Clinical trial NCT02022852: Neoadjuvant Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer
Official title: Efficacy and Safety of Neoadjuvant Chemo-chemoradio-chemo Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer: a Phase II Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: Rectal Cancer
Concurrent Chemoradiotherapy
Sequential Therapy
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2013-12-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease free survival
timeFrame: 3-year
Secondary outcomes:
measure: Local recurrence rate
timeFrame: 3 years
measure: Safety: Number of Participants with Adverse Events
timeFrame: 3 years
measure: R0 resection rate
timeFrame: 1 year
measure: Pathologic complete response
timeFrame: 1 year
Other outcomes:
measure: Compliance
timeFrame: 1 year
Locations:
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
Study officials:
affiliation: Department of Abdominal Surgery, Harbin Medical University Cancer Hospital
name: Binbin Cui, MD
role: PRINCIPAL_INVESTIGATOR
References: