Neoadjuvant Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer

Efficacy and Safety of Neoadjuvant Chemo-chemoradio-chemo Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer: a Phase II Trial

Compared curative effect，safety and compliance between concurrent chemoradiotherapy and chemo-chemoradio-chemo sequential therapy in locally advanced mid/low rectal cancer.

Study Overview

• Status: Unknown
• Conditions: Rectal Cancer
• Intervention / Treatment: Drug: Capecitabine; Drug: XELOX

Detailed Description

The patients were divided into two arms according to the defined conditions (pathology rectal adenocarcinoma；distal distance of tumor from anal verge < 10cm；TNM staging T3-4N0-2；no distant metastasis；Karnofsky score≥70) in this prospective, single center, open, non randomized trail (arm A:concurrent chemoradiotherapy, arm B:sequential therapy). Regimens:Arm A:50Gy,2Gy/day per time, 5 days a week, for 5 weeks. +capecitabine 850mg/m2 bid on the day accept radiotherapy. Rest for 8 weeks. Arm B: XELOX 2 cycles (oxaliplatin 130mg/m2 ivgtt 2-6h day 1, capecitabine 1000 mg/m2 Bid day 1-14, repeat every 3 weeks ) → 50Gy,2Gy/day per time, 5 days a week, for 5 weeks.+capecitabine 850mg/m2 bid on the day accept radiotherapy → XELOX 1 cycle. Rest for 2 weeks. Evaluate pre chemotherapy, pre radiotherapy and pre surgery individually. Surgeries followed TME(total mesorectal excision) and PANP(pelvic autonomic nerve preservation) for patients in both arms. Take pathological evaluation of tumors. Take XELOX therapy till 6-8 cycles(pre and after surgery total). Follow up according the schedule.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Binbin Cui, MD; Phone Number: +86 13351112888; Email: 13351112888@163.com

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Recruiting
      • Harbin medical university cancer hospital
      • Contact: Binbin Cui, MD; Phone Number: 13351112888; Email: 13351112888@163.com
      • Principal Investigator: Binbin Cui, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pathology rectal adenocarcinoma
• Distal distance of tumor from anal verge < 10cm
• TNM staging T3-4N0-2(MRI)
• No distant metastasis
• Karnofsky score≥70
• Female patients need contraception during the test
• Postmenopausal women for at least 12 months, expect pregnancy possibility
• Patients did not receive chemotherapy, radiotherapy in any form before
• No other severe related diseases (such as other tumor, severe cardiac and central nervous system diseases, etc.)

Exclusion Criteria:

• Be treated by radiotherapy, chemotherapy or tumor biological therapy before
• Received immunosuppressive therapy (including corticosteroids)
• Participated in other clinical trial(s) in 1 month
• With malignant tumor of colon
• Peripheral neuropathy (WHO I level and above)
• Neurological or psychiatric abnormalities affecting cognition , including central nervous system metastasis
• Severe allergies or allergic history
• Severe pulmonary or heart disease
• Pregnant or lactation or refuse contraception during the test
• Suffering other malignant tumors in past

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Concurrent chemoradiotherapy; Capecitabine neoadjuvant concurrent radiochemotherapy and XELOX adjuvant therapy	Drug: Capecitabine; 50Gy, 2Gy/day per time, 5 days a week, for 5 weeks+capecitabine 850mg/m2 bid on the day accept radiotherapy. Rest for 8 weeks and surgery followed.
Experimental: Sequential therapy; XELOX/capecitabine/XELOX neoadjuvant chemo-chemoradio-chemo sequential therapy and XELOX adjuvant therapy	Drug: XELOX; XELOX 2 cycles (oxaliplatin 130mg/m2 ivgtt 2-6h day 1,capecitabine 1000 mg/m2 bid day 1-14 repeat every 3 weeks) → 50Gy, 2Gy/day per time, 5 days a week, for 5 weeks+capecitabine 850mg/m2 bid on the day accept radiotherapy → XELOX 1 cycle. Rest for 2 weeks and surgery followed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease free survival	3-year

Secondary Outcome Measures

Outcome Measure	Time Frame
Local recurrence rate	3 years
Safety: Number of Participants with Adverse Events	3 years
R0 resection rate	1 year
Pathologic complete response	1 year

Other Outcome Measures

Outcome Measure	Time Frame
Compliance	1 year

Collaborators and Investigators

• Sponsor: Harbin Medical University
• Investigators: Principal Investigator: Binbin Cui, MD, Department of Abdominal Surgery, Harbin Medical University Cancer Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: December 9, 2013
• First Submitted That Met QC Criteria: December 23, 2013
• First Posted (Estimate): December 30, 2013

Study Record Updates

• Last Update Posted (Estimate): December 30, 2013
• Last Update Submitted That Met QC Criteria: December 23, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Rectal Cancer; Concurrent Chemoradiotherapy; Sequential Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: HarbinMU-BCui-001