Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT04389086
PHASE3

Induction Chemotherapy for Locally Recurrent Rectal Cancer

Sponsor: Catharina Ziekenhuis Eindhoven

View on ClinicalTrials.gov

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)

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

364

Start Date

2020-11-13

Completion Date

2030-03-01

Last Updated

2022-09-06

Healthy Volunteers

No

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) 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 (14)

UZ Gent

Ghent, Belgium

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, Netherlands

Oslo Universitetssykehus

Oslo, Norway

Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.

Lisbon, Portugal

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Skåne Universitetssjukhuset

Malmo, Sweden

Karolinska Universitetssjukhuset

Stockholm, Sweden