Induction Chemotherapy for Locally Recurrent Rectal Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

364

Participants

Timeline

Start Date

November 13, 2020

Primary Completion Date

March 1, 2024

Study Completion Date

March 1, 2030

Conditions
Recurrent Rectal Cancer
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."

Trial Locations (14)

Unknown

NOT_YET_RECRUITING

UZ Gent, Ghent

RECRUITING

Amsterdam UMC, Amsterdam

RECRUITING

Antoni van Leeuwenhoek, Amsterdam

RECRUITING

University Medical Centre Groningen, Groningen

RECRUITING

Leids University Medical Centre, Leiden

RECRUITING

Haaglanden Medical Centre, Leidschendam

RECRUITING

Maastricht University Medical Centre, Maastricht

RECRUITING

Erasmus Medical Centre, Rotterdam

NOT_YET_RECRUITING

Oslo Universitetssykehus, Oslo

NOT_YET_RECRUITING

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

NOT_YET_RECRUITING

Sahlgrenska Universitetssjukhuset, Gothenburg

NOT_YET_RECRUITING

Skåne Universitetssjukhuset, Malmo

NOT_YET_RECRUITING

Karolinska Universitetssjukhuset, Stockholm

5623EJ

RECRUITING

Catharina Hospital, Eindhoven

All Listed Sponsors
lead

Catharina Ziekenhuis Eindhoven

OTHER

NCT04389086 - Induction Chemotherapy for Locally Recurrent Rectal Cancer | Biotech Hunter | Biotech Hunter