Short Course Radiotherapy Followed Intensive Chemotherapy With Delayed Surgery for Rectal Cancer With Synchronous Distant Metastasis

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.

Conditions

• Rectal Cancer
• Liver Metastasis
• Lung Metastasis

Interventions

RADIATION

Short Course Radiotherapy

Radiotherapy to tumor and draining lymph node with 25 Gy in 5 fractions within 5 working days

DRUG

Chemotherapy

* Oxaliplatin 85 mg/m2 IV over 2 hrs on Day 1 * Irinotecan 180 mg/m2 IV over 30-90 mins on Day 1 * Leucovorin 400 mg/m2 IV over 2 hrs on Day 1 and 2 * 5-fluorouracil bolus 400 mg/m2 IV push on Day 1 and 2 (or 5-fluorouracil infusion 600 mg/m2 IV continuous infusion over 22 hrs). * Bevacizumab 5 mg/kg IV over 90 mins on Day 1 * Cetuximab (only for patients with K-ras wild type and positive EGFR mutation) 400 mg/m2 IV over 2 hrs on Day 1, and 250 mg/m2 IV over 1 hr on Day 8, 15, 22, 29, and 36. * FOLFOX or FOLFIRI (+-Bevacizumab ) repeats every 14 days for up to 3 courses. Cetuximab repeats every week for up to 6 courses * Postoperative FOLFOX or FOLFIRI (+-Bevacizumab or Cetuximab) for up to 9 cycles (total 12 cycles)

PROCEDURE

Delayed Surgery

If primary tumor and metastases is resectable after FOLFOX or FOLFIRI (+-Bevacizumab or Cetuximab) of 3 cycles, patients have surgical resection (and/or radiofrequency ablation to metastases).

Sponsors & Collaborators

• Kyung Hee University Hospital at Gangdong

  collaborator OTHER

• Gachon University Gil Medical Center

  collaborator OTHER

• Catholic University of Korea, Yeouido St. Mary's Hospital

  collaborator UNKNOWN

• Pusan National University Yangsan Hospital

  collaborator OTHER

• Gangnam Severance Hospital

  collaborator OTHER

• Severance Hospital

  collaborator OTHER

• Wonju Severance Christian Hospital

  collaborator OTHER

• Chungnam National University Hospital

  collaborator OTHER

• Dongtan Sacred Heart Hospital

  collaborator OTHER

• The Koreran Society of Coloproctology

  collaborator UNKNOWN

• The Catholic University of Korea

  collaborator OTHER

• Korea Cancer Center Hospital

  lead OTHER

Principal Investigators

• Sun Mi Moon, MD, PhD · Korea Cancer Center Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-08-31

Primary Completion

2020-12-31

Completion

2022-12-31

Countries

• South Korea

Study Locations