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Rectal CancerPhase 2FORTUNENCT02217020

Neoadjuvant FOLFOXIRI Chemotherapy Alone for Locally Advanced Rectal Cancer

A Phase 2 study testing FOLFOXIRI in people with Rectal Cancer, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The standard treatment for stage 2/3 rectal cancer is neoadjuvant 5-Fu based chemoradiation. However, preoperative radiation cause kinds of adverse events, some were irreversible. And the survival benefit was not obvious. Whether chemotherapy alone is effective enough in treating rectal cancer is not yet known. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Rectal Cancer
What is being tested?
FOLFOXIRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
15 Aug 2014to 15 Aug 2017
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of adenocarcinoma of the rectum
  • Age: 18-70 years old
  • Signed informed consent; able to comply with study and/or follow- up procedures
  • Stage of the primary tumor may be determined by ultrasound or MRI
  • Stage II (T3-4, N0 [N0 is defined as all imaged lymph nodes < 1.0 cm]) OR stage III (T1-4, N1-2 [with the definition of a clinically positive lymph node being any node ≥ 1.0 cm]
  • Tumor palpable by digital rectal exam OR accessible by proctoscope or sigmoidoscope
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  • Distal border of the tumor must be located < 12 cm from the anal verge
  • Tumor amenable to curative resection
  • Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
  • Leukocytes ≥ 3.0 x109/ L, absolute neutrophil count (ANC) ≥ 1.5 x109/ L, platelet count ≥ 100 x109/ L, hemoglobin (Hb) ≥ 9g/ dL.
  • Total bilirubin ≤1.5 x the upper limit of normal (ULN).
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.
  • Alkaline phosphatase limit ≤ 5x ULN.
  • Amylase and lipase ≤ 1.5 x the ULN.
  • Serum creatinine ≤ 1.5 x the ULN.
  • Calculated creatinine clearance or 24 hour creatinine clearance ≥ 50 mL/ min.
  • No renal disease that would preclude study treatment or follow-up
  • ECOG status: 0～1

Who cannot join

  • Hypersensitivity to fluorouracil, oxaliplatin or irinotecan.
  • No More than 4 weeks since prior participation in any investigational drug study
  • More than 4 weeks since prior participation in any investigational drug study
  • Clear indication of involvement of the pelvic side walls by imaging
  • With distant metastasis
  • History of invasive rectal malignancy, regardless of disease-free interval
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  • Fertile patients must use effective contraception
  • Uncontrolled hypertension
  • Cardiovascular disease that would preclude study treatment or follow-up
  • Lack of upper gastrointestinal tract integrity or malabsorption syndrome，active upper gastrointestinal tract bleeding
  • Synchronous colon cancer
  • Pregnant or nursing, Fertile patients do not use effective contraception
  • Other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum
  • No psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation
  • patients refused to signed informed consent.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Gastrointestinal Hospital, Sun Yatsen University

    Guangzhou, Guangdong, 510655

Other trials in China

About this study

Official title: A Phase II Study of Neoadjuvant FOLFOXIRI Chemotherapy Alone in Treating Patients With Locally Advanced Rectal Cancer

The standard treatment for stage 2/3 rectal cancer is neoadjuvant 5-Fu based chemoradiation. However, preoperative radiation cause kinds of adverse events, some were irreversible. And the survival benefit was not obvious. Whether chemotherapy alone is effective enough in treating rectal cancer is not yet known. Here, the investigators chose all the three active cytotoxic agents (5-FU, Oxaliplatin, Irinotecan) as the neoadjuvant treatment regimen (FOLFOXIRI). The purpose of the study is to evaluate the efficacy of FOLFOXIRI as neoadjuvant regimen in treating patients with locally advanced rectal cancer.

Read the detailed description

Preoperative chemoradiotherapy could improve the local control of locally advanced rectal cancer, but the role was limited, only 5%. The adverse event cause by radiotherapy was severe. This single phase II trial was aimed to evaluate the efficacy of triplet regimen (FOLFOXIRI) in treating patients with locally advanced rectal cancer. All patients will receive the study regimen every 2 weeks for 4-6 cycles. MRI of the pelvic will be performed after 4 cycles of chemotherapy to assess clinical response. If the tumor response over 20% after 4 cycles of treatment, the patient will go to surgery (TME) directly or 2 more cycles of treatment before surgery under the decision of MDT. On the contrary, if the tumor show poor response (<20%), radiotherapy will be performed before operation. After surgery, 6-8 cycles of mFOLFOX6 will be given as adjuvant chemotherapy.

Conditions
Rectal Cancer
Being tested
FOLFOXIRI
Keywords
Rectal Cancer, Locally advanced rectal cancer, Neoadjuvant, chemotherapy, FOLFOXIRI
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 5-FU, Oxaliplatin, Irinotecan

    irinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle

Study groups in NCT02217020
Study groupRoleWhat they receive
FOLFOXIRIExperimentalpatients received FOLFOXIRI alone for 4 cycles before surgery.
Receives: Drug: FOLFOXIRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 year

Secondary outcomes (4)

  1. Average neoadjuvant rectal cancer score

    neoadjuvant rectal cancer score (NAR) =[5*pN-3*(cT-pT)+12]^2/9.61 had been proposed and proven to be the surrogate endpoint of overall survival. It refered to the predictive value of lymphnode status and primary tumor downstaging on Overall survival of rectal cancer.

    Measured: 2 year

  2. the local Recurrence rate

    the ratio of patients with local recurrence within 3 years

    Measured: 3 year

  3. Recurrence free survival

    3 years recurrence free survival of this group of patients

    Measured: 3 years

  4. Reported Adverse events

    Number of patients with adverse events and severity according to NCI CTC 4.0 after treatment with this regimen.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2014 (estimated)
  2. Study start15 Aug 2014
  3. Primary completion15 Sep 2016
  4. Study completion15 Aug 2017

Resources

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
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02217020
Sponsor's protocol ID
GIHSYSU07
Acronym
FORTUNE
Status last verified
Apr 2021
First submitted
10 Aug 2014
Last updated
14 Apr 2021
Results posted
No
Data monitoring committee
No

Publications

  • Zhang J, Li J, Huang M, Xie X, Cai Y, Hu H, Ling J, Wu Z, Deng Y. Neoadjuvant Modified FOLFOXIRI With Selective Radiotherapy in Locally Advanced Rectal Cancer: Long-term Outcomes of Phase II Study and Propensity-Score-Matched Comparison With Chemoradiotherapy. Dis Colon Rectum. 2023 Jul 1;66(7):934-945. doi: 10.1097/DCR.0000000000002424. Epub 2022 Jul 12.

    PubMed 35834598

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FOLFOXIRI in people with Rectal Cancer, run by 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 18 inclusion and 15 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: finished, 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02217020, which also lists 1 linked publication.

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.

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