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
|Condition or disease||Intervention/treatment||Phase|
|Cancer, Rectum||Radiation: Short-course radiotherapy with neoadjuvant chemotherapy Radiation: Long-term chemoradiotherapy||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||552 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
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
- disease-free survival rate [ Time Frame: three year ]
- overall survival rate [ Time Frame: three year ]
- 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.
- 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.
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
|Contact: Yuan Tangemail@example.com|
|Contact: Jing Jinfirstname.lastname@example.org|
|Study Director:||Jing Jin||Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College|