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

NCT02941562 | Unknown Phase 2

• 1 other identifier: XHGC-004
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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

Conditions

Rectal Cancer, Radiotherapy

Keywords

rectal cancer, radiotherapy

Outcome Measures

Primary Outcomes (1)

• Pathological Response

  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)

  Surgery

Secondary Outcomes (2)

• 3-year Disease-Free Survival

  3 years

• 3-year Overall Survival

  3 year

Study Arms (2)

Preoperative chemotherapy with short-course radiotherapy

EXPERIMENTAL

Preoperative treatment:4 course of FOLFOX4 therapy combined with short-course radiotherapy

Radiation: Short-course radiotherapy; Drug: FOLFOX4 chemotherapy,preoperative; Procedure: Radical rectal cancer resection; Drug: FOLFOX4 chemotherapy,post-operative

Preoperative neo-adjuvant therapy

ACTIVE COMPARATOR

Preoperative treatment:neo-adjuvant therapy

Radiation: Radiotherapy of neo-adjuvant therapy; Drug: Concurrent chemotherapy of neo-adjuvant therapy; Procedure: Radical rectal cancer resection; Drug: FOLFOX4 chemotherapy,post-operative

Interventions

Short-course radiotherapy RADIATION

Preoperative Radiation doses: 25 Gy in 5 fractions to the pelvis

Preoperative chemotherapy with short-course radiotherapy

FOLFOX4 chemotherapy,preoperative DRUG

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

Preoperative chemotherapy with short-course radiotherapy

Radiotherapy of neo-adjuvant therapy RADIATION

Preoperative Radiation doses: 45 Gy in 25 fractions to the pelvis, 5.4 Gy in 3 fractions to the pelvis

Preoperative neo-adjuvant therapy

Concurrent chemotherapy of neo-adjuvant therapy DRUG

Capecitabine 825mg/m2 twice daily 5 days/week

Preoperative neo-adjuvant therapy

Radical rectal cancer resection PROCEDURE

Radical rectal cancer resection

Preoperative chemotherapy with short-course radiotherapy; Preoperative neo-adjuvant therapy

FOLFOX4 chemotherapy,post-operative DRUG

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

Preoperative chemotherapy with short-course radiotherapy; Preoperative neo-adjuvant therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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)
• With no presence of anemia (Hb≤60g/l) induced by tumor bleeding or bowel obstruction
• With no presence of other organ metastasis or extra-regional lymph node involvement
• With no history of chemotherapy
• ECOG score is 0 or 1
• Adequate ability of bone marrow, liver and kidney function
• No pregnancy

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Long Cui, MD.PhD.

CONTACT

+86-25077850; longcuidr@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Director of Colorectal Surgery

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: October 21, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2019
• Last Updated: October 24, 2016

Record last verified: 2016-10