Rectal Cancer, Radiotherapy
Conditions
Keywords
rectal cancer, radiotherapy
Brief summary
The study is designed to analyze the pathological tumor response on locally advanced rectal cancer after preoperative treatment with neo-adjuvant therapy regimen or with chemotherapy combined with short-course radiotherapy in a prospective cohort and to correlate this response with patient's outcome
Detailed description
This is a phase II , open label, randomized study in patients with confirmed diagnosis of locally advanced rectal cancer. The study is designed to analyze the pathological tumor response on locally advanced rectal cancer after preoperative treatment with neo-adjuvant therapy regimen or with chemotherapy combined with short-course radiotherapy.
Interventions
RADIATIONShort-course radiotherapy
Preoperative Radiation doses: 25 Gy in 5 fractions to the pelvis
DRUGFOLFOX4 chemotherapy,preoperative
FOLFOX4 chemotherapy：5-FU 400 mg/m2 i.v. bolus and Leucovorin 200 mg/m2 i.v. followed by 5-FU 600 mg/m2 i.v. 22 h-infusion day 1 + 2, oxaliplatin 85 mg/m2 day 1. Repeat every 2 weeks
RADIATIONRadiotherapy of neo-adjuvant therapy
Preoperative Radiation doses: 45 Gy in 25 fractions to the pelvis, 5.4 Gy in 3 fractions to the pelvis
DRUGConcurrent chemotherapy of neo-adjuvant therapy
Capecitabine 825mg/m2 twice daily 5 days/week
PROCEDURERadical rectal cancer resection
Radical rectal cancer resection
DRUGFOLFOX4 chemotherapy,post-operative
FOLFOX4 chemotherapy：5-FU 400 mg/m2 i.v. bolus and Leucovorin 200 mg/m2 i.v. followed by 5-FU 600 mg/m2 i.v. 22 h-infusion day 1 + 2, oxaliplatin 85 mg/m2 day 1. Repeat every 2 weeks
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Consent to this study * 2\. Histological or cytological confirmed diagnostic of rectal carcinoma * 3\. Locally advanced rectal cancer without metastasis, confirmed by pelvic MRI (cT3CRM+、cT4NX or cTxN2M0)(cT3CRM+: margin between the deepest point of tumor and rectal adventitia/serosa surface is less than 1 mm measured in pelvic MRI) * 4.With no presence of anemia (Hb≤60g/l) induced by tumor bleeding or bowel obstruction * 5.With no presence of other organ metastasis or extra-regional lymph node involvement * 6.With no history of chemotherapy * 7.ECOG score is 0 or 1 * 8.Adequate ability of bone marrow, liver and kidney function * 9.No pregnancy
Exclusion criteria
1. Unable to intake oral medicine 2. Arrhythmia need treatment(besides β-blocker or digoxin); Symptomatic coronary artery disease or history of myocardiac infarction within 6 months ；Congestive Heart Failure NYHA II grade or severe 3. HIV infection or Active chronic HBV or HCV 4. Severe clinical infection at active stage 5. Epileptic seizure need treatment 6. History of organ transplantation 7. Renal failure or intaking renal dialysis 8. Clinical hemorrhagic tendency or Disorders of blood coagulation or intaking anticoagulant or thrombolytics 9. Severe unhealed wound or skin ulcer or bone fraction 10. Measurable massive ascites 11 History of other malignant tumor(except cured cervical tumor in site and cured cutaneous basal cell carcinoma) in last 5 years 12.Chronic inflammatory bowel disease， bowel obstruction，hereditary fructose intolerance 13.Medicine abuse；medical，psychologic or social conditions might disturb patients or results 14.Known or suspected allergy to any drugs in this study 15.Any situation or status that might endanger patient's safety or compliance 16.Pregnant woman or suckling period woman; Fertility without taking sufficient contraception 17.History of pelvic radiotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Response | Surgery | Treatment effects of interventions. The tumor response should be graded on a scale of 0 (complete response- no viable cancer cells observed) to 3 (poor response - minimal or no tumor kill; extensive residual cancer) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year Disease-Free Survival | 3 years | time from radical resection to recurrence or end of follow-up |
| 3-year Overall Survival | 3 year | time from radical resection to cancer caused death or end of follow-up |
Contacts
Primary ContactLong Cui, MD.PhD.
Outcome results
None listed