Induction Chemotherapy for Locally Recurrent Rectal Cancer
ID: NCT04389086
Our intelligence engine has synthesized this trial record to answer your most important questions in clear, simple terms:
This is a multicentre, open-label, parallel arms, phase IIII study that randomises patients with locally recurrent rectal cancer in a 1:1 ratio to receive either induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm)
Induction chemotherapy consists of either three three-weekly cycles of CAPOX (oxaliplatin 130 mg/m2 BSA IV + capecitabine 1000 mg/m2 BSA, orally, twice daily) or four two-weekly cycles of FOLFOX (85 mg/m2 BSA of oxaliplatin IV + 400 mg/m2 BSA of leucovorin IV + 400 mg/m2 BSA of bolus 5-fluorouracil IV followed by 2400 mg/m2 BSA of continuous 5-fluorouracil IV). It is left to the discretion of the treating medical oncologist which of the two will be administered. In case of (previous) unacceptable toxicity (physician's discretion) to oxaliplatin, FOLFIRI may be prescribed. FOLFIRI (180 mg/m2 BSA of irinotecan IV + 400 mg/m2 BSA of leucovorin IV + 400 mg/m2 BSA of bolus 5-fluorouracil IV followed by 2400 mg/m2 BSA of continuous 5-fluorouracil IV) consists of four two-weekly cycles. If a patient has stable or responsive disease, induction chemotherapy will be continued with either one three-weekly cycle of CAPOX or two two-weekly cycles of FOLFOX/FOLFIRI.
Concomitant chemotherapy agent: capecitabine Radiotherapy dose: full course radiotherapy consists of 25x2.0 or 28x1.8 Gy. In case of previous radiotherapy, the radiotherapy dose will consist of 15x2.0 Gy.
Type of surgery depends on the location of the recurrence and involvement of adjacent structures and is left to the discretion of the operating surgeon. Intraoperative radiotherapy is optional.
Treatment Arms Description
Induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery
Neoadjuvant chemoradiotherapy followed by surgery
- 18 years or older
- Confirmed locally recurrent rectal cancer after total or partial mesorectal resection for rectal or distal sigmoidal cancer either by histopathology ór clinically proven (evidence on imaging in combination with clinical findings, with consensus in MDT)
- Resectable disease determined by magnetic resonance imaging (MRI) or deemed resectable after neoadjuvant treatment with chemoradiotherapy.
- WHO performance score 0-1
- Written informed consent
- Radiological evidence of metastatic disease (e.g. liver, lung) at time of randomisation or in the six months prior to randomisation.
- Known homozygous DPD deficiency
- Any chemotherapy in the past 6 months.
- Any contraindication for the planned chemotherapy, as determined by the medical oncologist.
- Radiotherapy in the past 6 months for primary rectal cancer.
- Any contraindication for the planned chemoradiotherapy, as determined by the medical oncologist and/or radiation oncologist.
- Any contraindication for surgery, as determined by the surgeon and/or anaesthesiologist.
- Concurrent malignancies that interfere with the planned study treatment or the prognosis of resected LRRC.
Primary Outcome Measures
- Proportion of patients with a clear resection margin — Time Frame: Scored within 1 one month of surgery
A resection margin is considered clear (R0), if there are no tumour cells in any of the resection surfaces as determined by microscopy (resection margin \> 0mm)
View Secondary Outcome Measures (17)
- Local recurrence free survival — Time Frame: Assessed up to 5 years
- Progression free survival — Time Frame: Assessed up to 5 years
- Metastasis free survival — Time Frame: Assessed up to 5 years
- Disease free survival — Time Frame: Assessed up to 5 years
- Overall survival — Time Frame: Assessed up to 5 years
- Pathologic response — Time Frame: Scored within 1 month of surgery
Scored according to Mandard
- Toxicity induction chemotherapy — Time Frame: Scored until one month after the last administration of the chemotherapy
Adverse events grade 3 or higher according to the NCI-CTCAE v5.0
- Compliance induction chemotherapy — Time Frame: Scored within 1 month after start chemoradiotherapy
- Toxicity chemoradiotherapy — Time Frame: Scored until 3 months after the last administration of the radiotherapy
Adverse events grade 3 or higher according to the NCI-CTCAE v5.0
- Compliance chemoradiotherapy — Time Frame: Evaluation at time of surgery
This trial is recruiting at 14 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 14 Facilities & Contact Sites
Want to apply or inquire about joining this study? Fill out this simple questionnaire, and our assistant will instantly generate a professional email draft you can copy and send to the central contact coordinator listed above!
View Official Medical/Scientific Title
Multicentre, Open-label, Randomised, Controlled, Parallel Arms Clinical Trial of Induction Chemotherapy Followed by Chemoradiotherapy Versus Chemoradiotherapy Alone as Neoadjuvant Treatment for Locally Recurrent Rectal Cancer - PelvEx II