Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk
For patients with locally advanced rectal cancer, radiotherapy and chemotherapy combined with surgery can improve the curative effect. Rectal magnetic resonance imaging (MRI) can be used to stratify the risk of locally advanced rectal cancer before treatment. In this study, we planned to use rectal MRI parameters and the possibility of patients with anal preservation to group, and to observe the R0 resection rate and disease-free survival rate of patients with stage II / III rectal cancer after individualized preoperative radiotherapy and chemotherapy combined with radical surgery.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group CRT | Active Comparator | concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group) |
|
| Group SCRT | Experimental | Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group) |
|
| Group es-SCRT | Experimental | Local dose increase of Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concurrent Chemoradiotherapy Radiotherapy | Combination Product | 50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. Concurrent chemotherapy: Capecitabine 1650 mg/m2/d. |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | R0 resection rate is R0 resection probability of radical surgery in patients with locally advanced rectal cancer after individualized chemoradiotherapy | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 3y OS | 3-year overall survival | 3 years |
| 3yDMFS | 3-year distant metastatic free survival | 3 years |
Not provided
Inclusion Criteria:
3) The distance between the lower limit of the lesion and the anal margin was less than or equal to 10 cm 4) Karnofsky score ≥ 80 or ECOG score 0-1
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan Tang, M.D. | Contact | +8615011304945 | tangyuan82@162.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuan Tang, M.D. | Chinese Academy of Medical Sciences and Peking Union Medical College | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Recruiting | Beijing | 100021 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Short-course Radiotherapy | Radiation | 25Gy in 5 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. |
|
|
| Local dose increase of Short-course Radiotherapy | Radiation | 25Gy in 5 fractions to the of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. And 4Gy in 1 fractions to the PGTV of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. |
|
|
| Consolidation chemotherapy | Drug | Intravenous infusion of oxaliplatin (130 mg/m2 over 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 4 cycles. 4 courses*3 weeks per course. |
|
|
| Adjuvant chemotherapy | Drug | 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 6 cycles. 6 courses*3 weeks per course |
|
|
| TME | Procedure | Total mesorectal excision |
|
| 3yLRRFS | 3-year locoregional recurrence-free survival | 3 years |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D060830 | Consolidation Chemotherapy |
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D003131 | Combined Modality Therapy |
Not provided
Not provided