MMP-7 Modulation by Short and Long Term Radiotherapy in R... | NCT03151759

Studies
MMP-7 Modulation by Short and Long Term Radiotherapy in Rectal Cancer Patients

NCT03151759

Sponsor

Region Skane

Status

Completed

Last Update Posted

May 12, 2017Actual

Enrollment

77Actual

Phase

Not provided

Conditions

Rectal Cancer

Interventions

Neoadjuvant radiotherapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 6, 2002Actual

Primary Completion Date

Mar 16, 2007Actual

Completion Date

Mar 16, 2007Actual

First Submitted Date

May 10, 2017

First Submission Date that Met QC Criteria

May 10, 2017

First Posted Date

May 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2017

Last Update Posted Date

May 12, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

77Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
No radiotherapy	Surgery only
25 Gray radiotherapy	Surgery after short term radiotherapy	Radiation: Neoadjuvant radiotherapy
50 Gray radiotherapy	Surgery after long term radiotherapy	Radiation: Neoadjuvant radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neoadjuvant radiotherapy	Radiation	Neoadjuvant radiotherapy prior to rectal cancer surgery	25 Gray radiotherapy 50 Gray radiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Matrilysin levels	Inflammatory markers	1 - 6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adenocarcinoma of the rectum, ability to understand written and oral information, written consent.

Exclusion Criteria:

Colon cancer, benign tumors, impaired general condition of patient, declining to participate in the study, synchronous colonic tumors, logistical reasons, inability to understand written and/or oral information, previous pelvic irradiation, ongoing immunosuppressive therapy, diabetes with systemic complications.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Rectal cancer patients undergoing surgery with or without neoadjuvant radiotherapy

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020360	Neoadjuvant Therapy

Ancestor Terms

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided