NCT05673772

Brief Summary

The treatment protocol proposed in this study is to perform short-term radiation therapy and 4 cycles of FOLFOX chemotherapy for neoadjuvant treatment of locally advanced rectal cancer. Compared to conventional chemoradiation therapy, the preoperative radiotherapy period is shortened, and the cure rate of rectal cancer patients can be improved by early treatment of micrometastasis using systemic chemotherapy. The patients who are assigned to the study group will received the short-course radiotherapy and 4 cycles of FOLFOX and patients in the control will received conventional chemoradiotherapy for preoperative treatment. All patients are recommended to receive total mesorectal excision (TME) after neoadjuvant treatment and adjuvant chemotherapy will be given according to the pathological stage.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
364

participants targeted

Target at P75+ for phase_2

Timeline
67mo left

Started Oct 2020

Longer than P75 for phase_2

Geographic Reach
1 country

9 active sites

Status
active not recruiting

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 Progress50%
Oct 2020Dec 2031

Study Start

First participant enrolled

October 23, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2028

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2031

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

8.2 years

First QC Date

December 21, 2022

Last Update Submit

February 10, 2026

Conditions

Rectal Cancer

Keywords

Rectal cancerNeoadjuvant treatmentshort-course radiotherapyConsolidation chemotherapy

Outcome Measures

Primary Outcomes (1)

  • 3-year disease-free survival

    To compare the 3-year disease-free survival between the experimental arm and the control arm

    3 years

Secondary Outcomes (15)

  • pCR rate

    within 30 days after TME

  • Toxicity of neoadjuvant radiotherapy and chemotherapy

    6 months

  • R0 resection

    within 30 days after TME

  • TRG

    within 30 days after TME

  • Surgical complications

    within 60 days after TME

  • +10 more secondary outcomes

Study Arms (2)

Study group

EXPERIMENTAL

Short-course radiotherapy and 4 cycles of mFOLFOX6 followed by TME. Adjuvant chemotherapy will be given according to the pathological stage (CR\~pStageI: 6 cycles of capecitabine or 4 cycles of 5-FU with leucovorin, pStageII-III: 8 cycles of mFOLFOX6)

Radiation: short-course radiotherapyDrug: mFOLFOX6Procedure: TME surgery

Control group

ACTIVE COMPARATOR

Conventional chemoradiotherapy followed by TME. Adjuvant chemotherapy will be given according to the pathological stage (CR\~pStageI: 6 cycles of capecitabine or 4 cycles of 5-FU with leucovorin, pStageII-III: 8 cycles of mFOLFOX6)

Radiation: ChemoradiotherapyProcedure: TME surgery

Interventions

short-course radiotherapyRADIATION

25 Gy in 5 fractions for 5 days

Study group
mFOLFOX6DRUG

Oxaliplatin 85 mg/m2, Levoleucovorin 200mg (or Leucovroin, Leucosodium 400mg)/m2, 5- FU 400 mg/m2, and continuous 5- FU 2,400 mg/m2 for 46 hours

Study group
ChemoradiotherapyRADIATION

45\~50.4 Gy/25fr with concurrent use of either capecitabine or 5-FU+leucovorin(or levoleucovorin or leucosodium)

Control group
TME surgeryPROCEDURE

TME surgery

Control groupStudy group

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Asian
  • ECOG (Eastern Cooperative Oncology Group) performance status 0-2
  • Pathologically confirmed rectal cancer (rectal cancer located 10 cm or low from the anal verge in pelvis MRI)
  • Histologic type: adenocarcinoma, mucinous carcinoma, and signet ring cell carcinoma
  • Locally advanced rectal cancer with one or more of the following factors based on pelvis MRI: cTanyN1-2, cT3-4N0, or presence of extramural vascular invasion

You may not qualify if:

  • Patients with appropriate organ (bone marrow, kidney, liver) function
  • A person who understands the study and willing to provide informed consent
  • Colon cancer or rectal cancer located more than 10 cm from the anal verge
  • Stage I rectal cancer (clinical stage cT1-2N0)
  • Clinically or pathologically diagnosed distant metastasis (cTanyNanyM1)
  • Familial adenomatous polyposis
  • Hereditary nonpolyposis colorectal cancer
  • History of chemotherapy or radiotherapy within 6 months
  • History of colorectal cancer or other type of malignancy within 5 years (except for cured nonmelanoma skin or in situ cervical cancer)
  • Comorbidities that make it difficult to undergo chemotherapy or radiotherapy
  • Bone marrow suppression with neutrophil count \<2 ×109/L or platelet count \<100 ×109/L prior to the first chemotherapy
  • Peripheral sensory neuropathy with functional impairment (grade 2 or higher)
  • Severe renal dysfunction (GFR ≤30ml/min by Wright or Cockroft formula)
  • Severe hepatic dysfunction
  • Genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Gyu seog Choi

Daegu, 702-210, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Chonnam National University Hwasun Hospital

Gwangju, South Korea

Location

Catholic University of Korea Incheon St. Mary's Hospital

Incheon, South Korea

Location

Jeonbuk National University Hospital

Jeonju, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

, Korea University Anam Hospital

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Seoul National University Bundang Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Kang MK, Park SY, Park JS, Kim HJ, Kim JG, Kang BW, Baek JH, Cho SH, Seo AN, Kim DW, Kim J, Baek SJ, Kim JH, Kim JY, Ha GW, Park EJ, Park IJ, Kim CH, Kang H, Choi GS. Preoperative sequential short-course radiation therapy and FOLFOX chemotherapy versus long-course chemoradiotherapy for locally advanced rectal cancer: a multicenter, randomized controlled trial (SOLAR trial). BMC Cancer. 2023 Nov 3;23(1):1059. doi: 10.1186/s12885-023-11363-7.

    PMID: 37923987DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyRadiotherapy

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 6, 2023

Study Start

October 23, 2020

Primary Completion (Estimated)

December 28, 2028

Study Completion (Estimated)

December 28, 2031

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, CSR

Locations

KR(9)