Re-irradiation Therapy of Locally Recurrent Rectal Cancer... | NCT05807984

Studies
Re-irradiation Therapy of Locally Recurrent Rectal Cancer With Carbon Ion

NCT05807984

Sponsor

Xin Cai

Status

Not yet recruiting

Last Update Posted

Apr 11, 2023Actual

Enrollment

31Estimated

Phase

Phase 2

Conditions

Rectal Cancer
Recurrent

Interventions

Carbon ion radiation therapy DT: 74Gy/20 fractions

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

Apr 2023

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2023Estimated

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Feb 16, 2023

First Submission Date that Met QC Criteria

Apr 7, 2023

First Posted Date

Apr 11, 2023Actual

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

Apr 7, 2023

Last Update Posted Date

Apr 11, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Description Module

Brief Summary

Prospective phase II clinical study aim to explore the clinical outcome of patients with unresectable locally recurrent rectal cancer (LRRC) treated with re-irradiation by carbon ion radiotherapy (CIRT)

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

31Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
carbon ion therapy for unresectable local recurrent rectal cancer	Experimental		Radiation: Carbon ion radiation therapy DT: 74Gy/20 fractions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Carbon ion radiation therapy DT: 74Gy/20 fractions	Radiation	patients with unresectable local recurrent rectal cancer will be treated with carbon ion radiation therapy as re-irradiation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
local control	local control rate of the lesion treated by CIRT	Local control at 3 years after CIRT

Secondary Outcomes

Measure	Description	Time Frame
overall survival	survival rate after CIRT	3 years after CIRT or patient died, measured erery 3 months after CIRT
progression free survival	progression free survival rate after CIRT

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1) pathologically confirmed rectal adenocarcinoma (including mucinous adenocarcinoma and signet-ring cell carcinoma) and LRRC confirmed by biopsy or clinical diagnosis,
2) received a radical operation for their primary tumor and regional lymph nodes,
3) received chemo-radiation or radiation in pelvic before CIRT,
4) received re-irradiation by CIRT after their pelvic radiotherapy.

Exclusion Criteria:

1) received more than once prior radiotherapy in the same treatment field,
2) time to the last radiotherapy was <1 year,
3) space between the lesion to organ at risk (OARs) (bladder or digestive tract) was too close (<5 mm).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xin Cai, Doctor	Contact	+86 13901601072		xin.cai@sphic.org.cn
Zheng Wang, Doctor	Contact	+86 021-38296666		zheng.wang@sphic.org.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Proton and Heavy ion center		Shanghai	Pudong	201321	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
D012004	Rectal Neoplasms
D012008	Recurrence

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