Preoperative SequentiShort-course Radiation Therapy and FOLFOX for Locally Advanced Rectal Cancer (SOLAR)

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0004874
• Lead Sponsor: Kyungpook National University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 August 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 364

Inclusion Criteria

1. A male/female adult between ages 20 and 75
2. Race : Asian
3. Eastern Cooperative Oncology Group performance score 0-2
4. Pathologically confirmed rectal cancer (rectal cancer located 10 cm or low from the anal verge in pelvis magnetic resonance imaging (MRI)]
5. Histologic type: adenocarcinoma, mucinous carcinoma, and signet ring cell carcinoma
6. 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
7. It is not an exclusion criterion if the pelvis MRI shows findings such as pelvic lymph node metastasis, anal sphincter invasion, MRF (+), and T4b. This will depend on the researcher’s discretion. 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.
8. Patients with appropriate organ (bone marrow, kidney, and liver) function Normal liver function (direct bilirubin< 0.4 mg/dL)
Normal renal function (glomerular filtration rate > 50 mL/min by Wright or Cockroft formula)
Normal bone marrow function (whilte blood cell > 3.0 × 109/L, platelet>100×109/l)
9. A person who understands the study and is willing to provide informed consent

Exclusion Criteria

1. Colon cancer or rectal cancer located above more than 10 cm from the anal verge
2. Stage I rectal cancer (clinical stage cT1-2N0)
3. Clinically or pathologically diagnosed distant metastasis (cTanyNanyM1)
4. Familial adenomatous polyposis
5. Hereditary nonpolyposis colorectal cancer
6. History of chemotherapy or radiotherapy within 6 months
7. History of colorectal cancer or other type of malignancy within 5 years
8. Currently under treatment or malignant tumors (except for cured nonmelanoma skin cancer or in situ cervical cancer)
9. Comorbidities that render it difficult to undergo chemotherapy or radiotherapy
10. Bone marrow suppression with neutrophil count < 2 x 109/L and/or platelet count < 100 x 109/L prior to the first chemotherapy
administration cycle
11. Peripheral sensory neuropathy with functional impairment prior to the first administration cycle (grade 2 or higher)
12. Severe renal dysfunction (GFR =30ml/min by Wright or Cockroft formula)
13. Severe hepatic dysfunction
14. Genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose- galactose malabsorption
15. Patients receiving tegafur, gimeracil, and oteracil complex and those within 7 days of discontinuation
16. Taking sorivudine or brivudine
17.
18. Significant heart disease or myocardial infarction within the past 6 months
18. Hereditary diseases or history of coagulopathy
19. Central nervous system disorders with disability or mental disorders
20. Pregnant or lactating women
21. Currently participating in other clinical trials or receiving research medication
22. Unhealed wounds, fractures, peptic ulcer, abscesses in the abdominal cavity
23. Active gastrointestinal bleeding
24. Active infection requiring intravenous antibiotics
25. Emergency surgery
26. History of hypersensitivity reaction to drugs in the study protocol
27. Dihydropyridine dehydrogenase deficiency
28. Not willing to participate

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3-year disease free survival

Secondary Outcome Measures

Name	Time	Method
pathologic completer response;Toxicity of neoadjuvant radiotherapy and chemotherapy;R0 resection;tumor regression grade (TRG);Surgical complications;Peripheral neuropathy;Quality of life QLQ C30;Quality of life QLQ CR29;Quality of life LARS;Quality of life IIEF-5, retrograde ejaculation;5-year disease-free survival;3-year overall survival;5-year overall survival;Loco-regional recurrence;Distant metastasis