Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05673772

Preoperative Sequential Short-course Radiation Therapy and FOLFOX 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gyu seog Choi, Daegu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

(one of the following criteria)

  • 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
  • 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

Treatment and study plan

Short-course radiotherapy

Radiation

25 Gy in 5 fractions for 5 days

mFOLFOX6

Drug

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

Chemoradiotherapy

Radiation

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

TME surgery

Procedure

TME surgery

Primary outcomes

  1. 3-year disease-free survival

    Time frame: 3 years

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

Secondary outcomes

  1. pCR rate

    Time frame: within 30 days after TME

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

  2. Toxicity of neoadjuvant radiotherapy and chemotherapy

    Time frame: 6 months

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

  3. R0 resection

    Time frame: within 30 days after TME

    Rate of R0 resection of TME

  4. TRG

    Time frame: within 30 days after TME

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

  5. Surgical complications

    Time frame: within 60 days after TME

    Surgical complications classified according to the Clavien-Dindo classification

  6. Incidence of peripheral neuropathy

    Time frame: 3 years

    Incidence of oxaliplatin-induced peripheral neuopathy

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

    Time frame: 2 year after surgery

    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

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

    Time frame: 2 year after surgery

    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.

  9. Low Anterior Resection Syndrome score

    Time frame: 2 year after surgery

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

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

    Time frame: 2 year after surgery

    Quality of life IIEF-5, retrograde ejaculation

  11. 5-year disease-free survival

    Time frame: 5 years

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

  12. 3-year overall survival

    Time frame: 3 years

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

  13. 5-year overall survival

    Time frame: 5 years

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

  14. Loco-regional recurrence

    Time frame: 5 years

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

  15. Distant metastasis

    Time frame: 5 years

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

Sponsors and collaborators

Lead sponsor

Kyungpook National University Hospital

Other

Collaborators

  • National Cancer Center, Korea

Registry information

Official study title

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

Acronym: SOLAR

Important dates

Study start
2020
Primary completion
2028
Study completion
2031
First posted
Jan 6, 2023
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.