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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04389086
Other study ID # NL73593
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 13, 2020
Est. completion date March 1, 2030

Study information

Verified date September 2022
Source Catharina Ziekenhuis Eindhoven
Contact Stefi Nordkamp, MD
Phone 0031 40 2398858
Email stefi.nordkamp@catharinaziekenhuis.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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)


Recruitment information / eligibility

Status Recruiting
Enrollment 364
Est. completion date March 1, 2030
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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) 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.
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.

Locations

Country Name City State
Belgium UZ Gent Gent
Netherlands Amsterdam UMC Amsterdam
Netherlands Antoni van Leeuwenhoek Amsterdam
Netherlands Catharina Hospital Eindhoven
Netherlands University Medical Centre Groningen Groningen
Netherlands Leids University Medical Centre Leiden
Netherlands Haaglanden Medical Centre Leidschendam
Netherlands Maastricht University Medical Centre Maastricht
Netherlands Erasmus Medical Centre Rotterdam
Norway Oslo Universitetssykehus Oslo
Portugal Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. Lisbon
Sweden Sahlgrenska Universitetssjukhuset Göteborg
Sweden Skåne Universitetssjukhuset Malmö
Sweden Karolinska Universitetssjukhuset Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Catharina Ziekenhuis Eindhoven

Countries where clinical trial is conducted

Belgium,  Netherlands,  Norway,  Portugal,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with a clear resection margin 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) Scored within 1 one month of surgery
Secondary Local recurrence free survival Assessed up to 5 years
Secondary Progression free survival Assessed up to 5 years
Secondary Metastasis free survival Assessed up to 5 years
Secondary Disease free survival Assessed up to 5 years
Secondary Overall survival Assessed up to 5 years
Secondary Pathologic response Scored according to Mandard Scored within 1 month of surgery
Secondary Toxicity induction chemotherapy Adverse events grade 3 or higher according to the NCI-CTCAE v5.0 Scored until one month after the last administration of the chemotherapy
Secondary Compliance induction chemotherapy Scored within 1 month after start chemoradiotherapy
Secondary Toxicity chemoradiotherapy Adverse events grade 3 or higher according to the NCI-CTCAE v5.0 Scored until 3 months after the last administration of the radiotherapy
Secondary Compliance chemoradiotherapy Evaluation at time of surgery
Secondary Number of patients undergoing surgery Surgery is scheduled 10-14 weeks after finishing chemoradiotherapy
Secondary Surgical characteristics including data on intra-operative radiotherapy Evaluation directly postoperative
Secondary Major surgical morbidity Clavien-Dindo grade 3 or higher 30 and 90-days postoperative
Secondary Radiological response mrTRG Restaging is performed after 3 cycles of CAPOX (1 cycle is 3 weeks) or 4 cycles of CAPOX/FOLFOX (1 cycle is 2 weeks). Second restaging is performed 4-6 weeks after finishing chemoradiotherapy
Secondary Cancer specific quality of life QLQ-C30 at baseline, 3 months and 12 months postoperative
Secondary Cost-effectiveness EQ-5D-5L at baseline, 3 months and 12 months postoperative
Secondary Colorectal cancer specific quality of life QLQ-CR29 at baseline, 3 months and 12 months postoperative
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