Contact Radiotherapy for Rectal Cancer (CORRECT): a Multicenter Randomized Phase II Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Rectum preservation
研究概览
简要总结
The aim of the CORRECT phase 2 study is to show non-inferiority of Contact x-ray brachytherapy (CXB) + short-course radiotherapy (SCRT) compared to the experimental arm of the OPERA trial in organ preservation for early and early intermediate rectal cancer (cT1-3abN1).
详细描述
The primary aim of this study is to determine whether a combination of CXB + SCRT is non-inferior to CXB + chemoradiotherapy (CRT) regarding the primary endpoint 2-year organ preservation rate. Additionally, we hypothesize that a chemotherapy-free, radiation-only experimental treatment CXB+SCRT is associated with less side-effects compared to the OPERA regime.
In the OPERA trial (Gerard et al, 2023), the CXB was delivered in combination with long-course CRT. A combination of short-course radiotherapy (SCRT) and CXB has previously been used mainly in elderly and comorbid patients not suitable for long-course chemoradiotherapy. Recently, an international multi-institution report showed good outcomes of planned organ preservation using SCRT together with contact brachytherapy boost. However, no randomized data on this combination therapy are available. There are further no trials comparing CRT+CXB and SCRT+CXB.
Study participants will be randomized to either the standard treatment consisting of CXB (90Gy/3 fractions/4 weeks) and CRT 45/50 Gy (1.8/2 Gy/fraction/5 weeks) with concurrent chemotherapy using capecitabine (900 mg/m2 bid, on radiation days) OR the experimental treatment consisting of CXB (90Gy/3 fractions/4 weeks) SCRT (25 Gy in 5 daily fractions over a total time of 1 week, treating 5 days per week, 1 fraction per day, using 5 Gy per fraction, over the maximum treatment period of eight calendar days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adenocarcinoma of the rectum classified as:
- •cT1-cT3ab, < 5 cm largest diameter and < ½ circumference (MRI staging), N0-N1 (<= 3 nodes < 8mm diameter), M0
- •Performance status (ECOG) 0-1
- •Operable patient
- •Tumor accessible to endocavitary contact X-ray brachytherapy with a distance from the lower tumor border to the anal verge ≤10 cm
- •18 years or above
- •No comorbidity preventing treatment
- •Patient having read the information note and having signed the informed consent
- •Follow-up possible
排除标准
- •Inoperable patient
- •T3cd, T4, T≥ 5cm, Involvement of more than half of the bowel circumference
- •Distance from the lower tumor border to the anal verge >10 cm
- •N2-status at diagnosis or N1 with any node>= 8 mm diameter
- •Patient presenting with metastasis at diagnosis (M1)
- •Previous pelvic irradiation
- •Tumor with extramural vascular invasion
- •Poorly differentiated tumor
- •Simultaneous progressive cancer
- •Tumor invading external anal sphincter or growth within 1 mm of the levator
- •Tumor within 1 mm from MRF (mesorectal fascia)
- •Patient unable to receive CXB or CRT
- •Any significant concurrent medical illness that in the opinion of the investigator would preclude protocol therapy
- •Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions that would interfere with the ability to comply with the study protocol
- •Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment within 28 days prior to the first dose of study treatment
- •Total DPD deficiency
研究组 & 干预措施
CXB + CRT
Contact x-ray brachytherapy (CXB) (90Gy/3 fractions/4 weeks) and chemoradiotherapy (CRT) 45/50 Gy (1.8/2 Gy/fraction/5 weeks) with concurrent chemotherapy using capecitabine (900 mg/m2 bid, on radiation days).
干预措施: Radiotherapy (Radiation)
CXB + CRT
Contact x-ray brachytherapy (CXB) (90Gy/3 fractions/4 weeks) and chemoradiotherapy (CRT) 45/50 Gy (1.8/2 Gy/fraction/5 weeks) with concurrent chemotherapy using capecitabine (900 mg/m2 bid, on radiation days).
干预措施: Contact x-ray brachytherapy (Radiation)
CXB + CRT
Contact x-ray brachytherapy (CXB) (90Gy/3 fractions/4 weeks) and chemoradiotherapy (CRT) 45/50 Gy (1.8/2 Gy/fraction/5 weeks) with concurrent chemotherapy using capecitabine (900 mg/m2 bid, on radiation days).
干预措施: Chemotherapy (Drug)
CXB + SCRT
Contact x-ray brachytherapy (CXB) (90Gy/3 fractions/4 weeks) and a short-course radiotherapy (SCRT) (25 Gy in 5 daily fractions over a total time of 1 week, treating 5 days per week, 1 fraction per day, using 5 Gy per fraction, over the maximum treatment period of eight calendar days).
干预措施: Short-course radiotherapy (Radiation)
CXB + SCRT
Contact x-ray brachytherapy (CXB) (90Gy/3 fractions/4 weeks) and a short-course radiotherapy (SCRT) (25 Gy in 5 daily fractions over a total time of 1 week, treating 5 days per week, 1 fraction per day, using 5 Gy per fraction, over the maximum treatment period of eight calendar days).
干预措施: Contact x-ray brachytherapy (Radiation)
结局指标
主要结局
Rectum preservation
时间窗: At 24 months after start of treatment
Proportion of patients with successful rectum preservation after standard vs experimental treatment. Organ preservation is considered to have failed if the rectum is removed OR if the patient develops non-salvageable locoregional failure
次要结局
- Late treatment related toxicity(From 90 days after ending treatment until end of study)
- Locoregional failure(At 24 months after start of treatment)
- Salvage TME resections(From 24 weeks after start of treatment until end of study)
- General Health Related Quality of Life (HR QoL)(At baseline and at 3, 6, 12, 24, 36, 48 and 60 months after start of treatment)
- Colorectal cancer specific Health Related Quality of Life (HR QoL)(At baseline and at 3, 6, 12, 24, 36, 48 and 60 months after start of treatment)
- Clinical complete response (cCR)(At 14-16 and 24-26 weeks after start of treatment)
- Stoma(At 12 and 24 months after start of treatment)
- Tumor regression grade(After 14-16 weeks and 24-26 weeks after start of treatment)
- Acute treatment-related toxicity(From start of treatment until 90 days after ending treatment)
- Postoperative complications(Within the first 30 days after Total Mesorectal Excision (TME) surgery)
- Metastasis-free survival(At 24 months after start of treatment)
- Overall survival(At 24 months after start of treatment)
- TME-free survival(At 24 months after start of treatment)
- Sphincter preservation(At 24 months after start of treatment)
- Bowel function(At baseline, 3, 6, 12, 24, 36, 48 and 60 months after start of treatment)
研究者
Alexander Valdman
National Principal Investigator
Karolinska University Hospital