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Status unknownNCT02510378Updated Jul 29, 2015

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

A Phase 2 interventional study of Short course radiotherapy in Stage IV Rectal Cancer, Liver Metastasis, Resectable, sponsored by Chinese Academy of Medical Sciences. Status unknown at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-07-29.

Sponsored by Chinese Academy of Medical Sciences · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
47
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Stage IV Rectal Cancer, Liver Metastasis, Resectable
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's planned enrollment of 47 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Chinese Academy of Medical Sciences is the lead sponsor of 235 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Obstruction of the gastrointestinal tract Previously constructed stoma prior radiotherapy of the pelvis
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
47 participants (estimated)

Study arms

  • Experimental
    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.

    Radiation: Short course radiotherapy

Interventions

  • RadiationShort 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.

06

What researchers measure

Primary outcomes

  1. percentage of patients undergo R0 surgery during the follow-up

    Time frame: 3 months

Secondary outcomes

  1. The rate of early toxicity of radiotherapy according to the NCI Common Toxicity Criteria for Adverse Effects (version 3.0)

    Time frame: 3 months

07

Study locations

2 of 2 sites recruiting
  • Dept of Radiation oncology, Cancer Hospital , Chinese Academy of Medical Science
    Beijing, Beijing 100021, China
    Recruiting
  • Cancer Hospital, CAMS
    Beijing, 100021, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02510378
Lead sponsor
Chinese Academy of Medical Sciences
Responsible party
Hua Ren (Attending physician, Chinese Academy of Medical Sciences) — Principal investigator
First posted
Jul 29, 2015
Start date
Jan 2014
Primary completion
Dec 2020 (estimated)
Completion
Dec 2022 (estimated)
Last update
Jul 29, 2015

Study contacts

Hua Ren
Contact
renhua2009@hotmail.com
8610-87788122
Jing Jin, chairman
Contact
jingjin1025@163.com
8610-87788122

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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