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Optimization of Preoperative Treatment in Locally Advanced Rectal Cancer (STELLAR)

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ClinicalTrials.gov Identifier: NCT02533271
Recruitment Status : Recruiting
First Posted : August 26, 2015
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Jing Jin, M.D., Chinese Academy of Medical Sciences

Brief Summary:
The purpose of this study is to compare effectiveness of short-term radiotherapy with neoadjuvant chemotherapy(Experimental group) with preoperative long-term chemoradiotherapy(Control group) in locally advanced rectal cancer. The hypothesis is 3-year disease-free survival in Experimental group was non-inferior to that in Control group.

Condition or disease Intervention/treatment Phase
Cancer, Rectum Radiation: Short-course radiotherapy with neoadjuvant chemotherapy Radiation: Long-term chemoradiotherapy Phase 3

Detailed Description:

The study is a prospective phase II/III randomized multicenter trial. The purpose of this study is to compare short-term radiotherapy with neoadjuvant chemotherapy(Experimental group) with preoperative long-term chemoradiotherapy(Control group) for middle-lower locally advanced rectal cancer. The primary endpoint is 3-year disease-free survival, and the secondary objectives are 3-year local recurrence-free survival, distant metastasis-free survival and overall survival. Furthermore, the late toxicity profile and quality of life (QoL) after 3 years follow-up are secondary endpoints. For each group, a plan for collection of serum/plasma/feces at different stages of treatment and for obtaining fresh tumor tissue for freezing prior to treatment was defined in the protocol.

The STELLAR-trial has been designed by National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, and the hypothesis is 3-year disease-free survival in Experimental group was non-inferior to that in Control group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 552 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II/III Study of Short-term Radiotherapy Plus Neoadjuvant Chemotherapy Versus Preoperative Long-term Chemoradiotherapy in Locally Advanced Rectal Cancer
Study Start Date : August 2015
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2025

Arm Intervention/treatment
Experimental: Experimental group
The intervention of Experimental group is Short-course radiotherapy with neoadjuvant chemotherapy, which consists of a short-course radiotherapy (SCRT, 5 Gy x 5 alone), then after 7-10 days of radiotherapy completed, patients will receive neoadjuvant chemotherapy, given in 3 week cycle of capecitabine 1000 mg/m2 twice daily, day 1-14 combined with oxaliplatin 130 mg/m2 once. In total, 4 cycles of neoadjuvant chemotherapy are prescribed preoperatively, then followed by a total mesorectal excision(TME) and postoperative adjuvant chemotherapy. If patients are eligible for postoperative chemotherapy this should consist of at least 2 cycles, which are the same as neoadjuvant chemotherapy.
Radiation: Short-course radiotherapy with neoadjuvant chemotherapy
Short-course radiotherapy with 4 cycles of neoadjuvant chemotherapy

Control group
The intervention of Control group is long-term chemoradiotherapy(CRT), which consists of a long-term chemoradiation (2 Gy x 25 with capecitabine) preoperatively, followed by a total mesorectal excision(TME) and then postoperative adjuvant chemotherapy. The radiotherapy is given in combination with capecitabine in a dose of 825 mg/m2 twice daily on days when radiotherapy, excluding weekends. If patients are eligible for postoperative chemotherapy this should consist of at least 6 cycles of capecitabine 1000 mg/m2 twice daily, day 1-14 combined with oxaliplatin 130 mg/m2 once every 3 weeks.
Radiation: Long-term chemoradiotherapy
Standard chemoradiotherapy




Primary Outcome Measures :
  1. disease-free survival rate [ Time Frame: three year ]

Secondary Outcome Measures :
  1. overall survival rate [ Time Frame: three year ]
  2. incidence of surgical complications [ Time Frame: one month ]
    Surgical complications are defined as those occurring within 30 days after surgery, such as re-operation, anastomotic fistula, bleeding, infection and death related to the operation.

  3. incidence of acute toxicities during radiation or chemotherapy [ Time Frame: three months ]
    Number of participants with abnormal laboratory values and/or adverse events that are related to radiation or chemotherapy as assessed by Common Toxicity Criteria for Adverse Effects(CTCAE) v3.0.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven rectal adenocarcinoma;
  • Distance between tumour and anal verge≤ 10cm;
  • Locally advanced tumour;(AJCC Cancer Staging:T3, T4 or N+)
  • Cancer Staging must be based on pelvic MRI;
  • Eastern Cooperative Oncology Group(ECOG) performance score ≤ 1;
  • Written informed consent;
  • Mentally and physically fit for chemotherapy;
  • Adequate blood counts: White blood cell count ≥3.5 x 109/L Haemoglobin levels ≥100g/L Platelet count ≥100 x 109/L Creatinine levels ≤1.0× upper normal limit(UNL) Urea nitrogen levels ≤1.0× upper normal limit(UNL) Alanine aminotransferase(ALT) ≤1.5× upper normal limit(UNL) Aspartate aminotransferase(AST) ≤1.5× upper normal limit(UNL) Alkaline phosphatase(ALP) ≤1.5× upper normal limit(UNL) Total bilirubin(TBIL) ≤1.5× upper normal limit(UNL)
  • No excision of tumor, chemotherapy or other anti-tumor treatment after the diagnosis.

Exclusion Criteria:

  • Distant metastases;
  • Recurrent rectal cancer;
  • Active Crohn's disease or ulcerative colitis;
  • Concomitant malignancies;(except basocellular carcinoma or in-situ cervical carcinoma)
  • Allergic to Fluorouracil or Platinum drugs;
  • Contraindications to MRI for any reason;
  • Concurrent uncontrolled medical condition;
  • Pregnancy or breast feeding;
  • Known malabsorption syndromes or lack of physical integrity of upper gastrointestinal tract;
  • Symptoms or history of peripheral neuropathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533271


Contacts
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Contact: Yuan Tang +86-15011304945 tangyuan82@126.com
Contact: Jing Jin +86-13601365130 jingjin1025@163.com

Locations
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China, Beijing
Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College Recruiting
Beijing, Beijing, China
Contact: Yang Tang    +86-15011304945    tangyuan82@126.com   
Contact: Jing Jin    +86-13601365130    jingjin1025@163.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Study Director: Jing Jin Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
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Responsible Party: Jing Jin, M.D., vice director of Radiotherapy Department, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02533271    
Other Study ID Numbers: XT2015-03
CH-GI-090 ( Other Identifier: Ethics Committee of Cancer Institute and Hospital, Chinese Academy of Medical Sciences )
First Posted: August 26, 2015    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jing Jin, M.D., Chinese Academy of Medical Sciences:
rectal cancer
short-term radiotherapy
neoadjuvant chemotherapy
total mesorectal excision
Additional relevant MeSH terms:
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Rectal Neoplasms
Rectal Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases