Study of IMRT Radiotherapy Concurrent Chemothrerapy for A... | NCT03381352

Studies
Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer

NCT03381352

Sponsor

Chinese Academy of Medical Sciences

Status

Unknown status

Last Update Posted

Jan 30, 2018Actual

Enrollment

27Estimated

Phase

Phase 2

Conditions

Anal Cancer

Interventions

Chemo-radiotherapy with IMRT technique
Capecitabine
Mitomycin C

Countries

China

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

Jan 2018

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

Dec 2, 2015Actual

Primary Completion Date

Dec 31, 2018Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Dec 13, 2017

First Submission Date that Met QC Criteria

Dec 17, 2017

First Posted Date

Dec 22, 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

Jan 28, 2018

Last Update Posted Date

Jan 30, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

LI Ning, Principal Investigator, Chinese Academy of Medical SciencesPrincipal Investigator

Lead Sponsor

Chinese Academy of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the efficacy and adverse events of intensity modulated radiation therapy (IMRT) concurrent with chemotherapy for anal squamous carcinoma. All enrolled anal squamous carcinoma patients are intented to receive IMRT concurrent with Capecitabine + mitomycin ± cetuximab targeted therapy.

Detailed Description

Not provided

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

27Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chemo-radiotherapy with IMRT technique	Experimental	Radiotherapy with IMRT technique concurrent with Capecitabine and MMC chemotherapy	Radiation: Chemo-radiotherapy with IMRT technique Drug: Capecitabine Drug: Mitomycin C

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chemo-radiotherapy with IMRT technique	Radiation	IMRT radiation technique; 50.4-54Gy/25F	Chemo-radiotherapy with IMRT technique

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response rate	To evaluate response rate of IMRT with chemotherapy	8 weeks after IMRT

Secondary Outcomes

Measure	Description	Time Frame
Adverse events	To assess the adverse events of IMRT with chemotherapy	from start of IMRT to 8 weeks after IMRT

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CT/MRI diagnosed stage cT1-4N0-3;
Histologically confirmed anal squamous carcinoma;
KPS >= 70
Adequate organ function;
No previous radiotherapy or chemotherapy;
No surgery.

Exclusion Criteria:

Previous malignant cancer history;
Allegic to 5-fu or MMC

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ning Li, MD	Contact	0086-13810381399		lee_ak@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chinese academy of medical sciences	Recruiting	Beijing	Beijing Municipality	100021	China

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
D001005	Anus Neoplasms

Ancestor Terms

ID	Term
D012004	Rectal Neoplasms
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069287	Capecitabine
D016685	Mitomycin

Ancestor Terms

ID	Term
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines

Browse Leaves

Not provided

Browse Branches

Not provided