Short Course Radiotherapy Combined With Chemotherapy in Stage IV Rectal Cancer With Resectable Liver Metastases

NCT ID: NCT02510378

Last Updated: 2015-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2022-12-31

Brief Summary

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Patients with rectal cancer and resectable liver metastases receive short course radiotherapy(5Gy/f x 5f) to the pelvis and XELOX consolidating chemotherapy al least 4 cycles after 2 weeks.

Detailed Description

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Patients with rectal cancer and resectable liver metastases receive 25 Gy in 5 fractions of 5 Gy over 5 days to the pelvis and XELOX consolidating chemotherapy (with or without target therapy) al least 4 cycles after 2 weeks.

After evaluation, patients with resectable rectal cancer and liver metastasis will undergo surgery. Those patients with unresectable lesions will receive chemotherapy.

Conditions

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Stage IV Rectal Cancer, Liver Metastasis, Resectable

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Short course radiotherapy

Patients with rectal cancer and resectable liver metastases receive 25 Gy in 5 fractions of 5 Gy over 5 days to the pelvis and XELOX consolidating chemotherapy (with or without target therapy) al least 4 cycles after 2 weeks.

After evaluation, patients with resectable rectal cancer and liver metastasis will undergo surgery. Those patients with unresectable lesions will receive chemotherapy.

Group Type EXPERIMENTAL

Short course radiotherapy

Intervention Type RADIATION

Patients with rectal cancer and resectable liver metastases receive 25 Gy in 5 fractions of 5 Gy over 5 days to the pelvis and XELOX consolidating chemotherapy (with or without target therapy) al least 4 cycles after 2 weeks.

After evaluation, patients with resectable rectal cancer and liver metastasis will undergo surgery. Those patients with unresectable lesions will receive chemotherapy.

Interventions

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Short course radiotherapy

Patients with rectal cancer and resectable liver metastases receive 25 Gy in 5 fractions of 5 Gy over 5 days to the pelvis and XELOX consolidating chemotherapy (with or without target therapy) al least 4 cycles after 2 weeks.

After evaluation, patients with resectable rectal cancer and liver metastasis will undergo surgery. Those patients with unresectable lesions will receive chemotherapy.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed primary carcinoma of the rectum (Lower border of tumour ≤ 10 cm from anal verge) locally advanced stage in primary site of rectum resectable synchronous liver metastases. The decision of resectable liver metastases will be made at multidisciplinary clinical meetings.

Exclusion Criteria

* Obstruction of the gastrointestinal tract Previously constructed stoma prior radiotherapy of the pelvis
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hua Ren

Attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dept of Radiation oncology, Cancer Hospital , Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

Site Status RECRUITING

Cancer Hospital, CAMS

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hua Ren

Role: CONTACT

8610-87788122

Jing Jin, chairman

Role: CONTACT

8610-87788122

Facility Contacts

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jing jin

Role: primary

8610-87788280

hua ren

Role: backup

8610-87788122

Jing Jin, professor

Role: primary

Hua Ren, attending

Role: backup

Other Identifiers

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CH-GI-072

Identifier Type: -

Identifier Source: org_study_id

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