Colonic NeoplasmsPhase 2/3NCT02777437
Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer
A Phase 2/3 study testing XELOX or FOLFOX chemotherapy in people with Colonic Neoplasms, run by Fudan University.
Trial summary
Primary Outcome Measures: Disease free survival Secondary Outcome Measures: Overall survival Adverse events (Mortality, morbidity) The proportion of completion of Laparoscopic Surgery Estimated Enrollment: Oct, 2016 Study Start Date: Oct, 2016 Estimated Study Completion Date: Oct, 2019 Estimated Primary Completion… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- XELOX or FOLFOX chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,960 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Oct 2021
- Phase
- Phase 2/3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent
- Histologically confirmed diagnosis of colon carcinoma
- CT or MRI verified as T4 colon cancer without involvement of other organs.
- Without multiple lesions other than carcinoma in situ
- Tumor size < 8 cm
- No bowel obstruction
Show all 12Show fewer
- Sufficient organ function
- No history of gastrointestinal surgery
- 18 years of age or older
- Performance Status (ECOG) 0, 1 or 2, life expectancy > 12 weeks
- Operable patients
- Completion of neoadjuvant systemic chemotherapy
Who cannot join
- Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding
- No intention to finish neoadjuvantive systemic therapy
- Unstable or uncompensated respiratory or cardiac disease
- Serious active infections
- Hypersensitivity to capecitabine/fluorouracil or oxaliplatin
- Stomatitis or ulceration in the mouth or gastrointestinal tract
- Severe diarrhea
- Peripheral sensory neuropathy with functional impairment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer: A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group Clinical Trial
Primary Outcome Measures: Disease free survival
Secondary Outcome Measures:
Overall survival
Adverse events (Mortality, morbidity)
The proportion of completion of Laparoscopic Surgery
Estimated Enrollment: Oct, 2016
Study Start Date: Oct, 2016
Estimated Study Completion Date: Oct, 2019
Estimated Primary Completion Date: Oct, 2021
Groups/Cohorts
- Laparoscopic surgery for T4 colon cancers
- Neoadjuvantive chemotherapy + Laparoscopic surgery for T4 colon cancers
Read the detailed description
Investigators' previous studies indicated that laparoscopic surgery is feasible in T4 colon cancers with comparable clinical and oncologic outcomes. Laparoscopy may be considered as an alternative approach for T4 colon cancers with the advantage of faster recovery. The survival outcome of T4 colon cancers still dismays clinicians and patients. Preoperative chemotherapy is an attractive concept for locally advanced colon cancer. Optimal systemic therapy at the earliest possible opportunity may be more effective at eradicating distant metastases than the same treatment given after the delay and immunological stress of surgery. Besides, the shrinkage of primary tumor before surgery may reduce the risk of incomplete surgical excision and the risk of shedding of tumor cells during surgery. The aim of the present study is to compare the short-and long-term survival outcomes between laparoscopic surgery alone and laparoscopic surgery with 4 cycles of neoadjuvant chemotherapy for T4 colon cancer as well as the mortality and the morbidity.
The number of patients, which needs to get power of 80%, is 1960. The average numbers of patients needs to reach approximately 200, and that of surgical centers needs to reach 10.
Arrangements in the preoperative, intraoperative and postoperative period will be in complete accordance with the usual care of the center.
The baseline demographics and conditions as well as the perioperative items and the postoperative occurrences will be recorded through a prior designed e-questionnaire.
Globally,the disease free survival rate (chemotherapy and surgery), mortality (chemotherapy and surgery), the morbidity (chemotherapy and surgery) and the proportion of completion of laparoscopic surgery of the two surgical strategies will be analized and compared.
- Conditions
- Colonic Neoplasms
- Being tested
- XELOX or FOLFOX chemotherapy
- Keywords
- Colonic Neoplasms, Laparoscopic Surgery, Neoadjuvant chemotherapy, T4
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XELOX or FOLFOX chemotherapyDrug
Also called Xeloda+ OXA or OXA+ 5-FU
4 cycles of XELOX or FOLFOX neoadjuvant chemotherapy before surgery
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic surgery | No intervention | Patients with T4 colon cancer receive laparoscopic surgery only. |
| Neoadjuvantive chemotherapy + Laparoscopic surgery | Experimental | Patients with T4 colon cancer receive neoadjuvantive chemotherapy and laparoscopic surgery. Receives: Drug: XELOX or FOLFOX chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
calculated from the date of surgery to the date of recurrence
Measured: 3-year
Secondary outcomes (3)
Overall survival
calculated from the date of diagnosis to the date of death from any cause
Measured: 3-year
Adverse events (mortality and morbidity)
Number of participants with treatment-related adverse events assessed by CTCAE v4.0
Measured: 3-month
The proportion of completion of laparoscopic surgery
The number of completion of laparoscopic surgery/the number of participants
Measured: 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2019 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,960 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine, Zhejiang University, Tongji University
- Responsible party
- Principal investigator, LI XIN-XIANG, Fudan University
- Investigators
- Xinxiang Li, MD,PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777437
- Sponsor's protocol ID
- FuDanLapT4
- Status last verified
- May 2016
- First submitted
- 2 May 2016
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer: A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group Clinical Trial
- ClinicalTrials.gov ID
- NCT02777437
- Acronym / sponsor ID
- FuDanLapT4
- Conditions
- Colonic Neoplasms
- Keywords
- Colonic Neoplasms, Laparoscopic Surgery, Neoadjuvant chemotherapy, T4
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,960 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine, Zhejiang University, Tongji University
- Study start
- Oct 2016
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 19 May 2016 (estimated)
- 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.
Primary Outcome Measures: Disease free survival
Secondary Outcome Measures:
Overall survival
Adverse events (Mortality, morbidity)
The proportion of completion of Laparoscopic Surgery
Estimated Enrollment: Oct, 2016
Study Start Date: Oct, 2016
Estimated Study Completion Date: Oct, 2019
Estimated Primary Completion Date: Oct, 2021
Groups/Cohorts
- Laparoscopic surgery for T4 colon cancers
- Neoadjuvantive chemotherapy + Laparoscopic surgery for T4 colon cancers
Detailed description
Investigators' previous studies indicated that laparoscopic surgery is feasible in T4 colon cancers with comparable clinical and oncologic outcomes. Laparoscopy may be considered as an alternative approach for T4 colon cancers with the advantage of faster recovery. The survival outcome of T4 colon cancers still dismays clinicians and patients. Preoperative chemotherapy is an attractive concept for locally advanced colon cancer. Optimal systemic therapy at the earliest possible opportunity may be more effective at eradicating distant metastases than the same treatment given after the delay and immunological stress of surgery. Besides, the shrinkage of primary tumor before surgery may reduce the risk of incomplete surgical excision and the risk of shedding of tumor cells during surgery. The aim of the present study is to compare the short-and long-term survival outcomes between laparoscopic surgery alone and laparoscopic surgery with 4 cycles of neoadjuvant chemotherapy for T4 colon cancer as well as the mortality and the morbidity.
The number of patients, which needs to get power of 80%, is 1960. The average numbers of patients needs to reach approximately 200, and that of surgical centers needs to reach 10.
Arrangements in the preoperative, intraoperative and postoperative period will be in complete accordance with the usual care of the center.
The baseline demographics and conditions as well as the perioperative items and the postoperative occurrences will be recorded through a prior designed e-questionnaire.
Globally,the disease free survival rate (chemotherapy and surgery), mortality (chemotherapy and surgery), the morbidity (chemotherapy and surgery) and the proportion of completion of laparoscopic surgery of the two surgical strategies will be analized and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic surgery | No intervention | –Patients with T4 colon cancer receive laparoscopic surgery only. |
| Neoadjuvantive chemotherapy + Laparoscopic surgery | Experimental | Drug: XELOX or FOLFOX chemotherapyPatients with T4 colon cancer receive neoadjuvantive chemotherapy and laparoscopic surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Able to provide written informed consent
- Histologically confirmed diagnosis of colon carcinoma
- CT or MRI verified as T4 colon cancer without involvement of other organs.
- Without multiple lesions other than carcinoma in situ
- Tumor size < 8 cm
Key exclusion criteria (8 listed)
- Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding
- No intention to finish neoadjuvantive systemic therapy
- Unstable or uncompensated respiratory or cardiac disease
- Serious active infections
- Hypersensitivity to capecitabine/fluorouracil or oxaliplatin
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 |
|---|---|---|
| XELOX or FOLFOX chemotherapyAlso: Xeloda+ OXA or OXA+ 5-FU4 cycles of XELOX or FOLFOX neoadjuvant chemotherapy before surgery | Drug | Neoadjuvantive chemotherapy + Laparoscopic surgery |
Primary outcome
Disease free survival
Time frame: 3-year
calculated from the date of surgery to the date of recurrence
3 secondary outcomes
Overall survival
Time frame: 3-year
Adverse events (mortality and morbidity)
Time frame: 3-month
The proportion of completion of laparoscopic surgery
Time frame: 1-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
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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.
Xinxiang Li, MD,PhD principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing XELOX or FOLFOX chemotherapy in people with Colonic Neoplasms, run by Fudan University.
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 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 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiong Wu, MD,PhD (0086-21-34610367, 18918298120@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: 3-year). 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 19 May 2016.