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Length of StayPhase 3NCT01080547

Study Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer

A Phase 3 study testing Laparoscopic Surgery for Colorectal Cancer, XELOX Chemotherapy and mFolfox6 chemotherapy in people with Length of Stay and Complications, run by Zhejiang University at 2 sites 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

A new notion"Fast Track Multi-Discipline Treatment" for colorectal cancer is thought with several benefits such as shorter hospitalization stay and less costs. This randomized study aims to compare the differences between conventional and Fast Track Multi-Discipline Treatment for colorectal cancer in hospitalization… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Length of Stay, Complications, Adverse Drug Event
What is being tested?
Laparoscopic Surgery for Colorectal Cancer, XELOX Chemotherapy and mFolfox6 chemotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
374 participants
Where
2 sitesChina
Study dates
Mar 2010to Dec 2014
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with pathologically confirmed colorectal cancer
  • Signed consent

Who cannot join

  • Tumor can be resected by endoscopic mucosal resection(EMR)
  • History of malignancy
  • Bowel obstruction or intestinal perforation
  • Evidence of metastasis by physical examination, chest roentgenogram and computed tomography of liver and pelvis
  • Acute diseases and acute attack of chronic diseases
  • Psychiatric history
Show all 11Show fewer
  • Deformity of spine
  • ASA score≥Ⅳ
  • Mid-low rectal cancer
  • Pregnant woman
  • Needing to use Chinese traditional patent drug

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Second Affiliated Hospital Zhejiang University College of Medicine

    Hangzhou, Zhejiang, 310999

  • People's Hospital of Shaoxing

    Shaoxing, Zhejiang, 312000

Other trials in China

About this study

Official title: Randomized Controlled Trial Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer

A new notion"Fast Track Multi-Discipline Treatment" for colorectal cancer is thought with several benefits such as shorter hospitalization stay and less costs. This randomized study aims to compare the differences between conventional and Fast Track Multi-Discipline Treatment for colorectal cancer in hospitalization day, complications, costs and quality of life.

Read the detailed description

Laparoscopic Surgery, Fast Track Treatment and XELOX Chemotherapy have been introduced in the treatment of colorectal cancer. All of these procedures are contributed to reduce the hospitalization stay. However, the most economical mode for combination of these procedures is still unclear. This is a randomized controlled study, a new notion"Fast Track Multi-Discipline Treatment" is proposed, which is the combination of the Laparoscopic Surgery, Fast track perioperative treatment during perioperative period and XELOX Chemotherapy. The purpose of this study is to compare the Fast Track Multi-Discipline Treatment with the conventional treatment(Open Surgery with conventional treatment during perioperative period and mFolfox6 chemotherapy) for colorectal cancer on several aspects like the average hospitalization day, complications, costs and quality of life.The focus of the study will be to investigate whether the Fast Track Multi-Discipline Treatment reduces hospital stay with similar complications compared with conventional perioperative treatment. Moreover, the trial will clarify whether laparoscopic surgery is essential for Fast Track Multi-Discipline Treatment.

Being tested
Laparoscopic Surgery for Colorectal Cancer, XELOX Chemotherapy, mFolfox6 chemotherapy, Fast Track Perioperative Treatment, Conventional Perioperative Treatment
Medical subject headings
Drug-Related Side Effects and Adverse Reactions

What participants receive

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

  • Laparoscopic Surgery for Colorectal CancerProcedure or surgery

    Also called STORZ laparoscope

    Laparoscopic surgery for colorectal cancer using STORZ laparoscope

  • XELOX ChemotherapyDrug

    Also called Capecitabine, Oxaliplatin

    XELOX chemotherapy

  • mFolfox6 chemotherapyDrug

    Also called Oxaliplatin

    Conventional (mFolfox6) chemotherapy

  • Fast Track Perioperative TreatmentOther

    Also called Fast track surgery

    Fast track treatment during perioperation period

  • Conventional Perioperative TreatmentOther

    Also called Traditional Perioperative Treatment

    Conventional treatment during perioperation period

  • Open Surgery for Colorectal CancerProcedure or surgery

    Also called Traditional open surgery

    Open surgery for colorectal cancer using conventional methods

Study groups in NCT01080547
Study groupRoleWhat they receive
Conventional Treatment （Laparoscopic）Active comparatorRandomized group of patients receiving laparoscopic colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
Receives: Procedure: Laparoscopic Surgery for Colorectal Cancer; Drug: mFolfox6 chemotherapy; Other: Conventional Perioperative Treatment
FTMD Treatment （Laparoscopic）Active comparatorRandomized group of patients receiving laparoscopic colectomy with Fast Track Multi-Displine（FTMD）treatment and XELOX chemotherapy.
Receives: Procedure: Laparoscopic Surgery for Colorectal Cancer; Drug: XELOX Chemotherapy; Other: Fast Track Perioperative Treatment
Conventional Treatment（Open Surgery）Active comparatorRandomized group of patients receiving open colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
Receives: Drug: mFolfox6 chemotherapy; Other: Conventional Perioperative Treatment; Procedure: Open Surgery for Colorectal Cancer
FTMD Treatment（Open Surgery）Active comparatorRandomized group of patients receiving open colectomy with Fast Track Multi-Displine（FTMD） treatment and XELOX chemotherapy.
Receives: Drug: XELOX Chemotherapy; Other: Fast Track Perioperative Treatment; Procedure: Open Surgery for Colorectal Cancer

What is being measured

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

  1. hospitalization day

    The overall hospitalization stay during treatment from the first day in hospital to leave hospital when finish adjuvant chemotherapy or surgery (for patients who don't need chemotherapy).

    Measured: 6-month post surgery

Secondary outcomes (4)

  1. surgical complications

    Surgical complications include injury of ureter, intraoperative transfusion, infection of incision and anastomotic leakage etc.

    Measured: 3-month post surgery

  2. chemotherapy related adverse event

    Chemotherapy related adverse event, according to NCI CTCAE Version 3.0, include nausea, vomit, diarrhea and neutropenia etc.

    Measured: 6-month post surgery

  3. quality of life

    Quality of life will be measured by EORTC QLQ-C30 and QLQ-CR38 questionaire.

    Measured: preoperation, 3-month post surgery and 6-month post surgery

  4. hospitalization costs

    The overall hospitalization costs from the first day in hospital to day that adjuvant chemotherapy finished.

    Measured: 6-month post surgery

Timeline

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

  1. First posted4 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionApr 2014
  4. Study completionDec 2014

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
374 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01080547
Sponsor's protocol ID
2009C13017
Status last verified
Dec 2016
First submitted
1 Mar 2010
Last updated
6 Apr 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Li J, Kong XX, Zhou JJ, Song YM, Huang XF, Li GH, Ying XJ, Dai XY, Lu M, Jiang K, Fu DL, Li XL, He JJ, Wang JW, Sun LF, Xu D, Xu JY, Chen M, Tian Y, Li JS, Yan M, Yuan Y, Ding KF. Fast-track multidisciplinary treatment versus conventional treatment for colorectal cancer: a multicenter, open-label randomized controlled study. BMC Cancer. 2019 Oct 23;19(1):988. doi: 10.1186/s12885-019-6188-x.

    PubMed 31647032

  • Xu D, Li J, Song Y, Zhou J, Sun F, Wang J, Duan Y, Hu Y, Liu Y, Wang X, Sun L, Wu L, Ding K. Laparoscopic surgery contributes more to nutritional and immunologic recovery than fast-track care in colorectal cancer. World J Surg Oncol. 2015 Feb 4;13:18. doi: 10.1186/s12957-015-0445-5.

    PubMed 25649903

  • Zhou JJ, Li J, Ying XJ, Song YM, Chen R, Chen G, Yan M, Ding KF. Fast track multi-discipline treatment (FTMDT trial) versus conventional treatment in colorectal cancer--the design of a prospective randomized controlled study. BMC Cancer. 2011 Nov 24;11:494. doi: 10.1186/1471-2407-11-494.

    PubMed 22111914

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Laparoscopic Surgery for Colorectal Cancer, XELOX Chemotherapy and mFolfox6 chemotherapy in people with Length of Stay and Complications, run by Zhejiang University at 2 sites 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 2 inclusion and 11 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 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

hospitalization day (time frame: 6-month post surgery). 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 NCT01080547, which also lists 3 linked publications.

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 6 Apr 2017.

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