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AzTrials

Locally Advanced Rectal CancerPhase 2NCT02167321

Rectal Cancer, Adjuvant Chemotherapy, FOLFOX(5-fluorouracil/Leucovorin/Oxaliplatin), Total Mesorectal Excision

A Phase 2 study testing Arm A : standard neoadjuvant chemoradiotherapy group and Arm B : adjuvant FOLFOX group in people with Locally Advanced Rectal Cancer, run by Yonsei University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The introduction of total mesorectal excision (TME) and the progress of neoadjuvant chemoradiotherapy has significantly reduced the risk of local recurrence in locally advanced rectal cancer. Read more about this study

Who is it for?
Ages 19 to 80 years
Conditions the study is for
Locally Advanced Rectal Cancer
What is being tested?
Arm A : standard neoadjuvant chemoradiotherapy group and Arm B : adjuvant FOLFOX group
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteSouth Korea
Study dates
Dec 2014to Aug 2021
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 19 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed adenocarcinoma of the rectum below 10 cm from the anal verge
  • Locally advanced rectal cancer (T3N0 or T1-3N+)
  • Age: 19-80 years old.
  • Without evidence of distant metastasis including paraortic lymph node, common \& external iliac lymph node metastasis
  • MRI scan confirmed more than 2 mm circumferential margin
  • ECOG(Eastern Cooperative Oncology Group) performance status 0-2
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  • preoperative ASA class I-III
  • No prior systemic treatment for rectal cancer (i.e. chemotherapy or immunotherapy)
  • No history of regional radiation treatment in the pelvic cavity
  • Adequate hematologic function: ANC(absolute neutrophil count) ≥ 1.5×109/L，Platelet ≥ 100×109/L, Adequate renal function: Cr ≤ 1.5×ULN or Glomerular filtration rate (Ccr calculated by Cockcroft formula) ≥ 50 ml/min, Adequate hepatic function: ALT(Alanine aminotransferase)/AST(aspartate aminotransferase) ≤ 2.5×ULN, Total bilirubin ≤ 1.5×ULN
  • Patients must be willing and able to comply with the protocol duration of the study
  • Signed informed consent

Who cannot join

  • Malignancy of the rectum other than adenocarcinoma or adenocarcinoma developed from inflammatory bowel disease
  • Suspicious distant metastasis
  • Patients with peripheral neuropathy ≥ NCI CTC(common terminology criteria) grade 1
  • Uncontrolled and significant cardiovascular disease (i.e. NYHA(New York Heart Association) class III or IV heart failure, myocardial infarction within the past 6 months, uncontrolled angina pectoris)
  • Uncontrolled active infection or serious concomitant systemic disorders incompatible with the study
  • Other co-existing malignancy or malignancy within the past 5 years, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin
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  • Patients requiring immunosuppressive treatment who received organ transplantation
  • Uncontrolled epilepsy and psychiatric disease
  • Pregnant or lactating patient
  • Females with a positive or no pregnancy test unless childbearing potential can be otherwise excluded (amenorrheic for at least 2 years,hysterectomy or oophorectomy)
  • Patients receiving a concomitant treatment with drugs interacting with 5-Fluorouracil or oxaliplatin such as flucytosine, phenytoin, or warfarin
  • Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-Fluorouracil or known dihydropyrimidine dehydrogenase (DPD) deficiency.
  • Known hypersensitivity to platinum-based drugs, leucovorin or capecitabine
  • Patients taking sorivudine or brivudine
  • Patients taking tegafur, gimeracil, oteracil potassium complex or stopped the medication within 7days before.
  • Patients who have hereditary disease like as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, etc.
  • Participant in any clinical trial within 4 weeks before initiation of the study
  • Treatment with bevacizumab, cetuximab, oxaliplatin or irinotecan before screening

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Severance Hospital

    Seoul

Other trials in South Korea

About this study

Official title: Adjuvant Chemotherapy With FOLFOX After Total Mesorectal Excision for Locally Advanced Rectal Cancer; an Open-label, Multicenter, Prospective, Randomized Phase 3 Trial

The introduction of total mesorectal excision (TME) and the progress of neoadjuvant chemoradiotherapy has significantly reduced the risk of local recurrence in locally advanced rectal cancer. However, systemic recurrence rate is not being improved and that is considered as the cause of unsatisfactory overall survival of patients with rectal cancer. Relatively higher systemic relapse rate than local recurrence rate is probably due to the insufficient control of systemic micrometastasis during adjuvant chemotherapy. The efficacy of adjuvant combination cytotoxic chemotherapy after surgery in treatment of rectal cancer remains controversial. In addition, preoperative radiotherapy increases surgical complication such as anastomosis site leakage and radiotherapy itself worsen sexual and urinary function and bowel habit which result in aggravation of the quality of life. Furthermore the preoperative chemoradiotherapy upto 3 months not only extends treatment period but increases cost of care. To reduce the possibility of overtreatment, it is needed to confirm that the preoperative chemoradiotherapy is absolutely necessary to locally advanced rectal cancer patients with safe circumferential margin (CRM) resected curatively by standardized TME operation.

In this study, investigators aim to evaluate the efficacy of adjuvant FOLFOX chemotherapy after TME without preoperative chemoradiotherapy in patients with locally advanced rectal cancer having spared CRM are not inferior to that of current standard treatment.

Being tested
Arm A : standard neoadjuvant chemoradiotherapy group, Arm B : adjuvant FOLFOX group

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arm A : standard neoadjuvant chemoradiotherapy groupDrug

    Also called fluoropyrimidine based CCRT -> TME -> adjuvant chemotherapy

    radiation : 45Gy±5.4Gy/28Fx/5.5weeks concurrent chemoradiotherapy : 5-FU (400 mg/m2, IV bolus on D1-3, D29-31), leucovorin (20 mg/m2, IV bolus on D1-3, D29-31), preoperative capecitabine : 825 mg/m² p.o. twice daily during XRT, postoperative FL : 5-FU (400 mg/m2, IV bolus)+leucovorin (20m g/m2, IV bolus) on days 1-5 of each 28 day postoperative capecitabine : 1250 mg/m² p.o. twice daily on days 1-14 of each 21 day cycle FOLFOX : oxaliplatin 85 mg/m2, IV over 2 hours on day 1 of each 14 day cycle, leucovorin 200 mg/m2, IV over 2 hours on day 1 of each 14 day cycle, 5-FU 400 mg/m2, IV bolus on day 1 followed by 1200mg/m2 IV over 24 hours on days 1 and 2 of each 14 day cycle

  • Arm B : adjuvant FOLFOX groupDrug

    Also called Total mesorectal excision (TME) -> 12 cycles of FOLFOX every 2 weeks, or Total mesorectal excision (TME) -> CCRT + 12 cycles of FOLFOX every 2 weeks

    FOLFOX : oxaliplatin (85 mg/m2, IV over 2 hours on day 1 of each 14 day cycle), leucovorin (200 mg/m2, IV over 2 hours on day 1 of each 14 day cycle), 5-FU (400 mg/m2, IV bolus on day 1 followed by 1200mg/m2 IV over 24 hours on days 1 and 2 of each 14 day cycle) postoperative irradiation(if needed) : 54Gy/30Fx/6weeks

Study groups in NCT02167321
Study groupRoleWhat they receive
Arm AActive comparatorArm A; standard neoadjuvant chemoradiotherapy group fluoropyrimidine based concurrent chemoradiotherapy-> TME -> adjuvant chemotherapy (Low risk: fluoropyrimidine-based chemotherapy, High risk: FOLFOX)
Receives: Drug: Arm A : standard neoadjuvant chemoradiotherapy group
Arm BExperimentalArm B : adjuvant FOLFOX group Total mesorectal excision (TME) --> 12 cycles of FOLFOX every 2 weeks (or Total mesorectal excision (TME) --> Concurrent chemoradiotherapy + 12 cycles of FOLFOX every 2 weeks)
Receives: Drug: Arm B : adjuvant FOLFOX group

What is being measured

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

  1. Disease free survival (DFS)

    Measured: 3 years

Secondary outcomes (6)

  1. Disease free survival (DFS)

    Measured: 5 years

  2. Overall survival (OS)

    Measured: 3 years and 5 years

  3. Local recurrence rate

    Measured: 3 years and 5 years

  4. Systemic recurrence rate

    Measured: 3 years and 5 years

  5. Total score for function of urination (IPSS) and defecation (Wexner's score)

    Measured: 1 month and 6 months after surgery

  6. Evaluation for rate of various events after surgery

    Measured: 14 days after surgery

Timeline

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

  1. First posted19 Jun 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionMay 2019
  4. Study completionAug 2021 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02167321
Sponsor's protocol ID
4-2014-0239
Status last verified
Apr 2021
First submitted
11 Jun 2014
Last updated
22 Apr 2021
Results posted
No
Data monitoring committee
No

Publications

  • Lee JB, Kim HS, Jung I, Shin SJ, Beom SH, Chang JS, Koom WS, Kim TI, Hur H, Min BS, Kim NK, Park S, Jeong SY, Baek JH, Kim SH, Lim JS, Lee KY, Ahn JB. Upfront radical surgery with total mesorectal excision followed by adjuvant FOLFOX chemotherapy for locally advanced rectal cancer (TME-FOLFOX): an open-label, multicenter, phase II randomized controlled trial. Trials. 2020 Apr 7;21(1):320. doi: 10.1186/s13063-020-04266-6.

    PubMed 32264919

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Arm A : standard neoadjuvant chemoradiotherapy group and Arm B : adjuvant FOLFOX group in people with Locally Advanced Rectal Cancer, run by Yonsei University at 1 site in South Korea.

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 12 inclusion and 18 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 22 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 South Korea. 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?

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?

Disease free survival (DFS) (time frame: 3 years). 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 NCT02167321, 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 22 Apr 2021.

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