NCT01952951

Brief Summary

The current standard treatment of locally advanced rectal cancer (clinical stage II or III) is preoperative radiation with chemotherapy (CRT) followed by surgery. But this approach can be suboptimal for patients with high risk features (more deeply-seated tumor or many regional lymph nodes involved)that are associated with recurrence. This study test a hypothesis that CRT followed by chemotherapy before surgery can improve efficacy of preoperative treatment.

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
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2014

Longer than P75 for phase_2

Geographic Reach
1 country

7 active sites

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

First Submitted

Initial submission to the registry

September 11, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 13, 2017

Status Verified

September 1, 2017

Enrollment Period

3.3 years

First QC Date

September 11, 2013

Last Update Submit

September 12, 2017

Conditions

Rectal NeoplasmsAdenocarcinoma

Keywords

rectal neoplasmsradiotherapyAntineoplastic Agents

Outcome Measures

Primary Outcomes (1)

  • downstaging rate

    downstaging rate is defined as the proportion of patients with ypStage (pathologic stage after preoperative treatment) 0 or I (from pathologic findings after preoperative treatment and surgery) out of all patients who were assigned to each arm.

    expected average of 15 weeks after start of study treatment

Secondary Outcomes (9)

  • pathologic response

    expected average of 15 weeks after start of study treatment

  • radiologic response rate

    expected average of 14 weeks after start of study treatment

  • toxicity profile

    expected average of 35 weeks after start of study treatment

  • pattern of failure

    3 years after surgery

  • local control rate

    3 years after surgery

  • +4 more secondary outcomes

Study Arms (2)

chemoradiation followed by CapOx

EXPERIMENTAL

preoperative chemoradiation 50.4Gy with capecitabine or 5-fluorouracil/leucovorin (pelvic radiation capecitabine 5-fluorouracil) followed by 2 cycles of chemotherapy (Capecitabine Oxaliplatin - CapOx) and surgery (total mesorectal excision)

Drug: Capecitabine OxaliplatinRadiation: pelvic radiation capecitabine 5-fluorouracil

chemoradiation

ACTIVE COMPARATOR

preoperative chemoradiation 50.4Gy with capecitabine or 5-fluorouracil/leucovorin (pelvic radiation capecitabine 5-fluorouracil) followed by rest for 8 weeks and surgery (total mesorectal excision)

Radiation: pelvic radiation capecitabine 5-fluorouracil

Interventions

Capecitabine OxaliplatinDRUG

after completion of chemoradiation, two cycles of capecitabine (850mg/m2 twice daily from D1 evening to D15 morning) and oxaliplatin (100mg/m2 on D1) will be administered every 3 weeks.

Also known as: Xeloda, Oxalitin
chemoradiation followed by CapOx
pelvic radiation capecitabine 5-fluorouracilRADIATION

50.4Gy of pelvic radiation with capecitabine or 5-fluorouracil

Also known as: preoperative chemoradiation, xeloda
chemoradiationchemoradiation followed by CapOx

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed adenocarcinoma of the rectum
  • distal margin of tumor located from 0 to 12 cm from anal verge measured by digital rectal examination
  • high risk clinical stage II or III in MRI (satisfying at least one of the followings)
  • circumferential resection margin \< 1 mm involved
  • low-lying tumor below anal verge 3 cm
  • T3 \> 5 mm extramural spread
  • T4 (involving surrounding structures or peritoneum)
  • cN2 (4 or more mixed signal intensity or irregularly bordered node or tumor deposit)
  • age 20 years or more
  • ECOG (Eastern Cooperative Oncology Group) performance status 0-2
  • No prior chemotherapy, radiotherapy to pelvis
  • Adequate bone marrow function
  • Adequate renal function
  • Adequate hepatic function
  • patients must sign the informed consent indicating that they were aware of the investigational nature of the study in keeping with the policy of the hospital

You may not qualify if:

  • malignant disease of the rectum other than adenocarcinoma or arisen from chronic inflammatory bowel disease
  • any unresected synchronous colon cancer
  • any distant metastases
  • intestinal obstruction or impending obstruction, but decompressing colostomy is permitted
  • any previous or concurrent malignancy withih 5 years other than non-melanoma skin cancer / in situ cancer of uterine cervix / early gastric cancer / thyroid cancer of low risk
  • any other morbidity or situation with relative contraindication for chemoradiotherapy
  • patients with history of significant gastric or small bowel resection, or malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may compromise the absorption of capecitabine
  • pregnant or lactating women or patients of childbearing potential not predicting adequate contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Hallym University Sacred Heart Hospital

Anyang, South Korea

Location

Gangneung Asan Hospital

Gangneung, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Chung-Ang University Hospital

Seoul, 06973, South Korea

Location

Related Publications (1)

  • Kim SY, Joo J, Kim TW, Hong YS, Kim JE, Hwang IG, Kim BG, Lee KW, Kim JW, Oh HS, Ahn JB, Zang DY, Kim DY, Oh JH, Baek JY. A Randomized Phase 2 Trial of Consolidation Chemotherapy After Preoperative Chemoradiation Therapy Versus Chemoradiation Therapy Alone for Locally Advanced Rectal Cancer: KCSG CO 14-03. Int J Radiat Oncol Biol Phys. 2018 Jul 15;101(4):889-899. doi: 10.1016/j.ijrobp.2018.04.013. Epub 2018 Apr 12.

    PMID: 29976501DERIVED

MeSH Terms

Conditions

Rectal NeoplasmsAdenocarcinoma

Interventions

XELOXCapecitabine

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Sun Young Kim, MD

    Asan Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 11, 2013

First Posted

September 30, 2013

Study Start

June 1, 2014

Primary Completion

September 1, 2017

Study Completion

December 1, 2019

Last Updated

September 13, 2017

Record last verified: 2017-09

Locations

KR(7)