Recruiting NCT04389086
Induction Chemotherapy for Locally Recurrent Rectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Combination drug, Chemoradiotherapy, Surgery locally recurrent rectal cancer.
- Who it may be relevant to
- Registry conditions: Recurrent Rectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Netherlands, Norway, Portugal, Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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)
Interventions
- Drug Combination drug
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) unacceptabl - Radiation Chemoradiotherapy
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. - Procedure Surgery locally recurrent rectal cancer
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.
Primary outcome measures
- Proportion of patients with a clear resection margin [Time frame: Scored within 1 one month of surgery]
Secondary outcome measures (12)
- 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]
- Toxicity induction chemotherapy [Time frame: Scored until one month after the last administration of the chemotherapy]
- 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]
- Compliance chemoradiotherapy [Time frame: Evaluation at time of surgery]
- Number of patients undergoing surgery [Time frame: Surgery is scheduled 10-14 weeks after finishing chemoradiotherapy]
- Surgical characteristics [Time frame: Evaluation directly postoperative]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 8 centers
- Amsterdam UMC — Amsterdam
- Antoni van Leeuwenhoek — Amsterdam
- Catharina Hospital — Eindhoven
- University Medical Centre Groningen — Groningen
- Leids University Medical Centre — Leiden
- Haaglanden Medical Centre — Leidschendam
- Maastricht University Medical Centre — Maastricht
- Erasmus Medical Centre — Rotterdam
Sweden · 3 centers
- Sahlgrenska Universitetssjukhuset — Gothenburg
- Skåne Universitetssjukhuset — Malmö
- Karolinska Universitetssjukhuset — Stockholm
Belgium · 1 center
- UZ Gent — Ghent
Norway · 1 center
- Oslo Universitetssykehus — Oslo
Portugal · 1 center
- Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. — Lisbon
Identifiers
NCT: NCT04389086 · NL73593