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Rectal Cancer And Pre-operative Induction Therapy Followed by Dedicated Operation. The RAPIDO Trial (RAPIDO)

Primary Purpose

Rectal Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
M1 scheme
standard long course chemoradiotherapy
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring rectal cancer, radiotherapy, chemotherapy, 5x5, capecitbine, oxaliplatin, CAPOX, FOLFOX, folinic acid, fluorouracil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Primary tumour characteristics:

  1. Histological proof of newly diagnosed primary adenocarcinoma of the rectum
  2. Locally advanced tumour fulfilling at least one of the following criteria on pelvic MRI indicating high risk of failing locally and/or systemically (T4a, i.e. overgrowth to an adjacent organ or structure like the prostate, urinary bladder, uterus, sacrum, pelvic floor or side wall (according to TNM version 5), cT4b, i.e. peritoneal involvement, extramural vascular invasion (EMVI+). N2, i.e. four or more lymph nodes in the mesorectum showing morphological signs on MRI indicating metastatic disease. Positive MRF, i.e. tumor or lymph node < 1 mm from the mesorectal fascia. Enlarged lateral nodes, > 1 cm (lat LN+)

Exclusion Criteria:

  1. Extensive growth into cranial part of the sacrum (above S3) or the lumbosacral nerve roots indicating that surgery will never be possible even if substantial tumour down-sizing is seen
  2. Presence of metastatic disease or recurrent rectal tumour
  3. Familial Adenomatosis Polyposis coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn¡¦s disease or active ulcerative Colitis
  4. Concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 5 years
  5. Known DPD deficiency
  6. Any contraindications to MRI (e.g. patients with pacemakers)
  7. Medical or psychiatric conditions that compromise the patient's ability to give informed consent
  8. Concurrent uncontrolled medical conditions
  9. Any investigational treatment for rectal cancer within the past month
  10. Pregnancy or breast feeding
  11. Patients with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract
  12. Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac dysrhythmia, e.g. atrial fibrillation, even if controlled with medication) or myocardial infarction within the past 12 months
  13. Patients with symptoms or history of peripheral neuropathy

Sites / Locations

  • Siteman Cancer Center, Washington University Medical School
  • Aalborg Universitetshospital
  • Odense Universitetshospital
  • University Medical Center Groningen
  • Noordwest Ziekenhuisgroep
  • Amsterdam UMC, location AMC
  • Amsterdam UMC, location VUMC
  • Nki / Avl
  • Onze Lieve Vrouwe Gasthuis
  • Wilhelmina Ziekenhuis
  • Amphia Ziekenhuis
  • Reinier de Graaf Groep
  • Bronovo Ziekenhuis
  • HaGaZiekenhuis
  • Medisch Centrum Haaglanden
  • Deventer Hospital
  • Catharina ZIekenhuis
  • Het Groene Hart Ziekenhuis
  • Martini Ziekenhuis
  • Universitair Medisch Centrum Groningen
  • de Tjongerschans
  • Ziekenhuisgroep Twente
  • Spaarne Ziekenhuis
  • Medisch Centrum Leeuwarden
  • Radiotherapeutisch Instituut Friesland
  • Leiden University Medical Center
  • Alrijne Ziekenhuis
  • UMC Nijmegen St Radboud
  • Antonius Ziekenhuis
  • Diakonessenhuis
  • Isala Klinieken
  • Sørlandet Sykehus Kristiansand
  • Oslo Universitetssykehus
  • Institute of Oncology
  • Hospital Vall d'Hebron
  • ICO Hospital Duran I Reynals
  • Consorcio Hospital General Universitario Valencia
  • Hospital Clínico Universitario de Valencia
  • Hospital Universitari i Politècnic la Fe
  • Södra Älvsborgs Sjukhus
  • Mälarsjukhuset
  • Falu Lasarett
  • Gävle sjukhus
  • Sahlgrenska Universitetssjukhuset
  • Kalmar Hospital
  • Centralsjukhuset i Karlstad
  • Linköpings Universitet
  • Universitetssjukhuset i Lund
  • Skaraborgs Sjukhus
  • Karolinska Universitetssjukhuset
  • Sundsvalls Sjukhus
  • Norrlands Universitetssjukhus
  • Akademiska Sjukhuset
  • Centrallasarett
  • Centrallasarettet Växjö
  • Universitetssjukhuset ÖREBRO

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

B: 5x5Gy -> CAPOX -> surgery

A: 5 weeks chemoradiation -> surgery

Arm Description

experimental group (arm B) M1 scheme

control group (arm A) standard long course chemoradiotherapy

Outcomes

Primary Outcome Measures

Disease related Treatment Failure (DrTF)
DrTF = Either local or distant relapse or death caused by the rectal carcinoma whichever comes first. In case of nonrectal cancer related death patients will be censored at date of death. In case of a second primary tumour patients will be censored at the date of diagnosis of the second primary tumour. In case of local regrowth after wait & watch strategy, followed by no resection or R2 resection, diagnosis local regrowth is taken. Patients lost to follow-up will be censored the last date of patient visit. Survival curves for Disease related Treatment Failure after 3 years of follow-up will be constructed using the method of Kaplan and Meier.

Secondary Outcome Measures

Overall survival
Overall survival will be computed as the time between randomization and colorectal cancer or treatment related death. Patients lost to follow-up will be censored the last date of patient visit. In case of a second primary tumour patients will be censored at the date of diagnosis of the second primary tumour.
CRM negative rate
Circumferential resection margin > 1 mm
pCR rate
Pathological complete response after neo-adjuvant treatment
Short and long-term toxicity
Treatment associated toxicity
Surgical complications
Wound rupture, bleeding, infection, rectal anastomotic leak
Quality of life QLQ-C30
Quality of life QLQ-C30
Quality of life QLQ-CR-29+
Quality of life QLQ-CR-29+
Quality of life QLQ-CIPN20
Quality of life QLQ-CIPN20
Quality of life LARS
LARS

Full Information

First Posted
March 18, 2012
Last Updated
January 11, 2023
Sponsor
University Medical Center Groningen
Collaborators
Karolinska University Hospital, Leiden University Medical Center, Uppsala University Hospital, Dutch Cancer Society
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1. Study Identification

Unique Protocol Identification Number
NCT01558921
Brief Title
Rectal Cancer And Pre-operative Induction Therapy Followed by Dedicated Operation. The RAPIDO Trial
Acronym
RAPIDO
Official Title
Randomized Multicentre Phase III Study of Short Course Radiation Therapy Followed by Prolonged Pre-operative Chemotherapy and Surgery in Primary High Risk Rectal Cancer Compared to Standard Chemoradiotherapy and Surgery and Optional Adjuvant Chemotherapy.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 21, 2011 (Actual)
Primary Completion Date
March 8, 2020 (Actual)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
Collaborators
Karolinska University Hospital, Leiden University Medical Center, Uppsala University Hospital, Dutch Cancer Society

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Currently the 3-year disease free survival of patients with locally advanced rectal cancer is about 50%. Current standard treatment for patients at high risk of failing locally and/or systemically includes pre-operative long course radiotherapy (5 weeks) in combination with chemotherapy (so called neoadjuvant chemoradiotherapy). The neoadjuvant chemoradiotherapy has been demonstrated to improve local control, but had no effect on the overall survival. Different studies in patients with rectal cancer studying the effect of adjuvant post operative chemotherapy did not result in an improved survival. This may be due the fact that rectal cancer surgery (TME) is associated with a high complication rate so substantial proportion of patients cannot receive chemotherapy postoperatively. An alternative approach is to administer the systemic therapy preoperative. To guarantee control of the rectum tumor short-course radiotherapy (5 days) is given, as different studies showed local control of the tumor for a long time. During this waiting period the patient is in a good condition to receive an optimal dose of chemotherapy. The investigators hypothesize that with this proposed protocol both the local tumour and possible micrometastases are effectively treated and that this will result in an increased survival. The investigators will compare this with the standard treatment of neoadjuvant chemoradiation followed by TME surgery and optional adjuvant chemotherapy.
Detailed Description
Patients will be randomized between an experimental group (arm B) in which short course 5 x 5 Gy radiation scheme is followed by six cycles of combination chemotherapy (capecitabine/5FU and oxaliplatin) and surgery and a control group (arm A) with long course chemoradiotherapy followed by surgery. In arm A adjuvant chemotherapy is allowed according to the local protocol of the institution. In both groups the rectal tumour will be removed by TME surgery or more extensive surgery if required because of tumour extent.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
rectal cancer, radiotherapy, chemotherapy, 5x5, capecitbine, oxaliplatin, CAPOX, FOLFOX, folinic acid, fluorouracil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
standard arm: 5.5 weeks chemoradiation -> surgery -> optional chemotherapy experimental arm: 5x5Gy -> 12 wks chemotherapy -> surgery
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
920 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B: 5x5Gy -> CAPOX -> surgery
Arm Type
Experimental
Arm Description
experimental group (arm B) M1 scheme
Arm Title
A: 5 weeks chemoradiation -> surgery
Arm Type
Active Comparator
Arm Description
control group (arm A) standard long course chemoradiotherapy
Intervention Type
Other
Intervention Name(s)
M1 scheme
Intervention Description
short course 5 x 5 Gy radiation scheme is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin (CAPOX)) and surgery. FOLFOX4 may be given as alternative for CAPOX
Intervention Type
Other
Intervention Name(s)
standard long course chemoradiotherapy
Intervention Description
long course chemoradiotherapy followed by surgery. Optional adjuvant chemotherapy (CAPOX or FOLFOX) is allowed in the control group.
Primary Outcome Measure Information:
Title
Disease related Treatment Failure (DrTF)
Description
DrTF = Either local or distant relapse or death caused by the rectal carcinoma whichever comes first. In case of nonrectal cancer related death patients will be censored at date of death. In case of a second primary tumour patients will be censored at the date of diagnosis of the second primary tumour. In case of local regrowth after wait & watch strategy, followed by no resection or R2 resection, diagnosis local regrowth is taken. Patients lost to follow-up will be censored the last date of patient visit. Survival curves for Disease related Treatment Failure after 3 years of follow-up will be constructed using the method of Kaplan and Meier.
Time Frame
3 year follow-up after surgery
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival will be computed as the time between randomization and colorectal cancer or treatment related death. Patients lost to follow-up will be censored the last date of patient visit. In case of a second primary tumour patients will be censored at the date of diagnosis of the second primary tumour.
Time Frame
10 year
Title
CRM negative rate
Description
Circumferential resection margin > 1 mm
Time Frame
within 30 days
Title
pCR rate
Description
Pathological complete response after neo-adjuvant treatment
Time Frame
within 30 days
Title
Short and long-term toxicity
Description
Treatment associated toxicity
Time Frame
3 year follow-up
Title
Surgical complications
Description
Wound rupture, bleeding, infection, rectal anastomotic leak
Time Frame
3 year follow-up
Title
Quality of life QLQ-C30
Description
Quality of life QLQ-C30
Time Frame
3 year after surgery
Title
Quality of life QLQ-CR-29+
Description
Quality of life QLQ-CR-29+
Time Frame
3 year after surgery
Title
Quality of life QLQ-CIPN20
Description
Quality of life QLQ-CIPN20
Time Frame
3 year after surgery
Title
Quality of life LARS
Description
LARS
Time Frame
3 year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary tumour characteristics: Histological proof of newly diagnosed primary adenocarcinoma of the rectum Locally advanced tumour fulfilling at least one of the following criteria on pelvic MRI indicating high risk of failing locally and/or systemically (T4a, i.e. overgrowth to an adjacent organ or structure like the prostate, urinary bladder, uterus, sacrum, pelvic floor or side wall (according to TNM version 5), cT4b, i.e. peritoneal involvement, extramural vascular invasion (EMVI+). N2, i.e. four or more lymph nodes in the mesorectum showing morphological signs on MRI indicating metastatic disease. Positive MRF, i.e. tumor or lymph node < 1 mm from the mesorectal fascia. Enlarged lateral nodes, > 1 cm (lat LN+) Exclusion Criteria: Extensive growth into cranial part of the sacrum (above S3) or the lumbosacral nerve roots indicating that surgery will never be possible even if substantial tumour down-sizing is seen Presence of metastatic disease or recurrent rectal tumour Familial Adenomatosis Polyposis coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn¡¦s disease or active ulcerative Colitis Concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 5 years Known DPD deficiency Any contraindications to MRI (e.g. patients with pacemakers) Medical or psychiatric conditions that compromise the patient's ability to give informed consent Concurrent uncontrolled medical conditions Any investigational treatment for rectal cancer within the past month Pregnancy or breast feeding Patients with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac dysrhythmia, e.g. atrial fibrillation, even if controlled with medication) or myocardial infarction within the past 12 months Patients with symptoms or history of peripheral neuropathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
B. van Etten, MD, PhD
Organizational Affiliation
University Medical Center Groningen, Department of Surgery, Groningen, The Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
B. Glimelius, MD, PhD
Organizational Affiliation
Akademiska Sjukhuset, Department of Oncology, Uppsala, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
G. A. Hospers, MD, PhD
Organizational Affiliation
University Medical Center Groningen, Department of Medical Oncology, Groningen, The Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
P. Nilsson, MD, PhD
Organizational Affiliation
Karolinska Universitetssjukhuset, Stockholm, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
C. J. van de Velde, MD, PhD
Organizational Affiliation
Leiden University Medical Center, Department of Surgery, Leiden, The Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
C.A.M. Marijnen, MD, PhD
Organizational Affiliation
Netherlands Cancer Institute, Amsterdam, the Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siteman Cancer Center, Washington University Medical School
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Aalborg Universitetshospital
City
Aalborg
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense
Country
Denmark
Facility Name
University Medical Center Groningen
City
Groningen
State/Province
Po Box 30001
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Noordwest Ziekenhuisgroep
City
Alkmaar
Country
Netherlands
Facility Name
Amsterdam UMC, location AMC
City
Amsterdam
Country
Netherlands
Facility Name
Amsterdam UMC, location VUMC
City
Amsterdam
Country
Netherlands
Facility Name
Nki / Avl
City
Amsterdam
Country
Netherlands
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
Country
Netherlands
Facility Name
Wilhelmina Ziekenhuis
City
Assen
Country
Netherlands
Facility Name
Amphia Ziekenhuis
City
Breda
Country
Netherlands
Facility Name
Reinier de Graaf Groep
City
Delft
Country
Netherlands
Facility Name
Bronovo Ziekenhuis
City
Den Haag
Country
Netherlands
Facility Name
HaGaZiekenhuis
City
Den Haag
Country
Netherlands
Facility Name
Medisch Centrum Haaglanden
City
Den Haag
Country
Netherlands
Facility Name
Deventer Hospital
City
Deventer
Country
Netherlands
Facility Name
Catharina ZIekenhuis
City
Eindhoven
Country
Netherlands
Facility Name
Het Groene Hart Ziekenhuis
City
Gouda
Country
Netherlands
Facility Name
Martini Ziekenhuis
City
Groningen
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
Country
Netherlands
Facility Name
de Tjongerschans
City
Heerenveen
Country
Netherlands
Facility Name
Ziekenhuisgroep Twente
City
Hengelo
Country
Netherlands
Facility Name
Spaarne Ziekenhuis
City
Hoofddorp
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
Country
Netherlands
Facility Name
Radiotherapeutisch Instituut Friesland
City
Leeuwarden
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
Country
Netherlands
Facility Name
Alrijne Ziekenhuis
City
Leiderdorp
Country
Netherlands
Facility Name
UMC Nijmegen St Radboud
City
Nijmegen
Country
Netherlands
Facility Name
Antonius Ziekenhuis
City
Sneek
Country
Netherlands
Facility Name
Diakonessenhuis
City
Utrecht
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
Country
Netherlands
Facility Name
Sørlandet Sykehus Kristiansand
City
Kristiansand
Country
Norway
Facility Name
Oslo Universitetssykehus
City
Oslo
Country
Norway
Facility Name
Institute of Oncology
City
Ljubljana
Country
Slovenia
Facility Name
Hospital Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
ICO Hospital Duran I Reynals
City
L'HOSPITALET de LLOBREGAT
Country
Spain
Facility Name
Consorcio Hospital General Universitario Valencia
City
Valencia
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
Country
Spain
Facility Name
Hospital Universitari i Politècnic la Fe
City
Valencia
Country
Spain
Facility Name
Södra Älvsborgs Sjukhus
City
Borås
Country
Sweden
Facility Name
Mälarsjukhuset
City
Eskilstuna
Country
Sweden
Facility Name
Falu Lasarett
City
Falun
Country
Sweden
Facility Name
Gävle sjukhus
City
Gävle
Country
Sweden
Facility Name
Sahlgrenska Universitetssjukhuset
City
Göteborg
Country
Sweden
Facility Name
Kalmar Hospital
City
Kalmar
Country
Sweden
Facility Name
Centralsjukhuset i Karlstad
City
Karlstad
Country
Sweden
Facility Name
Linköpings Universitet
City
Linköping
Country
Sweden
Facility Name
Universitetssjukhuset i Lund
City
Lund
Country
Sweden
Facility Name
Skaraborgs Sjukhus
City
Skövde
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset
City
Stockholm
Country
Sweden
Facility Name
Sundsvalls Sjukhus
City
Sundsvall
Country
Sweden
Facility Name
Norrlands Universitetssjukhus
City
Umeå
Country
Sweden
Facility Name
Akademiska Sjukhuset
City
Uppsala
Country
Sweden
Facility Name
Centrallasarett
City
Västerås
Country
Sweden
Facility Name
Centrallasarettet Växjö
City
Växjö
Country
Sweden
Facility Name
Universitetssjukhuset ÖREBRO
City
Örebro
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
32240909
Citation
van der Valk MJM, Marijnen CAM, van Etten B, Dijkstra EA, Hilling DE, Kranenbarg EM, Putter H, Roodvoets AGH, Bahadoer RR, Fokstuen T, Ten Tije AJ, Capdevila J, Hendriks MP, Edhemovic I, Cervantes AMR, de Groot DJA, Nilsson PJ, Glimelius B, van de Velde CJH, Hospers GAP; Collaborative investigators. Compliance and tolerability of short-course radiotherapy followed by preoperative chemotherapy and surgery for high-risk rectal cancer - Results of the international randomized RAPIDO-trial. Radiother Oncol. 2020 Jun;147:75-83. doi: 10.1016/j.radonc.2020.03.011. Epub 2020 Mar 30. Erratum In: Radiother Oncol. 2020 Jun;147:e1.
Results Reference
background
PubMed Identifier
33301740
Citation
Bahadoer RR, Dijkstra EA, van Etten B, Marijnen CAM, Putter H, Kranenbarg EM, Roodvoets AGH, Nagtegaal ID, Beets-Tan RGH, Blomqvist LK, Fokstuen T, Ten Tije AJ, Capdevila J, Hendriks MP, Edhemovic I, Cervantes A, Nilsson PJ, Glimelius B, van de Velde CJH, Hospers GAP; RAPIDO collaborative investigators. Short-course radiotherapy followed by chemotherapy before total mesorectal excision (TME) versus preoperative chemoradiotherapy, TME, and optional adjuvant chemotherapy in locally advanced rectal cancer (RAPIDO): a randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Jan;22(1):29-42. doi: 10.1016/S1470-2045(20)30555-6. Epub 2020 Dec 7. Erratum In: Lancet Oncol. 2021 Feb;22(2):e42.
Results Reference
background
PubMed Identifier
23742033
Citation
Nilsson PJ, van Etten B, Hospers GA, Pahlman L, van de Velde CJ, Beets-Tan RG, Blomqvist L, Beukema JC, Kapiteijn E, Marijnen CA, Nagtegaal ID, Wiggers T, Glimelius B. Short-course radiotherapy followed by neo-adjuvant chemotherapy in locally advanced rectal cancer--the RAPIDO trial. BMC Cancer. 2013 Jun 7;13:279. doi: 10.1186/1471-2407-13-279.
Results Reference
background
PubMed Identifier
35447283
Citation
Dijkstra EA, Hospers GAP, Kranenbarg EM, Fleer J, Roodvoets AGH, Bahadoer RR, Guren MG, Tjalma JJJ, Putter H, Crolla RMPH, Hendriks MP, Capdevila J, Radu C, van de Velde CJH, Nilsson PJ, Glimelius B, van Etten B, Marijnen CAM. Quality of life and late toxicity after short-course radiotherapy followed by chemotherapy or chemoradiotherapy for locally advanced rectal cancer - The RAPIDO trial. Radiother Oncol. 2022 Jun;171:69-76. doi: 10.1016/j.radonc.2022.04.013. Epub 2022 Apr 18.
Results Reference
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PubMed Identifier
33798955
Citation
Giunta EF, Bregni G, Pretta A, Deleporte A, Liberale G, Bali AM, Moretti L, Troiani T, Ciardiello F, Hendlisz A, Sclafani F. Total neoadjuvant therapy for rectal cancer: Making sense of the results from the RAPIDO and PRODIGE 23 trials. Cancer Treat Rev. 2021 May;96:102177. doi: 10.1016/j.ctrv.2021.102177. Epub 2021 Mar 16.
Results Reference
background
PubMed Identifier
35462008
Citation
Jimenez-Fonseca P, Salazar R, Valenti V, Msaouel P, Carmona-Bayonas A. Is short-course radiotherapy and total neoadjuvant therapy the new standard of care in locally advanced rectal cancer? A sensitivity analysis of the RAPIDO clinical trial. Ann Oncol. 2022 Aug;33(8):786-793. doi: 10.1016/j.annonc.2022.04.010. Epub 2022 Apr 22.
Results Reference
background
PubMed Identifier
35568280
Citation
Glynne-Jones R, Harrison M. Should the RAPIDO schedule represent standard of care in locally advanced rectal cancer? Ann Oncol. 2022 Aug;33(8):745-746. doi: 10.1016/j.annonc.2022.05.002. Epub 2022 May 12. No abstract available.
Results Reference
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PubMed Identifier
34308767
Citation
Patel A, Spychalski P, Corrao G, Jereczek-Fossa BA, Glynne-Jones R, Garcia-Aguilar J, Kobiela J. Neoadjuvant short-course radiotherapy with consolidation chemotherapy for locally advanced rectal cancer: a systematic review and meta-analysis. Acta Oncol. 2021 Oct;60(10):1308-1316. doi: 10.1080/0284186X.2021.1953137. Epub 2021 Jul 24.
Results Reference
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PubMed Identifier
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Citation
Papaccio F, Rosello S, Huerta M, Gambardella V, Tarazona N, Fleitas T, Roda D, Cervantes A. Neoadjuvant Chemotherapy in Locally Advanced Rectal Cancer. Cancers (Basel). 2020 Dec 3;12(12):3611. doi: 10.3390/cancers12123611.
Results Reference
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PubMed Identifier
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Citation
Dijkstra EA, Zwart WH, Putter H, Marijnen CAM, Nilsson PJ, van de Velde CJH, van Etten B, Hospers GAP, Glimelius B. Authors' reply-A sensitivity analysis of the RAPIDO clinical trial. Ann Oncol. 2023 Apr;34(4):446-447. doi: 10.1016/j.annonc.2022.12.012. Epub 2022 Dec 26. No abstract available.
Results Reference
background
Links:
URL
http://www.dccg.nl/trial/rapido
Description
Dutch Colorectal CancerGroup

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Rectal Cancer And Pre-operative Induction Therapy Followed by Dedicated Operation. The RAPIDO Trial

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