Palliative Radiochemotherapy Against Palliative Surgery i... | NCT01157806

Studies
Palliative Radiochemotherapy Against Palliative Surgery in Stage IV Rectal Cancer With Unresectable Metastases

NCT01157806

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Status

Unknown status

Last Update Posted

Feb 16, 2011Estimated

Enrollment

20Estimated

Phase

Phase 2

Conditions

Rectal Cancer

Interventions

short course of palliative radiotherapy

Countries

Poland

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

Feb 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Dec 2010Estimated

Completion Date

Jun 2012Estimated

First Submitted Date

Jul 6, 2010

First Submission Date that Met QC Criteria

Jul 6, 2010

First Posted Date

Jul 7, 2010Estimated

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

Feb 14, 2011

Last Update Posted Date

Feb 16, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Maria Sklodowska-Curie National Research Institute of OncologyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Short course palliative radiotherapy (5x5Gy)to the pelvis in patients with symptomatic rectal tumours and with unresectable metastases may prevent palliative surgery with a good palliative outcome.The consolidating chemotherapy of XELOX may increase the efficacy of irradiation.

Detailed Description

Patients with symptomatic rectal cancer and unresectable metastases receive 25 Gy in 5 fractions of 5 Gy over 5 days to the pelvis and XELOX consolidating chemotherapy after one week. Investigators arbitrarily assumed that palliative radiotherapy to the pelvis can replace the immediate surgery if at least 30% of patients would avoid delayed surgery until the end of their lives, or for at least 18 months in the case of long-term survival.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
radiochemotherapy instead of surgery	Experimental		Radiation: short course of palliative radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
short course of palliative radiotherapy	Radiation	5x5 Gy + XELOX 7 days after radiotherapy	radiochemotherapy instead of surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
percentage of patients not requiring palliative surgery during the follow-up		every three months

Secondary Outcomes

Measure	Description	Time Frame
The rate of early toxicity of radiotherapy according to the NCI CTCAE (version 3.0)	Assess prospectively by filling forms.	3 months
Palliative effect of radiotherapy	Assessment of radiochemotherpy effectivenes by patients using questionaire.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed primary carcinoma of the rectum (Lower border of tumour ≤ 10 cm from anal verge)
Occurrence of subjective clinical symptoms of the primary tumor
Non-resectable synchronous distant metastases. The decision of non-resectable metastases will be made at multidisciplinary clinical meetings.

Exclusion Criteria:

Obstruction of the gastrointestinal tract
Previously constructed stoma
prior radiotherapy of the pelvis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wojciech Michalski, M. S.	Contact	+48226433909		W.Michalski@coi.waw.pl
: Krzysztof Bujko, Prof.	Contact	+48226439287		bujko@coi.waw.pl

Overall Officials

Name	Affiliation	Role
Krzysztof Bujko, Prof.	M. Sklodowska-Curie Memorial Cancer Centre Warsaw, Poland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
M. Sklodowska-Curie Memorial Cancer Centre	Recruiting	Warsaw		02-781	Poland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24013512	Derived	Tyc-Szczepaniak D, Wyrwicz L, Kepka L, Michalski W, Olszyna-Serementa M, Palucki J, Pietrzak L, Rutkowski A, Bujko K. Palliative radiotherapy and chemotherapy instead of surgery in symptomatic rectal cancer with synchronous unresectable metastases: a phase II study. Ann Oncol. 2013 Nov;24(11):2829-34. doi: 10.1093/annonc/mdt363. Epub 2013 Sep 6.

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