Clinical trial NCT01923987: Short Course Radiotherapy Followed Intensive Chemotherapy With Delayed Surgery for Rectal Cancer With Synchronous Distant Metastasis
Official title: Multicenter Phase II Study of Short Course Radiotherapy Followed by Intensive Chemotherapy With Delayed Surgery for Rectal Cancer With Synchronous Distant Metastasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rectal Cancer
Liver Metastasis
Lung Metastasis
Keywords: Short course radiotherapy
Modified FOLFOX6
Delayed surgery
Rectal cancer
Synchronous metastasis
Liver metastasis
Lung metastasis
Lead sponsor: Korea Cancer Center Hospital
Sponsor class: OTHER
Collaborators: name: Kyung Hee University Hospital at Gangdong
name: Gachon University Gil Medical Center
name: Catholic University of Korea, Yeouido St. Mary's Hospital
name: Pusan National University Yangsan Hospital
name: Gangnam Severance Hospital
name: Severance Hospital
name: Wonju Severance Christian Hospital
name: Chungnam National University Hospital
name: Dongtan Sacred Heart Hospital
name: The Koreran Society of Coloproctology
name: The Catholic University of Korea
First posted: 2013-08-16
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Radical treatment of primary rectal cancer with synchronous distant metastases includes surgical resection of primary and metastatic lesion. However, primary rectal cancer in case of metastasized disease are often locally advanced disease and need downsizing before surgery. It is reported that pelvic recurrence rates and distant metastasis rates outside liver are 30\~35% and 60%, respectively. Therefore, combined treatment with radiotherapy and chemotherapy is used. However, the sequence of treatment modalities is not yet definitely established and preoperative chemoradiotherapy and surgical resection is accepted as an option of treatment. Conventional long course chemoradiotherapy delays administration of full-dose chemotherapy, and metastatic lesion can be progressed during chemoradiotherapy. In present study, we evaluate the efficacy of short course radiotherapy (SCRT) followed by full-dose chemotherapy with delayed surgical resection of the primary tumor and metastases.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed adenocarcinoma of rectum
* Lower margin of tumor within 12 cm from anal verge
* Clinically locally advanced (T3-4 or N1-2) disease
* Potentially resectable and synchronous distant metastases in liver and/or lung. The resectability of metastatic lesions is determined by size, number, location, general condition, liver function, and lung function.
* Over 18 years
* Eastern Cooperative Oncology Group performance status 0-2
* Proper organ function (Hemoglobin ≥ 10 g/dl, Absolute neutrophil count (ANC) ≥ 1,500/mm3, Platelet ≥ 100,000/mm3, Creatinine ≤ 1.5 mg/dl, Clearance of creatinine \>50 ml/min using Cockcroft-Gault formula, Bilirubin ≤ 1.5 x upper limit of normal (ULN), Liver enzyme (Aspartate aminotransferase/Alanine transaminase/Alkaline phosphatase) ≤ 2.5 x ULN)
* Subject who should sign on the informed consent form before participate the trial.

Exclusion Criteria:

* Metastases in other organ except liver or lung
* History of other type of malignancies within 3 years other than non-melanoma of the skin or carcinoma in situ of cervix
* Hereditary colorectal cancer (FAP, HNPCC, and etc)
* Bowel obstruction or impending bowel obstruction
* Uncontrolled severe illness, unsuitable to chemoradiotherapy (within 6 months, myocardial infarct, unstable angina, heart failure, uncontrolled arrhythmia, uncontrolled epilepsy, central nervous system disease, psychological disorder, and etc)
* Subject pregnant or breast feeding, or incapable of appropriate contraception
* Unresected synchronous colorectal cancer
* History of prior pelvic radiotherapy
* History of prior chemotherapy for colorectal cancer
* Great surgery within 4 week before study enrollment
* Participant in other trial within 4 week before study enrollment

Primary outcomes:
measure: R0 resection rate
timeFrame: Expected average of 12 weeks (after resection)
Secondary outcomes:
measure: Overall survival rate
timeFrame: 2 years
measure: Progression free survival rate
timeFrame: 2 years
measure: Tumor regression grade
timeFrame: Just after resection & pathologic report
measure: Toxicity
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Gangdong Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital
Study officials:
affiliation: Korea Cancer Center Hospital
name: Sun Mi Moon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: