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Neoadjuvant Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer

NCT ID: NCT02022852

Last Updated: 2013-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2018-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Rectal Cancer

Keywords

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Rectal Cancer Concurrent Chemoradiotherapy Sequential Therapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Concurrent chemoradiotherapy

Capecitabine neoadjuvant concurrent radiochemotherapy and XELOX adjuvant therapy

Group Type ACTIVE_COMPARATOR

Capecitabine

Intervention Type DRUG

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.

Sequential therapy

XELOX/capecitabine/XELOX neoadjuvant chemo-chemoradio-chemo sequential therapy and XELOX adjuvant therapy

Group Type EXPERIMENTAL

XELOX

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harbin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Binbin Cui

Director of Abdominal Surgery Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Binbin Cui, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Abdominal Surgery, Harbin Medical University Cancer Hospital

Locations

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Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Binbin Cui, MD

Role: CONTACT

Phone: +86 13351112888

Email: [email protected]

Facility Contacts

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Binbin Cui, MD

Role: primary

Other Identifiers

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HarbinMU-BCui-001

Identifier Type: -

Identifier Source: org_study_id