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Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial

ConditionRectal Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLarissa University Hospital

About this trial

The purpose of this protocol is to compare neoadjuvant chemoradiation plus consolidation chemotherapy before surgical resection with the standard neoadjuvant chemoradiation followed by surgical resection and adjuvant chemotherapy in patients with rectal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed rectal adenocarcinoma

cT3, cT4, threatened CRM / MRF, EMVI (+), ≥N1

Multidisciplinary tumor board decision for neoadjuvant treatment

Tumor distance from the anal verge <15 cm based on endoscopy or magnetic resonance imaging

Disqualifiers

Distant metastases

Non-resectable cancer

Contraindications for the administration of chemotherapy

Previous pelvic radiotherapy or chemotherapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neoadjuvant Chemoradiotherapy

    Radiation

    5-week neoadjuvant radiotherapy regimen (28 x 1.8 Gy) combined with Capecitabine (bid 800 mg/m2, twice daily, on days 1-33-38)

  • Adjuvant Chemotherapy

    Drug

    8 cycles of CAPOX (Capecitabine bid 1000 mg/m2, twice daily, day 1-14, every 3 weeks and Oxaliplatin 130 mg/m2, day 1, every 3 weeks) or alternatively, 12 cycles of folinate, fluorouracil and oxaliplatin (FOLFOX)

  • Consolidation Chemotherapy

    Drug

    CAPOX (Capecitabine bid1000 mg/m2 and Oxaliplatin 130 mg/m2, day 1, every 3 weeks) or alternatively FOLFOX

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Neoadjuvant Chemoradiotherapy and Consolidation ChemotherapyExperimental treatment 2 interventions
Group B: Neoadjuvant Chemoradiotherapy and Adjuvant ChemotherapyActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Disease Free Survival

Occurence of Disease Free Survival. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

Time frame
3 years postoperatively

Secondary outcomes

1

Complete Pathological Response

Occurence of Complete Pathological Response. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

Time frame
1 month postoperatively
2

Postoperative Complication

Occurence of postoperative complications based on the Clavien Dindo Classification. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

Time frame
1 month postoperatively
3

Length of Hospital Stay

Postoperative time that the patient can be safely discharged. Measurement unit: days. The patient will be discharged, when it is ensured that is medically safe to be released. In particular, as the exit time of the patient, will be regarded the time that the patient will fulfil the Clinical Discharge Criteria

Time frame
Maximum time frame 39 days postoperatively
4

Readmission

Occurence of postoperative readmission. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

Time frame
1 month postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Larissa University Hospital

Lead sponsor

Source ClinicalTrials.gov
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