI+short-course radiation+XELOX | Experimental | Firstly, 4 cycles of neoadjuvant FOLFOXIRI chemotherapy were administered. Subsequently, a short-course radiation therapy (5Gy*5) will be performed. After that, 4 cycles of XELOX chemotherapy will be administered followed by surgery. Receives: Drug: FOLFOXIRI; Radiation: Short-Course Radiation Therapy(5Gy*5); Drug: XELOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of tumor downstaging to stage 0 and stage I
Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I
Measured: 2 years
Secondary outcomes (7)
Tumor regression grade (TRG)
The level of tumor regression under pathological examination
Measured: 2 years
Disease free survival
Estimated from the date of surgery to the date of recurrence.
Measured: 3 years
Overall survival time
Estimated from the date of enrollment to death from any cause.
Measured: 3 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The grade of toxicity will be assessed using the NCI-CTCAE version 4.0.
Measured: 3 years
ctDNA change
The relationship between ctDNA and survival will be evaluated.
Measured: 3 years
SUVmax changes
Tumor metabolic response through FDG-PET examination before and after 4 cycles of neoadjuvant FOLFOXIRI chemotherapy
Measured: At the beginning of Cycle 1 and the end of Cycle 4 (each cycle is 14 days)
Quality of life (QLQ C30)
Scores according to EORTC QLQ-C30 scoring manual
Measured: Every 2 weeks after the first treatment until 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start1 Apr 2018
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingdong Zhang, China Medical University, China
- Investigators
- Jingdong Zhang, Principal investigator, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484221
- Sponsor's protocol ID
- LGIOG-2017-02
- Status last verified
- Apr 2021
- First submitted
- 23 Mar 2018
- Last updated
- 14 Apr 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 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Totally Neoadjuvant FOLFOXIRI Chemotherapy Followed by Short-course Radiation and XELOX Chemotherapy in Patients With Locally Advanced Rectal Cancer：an Open-label, Single-arm, Multicenter Phase II Study.
- ClinicalTrials.gov ID
- NCT03484221
- Acronym / sponsor ID
- LGIOG-2017-02
- Conditions
- Rectal Neoplasms, Drug Therapy, Radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 30 Mar 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.
To evaluate the efficacy and safety of totally neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) followed by short-course radiation therapy and XELOX chemotherapy in the patients with locally advanced rectal cancer.
Detailed description
Neoadjuvant chemoradiation therapy with double cytotoxic agents is the standard treatment for the patients with locally advanced rectal cancer. Conventional treatment reduced the local recurrence but did not prolong the long-term survival. Furthermore, the patients with pathological complete response (pCR) did not benefit from double cytotoxic chemotherapy. Therefore, we chose triple cytotoxic agents FOLFOXIRI as the neoadjuvant chemotherapy. We will evaluate the efficacy and safety of totally neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) followed by short-course radiation and XELOX chemotherapy in the patients with locally advanced rectal cancer to achieve more pCR and longer survival.
In this prospective study, 30 patients with locally advanced rectal cancer will be recruited. Firstly, 4 cycles of neoadjuvant FOLFOXIRI chemotherapy were administered. Subsequently, a short-course radiation therapy (5Gy*5) will be performed. After that, 4 cycles of XELOX chemotherapy will be administered followed by TME surgery. PET-CT examination will be performed before and after the 4 cycles of neoadjuvant FOLFOXIRI chemotherapy to assess the SUVmax changes. In addition, the dynamic changes of ctDNA in peripheral blood will be monitored at the PET-CT examination. In the course of treatment, safety evaluation will be carried out according to the standard of adverse reaction classification (CTCAE) 4.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFOXIRI+short-course radiation+XELOX | Experimental | Drug: FOLFOXIRI, Radiation: Short-Course Radiation Therapy(5Gy*5), Drug: XELOXFirstly, 4 cycles of neoadjuvant FOLFOXIRI chemotherapy were administered. Subsequently, a short-course radiation therapy (5Gy*5) will be performed. After that, 4 cycles of XELOX chemotherapy will be administered followed by surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 18-75 years old
- Primary and pathological diagnosis of rectal adenocarcinoma
- Radiographic evaluation of initial resectable rectal cancer
- T staging was determined by MRI as T3N+ or T4Nx
- Distal border of the tumor must be located < 12 cm from the anal verge
Key exclusion criteria (19 listed)
- Previous treatment with oxaliplatin, irinotecan or fluorouracil
- Hypersensitivity to fluorouracil, oxaliplatin or irinotecan.
- Clear indication of involvement of the pelvic side walls by imaging
- With distant metastasis
- A history of malignant rectal cancer (i. e. sarcoma, lymphoma, carcinoid, squamous cell carcinoma) or synchronous colon cancer
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 |
|---|---|---|
| FOLFOXIRIAlso: Irinotecan, Oxaliplatin, 5-FluorouracilIRINOTECAN 150 mg/m^2 IV over 1-h, day 1 + OXALIPLATIN 85 mg/m^2 IV over 2-h, day 1 + L-LEUCOVORIN 200 mg/m^2 IV over 2-h, day 1 + 5-FLUOROURACIL 2800 mg/m^2 IV 48-h continuous infusion, starting on day 1 administered every two weeks for 4 cycles (2 months). | Drug | FOLFOXIRI+short-course radiation+XELOX |
| Short-Course Radiation Therapy(5Gy*5)Patients received a short-course radiation therapy(5Gy*5) after 4 cycles of FOLFOXIRI. | Radiation | FOLFOXIRI+short-course radiation+XELOX |
| XELOXAlso: Capecitabine, OxaliplatinOXALIPLATIN 130 mg/m^2 IV over 2-h, day 1 Capecitabine 1000 mg/m^2 twice daily days 1-14 every 3 weeks for 4 cycles. | Drug | FOLFOXIRI+short-course radiation+XELOX |
Primary outcome
The ratio of tumor downstaging to stage 0 and stage I
Time frame: 2 years
Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I
7 secondary outcomes
Tumor regression grade (TRG)
Time frame: 2 years
Disease free survival
Time frame: 3 years
Overall survival time
Time frame: 3 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 3 years
ctDNA change
Time frame: 3 years
SUVmax changes
Time frame: At the beginning of Cycle 1 and the end of Cycle 4 (each cycle is 14 days)
Quality of life (QLQ C30)
Time frame: Every 2 weeks after the first treatment until 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 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.
Jingdong Zhang principal investigator
China Medical University, China
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 FOLFOXIRI, Short-Course Radiation Therapy(5Gy*5) and XELOX in people with Rectal Neoplasms and Drug Therapy, run by China Medical University, China 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 9 inclusion and 19 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 14 Apr 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 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 Yuanhe Wang, PhD (18900918794, zhangjd0228@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ratio of tumor downstaging to stage 0 and stage I (time frame: 2 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 14 Apr 2021.