NCT02022852

Brief Summary

Compared curative effect，safety and compliance between concurrent chemoradiotherapy and chemo-chemoradio-chemo sequential therapy in locally advanced mid/low rectal cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

December 30, 2013

Status Verified

December 1, 2013

Enrollment Period

2 years

First QC Date

December 9, 2013

Last Update Submit

December 23, 2013

Conditions

Rectal Cancer

Keywords

Rectal CancerConcurrent ChemoradiotherapySequential Therapy

Outcome Measures

Primary Outcomes (1)

  • Disease free survival

    3-year

Secondary Outcomes (4)

  • Local recurrence rate

    3 years

  • Safety: Number of Participants with Adverse Events

    3 years

  • R0 resection rate

    1 year

  • Pathologic complete response

    1 year

Other Outcomes (1)

  • Compliance

    1 year

Study Arms (2)

Concurrent chemoradiotherapy

ACTIVE COMPARATOR

Capecitabine neoadjuvant concurrent radiochemotherapy and XELOX adjuvant therapy

Drug: Capecitabine

Sequential therapy

EXPERIMENTAL

XELOX/capecitabine/XELOX neoadjuvant chemo-chemoradio-chemo sequential therapy and XELOX adjuvant therapy

Drug: XELOX

Interventions

CapecitabineDRUG

50Gy, 2Gy/day per time, 5 days a week, for 5 weeks+capecitabine 850mg/m2 bid on the day accept radiotherapy. Rest for 8 weeks and surgery followed.

Concurrent chemoradiotherapy
XELOXDRUG

XELOX 2 cycles (oxaliplatin 130mg/m2 ivgtt 2-6h day 1,capecitabine 1000 mg/m2 bid day 1-14 repeat every 3 weeks) → 50Gy, 2Gy/day per time, 5 days a week, for 5 weeks+capecitabine 850mg/m2 bid on the day accept radiotherapy → XELOX 1 cycle. Rest for 2 weeks and surgery followed.

Sequential therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathology rectal adenocarcinoma
  • Distal distance of tumor from anal verge \< 10cm
  • TNM staging T3-4N0-2(MRI)
  • No distant metastasis
  • Karnofsky score≥70
  • Female patients need contraception during the test
  • Postmenopausal women for at least 12 months, expect pregnancy possibility
  • Patients did not receive chemotherapy, radiotherapy in any form before
  • No other severe related diseases (such as other tumor, severe cardiac and central nervous system diseases, etc.)

You may not qualify if:

  • Be treated by radiotherapy, chemotherapy or tumor biological therapy before
  • Received immunosuppressive therapy (including corticosteroids)
  • Participated in other clinical trial(s) in 1 month
  • With malignant tumor of colon
  • Peripheral neuropathy (WHO I level and above)
  • Neurological or psychiatric abnormalities affecting cognition , including central nervous system metastasis
  • Severe allergies or allergic history
  • Severe pulmonary or heart disease
  • Pregnant or lactation or refuse contraception during the test
  • Suffering other malignant tumors in past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

CapecitabineXELOX

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Binbin Cui, MD

    Department of Abdominal Surgery, Harbin Medical University Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Binbin Cui, MD

CONTACT

+86 1335111288813351112888@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Abdominal Surgery Department

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 30, 2013

Study Start

July 1, 2013

Primary Completion

July 1, 2015

Study Completion

January 1, 2018

Last Updated

December 30, 2013

Record last verified: 2013-12

Locations

CN(1)