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Rectal NeoplasmsPhase 2PREPARENCT01952951

Preoperative Chemoradiation Followed by Chemotherapy for Locally Advanced Rectal Cancer

A Phase 2 study testing Capecitabine Oxaliplatin and pelvic radiation capecitabine 5-fluorouracil in people with Rectal Neoplasms and Adenocarcinoma, run by National Cancer Center, Korea at 7 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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 current standard treatment of locally advanced rectal cancer (clinical stage II or III) is preoperative radiation with chemotherapy (CRT) followed by surgery. But this approach can be suboptimal for patients with high risk features (more deeply-seated tumor or many regional lymph nodes involved)that are associated… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Rectal Neoplasms, Adenocarcinoma
What is being tested?
Capecitabine Oxaliplatin and pelvic radiation capecitabine 5-fluorouracil
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
7 sitesSouth Korea
Study dates
Jun 2014to Dec 2019
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • histologically confirmed adenocarcinoma of the rectum
  • distal margin of tumor located from 0 to 12 cm from anal verge measured by digital rectal examination
  • high risk clinical stage II or III in MRI (satisfying at least one of the followings)
  • circumferential resection margin < 1 mm involved
  • low-lying tumor below anal verge 3 cm
  • T3 > 5 mm extramural spread
Show all 15Show fewer
  • T4 (involving surrounding structures or peritoneum)
  • cN2 (4 or more mixed signal intensity or irregularly bordered node or tumor deposit)
  • age 20 years or more
  • ECOG (Eastern Cooperative Oncology Group) performance status 0-2
  • No prior chemotherapy, radiotherapy to pelvis
  • Adequate bone marrow function
  • Adequate renal function
  • Adequate hepatic function
  • patients must sign the informed consent indicating that they were aware of the investigational nature of the study in keeping with the policy of the hospital

Who cannot join

  • malignant disease of the rectum other than adenocarcinoma or arisen from chronic inflammatory bowel disease
  • any unresected synchronous colon cancer
  • any distant metastases
  • intestinal obstruction or impending obstruction, but decompressing colostomy is permitted
  • any previous or concurrent malignancy withih 5 years other than non-melanoma skin cancer / in situ cancer of uterine cervix / early gastric cancer / thyroid cancer of low risk
  • any other morbidity or situation with relative contraindication for chemoradiotherapy
  • patients with history of significant gastric or small bowel resection, or malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may compromise the absorption of capecitabine
  • pregnant or lactating women or patients of childbearing potential not predicting adequate contraception

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

South Korea7 sites

  • Hallym University Sacred Heart Hospital

    Anyang

  • Gangneung Asan Hospital

    Gangneung

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 410-769

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Chung-Ang University Hospital

    Seoul, 06973

Other trials in South Korea

About this study

Official title: A Randomized Phase II Trial of Preoperative Chemoradiation (Preop CRT) Followed by CapOx (Capecitabine Plus Oxaliplatin) Versus Preop CRT Alone for Locally Advanced Rectal Cancer (LARC)

The current standard treatment of locally advanced rectal cancer (clinical stage II or III) is preoperative radiation with chemotherapy (CRT) followed by surgery. But this approach can be suboptimal for patients with high risk features (more deeply-seated tumor or many regional lymph nodes involved)that are associated with recurrence. This study test a hypothesis that CRT followed by chemotherapy before surgery can improve efficacy of preoperative treatment.

Read the detailed description

Downstaging rate with CRT using fluoropyrimidine monotherapy is usually 30-40%.In MRI-defined high-risk patients, downstaging rate with conventional fluoropyrimidine-based monotherapy with radiation has not been shown. We assume that the downstaging rate of chemoradiation arm (control arm) would be 30%, and that addition of CapOx after CRT (experimental arm) may increase downstaging rate 30% to 50%. A sample size of 52 patients per group is needed have 85% power to detect downstaging rate = 50% as compared to 30% with type I error rate of 15%. We will perform one interim futility analysis when half of the patients are recruited and evaluated for the primary endpoint. O'Brien-Fleming boundary will be considered. Therefore, when 26 patients per arm are evaluated, the interim futility analysis will be performed, and when the Z score at the interim is less than -0.09192 (one-sided p-value greater than 0.5366192), the study will be stopped for futility. Considering 5% follow-up loss, a sample size of 55 per arm (a total of 110 patients) will be studied.

Being tested
Capecitabine Oxaliplatin, pelvic radiation capecitabine 5-fluorouracil
Keywords
rectal neoplasms, radiotherapy, Antineoplastic Agents
Medical subject headings
Rectal Neoplasms, Adenocarcinoma

What participants receive

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

  • Capecitabine OxaliplatinDrug

    Also called Xeloda, Oxalitin

    after completion of chemoradiation, two cycles of capecitabine (850mg/m2 twice daily from D1 evening to D15 morning) and oxaliplatin (100mg/m2 on D1) will be administered every 3 weeks.

  • pelvic radiation capecitabine 5-fluorouracilRadiation

    Also called preoperative chemoradiation, xeloda

    50.4Gy of pelvic radiation with capecitabine or 5-fluorouracil

Study groups in NCT01952951
Study groupRoleWhat they receive
chemoradiation followed by CapOxExperimentalpreoperative chemoradiation 50.4Gy with capecitabine or 5-fluorouracil/leucovorin (pelvic radiation capecitabine 5-fluorouracil) followed by 2 cycles of chemotherapy (Capecitabine Oxaliplatin - CapOx) and surgery (total mesorectal excision)
Receives: Drug: Capecitabine Oxaliplatin; Radiation: pelvic radiation capecitabine 5-fluorouracil
chemoradiationActive comparatorpreoperative chemoradiation 50.4Gy with capecitabine or 5-fluorouracil/leucovorin (pelvic radiation capecitabine 5-fluorouracil) followed by rest for 8 weeks and surgery (total mesorectal excision)
Receives: Radiation: pelvic radiation capecitabine 5-fluorouracil

What is being measured

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

  1. downstaging rate

    downstaging rate is defined as the proportion of patients with ypStage (pathologic stage after preoperative treatment) 0 or I (from pathologic findings after preoperative treatment and surgery) out of all patients who were assigned to each arm.

    Measured: expected average of 15 weeks after start of study treatment

Secondary outcomes (9)

  1. pathologic response

    pathologic response is assessed by Dworak's grading system from postoperative specimen.

    Measured: expected average of 15 weeks after start of study treatment

  2. radiologic response rate

    radiologic response will be assessed according to RECIST (Response Evaluation Criteria in Solid Tumors) guideline 1.1

    Measured: expected average of 14 weeks after start of study treatment

  3. toxicity profile

    Toxicities or any adverse events during study treatment, surgery and follow-up period will be assessed according to NCI CTCAE (Common Terminology Criteria for Adverse Events) version 4.0

    Measured: expected average of 35 weeks after start of study treatment

  4. pattern of failure

    if any recurrent lesion is noticed, anatomic sites of recurrent lesions and the date and the name of exam or imaging study (physical exam, CT or MRI…) will be recorded in case report form.

    Measured: 3 years after surgery

  5. local control rate

    Local recurrence is defined as tumor recurrence confined in radiation field (pelvic cavity). Cumulative incidence of local recurrence will be suggested.

    Measured: 3 years after surgery

  6. relapse-free survival

    Time from date of operation to date of recurrence of disease or deaths due to recurrence or progression of disease.

    Measured: 3 years after surgery

  7. Disease-free survival

    time from date of operation to date of recurrence of disease, a new occurrence of secondary colorectal cancer, a new occurrence of other malignancy, or deaths from any cause.

    Measured: 3 years after surgery

  8. overall survival

    time from date of operation to date of death due to any cause.

    Measured: 3 years after surgery

  9. quality of life

    quality of life will be measured with FACT-C

    Measured: before study treatment, 7 weeks after completion of chemoradiation, and at 4 weeks 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 posted30 Sep 2013 (estimated)
  2. Study startJun 2014
  3. Primary completionSep 2017
  4. Study completionDec 2019 (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
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01952951
Sponsor's protocol ID
KCSG CO14-03
Acronym
PREPARE
Status last verified
Sep 2017
First submitted
11 Sep 2013
Last updated
13 Sep 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Kim SY, Joo J, Kim TW, Hong YS, Kim JE, Hwang IG, Kim BG, Lee KW, Kim JW, Oh HS, Ahn JB, Zang DY, Kim DY, Oh JH, Baek JY. A Randomized Phase 2 Trial of Consolidation Chemotherapy After Preoperative Chemoradiation Therapy Versus Chemoradiation Therapy Alone for Locally Advanced Rectal Cancer: KCSG CO 14-03. Int J Radiat Oncol Biol Phys. 2018 Jul 15;101(4):889-899. doi: 10.1016/j.ijrobp.2018.04.013. Epub 2018 Apr 12.

    PubMed 29976501

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine Oxaliplatin and pelvic radiation capecitabine 5-fluorouracil in people with Rectal Neoplasms and Adenocarcinoma, run by National Cancer Center, Korea at 7 sites 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 15 inclusion and 8 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 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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?

downstaging rate (time frame: expected average of 15 weeks after start of study treatment). 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 NCT01952951, 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 13 Sep 2017.

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