AzTrials
AzTrials

Rectal CancerPhase 2SOLARNCT05673772

Preoperative Sequential Short-course Radiation Therapy and FOLFOX for Locally Advanced Rectal Cancer

A Phase 2 study testing short-course radiotherapy, mFOLFOX6 and Chemoradiotherapy in people with Rectal Cancer, run by Kyungpook National University Hospital at 9 sites in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Rectal Cancer
What is being tested?
short-course radiotherapy, mFOLFOX6 and Chemoradiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
364 participants
Where
9 sitesSouth Korea
Study dates
23 Oct 2020to 28 Dec 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • MRI findings such as pelvic lymph node metastasis, anal sphincter invasion, and T4b are not included in the exclusion criteria, which cases will be enrolled by the researcher's discretion
  • Patients with appropriate organ (bone marrow, kidney, liver) function
  • A person who understands the study and willing to provide informed consent

Who cannot join

  • 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
Show all 28Show fewer
  • 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
  • Taking tegafur, gimeracil, and oteracil potassium complex and those within 7 days of discontinuation
  • Taking sorivudine or brivudine
  • Significant heart disease or myocardial infarction within the last 6 months
  • Hereditary diseases or history of coagulopathy
  • Central nervous system disorders with disability or mental disorders
  • Pregnant or lactating women
  • Currently participating in other clinical trials or receiving research medication
  • Unhealed wounds, fractures, peptic ulcer, abscesses in the abdominal cavity
  • Active gastrointestinal bleeding
  • Active infections requiring antibiotics for injection
  • Emergency Surgery
  • History of hypersensitivity to the drugs in study protocol
  • Patients with non-malignant tumor diseases
  • Dihydropyrimidine dehydrogenase deficiency
  • Not willing to participate

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

South Korea9 sites

  • Gyu seog Choi

    Daegu, 702-210

  • Chungnam National University Hospital

    Daejeon

  • Chonnam National University Hwasun Hospital

    Gwangju

  • Catholic University of Korea Incheon St. Mary's Hospital

    Incheon

  • Jeonbuk National University Hospital

    Jeonju

  • Asan Medical Center

    Seoul, 05505

  • , Korea University Anam Hospital

    Seoul

  • Gangnam Severance Hospital

    Seoul

  • Seoul National University Bundang Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Multicenter, Randomized Controlled Trial of Preoperative Sequential Short-course Radiation Therapy and Oxaliplatin-based Consolidation Chemotherapy for Locally Advanced Rectal Cancer

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.

Conditions
Rectal Cancer
Being tested
short-course radiotherapy, mFOLFOX6, Chemoradiotherapy, TME surgery
Keywords
Rectal cancer, Neoadjuvant treatment, short-course radiotherapy, Consolidation chemotherapy
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • short-course radiotherapyRadiation

    25 Gy in 5 fractions for 5 days

  • 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

  • ChemoradiotherapyRadiation

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

  • TME surgeryProcedure or surgery

    TME surgery

Study groups in NCT05673772
Study groupRoleWhat they receive
Study groupExperimentalShort-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)
Receives: Radiation: short-course radiotherapy; Drug: mFOLFOX6; Procedure: TME surgery
Control groupActive comparatorConventional 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)
Receives: Radiation: Chemoradiotherapy; Procedure: TME surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3-year disease-free survival

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

    Measured: 3 years

Secondary outcomes (15)

  1. pCR rate

    CR (complete regression), no tumor cells and only fibrotic mass or acellular mucin pools

    Measured: within 30 days after TME

  2. Toxicity of neoadjuvant radiotherapy and chemotherapy

    Neoadjuvant treatment associated toxicity (Common Terminology Criteria for Adverse Events version v5.0)

    Measured: 6 months

  3. R0 resection

    Rate of R0 resection of TME

    Measured: within 30 days after TME

  4. TRG

    Pathological tumor regression grade (TRG) (Dworak/Mandard/AJCC TRG classification)

    Measured: within 30 days after TME

  5. Surgical complications

    Surgical complications classified according to the Clavien-Dindo classification

    Measured: within 60 days after TME

  6. Incidence of peripheral neuropathy

    Incidence of oxaliplatin-induced peripheral neuopathy

    Measured: 3 years

  7. European Organization for Research and Treatment of Cancer Quality of Life C30

    The EORTC Core Questionnaire (QLQ-C30) includes six clearly distinguishable functioning scales that have been thoroughly tested and validated on an international level and that are available in 110 different language versions

    Measured: 2 year after surgery

  8. European Organization for Research and Treatment of Cancer Quality of Life CR29

    The QLQ-CR29 has five functional and 18 symptom scales. It contains four subscales (urinary frequency (UF), blood and mucus in stool (BMS), stool frequency (SF), and body image (BI)) and 19 single items (urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, anxiety, weight, flatulence, fecal incontinence, sore skin, embarrassment, stoma care problems, sexual interest (men), impotence, sexual interest (women), and dyspareunia) [11]. Patients are asked to indicate their symptoms during the past week(s). Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.

    Measured: 2 year after surgery

  9. Low Anterior Resection Syndrome score

    Low anterior resection syndrome (LARS) score ; 0 to 20 (no LARS), 21 to 29 (minor LARS ) and 30 to 42 (Major LARS )

    Measured: 2 year after surgery

  10. The International Index of Erectile Function-5 score, retrograde ejaculation

    Quality of life IIEF-5, retrograde ejaculation

    Measured: 2 year after surgery

  11. 5-year disease-free survival

    To compare the 5-year disease-free survival between the experimental arm and the control arm

    Measured: 5 years

  12. 3-year overall survival

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

    Measured: 3 years

  13. 5-year overall survival

    To compare the 5-year overall survival between the experimental arm and the control arm

    Measured: 5 years

  14. Loco-regional recurrence

    To compare the 3 year and 5-year loco-regional recurrence between the experimental arm and the control arm

    Measured: 5 years

  15. Distant metastasis

    To compare the 3 year and 5-year distant metastasis between the experimental arm and the control arm

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2023
  2. Study start23 Oct 2020
  3. Primary completion28 Dec 2028 (estimated)
  4. Study completion28 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
364 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05673772
Sponsor's protocol ID
KNUHCRC007
Acronym
SOLAR
Status last verified
Feb 2026
First submitted
21 Dec 2022
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 37923987

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing short-course radiotherapy, mFOLFOX6 and Chemoradiotherapy in people with Rectal Cancer, run by Kyungpook National University Hospital at 9 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-year disease-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05673772, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in