A Prospective Phase II Randomized Clinical Trial of Preoperative Chemotherapy Combined With Short-course Radiotherapy Versus Conventional Neo-adjuvant Therapy for Locally Advanced Rectal Cancer Implemented by MDT
Overview
- Phase
- Phase 2
- Intervention
- Short-course radiotherapy
- Conditions
- Rectal Cancer, Radiotherapy
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Enrollment
- 150
- Primary Endpoint
- Pathological Response
- Last Updated
- 9 years ago
Overview
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.
Investigators
Long Cui
Chief Director of Colorectal Surgery
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility Criteria
Inclusion Criteria
- •Consent to this study
- •Histological or cytological confirmed diagnostic of rectal carcinoma
- •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
- •Unable to intake oral medicine
- •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
- •HIV infection or Active chronic HBV or HCV
- •Severe clinical infection at active stage
- •Epileptic seizure need treatment
- •History of organ transplantation
- •Renal failure or intaking renal dialysis
- •Clinical hemorrhagic tendency or Disorders of blood coagulation or intaking anticoagulant or thrombolytics
- •Severe unhealed wound or skin ulcer or bone fraction
- •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
Arms & Interventions
Preoperative chemotherapy with short-course radiotherapy
Preoperative treatment:4 course of FOLFOX4 therapy combined with short-course radiotherapy
Intervention: Short-course radiotherapy
Preoperative chemotherapy with short-course radiotherapy
Preoperative treatment:4 course of FOLFOX4 therapy combined with short-course radiotherapy
Intervention: FOLFOX4 chemotherapy,preoperative
Preoperative chemotherapy with short-course radiotherapy
Preoperative treatment:4 course of FOLFOX4 therapy combined with short-course radiotherapy
Intervention: Radical rectal cancer resection
Preoperative chemotherapy with short-course radiotherapy
Preoperative treatment:4 course of FOLFOX4 therapy combined with short-course radiotherapy
Intervention: FOLFOX4 chemotherapy,post-operative
Preoperative neo-adjuvant therapy
Preoperative treatment:neo-adjuvant therapy
Intervention: Radiotherapy of neo-adjuvant therapy
Preoperative neo-adjuvant therapy
Preoperative treatment:neo-adjuvant therapy
Intervention: Concurrent chemotherapy of neo-adjuvant therapy
Preoperative neo-adjuvant therapy
Preoperative treatment:neo-adjuvant therapy
Intervention: Radical rectal cancer resection
Preoperative neo-adjuvant therapy
Preoperative treatment:neo-adjuvant therapy
Intervention: FOLFOX4 chemotherapy,post-operative
Outcomes
Primary Outcomes
Pathological Response
Time Frame: 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 Outcomes
- 3-year Disease-Free Survival(3 years)
- 3-year Overall Survival(3 year)