Efficacy and Safety of SCRT Versus TNT in Older Patients With Locally Advanced Rectal Cancer

NARecruitingINTERVENTIONAL
Enrollment

230

Participants

Timeline

Start Date

February 7, 2024

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2033

Conditions
Locally Advanced Rectal CancerOlder People
Interventions
RADIATION

Short course radiotherapy

Patients will receive 5 daily fractions of radiotherapy. Each fraction will consist of 5 Gy for a total dose of 25 Gy.

DRUG

Adjuvant chemotherapy (optional)

The choice of the adjuvant chemotherapy is to the investigator's discretion.

PROCEDURE

Total mesorectal excision

"Surgery must be performed according to the principles of total mesorectal excision. A watch \& wait approach is allowed for those subjects who have clinical complete response according to the local assessment."

COMBINATION_PRODUCT

Total neoadjuvant therapy

"The choice of the TNT is left to the investigator's discretion.~If RAPIDO:~* SCRT (5 fractions of 5 Gy), followed by~* Up to 18 weeks of oxaliplatin based chemotherapy (mFOLFOX6 or CAPOX)~If RAPIDO light:~* SCRT (5 fractions of 5 Gy), followed by~* Up to 12 weeks of oxaliplatin based chemotherapy (mFOLFOX6 or CAPOX)~If OPRA with induction chemotherapy:~* Up to 16 weeks of oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX), followed by~* CRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion fluorouracil or capecitabine)~If OPRA with consolidation chemotherapy:~* CRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion fluorouracil or capecitabine) followed by~* Up to 16 weeks of oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX)"

Trial Locations (19)

1000

RECRUITING

CHU Saint-Pierre, Brussels

1020

RECRUITING

CHU Brugmann, Brussels

1070

RECRUITING

Institut Jules Bordet, Anderlecht

1160

RECRUITING

Chirec Delta, Auderghem

2300

RECRUITING

AZ Turnhout, Turnhout

2610

RECRUITING

ZAS Antwerpen, Antwerp

2650

RECRUITING

UZA Antwerpen, Edegem

4000

RECRUITING

CHU de Liège - Sart Tilman, Liège

5000

NOT_YET_RECRUITING

CHR Sambre et Meuse (site Meuse), Namur

RECRUITING

CHU St Elisabeth, Namur

5530

RECRUITING

CHU UCL Namur, Godinne

6000

SUSPENDED

Grand Hôpital De Charleroi, Charleroi

6042

NOT_YET_RECRUITING

CHU Charleroi, Charleroi

6800

RECRUITING

CHA Libramont, Libramont

7000

NOT_YET_RECRUITING

CHU Ambroise Pare, Mons

7100

RECRUITING

Hôpital de Jolimont, Haine-Saint-Paul

7301

RECRUITING

Epicura, Hornu

9000

RECRUITING

UZ Gent, Ghent

9100

RECRUITING

AZ Nikolaas, Sint-Niklaas

Sponsors
All Listed Sponsors
lead

Jules Bordet Institute

OTHER