Genotype-driven Phase I Study of Irinotecan Administered... | NCT01474187

Studies
Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer

NCT01474187

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Nov 18, 2011Estimated

Enrollment

60Estimated

Phase

Phase 1

Conditions

Rectal Cancer

Interventions

Irinotecan
Capecitabine
Radiotherapy

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 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

Nov 2011

Primary Completion Date

Nov 2011Actual

Completion Date

Dec 2012Estimated

First Submitted Date

Nov 11, 2011

First Submission Date that Met QC Criteria

Nov 15, 2011

First Posted Date

Nov 18, 2011Estimated

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

Nov 15, 2011

Last Update Posted Date

Nov 18, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhu Ji, Chief of Department of Radiation Oncology, Cancer Hospital, Fudan UniversityPrincipal Investigator

Lead Sponsor

Fudan UniversityOTHER

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

Irinotecan is one of effective drugs for colorectal cancer. In neoadjuvant chemoradiotherapy (CRT), Irinotecan is prescribed in a low dose of 50mg/m2/week because of toxicity. Some current studies showed that irinotecan's dose can be increased significantly for those patients with 6/6 or 6/7 genotype of UGT1A1. therefore, the investigators designed this trial to explore the maximal tolerable dose (MTD) of Irinotecan in combined neoadjuvant CRT.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Irinotecan	Experimental	irinotecan dose initial from 50mg/m2/week, increased by 15mg/mg/week	Drug: Irinotecan Drug: Capecitabine Radiation: Radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Irinotecan	Drug	initial from 50mg/m2/week and increased by 15mg/m2/week	Irinotecan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
toxicity	Grade 4 hemato-toxicity Grade 3 nonhemato-toxicity (not include grade 3 anal verge skin toxicity)	5 weeks

Secondary Outcomes

Measure	Description	Time Frame
pathological complete response (pCR)		within 14days after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with rectal adenocarcinoma
Clinical staged T3/4 or any node-positive disease
Age of 18-75 years
Karnofsky Performance Status > 80
Adequate bone marrow reserve, renal and hepatic functions
Without previous antitumoural chemotherapy
No evidence of metastatic disease
Written informed consent before randomization
UGT1A1's genotype of 6/6 or 6/7

Exclusion Criteria:

Clinical staged I or IV
Age of <18 or >75 years
Karnofsky Performance Status < 80
Previous pelvis radiotherapy
Previous antitumoural chemotherapy
Clinically significant internal disease
Refuse to write informed consent before randomization
UGT1A1's genotype of 7/7

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ji Zhu, MD	Contact			leo.zhu@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Hospital, Fudan University	Recruiting	Shanghai	Shanghai Municipality	200032	China

Type	Date	Date Unknown
Release	Jun 13, 2018
Reset	Dec 21, 2018
Release	Dec 25, 2018
Reset	Mar 28, 2019

Submission Tracking

Estimated Results First Submitted Date

Jun 13, 2018

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 13, 2018			Dec 21, 2018
Dec 25, 2018

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
D000077146	Irinotecan
D000069287	Capecitabine
D011878	Radiotherapy

Ancestor Terms

ID	Term
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds
D003841	Deoxycytidine

Browse Leaves

Not provided

Browse Branches

Not provided