Neoadjuvant Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02022852
• Other study ID #: HarbinMU-BCui-001
• Status: Recruiting
• Phase: Phase 2
• First received: December 9, 2013
• Last updated: December 23, 2013
• Start date: July 2013
• Est. completion date: January 2018

Study information

• Verified date: December 2013
• Source: Harbin Medical University
• Contact: Binbin Cui, MD
• Phone: +86 13351112888
• Email: 13351112888[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2018
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance		1 year	Yes
Primary	Disease free survival		3-year	Yes
Secondary	Local recurrence rate		3 years	No
Secondary	Safety: Number of Participants with Adverse Events		3 years	Yes
Secondary	R0 resection rate		1 year	No
Secondary	Pathologic complete response		1 year	No