Rectal Cancer
Conditions
Keywords
Rectal cancer, Neoadjuvant treatment, short-course radiotherapy, Consolidation chemotherapy
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.
Interventions
RADIATIONshort-course radiotherapy
25 Gy in 5 fractions for 5 days
DRUGmFOLFOX6
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
RADIATIONChemoradiotherapy
45\~50.4 Gy/25fr with concurrent use of either capecitabine or 5-FU+leucovorin(or levoleucovorin or leucosodium)
PROCEDURETME surgery
TME surgery
Sponsors
Kyungpook National University Hospital
National Cancer Center, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease-free survival | 3 years | To compare the 3-year disease-free survival between the experimental arm and the control arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pCR rate | within 30 days after TME | CR (complete regression), no tumor cells and only fibrotic mass or acellular mucin pools |
| Toxicity of neoadjuvant radiotherapy and chemotherapy | 6 months | Neoadjuvant treatment associated toxicity (Common Terminology Criteria for Adverse Events version v5.0) |
| R0 resection | within 30 days after TME | Rate of R0 resection of TME |
| TRG | within 30 days after TME | Pathological tumor regression grade (TRG) (Dworak/Mandard/AJCC TRG classification) |
| Surgical complications | within 60 days after TME | Surgical complications classified according to the Clavien-Dindo classification |
| Incidence of peripheral neuropathy | 3 years | Incidence of oxaliplatin-induced peripheral neuopathy |
| European Organization for Research and Treatment of Cancer Quality of Life C30 | 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 |
| European Organization for Research and Treatment of Cancer Quality of Life CR29 | 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. |
| Low Anterior Resection Syndrome score | 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 ) |
| The International Index of Erectile Function-5 score, retrograde ejaculation | 2 year after surgery | Quality of life IIEF-5, retrograde ejaculation |
| 5-year disease-free survival | 5 years | To compare the 5-year disease-free survival between the experimental arm and the control arm |
| 3-year overall survival | 3 years | To compare the 3-year overall survival between the experimental arm and the control arm |
| 5-year overall survival | 5 years | To compare the 5-year overall survival between the experimental arm and the control arm |
| Loco-regional recurrence | 5 years | To compare the 3 year and 5-year loco-regional recurrence between the experimental arm and the control arm |
| Distant metastasis | 5 years | To compare the 3 year and 5-year distant metastasis between the experimental arm and the control arm |
Countries
South Korea
Outcome results
None listed