Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4LACCNCT04646772

Surgery for Locally Advanced Colon Cancer: is it Worth it? A Multicenter Retrospective Analysis.

An observational study of Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4, run by Santo Spirito Hospital, Italy.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 aim of the present study is to assess the post-operative outcomes (morbidity and mortality) in relation to preoperative data and the oncological outcomes (overall and disease-free survival) in patients with a locally advanced colon cancer (LACC) with the necessity of a multivisceral resection (MVR). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4
What is being tested?: Multivisceral resection
Type of treatment: Surgery or procedure
How many people: 100 participants
Where: No sites listed yet
Study dates: 1 Jan 2021to 30 Jun 2021
Phase: Observational
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

Study population: Patients with a locally advanced colon cancer (LACC) with the necessity of a multivisceral resection (MVR).

Who may be able to join

> 18 aa
Patients with a locally advanced colon cancer (LACC) with the necessity of a multivisceral resection (MVR).

Who cannot join

Stage IV
Rectal cancer
Emergency surgery (<48 hours from admission)
ASA > III

About this study

Official title: Surgery for Locally Advanced Colon Cancer: is it Worth it? A Multicenter Retrospective Analysis. (LACC Trial)

Read the detailed description

All patients that meet the inclusion criteria will be registered in a retrospective database from 2014 to 2019 (5 years) Data will be reported for every patients with colon cancer to have had either a resection of another organ or structure in addition to resection of the primary tumor, or to have had a T4 (a or b) tumour on postoperative histopathology.

Data included are patient demographics, ASA score, tumor localization, preoperative imaging, neoadjuvant treatments, type of bowel resection and adjacent organs resected, tecnique (laparoscopic/laparotomic), postoperative complications and 30-day mortality, histopathology data including TNM scoring, completeness of surgical procedure (R0 to R2) and infiltration of tumor cells in resected tissues, adjuvant oncological treatments, and long term follow-up data on local and distant recurrence and survival.

Conditions: Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4
Being tested: Multivisceral resection

What participants receive

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

Multivisceral resectionProcedure or surgery
Multivisceral resection for locally advanced colon cancer.

What is being measured

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

Postoperative morbidity
I evaluate peri and post-operative surgical (e.g. intraabdominal collection, fistula, anastomotic leak) and medical (e.g. pneumoniae, deep vein thrombosis) complications
Measured: 30 days
Postoperative mortality
I evaluate in-hospital and 30-day mortality correlate to the intervention
Measured: 30 days

Secondary outcomes (2)

Overall Survival
The length of time from the intervention that patients diagnosed with a T4 colon cancer are still alive.
Measured: 5 years
Disease Free Survival
The measure of time after treatment during which no sign of recurrence (local or metastatic) is found.
Measured: 5 years

Timeline

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

1 Jan 202130 Jun 2021

First posted30 Nov 2020
Study start1 Jan 2021 (estimated)
Primary completion1 Jan 2021 (estimated)
Study completion30 Jun 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (27)Papers the sponsor has linked to this study.
Other trials for Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4Studies of the same condition, open and under way.
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: Observational
Observational model: Other
Time perspective: Retrospective
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04646772
Sponsor's protocol ID: LACC Trial
Acronym: LACC
Status last verified: Nov 2020
First submitted: 17 Nov 2020
Last updated: 1 Dec 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Data will retrospectively collected from a maintained database in each center, created by the. A local study manager will be identified for each participating center.

Publications

Gebhardt C, Meyer W, Ruckriegel S, Meier U. Multivisceral resection of advanced colorectal carcinoma. Langenbecks Arch Surg. 1999 Apr;384(2):194-9. doi: 10.1007/s004230050191.
PubMed 10328174
Sugarbaker PH, Corlew S. Influence of surgical techniques on survival in patients with colorectal cancer. Dis Colon Rectum. 1982 Sep;25(6):545-57. doi: 10.1007/BF02564164.
PubMed 6749455
Edge SB, Compton CC. The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual and the future of TNM. Ann Surg Oncol. 2010 Jun;17(6):1471-4. doi: 10.1245/s10434-010-0985-4.
PubMed 20180029
Vieira RA, Lopes A, Almeida PA, Rossi BM, Nakagawa WT, Ferreira FO, Melo CA. Prognostic factors in locally advanced colon cancer treated by extended resection. Rev Hosp Clin Fac Med Sao Paulo. 2004 Dec;59(6):361-8. doi: 10.1590/s0041-87812004000600009. Epub 2005 Jan 11.
PubMed 15654490
Pittam MR, Thornton H, Ellis H. Survival after extended resection for locally advanced carcinomas of the colon and rectum. Ann R Coll Surg Engl. 1984 Mar;66(2):81-4.
PubMed 6703633
Courtney D, McDermott F, Heeney A, Winter DC. Clinical review: surgical management of locally advanced and recurrent colorectal cancer. Langenbecks Arch Surg. 2014 Jan;399(1):33-40. doi: 10.1007/s00423-013-1134-x. Epub 2013 Nov 19.
PubMed 24249035
Croner RS, Merkel S, Papadopoulos T, Schellerer V, Hohenberger W, Goehl J. Multivisceral resection for colon carcinoma. Dis Colon Rectum. 2009 Aug;52(8):1381-6. doi: 10.1007/DCR.0b013e3181ab580b.
PubMed 19617748
Hoffmann M, Phillips C, Oevermann E, Killaitis C, Roblick UJ, Hildebrand P, Buerk CG, Wolken H, Kujath P, Schloericke E, Bruch HP. Multivisceral and standard resections in colorectal cancer. Langenbecks Arch Surg. 2012 Jan;397(1):75-84. doi: 10.1007/s00423-011-0854-z. Epub 2011 Oct 4.
PubMed 21968828
Mohan HM, Evans MD, Larkin JO, Beynon J, Winter DC. Multivisceral resection in colorectal cancer: a systematic review. Ann Surg Oncol. 2013 Sep;20(9):2929-36. doi: 10.1245/s10434-013-2967-9. Epub 2013 May 11.
PubMed 23666095
Zoucas E, Frederiksen S, Lydrup ML, Mansson W, Gustafson P, Alberius P. Pelvic exenteration for advanced and recurrent malignancy. World J Surg. 2010 Sep;34(9):2177-84. doi: 10.1007/s00268-010-0637-7.
PubMed 20512493
Chang GJ, Kaiser AM, Mills S, Rafferty JF, Buie WD; Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for the management of colon cancer. Dis Colon Rectum. 2012 Aug;55(8):831-43. doi: 10.1097/DCR.0b013e3182567e13. No abstract available.
PubMed 22810468
Kapoor S, Das B, Pal S, Sahni P, Chattopadhyay TK. En bloc resection of right-sided colonic adenocarcinoma with adjacent organ invasion. Int J Colorectal Dis. 2006 Apr;21(3):265-8. doi: 10.1007/s00384-005-0756-z. Epub 2005 Jun 7.
PubMed 15940511
Landmann RG, Weiser MR. Surgical management of locally advanced and locally recurrent colon cancer. Clin Colon Rectal Surg. 2005 Aug;18(3):182-9. doi: 10.1055/s-2005-916279.
PubMed 20011301
Lehnert T, Methner M, Pollok A, Schaible A, Hinz U, Herfarth C. Multivisceral resection for locally advanced primary colon and rectal cancer: an analysis of prognostic factors in 201 patients. Ann Surg. 2002 Feb;235(2):217-25. doi: 10.1097/00000658-200202000-00009.
PubMed 11807361
Lopez-Cano M, Manas MJ, Hermosilla E, Espin E. Multivisceral resection for colon cancer: analysis of prognostic factors. Dig Surg. 2010 Aug;27(3):238-45. doi: 10.1159/000276974. Epub 2010 Jun 22.
PubMed 20571272

Study at a glance

From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Surgery for Locally Advanced Colon Cancer: is it Worth it? A Multicenter Retrospective Analysis. (LACC Trial)
ClinicalTrials.gov ID: NCT04646772
Acronym / sponsor ID: LACC / LACC Trial
Conditions: Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4
Study type: Observational
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Santo Spirito Hospital, ItalyUniversity, hospital or other
Study start: 1 Jan 2021 (estimated)
Primary completion: 1 Jan 2021 (estimated)
Study completion: 30 Jun 2021 (estimated)
First posted: 30 Nov 2020 (actual)
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.

Detailed description

Study design

Observational model: Other
Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with a locally advanced colon cancer (LACC) with the necessity of a multivisceral resection (MVR).

Key inclusion criteria (2 listed)

> 18 aa
Patients with a locally advanced colon cancer (LACC) with the necessity of a multivisceral resection (MVR).

Key exclusion criteria (4 listed)

Stage IV
Rectal cancer
Emergency surgery (<48 hours from admission)
ASA > III

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
Multivisceral resectionMultivisceral resection for locally advanced colon cancer.	Procedure or surgery	–

Primary outcome

Postoperative morbidity
Time frame: 30 days
I evaluate peri and post-operative surgical (e.g. intraabdominal collection, fistula, anastomotic leak) and medical (e.g. pneumoniae, deep vein thrombosis) complications
Postoperative mortality
Time frame: 30 days
I evaluate in-hospital and 30-day mortality correlate to the intervention

2 secondary outcomes

Overall Survival
Time frame: 5 years
Disease Free Survival
Time frame: 5 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
Background: PubMed 10328174Gebhardt C, Meyer W, Ruckriegel S, Meier U. Multivisceral resection of advanced colorectal carcinoma. Langenbecks Arch Surg. 1999 Apr;384(2):194-9. doi: 10.1007/s004230050191.
Background: PubMed 6749455Sugarbaker PH, Corlew S. Influence of surgical techniques on survival in patients with colorectal cancer. Dis Colon Rectum. 1982 Sep;25(6):545-57. doi: 10.1007/BF02564164.
Background: PubMed 20180029Edge SB, Compton CC. The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual and the future of TNM. Ann Surg Oncol. 2010 Jun;17(6):1471-4. doi: 10.1245/s10434-010-0985-4.
Background: PubMed 15654490Vieira RA, Lopes A, Almeida PA, Rossi BM, Nakagawa WT, Ferreira FO, Melo CA. Prognostic factors in locally advanced colon cancer treated by extended resection. Rev Hosp Clin Fac Med Sao Paulo. 2004 Dec;59(6):361-8. doi: 10.1590/s0041-87812004000600009. Epub 2005 Jan 11.
Background: PubMed 6703633Pittam MR, Thornton H, Ellis H. Survival after extended resection for locally advanced carcinomas of the colon and rectum. Ann R Coll Surg Engl. 1984 Mar;66(2):81-4.
Background: PubMed 24249035Courtney D, McDermott F, Heeney A, Winter DC. Clinical review: surgical management of locally advanced and recurrent colorectal cancer. Langenbecks Arch Surg. 2014 Jan;399(1):33-40. doi: 10.1007/s00423-013-1134-x. Epub 2013 Nov 19.
Background: PubMed 19617748Croner RS, Merkel S, Papadopoulos T, Schellerer V, Hohenberger W, Goehl J. Multivisceral resection for colon carcinoma. Dis Colon Rectum. 2009 Aug;52(8):1381-6. doi: 10.1007/DCR.0b013e3181ab580b.
Background: PubMed 21968828Hoffmann M, Phillips C, Oevermann E, Killaitis C, Roblick UJ, Hildebrand P, Buerk CG, Wolken H, Kujath P, Schloericke E, Bruch HP. Multivisceral and standard resections in colorectal cancer. Langenbecks Arch Surg. 2012 Jan;397(1):75-84. doi: 10.1007/s00423-011-0854-z. Epub 2011 Oct 4.
Background: PubMed 23666095Mohan HM, Evans MD, Larkin JO, Beynon J, Winter DC. Multivisceral resection in colorectal cancer: a systematic review. Ann Surg Oncol. 2013 Sep;20(9):2929-36. doi: 10.1245/s10434-013-2967-9. Epub 2013 May 11.
Background: PubMed 20512493Zoucas E, Frederiksen S, Lydrup ML, Mansson W, Gustafson P, Alberius P. Pelvic exenteration for advanced and recurrent malignancy. World J Surg. 2010 Sep;34(9):2177-84. doi: 10.1007/s00268-010-0637-7.
Background: PubMed 22810468Chang GJ, Kaiser AM, Mills S, Rafferty JF, Buie WD; Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for the management of colon cancer. Dis Colon Rectum. 2012 Aug;55(8):831-43. doi: 10.1097/DCR.0b013e3182567e13. No abstract available.
Background: PubMed 15940511Kapoor S, Das B, Pal S, Sahni P, Chattopadhyay TK. En bloc resection of right-sided colonic adenocarcinoma with adjacent organ invasion. Int J Colorectal Dis. 2006 Apr;21(3):265-8. doi: 10.1007/s00384-005-0756-z. Epub 2005 Jun 7.
Individual participant dataSharing planned: No. Data will retrospectively collected from a maintained database in each center, created by the. A local study manager will be identified for each participating center.

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4, run by Santo Spirito Hospital, Italy.

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 4 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 1 Dec 2020. 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.

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?

Postoperative morbidity (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT04646772, which also lists 27 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 1 Dec 2020.